VOL. 23, NO. 5 MAY 1968 luuiJUiij^ üdjjmji:hiyf J O U R N A L The FDA Self-Certification Program ........................................................................ H. A. GOLLE Prescription-Drug Advertising—-Blight or Light? . . . . IRVING H. JUROW A COMMERCE C L E A R I N G HOUS E P U B L I C A T I O N PUBLISHED IN ASSOCIATION WITH THE FOOD AND DRUG LAW INSTITUTE, INC. H E E D IT O R IA L P O L IC Y of this J o u r n a l is to record the progress of the law in the field of food, drugs and cosmetics, and to provide a constructive discussion of it, according to the highest professional stan­ dards. The F ood D rug C o sm e t ic L a w J o u r n a l is the only forum for current discussion of such law and it renders an im portant public service, for it is an invaluable m eans (1) to create a better knowledge and understanding of food, drug and cosmetic law, (2) to pro­ mote its due operation and developm ent and thus (3) to effectuate its great remedial pur­ poses. In sho rt: While this law receives norm al legal, adm inistrative and judicial considera­ tion, there remains a basic need for its appro­ priate study as a fundamental law of the land; the J o u r n a l is designed to satisfy that need. The editorial policy also is to allow frank discussion of food-drug-cosm etic issues. The views stated are those of the contributors and not necessarily those of the publishers. On this basis, contributions and com m ents are invited. The F ood D rug C osmetic L aw J our ­ nal is published monthly by Commerce Clearing House, Inc. Subscription price: 1 year, $20; single copies, $2. Editorial and business offices, 4025 W. Peterson Ave., Chicago, 111. 60646. Printed in United States of America. May, 1968 Volume 23 • N um ber 5 Second-class postage paid at Chicago, Illinois and at additional mailing offices. F ood D rug C osmetic L aw J ournal Table of Contents . . . . May, 1968 Page Reports to the Reader 235 The FDA Self-Certification Program H. A. Golle 236 Prescription-Drug Advertising— Blight or Light? ........................................................................ Irving H. Jurow 242 Food and Drug Legislation in Central America and Panama .............................. Andrzej E. Olszyna-M arzys 253 A Reasoned Approach to Regulation Based on Toxi­ cologic Considerations John P. Fraw ley 260 Report of the Fifth Session of the Joint FA O /W H O Codex Alimentarius Commission . Franklin M. Depew 271 VO LUM E 23 NUM BER 5 © 1968, Commerce Clearing House, Inc., Chicago, Illinois 60646 All rights Reserved Printed in the United States of America 1 i n .n , 2511 F o o d D r u g C o s m e t ic L a w J o u r n a l Editorial Advisory Board Frank T. Dierson, New York City, Chairman; Secretary, The Food and Drug Law Institute ; General Counsel, Grocery Manufacturers of America, Inc. Warren S. Adams, II, New York City, General Counsel, Corn Products Company H . Thomas Austern, W ashington, D. C., General Counsel, National Canners Association Kendall M. Cole, W hite Plains, New York, Vice President and General Counsel, General Foods Corporation Robert E. Curran, Q. C., Ottawa, Canada, Legal Advisor, Canadian Department of National Health and Welfare Franklin M. Depew, New York City, President, The Food and Drug Law Institute A. M. Gilbert, New York City James F. Hoge, New York City, General Counsel, Proprietary Association of America; Counsel, American Foundation for Pharmaceutical Education Irving H . Jurow, Bloomfield, New Jersey, Vice President and General Counsel, Schering Corporation Vincent A. Kleinfeld, W ashington, D. C , former Food and Drug Law Attorney, United States Department of Justice Michael F. Markel, Washington, D. C., General Counsel, Corn Industries Re­ search Foundation Bradshaw Mintener, W ashington, D. C , former Assistant Secretary of Health, Education, and Welfare William E. Nuessle, New York City, Vice President and General Counsel, Na­ tional Dairy Products Corporation Merrill E. Olsen, Chicago, General Counsel, Quaker Oats Company John W. Riehm, Englewood Cliffs, New Jersey, Vice President and Secretary, Thomas J. Lipton, Inc. C. Joseph Stetler, Washington, D. C., President, Pharmaceutical Manufacturers Association Edward Brown Williams, W ashington, D. C., former Principal Attorney, United States Food and Drug Administration Julius G. Zimmerman, New York City, Attorney, The Coca-Cola Export Cor­ poration T he E ditorial A dvisory Board advises on policies, subjects and authors. It assumes no responsibility otherwise. Its members render this public service without compensation, in order that the F ood D rug Cosmetic L aw J ournal may comply with the highest professional standards. Editor of Comments: Franklin M. Depew Editor of Canadian Law: Robert E. Curran, Q. C. Editor of Foreign Law: Julius G. Zimmerman Associate Editor for Europe: Ernst Abramson, M. D. Scientific Editor: Bernard L. Oser REPORTS TO THE READER The FD A Self-Certification Pro­ U ntil recently, much of the food and gram.—This article, which begins on drug legislation has been based on page 236, was presented by H. A. Gollc antiquated Sanitary Codes. However, at the 1968 annual m eeting of Food steps are now being taken to organize Industry R epresentatives at the U ni­ program s of integrated food and drug versity of W isconsin on April 10, 1968. control designed specifically for the The author, who is Director, Corpo­ needs of the Isthm us countries. rate Q uality Assurance, General Foods Corporation, discusses the progress of A Reasoned Approach to Regulation the self-certification agreem ent worked Based on Toxicologic Considerations. out between that company and the — In an article which begins on page FD A in 1967. H e concludes that some 260, John P. Fraiolcy, Ph.D., presents form of industry-governm ent coopera­ a plea for a more rational scientific tion is not only appropriate but desir­ approach to the “procedural and inter­ able at this time. pretive regulations” guiding those en­ gaged in environmental health research, Prescription-Drug Advertising — and. specifically, those who are re­ Blight or Light? —Basic to the recent sponsible for determ ining the degree government-industry confrontation over of toxicity in food packaging materials. the F D A ’s proposed revised regulations The author, who is Chief Toxicologist concerning prescription-drug advertis­ of Hercules, Incorporated, W ilm ing­ ing is a difference in attitudes toward ton, Delaware, originally presented this the role of advertising. This difference article as a speech before the National is the subject of the article by Irving Conference for Indirect Food Addi­ H. Juroiv, which begins on page 242. tives held in W ashington, D. C., Feb­ The author, who is Vice President and ruary 13, 1968. General Counsel of the Schering Cor­ poration, concludes that the criticism WFifth Session of the Joint FA O / of prescription-drug advertising is but sion.HO Codex Alimentarius Commis­ a part of the attack on advertising in the —Franklin M. Depew, President of general, and that it is im portant for Inc., Food and D rug Law Institute, reports on the fifth session of the industry to revive its image. The article was presented as a speech at the Codex Alim entarius Commission held at the Rome, Italy, H eadquarters the Pharm aceutical Advertising Club of the Food and Agriculture O rganiza­ in New Y ork City. tion, February 20 to M arch 1, 1968. Food and Drug Legislation in Cen­ Included is a discussion of the reports tral America and Panama.—Andrzej E. made by the different Codex Commit­ Olssyna-Marsys, a m em ber of the In sti­ tees on the progress of various food standards. The outstanding feature of tute of N utrition of C entral America this session. Mr. Depew believes, was and Panam a, in Guatemala, discusses the spirit of cooperation that existed in an article which begins on page 253, between the delegates and that pre­ the urgent need for uniform sanitary vailed over “nationalistic or narrow ­ food standards throughout the coun­ minded interests.” The report begins tries of the C entral Am erican Isthm us. on page 271. REPORTS TO THE READER PAGE 2 3 5 Vol. 23, No. 5 May, 1968 Rod Drug-Cosmetic Law -------------------------- --------------------------------------------------------------- The FDA Self-Certification Program By H. A. GOLLE This Paper W as Presented at the 1968 Annual Meeting of Food Industry Representatives at the University of Wisconsin on April 10, 1968. Mr. G olle Is Director, Corporate Q uality Assurance, G eneral Foods Corporation. T OO L IT T L E K N O W L E D G E often leads to m isunderstanding, so I would like to begin with a brief, chronological sum m ary of events leading up to the self-certification pilot study we are currently conducting in conjunction with the Food and D rug A dm inistration (FD A ) at our plant in Dover. Delaware. The first serious suggestion that industry be encouraged tow ard self-regulation was contained in a series of recom m endations sub­ m itted by the Citizens Advisory Comm ittee to the Secretary of Health, Education and W elfare in 1962. T hat same year, at a conference of FD A and Food & D rug Law Institute representatives, C. W . Cook, then president of General Foods, pointed out the grow ing need for m utual respect between FD A and the food industry. “W e respect the governm ent's function of establishing rules of fair play.” he said, “and in turn we seek respect for our own sense of responsibility.” In 1964. these and other argum ents for better governm ent-indus­ try cooperation were discussed and endorsed during a national con­ ference on Salmonellosis conducted by Dr. Jam es L. Goddard at the Communicable Disease Center in A tlanta. There was general agree­ m ent that traditional law enforcem ent no longer was the sole answer. In the spring of 1966. Dr. Goddard discussed his concern with the National Advisory Council to FDA, a continuing group of 18 representa­ tives of education, science, labor and industry. There was general page 2 3 6 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1 9 6 8 agreem ent am ong the group that the increased com plexity of food processing and distribution, coupled w ith the limited resources of FD A itself, called for approaches not foreseen by the w riters of the Food and D rug Act of 1938. Air. Cook, now General Food's chair­ man and the food industry’s only representative on the Council, volun­ teered to cooperate with FD A in seeking new relationships and solutions. T his helped to start an informal dialogue between FD A and the industry, which became a formal dialogue beween FD A and General Foods on May 3, 1967. On that m orning, just about a year ago, two representatives from the FD A in W ashington m et with seven General Foods representa­ tives in one of the conference rooms at our corporate headquarters in W hite Plains. N. Y. This first m eeting, which was mainly a session of probing and exchanging views, lasted tw o days and included a general tour of our Technical Center in T arry town. N. Y. and of our processing plant in Dover. Subsequent m eetings were held on Alay 25. July 11. and A ugust 8, and included pretty much the same personnel. Details were slowly worked out, and drafts of a self-certification agreem ent for the pilot study were exchanged and discussed. The final, approved document, effective Septem ber 1, 1967. was signed on A ugust 10 by Dr. Jam es L. Goddard for the Food and D rug A dm inistration and by Chairm an C. W . Cook for General Foods. The Dover Agreement T his docum ent, which we now refer to as The Dover A gree­ m ent. contains the following elem ents : (1) It is concerned with product safety only, r ot with product elegance, that is, those factors related to consum er satisfaction, such as texture, taste and perform ance; (2) It is effective for one y e a r; (3) It covers only two products m anufactured at only one plant, Jell-0 Gelatin D essert and Jell-O Golden Egg Custard Mix. These two products were selected because microbiologically they represent both critical and non-critical food ty p e s: (4) It spells out agreed-upon specifications, control proce­ dures and reporting' m ethods for the two p ro d u cts; (5) It sets standards against which these controls are measured; (6) It establishes the procedure to be followed should these standards not be m e t; (7) It states the types of data to be made available to FD A , including a list of ingredients and additives in the tw o products, T H E FDA SE L F-C E R T IFIC A T IO N PROGRAM p a g e 237 but not form ulas. At no tim e did FD A request formulas, because we both agreed that they were not essential to this type of program ; (8) It describes specific quality control inform ation on the tw o products which General Foods will subm it in m onthly re­ ports to the Baltim ore office of the F D A ; (9) It states that General Foods will provide m onthly sum ­ m ary reports on consum er com plaints it receives on the tw o products related to health, foreign m atter and w eig h ts; (10) It states that, in return, the FD A will furnish General Foods with copies of all FD A inspections of facilities involving the two products, plus copies of any consum er com plaints re­ ceived by FD A concerning the two products. Since The Dover Agreem ent w ent into effect last Septem ber 1, five m eetings have been held either at FD A offices in Baltim ore and W ashington or at General Foods facilities in Dover and T arry- town. Because of the need for maximum exposure, a considerable num ber of representatives from both sides are attending these current m eetings, whose purpose is to discuss progress at Dover and to rework specifications for the tw o products in an attem pt to eliminate excess paper work, m anhours and costs. O ur principal goal is to arrive at the m inim um num ber of control points both parties feel will give assurance th at the products are m eeting agreed-upon standards for consum er safety. Both of us recognize that the initial plan may be too complex and may contain more controls than are actually neces­ sary. This, of course, is common to most pilot studies. Because we are attem pting to establish both general guidelines and specific rules, FD A inspectors are spending much more time at our Dover plant than is norm al—a total of over 20 man days since last Septem ber 1st. They are also picking up and sam pling larger quantities of finished product from our distribution centers, a practice we have not objected to because we are just as anxious as FD A to thoroughly check the efficacy of this new system. T heir detailed reports, and ours, form the basis for much of our monthly- m eeting discussion. The Dover A greem ent is now just past the half-way mark. I cannot actually say that it is either ahead of schedule or behind schedule. W e are discovering issues neither of us anticipated. There has been a certain am ount of m utual education and rethinking of the original concept. W e have had to develop trust and understanding, plus problem -solving approaches acceptable to both sides. All of this takes time, because none of it comes easily to partners who classically p a g e 238 FOOD DRUG COSMETIC LAW JOU RN A L— MAY, 1968 have had an adversary relationship. However, I would like to make some observations. I think both of us have been a little surprised and gratified by the depth of desire on both sides to replace the traditional “w atch­ dog” concept. A lthough we don't sit around and sing old college songs when we get together each m onth, we have reached a healthy tru st level based on m utual respect for both the m otives and the professional competence of the other side. I think FD A is now pretty thoroughly convinced th at General Foods and m ost companies in our industry always have taken seriously their responsibilities to the public, and w ithout undue prodding. The agency has. in the past, stated that it has no choice but to protect the consum er, but th a t industry, in theory if not in practice, does have a choice: it can be responsible or irresponsible. O ut of our continuing dialogue seems to come acceptance th at where the purity of food is concerned, no one really has a choice. Public safety is a com m itm ent which m ust be understood equally by both parties and practiced equally by both parties. A Small Beginning The pilot study at Dover, of course, is a small beginning. It contains some risk, but it holds much promise. And it is neither m ysterious nor unique nor revolutionary. The airlines have m ain­ tained a rem arkable record of public safety through a kind of self- certification program developed cooperatively by the industry and the Federal Aviation A dm inistration. This program involves the daily m aintenance of commercial aircraft, and a second one is now being developed for pilots. The purpose of both is to replace govern­ m ent regulation and surveillance with industry self-responsibility. A t Dover, we are trying to do pretty much the same thing. W e are trying to reach honest agreem ent on w hat constitutes adequate, realistic protection for the consum er. W e are trying to reach agree­ m ent on w hat controls are necessary to assure this protection. And we are trying to set up workable procedures on w hat steps to take when som ething goes wrong. In the past, our ideas on consum er protection and F D A ’s ideas have not necessarily been the same. To correct this, we are now attem pting to combine the best of both approaches, with the m ajor responsibility for this protection placed not in the hands of FD A but in the hands of industry—w here it belongs. General Foods agreed to work w ith the FD A in this experim ent because we believe th at any legitim ate and constructive means of T H E FDA SELF-CERTIFICATION PROGRAM PAGE 239 protecting the consum er has to be in the best interest of General Foods and the industry, for our entire franchise is built on public trust. And we believe there has to be a better way than stronger legislation and more public seizures, followed by the inevitable “trial by new spaper.” W e have yet to win one of those. This, basically, is the option. Unless we w ant more regulation, we m ust assum e more responsibility. And this requires closer co­ operation w ith governm ent and the establishm ent of the kind of m eaningful dialogue that can lead to greater understanding and more respect and trust. W e have a good dialogue going at Dover. Both sides have a better understanding of each other’s problem s and of each other’s legitim ate interests and responsibilities. It is truly surprising how little we knew about each other. Let me reassure everyone th at we have not given away the keys to the vault. W e have released to the FD A only as much inform ation as we feel they legitim ately need to make the current pilot study work. And this inform ation pertains only to product safety. W e have shared nothing th at has anything to do with product elegance. Should the experim ent prove not to be the best approach, neither General Foods nor the industry as a whole will be any more vulnerable than they were before it began. W e do not think it is going to fail. Even at this half-way point, with several problem s still unsolved, we are sufficiently encouraged to be developing plans for self-certification coverage of all 23 product lines, representing some 375 product codes, at our Dover plant. W e have been asked m any times by m any people “W h at’s in it for General Foods; how will self-certification benefit the industry?” Quite frankly, thus far we have been unable to answ er that question to our total satisfaction. It is too soon to tell. W e feel, however, th at certain incentives are going to have to be identified before the industry as a whole will voluntarily and readily participate in this type of self-certification program . As one example, ii has been suggested, and FD A has expressed a willingness to consider, the establishm ent of some form of product seal, a kind of self-certification stam p that would be im printed on every package of a product m anufactured under a self-certification agreem ent. Such a plan, of course, would have to be adm inistered with great care to assure proper use and to avoid misuse. The idea has not been refined, nor explored in depth, but FD A has shown a willingness to consider proposals along these lines. W e as a company have not given too much thought yet as to m arketing value of such a designation. p a g e 240 FOOD DRUG COSMETIC LAW JOU RN A L— MAY. 1968 Self-certification also m ight provide a vehicle for m odifying F D A ’s approach to the recall of products. A nything that protects us against the loss of public confidence that adverse publicity can cause has got to be a “plus.” In fact, any im provem ent in relationships between governm ent and industry is a goal w orth pursuing, on the possibility that it could lead to benefits for both industry and the public. As I stated earlier, the dialogue which has been carried on between General Foods and FD A over the past year has m arkedly increased our understanding of each other's approach to food safety, including m ethodology, which in turn has helped replace w asteful friction with a far more effective, efficient w orking relationship. Let me stress one point in particular. Self-certification would represent a whole new way of life for our industry. It could require considerable education and re-orientation of thinking and attitudes about food safety and the responsibility for safety. It is also quite possible that quality assurance personnel would have to be trained in the science of “self-inspection.” W e discovered early in our pilot study th at to make the concept work you m ust believe in it. If you lack this conviction, all you are doing is adding one more frustration, one more area of potential conflict with the governm ent. In fact, rather than establishing a new. m eaningful dialogue, you will sim ply be continuing an old argum ent. Ours has been a regulated industry since M assachusetts passed the first food law in 1784, and periodic legislation generally has fol­ lowed changes in the industry itself, which in turn m ust follow the needs and desires of the consumer. The trend to convenience foods, for example, has created a whole new set of problems for our industry. So has mass processing and mass distribution and increases in population density. Each has generated the need for greater care, and each has stim ulated interest am ong the “w atchdogs.” Do we let these new problem s create a new vacuum to be filled by more governm ent legislation and controls? O r do we assum e the responsibility ourselves and minimize the need for regulation and reduce the need for inspection surveillance? W hether you call it self-certification or self-responsibility, some form of industry-governm ent cooperative effort seems appropriate at this time, if for no other purpose than to define w hat form and shape th at cooperation should take. It is certainly w orth exploring. And this is precisely w hat we are doing through The Dover Agreem ent. W e are exploring. [The End] T H E FDA SELF-CERTIFICATION PROGRAM PAGE 241 Prescription-Drug Advertising— Blight or Light? By IRVING H. JURO W Mr. Jurow, W ho Is Vice President and G eneral Counsel of the Schering Corporation, Bloomfield, New Jersey, Presented the Following on October 19, 1967, at the Pharmaceutical Advertising Club, New York, N. Y. T H IS IS A PR O G R E SS R E P O R T on the state of the advertising dialogue or, if you prefer, the advertising dilemma in the pre­ scription-drug industry. Despite increasing frustrations, I rem ain an optim ist. Consequently, I believe th at if we persevere in the dialogue, we will eventually emerge from the darkness. A bit of history is needed to provide a frame of reference and a proper perspective. You need hardly be rem inded of the gloomy days of the Kefauver investigation, when the advertising practices of the prescription-drug industry—as well as its agencies— were the subject of sharp and relentless criticism. M otives and integrity were impugned. The parade of examples—torn out of context, minimal in num ber and highly selective to prove negative preconceptions— were exaggerated into a broad and universal condem nation of the industry’s entire prom otional effort. The result, as you know, was the 1962 am endm ent which added Section 502 (n) to the Food, Drug and Cosmetic Act. You are all fam iliar w ith the Spartan-like provisions of th at section; they require the established name, the quantitative formula, and “such other inform ation in brief sum m ary relating to side effects, contraindications, and effectiveness” as shall be required by regula­ tions of the A dm inistration. Im plem enting the authority granted by the statute, regulations were proposed by the Food and D rug A dm inistration (FD A ) in February of 1963, were m ade final in June of th at year, were noticed for formal hearings on objections of the industry (which were even­ tually disposed of through an exchange of clarifying correspondence p a g e 242 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 between the FD A and the Pharm aceutical M anufacturers Associa­ tion [P M A ]), and were made effective as of J an nary, 1964. You are equally familiar w ith these earlier regulations still in effect. Section 1.105 (21 C FR § 1.105) tracks the language of the statute in requiring the inclusion of a “brief sum m ary relating to side effects, contraindications, and effectiveness” (§ 1.105(e)) in any prescription-drug advertisem ent which provides inform ation regard­ ing indications or dosage recom m endations. It calls for a “fair bal­ ance" in presenting the inform ation on effectiveness and th at on side effects and contraindications. M oreover, the latter inform ation m ust appear “in reasonably close association” with the former, and have “the same relative degree of prom inence” (§ 1.105(i)). “ Brief sum m ary," “fair balance," “relative degree of prom inence." "reasonably close association”—though these are “words of ordinary English,” they nevertheless reflect imprecise, and therefore flexible, criteria, since they define by objective not measurable by a slide rule. It was not surprising, therefore, to find that they produced subjective reactions; that reasonable men honestly differed as to the application of these criteria to any particular piece of prom otional m aterial. The optimism th at was reflected in the exchange of interpretive correspondence in the Fall of 1963 was, however, short-lived. T he change in adm inistration which followed shortly thereafter was not only a change in personalities; it was a change in philosophy, in attitudes, in concepts. The words of the regulation, accordingly, took on a new and decidedly different meaning. As a consequence, the next tw o and a half years w itnessed a continuous exchange of m utual, sharp criticism . Broad attacks by the A dm inistration on the advertising and prom otional practices of the industry, public criticism of the journal ads of companies of high repute, governm ent press releases in significant num ber, a spate of seizures, a crop of crim inal indictm ents, produced agonizing cries from industry for rationality and for definition of the ground rules. The dimensions of the confrontation may be m easured by the fact that the FD A considered it of sufficient im portance to justify the publication of a 67-page docum ent entitled “Compendium of Medi­ cal A dvertising." The governm ent’s response to industry's com plaints has come in the proposed revised regulations published in the Federal Register in M ay of this year (32 F. R. 7533, M ay 23, 1967). Objections have been filed and we now await the final regulation. PRESCRIPTION-DRUG ADVERTISING----BLIGHT OR LIG H T ? PAGE 243 T hat the A dm inistration considers that it is indeed responding to the industry’s “request” for “clarification” of the earlier regulation is evident from the very first pream ble to the new proposals. If, how ­ ever, the A dm inistration believes th at w hat follows in the dozen columns of single-spaced, 8-point type set out in the Federal Register is “clarification,” the volume of critical com m ent that has been filed should disabuse it of that belief. If the industry did, indeed, ask for clarity, it m ay very well reap a whirlwind of confusion and a paralysis of its prom otional effort. Difference in Attitudes Basic to the governm ent-industry confrontation is the obvious difference in attitudes tow ard the role of advertising. The FD A has failed either to recognize or to fully accept the function of advertising in prom oting prescription d ru g s: it is prom otion addressed not only to an exceptionally learned audience, but one which has readily avail­ able the totality of the approved inform ation in the product brochure authorized by the FDA. The proposed regulation appears to be based on the prem ise that each and every piece of advertising m ust be prepared and dissem inated on the assum ption that it is the only inform ation which the prescrib­ ing physician has. or will use. to evaluate the drug. Advertising, how­ ever. does not function in a vacuum, nor does it function as a reference m onograph. It is but one com ponent of an inform ational mix which includes m any other and more detailed data from m any sources. A part from the fact th at the F D A ’s assum ption depreciates the usefulness and function of all the “labeling” available, and particu­ larly the authoritative package insert, it does a grave injustice to the medical profession. I refuse to believe that the medical profession is so irresponsible as to fail to investigate thoroughly the full recital of facts set out in the product inform ation insert, or that physicians fail to obtain “full disclosure” from the other com petent and authori­ tative sources available to them for th at purpose, and that they pre­ scribe, instead, relying upon the abbreviated inform ation in prom o­ tional advertising. It may well be th at in the critical prescription-drug industry advertising should be created with greater care, w ith sharper attention to nuances and sem antics, and w ith the same superior quality-control that characterizes our products, as distinguished, perhaps, from ordi­ nary consum er products and consum er advertising. But th at is a question of degree. It does not mean, nor does it follow, th at the p a g e 244 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 mission of prescription-drug advertising is any more expansive than advertising in general. Its role, its purpose, is to stim ulate interest in the advertised product and to call attention to it. Once that interest has been aroused and information as to the product’s availability broadcast, other means to convey in detail the nature and the uses of the product are not only available, but should be used. These include medical texts, medical m eetings, journal articles, detailm en, and above all. the “full disclosure” of labeling. It is true th at the current regulation, as well as the new proposal, provide for some relief in “rem inder” advertising. As defined by the proposed regulation, however, this exemption is all but meaningless. Rem inder advertising, in the pristine form acceptable to the A dm inis­ tration, may do for the physician who is fully informed and needs only the stim ulus of the name of the product. To qualify for the exem ption, reads the proposal, the advertisem ent m ust “not recom ­ mend or suggest by printing or graphics any indication for use. drug dosage, or claim for safety, effectiveness, or other quality of the drug.” To the phj'sician who has yet to become acquainted with the product, or to have his m em ory joggled, so bare an advertisem ent conveys nothing. Unless, for example, the allergist is at least told or reminded that the product is an antihistam ine available for his allergic patients, why should his interest be aroused? Nevertheless, under the proposal, even so casual an observation is an “indication” requiring expansive inform ation in the advertisem ent. In enacting Section 502(n). Congress recognized w hat is common knowledge : that advertising is inform ative, not instructive ; that it is an attention-getting mechanism, not a statem ent of directions for use. Since it authorized regulations requiring a true statem ent of inform ation relating to side effects, contraindications, and effective­ ness. but only “in brief sum m ary,” it did not authorize regulations requiring advertisem ents to assum e the role of a textbook on pharm a­ cology. M oreover, it is obvious that Congress did not intend, and could not have m eant, th at “full disclosure." which is required in “labeling,” should also be the test, albeit to a limited extent, for prescription-drug advertising. Recall w hat was said by Congressm an H arris, co-sponsor of the 1962 legislation: A re w e g o in g to s a y th a t w e e x p e c t th e p h y s ic ia n s . . . to p ra c tic e m e d ic in e b y a n a d v e rtis e m e n t c o n ta in e d in a m a g a z in e s o m e w h e re ? If th a t is w h a t y o u a re g o in g to sa y , le t m e s h o w y o u h o w d iffic u lt it w o u ld b e to in c lu d e e v e ry th in g a b o u t a d r u g in an a d v e rtis e m e n t in so m e m e d ic a l jo u rn a l s o m e w h e re . PRESCRIPTION-DRUG ADVERTISING— BLIGHT OR LIGHT ? PAGE 245 W h e n y o u tr y to s a y th a t e v e ry th in g w ith re s p e c t to sid e e ffe c ts, c o n tr a in d i­ catio n s, an d effectiveness ( is ) to be p u t in to an a d v e rtise m e n t som ew h ere, I ca n say to y o u it is n o t p o s sib le to d o it. I th in k it is a lm o s t a n in s u lt to th e m e d ic a l p ro fe s s io n to g iv e th e im p re s s io n th a t th e y p ra c tic e m e d ic in e fr o m a d v e rtis e m e n ts in m e d ic a l jo u rn a ls .1 If advertising is to reflect something different from “labeling," if “brief sum m ary” is to have any m eaning short of “full disclosure.” if prom otion is to serve its proper function, then obviously prom o­ tional m aterial m ust contain a subjective selection and omission from the text of the approved labeling, and it is in this area of subjective selection and omission th at our differences arise. None of us wishes to compromise with the basic requirement that prescription-drug advertising and prom otion be honest, truthful and accurate. On the other hand, I see no inconsistency in achieving these objectives while still perm itting advertising to perform its real and prim ary function. Less a Science than an Art A dvertising is less a science than an art. By its nature it is open to a variety of interpretations. No standard can assure that every individual will view or interpret an advertisem ent in the same way. I commend to you Justice H olm es’ observation: A w o r d is n o t a c ry s ta l, tr a n s p a r e n t a n d u n c h a n g e d , it is th e s k in o f a liv in g th o u g h t a n d m ay v a ry g re a tly in c o lo r a n d c o n te n t a c c o rd in g to th e c irc u m ­ stan ces an d th e tim e in w hich it is u sed.2 As I have indicated, advertising and prom otional m aterial are inform ative, but not in the same sense as “labeling.” To achieve its purpose, advertising m ust do less. As a practical m atter, if the drug product is to be used by the patient, it m ust be prescribed. To get it prescribed, it m ust be brought to the attention of the physician to encourage him to investigate its uses and, if persuaded, to employ it. To require that advertising give him the complete “full disclosure” story is asking too much of it. In its com m ents on the proposed regulations, the Pharm aceutical A dvertising Club sa id : G o o d m e d ic a l a d v e rtis in g se lls d ru g s th r o u g h th e fa c tu a l, a c c u ra te a n d tim e ly p r e s e n ta tio n o f in fo rm a tio n . I t s fu n c tio n is to p ro m o te th e u se o f a d r u g w ith in its th e r a p e u tic p o te n tia l fo r th e a lle v ia tio n o f illn e s s a n d to d o so in a c c o rd w ith g o o d m e d ic a l a n d g o o d b u s in e s s p ra c tic e s . I n th is s e n se it is in fo rm a tiv e a s w e ll a s fa c tu a l a n d a c c u ra te . M e d ic a l a d v e rtis in g c a n n o t c a rr y th e re s p o n s ib ility o f b e in g , b y itse lf, th e e d u c a tio n a l v e h ic le w h e re b y p h y s ic ia n s le a rn o f d ru g s . I t m u s t re c o g n iz e , m u s t b e b a s e d u p o n , a n d s h o u ld (in a m e a s u re ) c o n trib u te to th e b a c k g ro u n d o f p h y s ic ia n s w h ic h th e y a c q u ire d a t m e d ic a l s c h o o ls a n d in h o s p ita ls , th r o u g h re s e a r c h in la b o ra to rie s a n d clin ic s, a n d th e d is s e m in a tio n o f 1 108 C o n g . R ec . 19924, S e p t. 27, 1962. 2 H o lm e s , J ., Towne v. Eisner, 245 U . S. 418, 425 (1 9 1 8 ). PAGE 246 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 re s e a rc h a n d c lin ic a l fin d in g s b y s c ie n tific a rtic le s in re c o g n iz e d m e d ic a l p e rio d ­ ic als, b y th e d is s e m in a tio n o f th e s e in re p r in t a n d a b s tr a c t fo rm , b y sc ie n tific p a p e rs d e liv e re d a t m e e tin g s a n d s y m p o s ia , b y sc ie n tific e x h ib its , a n d m e d ic a l re p o rtin g . Just as we dem and that our prescription products be safe and effective, so should their advertising be effective, as well as safe. Safety is achieved by honest, fair, nondeceptive. and nonm isleading advertising; effectiveness is achieved by utilizing the techniques im­ plicit in good advertising to obtain reader attention, reader interest, reader investigation, and reader use of the advertised products. Unless advertising is thus effective, as well as safe, it represents a waste of money. Indeed, there is danger in allow ing or encouraging physicians to believe that they m ay rely upon advertisem ents for frill inform ation, and if this be the result of the proposed regulation, we shall be doing the public and the medical profession a grave injustice. In short, the proposed regulation of the FDA ignores the tradi­ tional and w ell-understood role of advertising as distinguished from a compendium, or even package-insert labeling. W hat is therefore needed, it seems to me, is a rational appraisal of the role and function of prescription-drug advertising, a more valid distinction between it and “labeling,” and the adoption of guidelines specifically to be applied to each. But in so doing we m ust avoid overburdening the function of prescription-drug advertising, and in turn depreciating the function of labeling. ". . . we should not,” said Congressm an H arris, “by legislation, require (advertising) to be som ething which it cannot be.”3 I can hardly do justice to the wealth of critical comment that has been filed with the FD A responsive to the published proposals. I should say to you, however, that a serious question has been raised as to w hether or not the proposed regulation is arbitrary, an unlawful extension of the statutory authority, and so vague as to pose serious constitutional questions since crim inal sanctions may be the result of violations. This question has presented us with a serious challenge to defend advertising. Definition of Advertising One of the targets of this challenge is the proposal of the FD A to define advertisem ents (§ 1.105(1) (1)). an effort which would ap­ pear to be responsive to the suggestion that there be a rational reap­ praisal of the roles and functions of, and the distinction between, prescription-drug advertising and labeling. 3 108 C ong. R ec. 19927, S ept. 27, 1962. PRESCRIPTION-DRUG ADVERTISING— BLIGHT OR L IG H T ? PAGE 2 4 7 nnjoyiirw hfM As is pointed out, however, in the detailed com m ents filed by the PM A, the proposed definition subjects to the regulation not only those advertisem ents published in “journals, m agazines, . . . period­ icals, and new spapers,” but also those “broadcast through media such as radio, television, and telephone com m unications system s.” That the inclusion of the latter media is beyond the authority granted by the Congress follows clearly from a reading of Section 502(n) and its legislative history; the statute applies, by its express term s, only to “printed m atter.” The further provisions of th at Sec­ tion fortify this conclusion. They provide, you will recall, th at the established name m ust be “printed” in half-size type, and also that the Section is not applicable to any “printed m atter” determ ined to be labeling. These clear references to “printed m atter" preclude, in our view, em bracing in the FD A regulation prescription-drug advertisem ents dissem inated through the media of radio, television, or telephone. Lest this rouse public concern that such advertising is, therefore, unregulated, it should be noted that the very Section relegates it to the jurisdiction of the Federal T rade Commission under the Federal Trade Commission Act. M oreover, the FDA may also be able to regulate such advertise­ m ents indirectly by requiring the labeling, over which, of course, it has exclusive ju risd ic tio n , to contain adequate directions for use and appropriate inform ation w ith respect to all advertised uses. Expansive Definition of Labeling A second target of the challenge is the expansive definition of labeling set out in the proposed regulation (§ 1.105(1) (2)). In addi­ tion to the well-known items, such as “brochures, booklets, mailing . . . [and] detailing pieces, file cards, bulletins,” and the like, the FD A proposes now to include “sound recordings” and “sim ilar pieces of . . . audio . . . m atter.” B ut the exercise of the authority under Section 502(n) to deter­ mine w hat is labeling, as distinct from advertising, m ust be consistent with the statutory definition of labeling (§201(m )). Section 201(m) of the Food, D rug and Cosmetic Act defines “labeling” to m ean “all labels and other w ritten, printed, or graphic m atter” on the product or its containers or wrappers, or “accom panying” it. The term “label” is defined (§ 201 (k )) to mean a “display of w ritten, printed, or graphic m atter” on the im m ediate container of the product. Both “label” and “labeling,” you will observe, are defined in term s of “w ritten, printed, or graphic m atter.” Since they hardly can p a g e 248 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 be characterized as “w ritten, printed, or graphic m atter,” are “sound recordings” and “sim ilar . . . audio . . . m atter” properly included in the definition and subject to FD A regulation? A second and perhaps more critical question is posed by the fact that the proposed regulation treats this long list of items, including such things as “calendars, price lists, catalogs, house organs, letters, . . . films, film strips, lantern slides, . . . [and] exhibits,” as labeling if they “concern” a drug. Note th at the regulation says “concern,” not “accom pany.” I have already referred to the statutory definition of “labeling” and pointed out th at it requires the m atter to “accom­ pany" the product to be deemed “labeling.” N otw ithstanding court decisions th at have expanded the m eaning of “accom panying” ( Kor - del v. U. S.,45U. S. v. Urbeteit,3 cf., Alberty Food Products v. U. S.6), the requirem ent has not yet been com pletely elim inated. It is true th at the decisions tend to adopt a functional rather than a physical test to determ ine w hether the test of “accom panying” is satisfied. But it certainly cannot be said that in all instances the items referred to are “labeling.” since many do not ordinarily accompany the drug, even in the functional sense. In our view, therefore, the definition of “labeling” in the proposed regulation reaches too far and, in all likelihood, is an unauthorized exercise of the delegated authority. Basic Requirement The proposed regulation starts out with a basic requirem ent that prescription-drug advertisem ents include a “true statem ent of infor­ mation in brief sum m ary relating to side effects, contraindications, and effectiveness.” An objective is thus established consistent with the specific intent of the Congressional enactm ent. Proceeding from that point, the proposed regulation defines four com ponents, any one of which causes the advertisem ent to fail to satisfy that requirem ent and objective, and the regulation then proceeds to set forth some 34 examples of practices which would cause the advertisem ent to violate the law. The 4 and 34 “blackbirds” so elaborated (§ 1.105(e) (4) (e) (5)) are oriented tow ard the entire advertisem ent, not m erely tow ard the “brief sum m ary.” M oreover, they constitute per sc violations, a regu­ latory procedure which can hardly be reconciled with the vagaries of advertising, where, since circum stances and context differ so widely, a rule of reason should be applied. ‘ 335 U . S. 345 (1 9 4 8 ). 6 185 F . 2d 321 (C A 9 , 1950). 5 335 U . S. 355 (1 9 4 8 ). PRESCRIPTION-DRUG ADVERTISING----BLIGHT OR L IG H T ? PAGE 249 For example, the concept of "fair balance" reflected in the pro­ posed regulation rem inds me of the flight of a shuttlecock in badmin­ ton—one for you and one for me. W hether, as is argued in one of the com m ents filed, the requirem ent that there be “fair balance ' throughout the ‘‘advertisem ent as a whole" (§ 1.105(e) (2) (i)) goes beyond the statutory authority of Section 502(n), which merely calls for the inclusion in advertisem ents of a "brief sum m ary." need not detain us, for that is a complex legal question. However, in the context of good advertising and prom otion, and w ithout in any way m inim izing the need to be honest, truthful, and accurate, is it neces­ sary or rational, or realistic in practice, to demand the “sim ultaneous" or “im m ediate conjunction" interw eaving of adverse inform ation with claims for safety or effectiveness (§ 1.105(e) (5) (ii). (xxvii), (xxviii))? Sim ilarly, is there any basis, either in the statutory authority, or by setting up the standards of linear m easurem ents of advertisem ents as is proposed, to require, in addition to the "brief sum m ary" con­ tem plated by the Congress, a “brief discussion sum m ary” (§ 1.105(e) (5) (xxix) (b )) comparable with the “full disclosure" required in “labeling” (§ 1.106(b) (3)) ? To require not m erely the inclusion of adequate and accurate inform ation, but to regulate form at, style, design, and even the very position, of the text, is surely at least arbitrary; moreover, since vio­ lation invites crim inal indictm ent, it may come dangerously close to “cruel and unusual punishm ent." I m ust say in all candor that no copyw riter can feel safe in preparing prescription-drug advertising under these m inutiae of regu­ latory detail w ithout having at his side, w eighing every word, graph, illustration, and perhaps punctuation m ark, a law yer expert in regula­ tory pract;ce, and even he. I dare say. could not assure you that the end result would be snow-white innocence. If the objective were to elim inate or sharply decrease prescrip­ tion-drug advertising, one could hardly imagine a more effective set of regulations to that end. Surely the progress of medicine will not be advanced by the government’s requiring copy to be revised solely to change the m anufacturer’s reference to “cuts [and] scrapes" to read “abrasions [and] lacerations," nor by debate as to w hether a product should be labeled an “antihistam inic/antipyretic” or an “an- tipyretic/antihistam inic.” Shortly before the publication of the proposed regulations, an official of the FDA, J. Hauser, stated the objectives of the Administra­ tion in these w o rd s: p a g e 250 FOOD DRUG COSMETIC LAW JOURNAL— MAY, 1968 I t is th e g o a l o f F D A to a s s u re th a t th e la b e lin g a n d a d v e rtis in g o f p r e s c r ip ­ tio n d ru g s c o n v e y to p h y s ic ia n s tr u th f u lly , a d e q u a te ly , a n d e ffe c tiv e ly th e best a v a ila b le d ru g -u s e in fo rm a tio n . T h is g o a l s im p ly m e a n s : T h e la b e lin g a n d a d v e rtis in g o f a p re s c r ip tio n d ru g s h a ll fa ith fu lly fu rn is h th e d o c to r th e in fo rm a ­ tio n e a c h o f u s w a n ts h im to h a v e in m in d w h e n h e is a b o u t to u se a d r u g o n u s o r o n th o s e w e lo v e !7 Can anyone quarrel with such an objective? Is there any doubt that pharm aceutical m anufacturers and their advertising agencies fully support this goal, conscientiously strive to achieve it? O ur frustrations and conflicts derive from w hat I suggest may be an apothegm atic answ er to these questions: The purpose is ap­ pealing, but the procedure is appalling! The halcyon days when agencies, like lawyers, could feel secure because it was the client who went to jail are gone, and responsibility is the agency's as much as the client’s. Accordingly, you have the right to dem and th at the regulations by which you m ust abide be clear and unam biguous, th at they be rational and practical, and that they allow for the creativity and innovation characteristic of modern advertising, which adm ittedly has played a m ajor role in the develop­ m ent of the economy of this country. A lthough it may be of little consolation, you are aware that the criticism of prescription-drug advertising is but a part of the attack on advertising in general. This is not the time and place to review the current governm ental scrutiny of all advertising and its relation to our free m arket economy. You should, however, be aware of the publicly expressed attitude of the chief of the A ntitrust Division, as well as the in-depth defense of advertising by Professor Backman in his book. “.Advertising and Com petition.” You therefore have the problem that all advertising faces, though yours may be an additional one because you serve a special audience, and sell special products, products that people need but do not want because they believe, quite understandably, that they have a constitutional right to be healthy and to be free from disease. You need, therefore, to be ready to defend, not prescription-drug advertising alone, but all advertising, just as all advertising needs to defend prescription-drug advertising. An industry that is m arked by annual expenditures in excess of $15 billion and th at is singularly honored by a special column in the prestigious New York Times surely 7 F o o d & D r u g L a w I n s t itu te S e m ­ in a r, A p ril 14, 1967, N o r th w e s te r n U n i­ v e rs ity S c h o o l o f L a w . PRESCRIPTION-DRUG ADVERTISING----BLIGHT OR L IG H T ? PAGE 251 is im portant enough to m erit a “handle-w ith-care” label. More than a quarter of a century ago, Franklin D. Roosevelt said of advertising: T h e g e n e ra l r a is in g o f th e s ta n d a rd s o f m o d e rn c iv iliz a tio n a m o n g a ll g ro u p s o f p e o p le d u r in g th e p a s t h a lf c e n tu r y w o u ld h a v e b e e n im p o s s ib le w ith o u t th e s p re a d in g o f th e k n o w le d g e o f h ig h e r s ta n d a rd s b y m e a n s o f a d v e rtis in g .8 Advertising, as a means of com m unication and inform ation, has always been creative and im aginative. But these proposed regulations will surely hobble and lessen the effectiveness of prescription-drug advertising if they destroy those characteristics. If these regulations stereotype advertising, and dictate form, placem ent, design, and con­ tent, quite apart from, and above, truthfulness and accuracy, and straitjacket the creativity that has characterized the history of ad­ vertising in this country, we may end up w ith superefficient—but surely colorless and ineffectual—ads. W hether advertising is a “blight" on the economy or w hether, as we contend, it does indeed shed “light." will be reflected in w hat you and the advertising com m unity do to revive its image. [The End] INTENSIFIED DRUG PLANT INSPECTION D r. J a m e s L . G o d d a rd , C o m m is s io n e r o f th e F o o d a n d D ru g A d ­ m in is tra tio n , d is c lo s e d th a t th e F D A p la n s to c o n d u c t an in te n s ifie d d r u g p la n t in s p e c tio n p ro g r a m in th e c o m in g fiscal y e a r. T h e C o m ­ m is s io n e r, w h o w a s s p e a k in g to th e a n n u a l R u tg e r s P h a rm a c e u tic a l C on ference in N ew B ru n sw ic k , N . J., sta te d th a t th e in tensified in spections w ill b e m a d e o f c e rta in firm s — a b o u t 250 o f th e m — w h ic h h a v e a s ig n ifi­ c a n t h is to r y o f v io la tio n s re s u ltin g in d is c ip lin a ry a c tio n s . T h e F D A 's a im in d o in g so , h e s ta te d , w a s n o t to s h u t d o w n c o m p a n ie s, b u t to “ p ro v id e a g r e a te r m e a s u re o f p u b lic c o n fid e n c e in d ru g s ." D r. G o d d a rd s a id th a t u n d e r in te n s ifie d in s p e c tio n , fe d e ra l in s p e c ­ to r s w ill b e p re s e n t in a d r u g p la n t fro m th e s ta r t to th e e n d o f m a n y ru n s so th a t th e y c a n m a k e v a lid c ritic is m s a n d s u g g e s tio n s . I f th e F D A th e n fin d s th a t th e firm d o e s n o t, o r c a n n o t, m e a s u re u p to g o o d m a n u fa c tu rin g p ra c tic e s s ta n d a rd s , s te p s to k e e p its p ro d u c ts o ff th e m a r k e t w ill b e ta k e n . 8 A d d re s s b e fo re A n n u a l C o n v e n tio n o f th e A d v e rtisin g F e d e ra tio n o f A m erica , J u n e , 1931. PAGE 252 FOOD DRUG COSMETIC LAW JOU RN A L----MAY, 1968 Food and Drug Legislation in Central America and Panama By ANDRZEJ E. OLSZYNA-MARZYS Mr. Oiszyna-Marzys Is a Member of the Institute of Nutrition of Central America and Panama. I NtitledT H E“TheJU LYLatin, 1967American ISSU E O F T H IS JO U RN A L,* an article en­ Common Market and Food Legislation,” by Mr. Enrique E. Bledel, contained a brief analysis of food legislation in L atin America as a whole. Mr. Bledel describes efforts to harmonize the legal provisions in force in each country, in connection with the existence of the L atin Am erican Free T rade Association (L A F T A ) and the proposed creation, by 1970, of a Latin American Common Market. While the latter large-scale conception is still not much more than a dream, and will require a lot of intelligent effort and good will, encouragem ent that it may one day become a reality can be taken from the success of a sm aller organism of the same nature and in the same area which can be considered as a pilot project and indeed a nucleus of the proposed larger enterprise—the Central Am erican Common M arket. The Central Am erican Isthm us between the frontiers of Mexico and Colombia, w ith a total area of only 188,500 square miles and a population estim ated at 15,000,000 (although w ith the rate of popula­ tion grow th highest of all the regions of the w orld), is divided into six small but fully independent republics (plus the territory of British H onduras or Belize destined for independence shortly but claimed by G uatem ala). Since the attainm ent of independence from Spain in the first half of the nineteenth century efforts to integrate the area polit­ ically have not been very successful. In spite of its relatively small size and common history, the area represents extrem e geographical, ethnical and cultural diversity and its com ponent parts have been, * 22 F ood D rug Cosmetic L aw J ournal 402. LEGISLATION IN CENTRAL AMERICA AND PANAM A PAGE 2 5 3 and still are in many cases, entities isolated by geographical obstacles and lack of adequate communications. The independent developm ent of the six republics since independence has also resulted in great diversification of their detailed legislation, including food and drug legislation, in spite of the common original basis. The organization of the Central American Common Market, with Panam a not yet a full m em ber but taking active part as associate m ember in m any of the activities of its institutions, has been an effort to tackle the problem from another end first—economic instead of political. The success story of this venture, although inevitably slowed down in the m ost recent few years, is today common knowledge. One of the m ost notable phenom ena has been the rem arkable grow th of trade—more than tenfold between 1954 and 1963—am ong the countries of the Common M ark et: from $8,300,000 in 1954, it reached $36,000,000 w ithin a year of its establishm ent (1961). $50,000,000 in 1962 and more than $80,000,000 in 1963. A further result has been rapid industrial development, increase in both exports and im ports to and from the countries outside the zone, and increase in the consum ption of consum er products. In both production and exports, agricultural products occupy the first place in all the countries concerned. E xports from the countries of the Isthm us to those outside the zone have consisted principally of food products, w ith an average of 70% of the total, while in the intrazonal trade the percentage was 29%, being exceeded only by m anufactured goods. The food industry, in relation to others, holds the m ajor part of industrial capital, occupies m ost labor, adds a m ajor part to the national product and constitutes, as just shown, the second largest item in inter-Central American trade. In 1962 food and beverage m anufacturing plants constituted 32.1% of all industrial enterprises, em ployed 36.9% of total labor, had 47.9% of total fixed capital and produced 50.3%> of total gross value of industrial production. From the quoted figures it can easily be seen that the food in­ dustry is the m ost im portant activity of all the industrial branches of the Central Am erican Isthm us. Its grow th has also been progress­ ing at a fast pace. Between 1955 and 1965, the gross value of the average annual grow th of the food industry was 7.6%. p a g e 254 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 Need for Adequate Legislation Such fast expansion obviously requires adequate legislation, regulation and norm alization to protect both the pocket and the health of the consum er, and to m aintain the high quality of exports in order to gain and m aintain world m arkets in the face of fierce competition. This competition has been rapidly increasing, com ing not only from industrialized countries but also from the newly em erging countries of Africa and Asia, especially in view of the fact that virtually all the main products exported by Central Am erica—coffee, cotton, bananas, sugar—are also produced in those two continents. Furtherm ore, in order to prom ote intrazonal trade w ithin the Isthm us instead of ham pering it, uniform ity of legislation and reciprocal acceptance of control m easures are essential. M eanwhile, food legislation in the six countries of the area at the beginning of the Common M arket era was quite inadequate to cope with the rapid industrial and commercial expansion, being based mainly on the general Sanitary Codes and isolated regulations (for example, those referring to milk, meat, salt and flour). According to findings of consultants commissioned by the Pan A.merican H ealth O rganization between 1963-1965, “the Codes were either antiquated and disjointed, or were invalidated by other regulations, or their enforcem ent was impossible due to lack of trained personnel.” Only Costa Rica possessed a few food standards, although in all the countries moves were under way to bring the codes and regulations based on them up to date. Progress, however, has been slow. Two distinct patterns of food and drug control can be distinguished among the countries of the Isth m u s; the first is w hat one could call the “Anglo-Saxon” pattern, where the enforcem ent of food and drug legislation, including inspection of food and drug factories and collec­ tion of samples of both, is vested in the same organization, and analysis is made of both foods and drugs in the same official laboratories. This is the situation th at exists in the U nited States of America, Canada and the U nited Kingdom . Two of the countries of the Isthm us have this system : N icaragua and Panam a. The other pattern, which we m ight call the “European-Con­ tinen tal” type, is where the control of foods and th at of drugs are com pletely separated, being covered by distinct legislation and en­ forced by different organizations, the drug control being usually en­ trusted to the pharmaceutical profession, which guards this preroga­ tive rather jealously. This type of situation exists in Costa Rica, El LEGISLATION IN CENTRAL AMERICA AND PANAM A p a g e 255 Salvador, Guatem ala and H onduras. It may be added, however, that even in one of the tw o countries with the joint “A nglo-Saxon” type of food and drug control, nam ely Panam a, m arketing of drugs m ust now be approved by the National College of Pharm acists before being subm itted for registration (period: 5 years) to the FD A , which in this case stands for “Farm acias, Drogas y A lim entos”—a departm ent of the M inistry of Labor, Social Security and Public H ealth, which nevertheless corresponds roughly in its functions to the Food and D rug A dm inistration of the U nited States. It may be m entioned th at in addition to registration of pharm a­ ceutical products, the Latin Am erican practice of requiring registra­ tion of processed foodstuffs has been heretofore in operation in Costa Rica (period: 6 m onths for im ported products, 1 year for national ones, no fee), Guatem ala (period: indefinite, nominal fee for analysis previous to registration) and Panam a (period: 10 years, fees for registration itself and for an analysis previous to it). Decrees Issued Food and drug control was put on a rational basis in Panam a through three decrees issued on the basis of the Sanitary Code of Novem ber 10, 1947: No. 256 of June 13, 1962 which in 260 articles presents very complete food regulations; No. 93 of February 16, 1962, which regulates drugs in a sim ilar w ay; and No. 6 of April 18, 1963, which created the above m entioned FDA . M oreover, tow ard the end of 1961 the U niversity of Panam a inaugurated LEA , or Laboratorios Especializados de Análisis, a very am ply equipped and staffed labora­ tory for food and drug analysis, which has been legally designated as the official food and drug laboratory for the Republic, and has been acting as a drug reference laboratory for the whole of the Isthm us and as a center of training for its food and drug laboratory staffs. The other country w ith the combined food and drug control, Nicaragua, is not so favored, since its food legislation is based on a very antiquated and deficient Sanitary Code, although the decree No. 568 of M arch 11. 1961, has rationalized the registration and control of pharm aceuticals. Nevertheless, the FD A . w ith a name identical w ith that of the corresponding organization in Panam a, is well or­ ganized and staffed and carries out vigorous inspection work. L aboratory facilities are represented by a section of the Public H ealth Laboratory, as is the case in all the other countries as far as food analysis is concerned, except for Panam a and El Salvador. PAGE 256 FOOD DRUG COSMETIC LAW JOU RN A L----MAY, 1968 Of the four countries w ith separated food control and drug con­ trol, three carry out food inspection through sections of the V eteri­ nary Public H ealth D epartm ents of the M inistries of H ealth. In one (El Salvador), inspection is the responsibility of the Environm ental H ealth Division, which also has its own food control laboratory. In Costa Rica, the old Sanitary Code was revised on Novem ber 2, 1949, by Decree No. 809/49, with article 249 dealing with food control, but a com pletely new Code has been under consideration by the National Assem bly for some time. T here exists a series of regu­ lations on specific foods and a dozen or so food standards elaborated by the Standards, Industrial and Technical Assistance Comm ittee of the M inistry of A griculture and Industries, established by Law No. 1698 of Novem ber 26, 1953 and Executive Decree No. 6 of Septem ber 21, 1951, the only national standards com m ittee in Central America. The College of Pharm acists, in charge of drug control (w ith analyses carried out at the Faculty of Pharm acy of the U niversity of Costa Rica), lost the registration and control of generic and of­ ficial drugs to the R egistration Council of the M inistry of H ealth in April. 1966. In El Salvador, food legislation has been based so far on Article 90 of the alm ost 40-year-old Sanitary Code of O ctober 13, 1930 (al­ though a new one has been under consideration) and on decrees regu­ lating the production of milk and m eat and their products. R egistra­ tion of processed foodstuffs is now being introduced. D rug control and registration (renewable annually) is ultim ately in the hands of the Superior Council of Public H ealth but is effected in practice by a pharm acist responsible to i t ; there is virtually no inspection or analytical control. In Guatem ala, drug registration is for an indefinite period and is effected by the Inspectorate General of Pharm acies and Narcotic D rugs of the M inistry of H ealth, w ithout any previous or subsequent analytical control, although such is effected for the registration of processed foodstuffs in a relatively well-equipped laboratory. The legislative basis is the Sanitary Code of April 30, 1937, in which articles 144 and 158 deal with registration and inspection of foodstuffs respectively, and article 40 provides for drug control. T here exists also a num ber of decrees dealing w ith specific subjects such as milk production, salt iodization, flour enrichm ent, etc. LEGISLATION IN CENTRAL AMERICA AND PANAM A PAGE 2 5 7 Finally, although in H onduras food legislation, inspection and analytical control were perhaps w eakest of all the Isthm us, recently vigorous steps have been taken to remedy the situation. This country was the first one to actually prom ulgate a new Sanitary Code (of Novem ber 14, 1966), and on the basis of its T itle V, articles 83-103, to present for m inisterial approval early this year a very com prehen­ sive food control ordinance. A t the same time, steps were taken to strengthen food inspection and laboratory services. D rug registration (for 3 years) is effected by the College of Chemistry and Pharmacy established by a decree of August 29, 1963, w ith the local U niversity contracted to effect analyses. In view of this diversity of legislative and organizational posi­ tions and general inadequacy of control services, it is not surprising th at the regional organs should feel urgent need for uniform legal provisions, and for reorganization and strengthening of enforcem ent services, also on a uniform basis. Requests for Assistance The six M inisters of H ealth, gathered at their eighth regular annual m eeting in San José, Costa Rica, in 1963, officially requested the assistance of the Pan Am erican Sanitary Bureau, the Regional Office of the W orld H ealth O rganization (P A S B /W H O ), in the field of food control. One of the first needs, it was felt, was the introduction of a set of common minimum sanitary food standards. A lthough one of the regional institutions, the Central Am erican Research Institute for Industry (IC A IT I), had been entrusted w ith establishing standards for all industrial products, those are the voluntary trading standards specifying quality grades and only a few of those issued to date referred to food products. P A S B /W H O commissioned the Adolfo L utz Institute of Sao Paulo, Brazil for the work of preparing obliga­ tory sanitary standards and at the same time initiating and financing- regular annual Sem inars of Food and D rug Control for Central A m erica and Panam a, grouping representatives of the control services of the six countries. In 1963-1965 a set of about 380 food standards, including analytical methods, lists of perm itted additives, etc., was elaborated, revised at the Sem inars, presented to the M inisters and recommended by them for inclusion in the legislations of the six countries. p a g e 258 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 In this work, in addition to national laws and standards of many countries, the provisions of Latin Am erican Food Code and the work of the Joint Food and A griculture O rganization/W orld H ealth O r­ ganization Codex A lim entarius were taken into account. However, it was felt that the form er offered only very general principles while the work of the latter proceeded rather slowly and neither included standards for specifically local Central Am erican products nor took account of local conditions. Therefore, this more detailed set specifi­ cally adapted to local needs was felt necessary. P A S B /W H O has also been helping in the strengthening and reorganizing of food inspection and laboratory services in the area. D etailed proposals for their uniform organization and for uniform regulations were made by P A S B /W H O consultants especially at the last Food and D rug Sem inar (in 1967). These referred particularly to such things as a common system of registration of processed food­ stuffs w ith validity of five years and identical scale of fees, pesticide residue limit lists, etc. They were accepted by the group and recom ­ mended by them to the Council of M inisters of H ealth, who in turn adopted them and recom m ended their inclusion in national legislations. By the resolution of the M inisters, the Institute of N utrition of Central Am erica and Panam a (IN C A P ), situated in Guatem ala City and adm inistered by P A S B /W H O , was asked to organize a new Division of Food Control and Analysis which would act as a Regional Food Reference Laboratory. U nder P A S B /W H O auspices, a large-scale project is now being elaborated by IN C A P for an integrated food control organization, which could include all the national food inspection and laboratory services, as well as the new Division of IN CA P, the L EA and the standardization section of IC A IT I, and it is hoped to obtain the assistance of the Special Fund of the U nited Nations Developm ent Program for the project. Summary If all these labors succeed, it will be yet another im portant step in the integration activities of the area, the ultim ate goal of which m ight be a political union, the aspiration of the best sons of Central Am erica for some hundred and fifty years. [The End] LEGISLATION IN CENTRAL AMERICA AND PANAM A PAGE 259 A Reasoned Approach to Regulation Based on Toxicologic Considerations By JOHN P. FRAWLEY The Following Article W as Presented at the National Con­ ference on Indirect Food Additives Held in Washington, D. C., Tuesday, February 13, 1968. Dr. Frawley Is Chief Toxi­ cologist for Hercules, Incorporated, Wilmington, Delaware. A LM O ST 2400 Y EA R S AGO, one of the greatest philosophers of our culture, Plato, advised the rulers of ancient Greece: “N oth­ ing is more unw orthy of a wise man, or ought to trouble him more, than to have allowed more tim e for trifling and useless things, than they deserved.” I do not pretend to be a wise man, but I am troubled and the m ajority of the toxicology profession is troubled because we spend so much time on trifling and useless things. In no other area of environ­ m ental health have we invested so much tim e and effort in unprofit­ able research, as we have on indirect food additives. I think the very fact th at this N ational Conference on Indirect Food Additives is being held constitutes a recognition by governm ent th at our priorities should be re-evaluated. I also think th at this Con­ ference has been called because the Food and D rug A dm inistration (FD A ) sincerely wishes our opinions and advice on how we can protect public health in a more efficient m anner than with our current regulatory procedures on indirect additives. If my assum ption is correct, we have the unprecedented opportunity to offer our sugges­ tions and the responsibility to propose specific constructive m ech­ anisms to improve our system. I think it is im perative in any discussion of environm ental health to put the specific subject in perspective. O ur environm ent is com ­ posed com pletely of chemicals, m ost of which are of natural origin p a g e 260 FOOD DRUG COSM ETIC LAW JO U R N A L ---- M A Y, 1968 and only a small percentage of m an's invention. Despite the well- established fact th at the m ost highly toxic chemicals are of natural origin, toxicologists spend m ost of their tim e evaluating the potential hazard from m an-made environm ental chemicals. There are m any historic and religious reasons for our preoccupation w ith m an’s con­ tribution to the environm ent rather than nature’s, but that is a sub­ ject for another discussion. If we limit our considerations to man-made or synthetic products, toxicologists are faced with the staggering task of evaluating the safety of air pollutants, pesticides, drugs, direct food additives, w ater pollutants, cosmetic chemicals, synthetic fibers, rocket exhausts, in­ dustrial chemicals in our plants, indirect food additives, and so on. There is a severely lim ited supply of toxicologists and other experts qualified to work in this field and from a national and international point of view, any concentration of emphasis on one problem dilutes the effort on the other problems. The same can be said of our financial resources. Even in this country there are lim ited funds available for environm ental health research, and any concentration of effort on one problem restricts the funds available for other problems. Commissioner Goddard and his staff at the FD A recognize these lim itations on m anpower and money and constantly m ust re-evaluate priorities so th at m ajor health hazards receive the A dm inistration’s m ajor effort. Ten years ago when the 1958 Am endm ent was passed, the degree of health hazard from food packaging was unknown. Con­ sequently, a relatively high priority was assigned to this source of en­ vironm ental exposure. In these intervening years we have learned th at the potential health hazard is slight but we have not yet figured out a mechanism for reducing our effort and at the same time provide protection against some future developm ent which m ight pose a threat to health. As m any of you know, about two years ago I became disturbed about the continuing investm ent of governm ent and industry resources in the investigation of safety of trivial uses of food packaging com ­ ponents. I realized th at I personally had spent over a million dollars of my Corporation’s money investigating the safety of food packaging m aterials, and from society’s point of view it was all wasted, because all were proven to be safe. The benefit to the consum er was zero. The loss to society was a million dollars. I also realized th at this situation had been repeated in laboratories throughout the country w ith the net result th at essentially all of the practices of the food packaging industry prior to the 1958 A m endm ent had been confirmed as safe A REASONED APPROACH PAGE 261 and inscribed into a set of regulations too complex for anyone to understand. I felt that it was tim e to re-evaluate our priorities. In trying to determ ine w hat decisions had been responsible for this waste of effort, it was apparent th at the toxicology and legal professions had failed mutually to cope with the problem of insignifi­ cance or "de minimis” in a reasonable and intelligent manner. The tw o professions had not reached a m utual understanding of the con­ cept of toxicological insignificance and as a result its validity was denied. This is the heart of the problem which not only plagues us in the field of indirect additives, but in all areas of environm ental health. If we are to avoid continued waste, we m ust recognize the validity of this concept and w ith the help of our lawyers find some mechanism to put it to work for us. Let me briefly describe a typical situation which I conservatively estim ate has occurred a thousand times in the field of food packaging. A m anufacturer is trying to evaluate the safety of a food packaging component. His bright young chem ist w ith a new and expensive analytical instrum ent discovers that 10 parts per billion of a chemical m igrates from the container to food. The law yer says th at because it can m igrate to food, it is a food additive and m ust be established as safe. The toxicologist says th at he cannot conclude that it is safe until toxicologic studies are conducted. This is the ever famous tri­ chotom y which we have all experienced. Alternatives in Establishing insignificance Now there are three obvious ways to break this vicious circle. F irst of all the chem ist can say that it isn’t there. He can use a less sensitive analytical m ethod and report a negative finding and then the law yer and toxicologist aren’t worried because as far as they know it isn’t there. Secondly, if the chem ist doesn’t w ant to say it is not there, the law yer can say “de minimis non curat lex”— the law does not concern itself with trifles—and conclude that the Food and Drug Law was not intended to concern itself with these minuscule contaminants. Thirdly, the toxicologist can say it is safe on the basis of insignificance. In my opinion, the responsibility for finding an intelligent solu­ tion to this problem rests w ith the lawyers and toxicologists, and not with the chemists. Chem istry is an exact science, unlike toxicology, and it is scientifically dishonest to ask a chem ist to prove the absence of som ething by using the least sensitive analytical technique which he thinks will satisfy the toxicologist. I wonder how often this is done, because 10 parts per billion of a chemical is considered legally pa g e 262 FOOD DRUG COSMETIC LAW JOURNAL— MAY, 1968 a food additive if detected, but if “not detected” at a sensitivity of 10 or even 100 parts per billion it is not considered a food additive. A num ber of my scientific colleagues attem pt to put the blame on our lawyers. I disagree. I think toxicologists have the initial responsibility to decide w hat is insignificant, and secondarily lawyers have the responsibility for using the law and regulations as a m ech­ anism for putting sound scientific principles into operation. The regulations should not be a straight jacket for the scientist, but a vital, living instrum ent used in a flexible m anner to provide the greatest protection of health in the m ost efficient manner. As new scientific knowledge is evolved, the procedural and interpretive regu­ lations should be modified to reflect this knowledge rather than remain outm oded, perm anent obstacles to a rational scientific con­ clusion. I subm it that lawyers and toxicologists can work together to solve this problem. O ur objective is the same—maximum pro­ tection of public health. Guidelines for Establishing Insignificance Because I considered it to be the responsibility of the toxicologist to break this vicious circle, I tried to develop some workable guide­ lines which could be used by our profession in deciding insignificance. I first had to ask m yself: can any safe level of a compound he estab­ lished w ithout toxicologic data? My first answ er was no, probably because I have heard this said so many tim es that I accepted it as fact. I then realized the illogical conclusions which follow such a position. If we consider one molecule of a chemical potentially toxic until we have proven otherw ise by toxicity studies, we cannot allow synthesis of any new compounds because the chem ist will be exposed to at least one molecule. Conversely we cannot conduct a toxicologic study until the chem ist makes the compound. W e do in practice and in fact accept one molecule of an unknow n chemical as safe because we have never discovered a chemical which would be toxic at this level and because we realize th at the alternative would be unaccept­ able to society. Next, I asked m yself: can we consider a dietary concentration of one part per billion of a compound to be safe w ithout toxicity data? My first reaction again was to answ er no, but then I realized th at we do in fact make this assum ption everyday of our lives. Every time a chem ist synthesizes a new compound, his exposure exceeds this level. Every tim e a chemical is handled in developm ent to determ ine its physical properties and usefulness, the exposure exceeds this level. If we did not allow this to take place w ithout toxicologic A REASONED APPROACH PAGE 263 studies, the toxicologist himself and his technicians would be exposed to more than one part per billion in the process of investigating its toxicit . Again we routinely accept one part per billion as toxi­ cologic ally insignificant because experience has confirmed that it is valid. The third question I asked myself w a s : can we consider one part per million of a com pound to be safe w ithout toxicity data? Here my answ er was em phatically no, because experience has taught us that a few com pounds cause minimal toxic effects at this level and a few chemical w arfare agents cause severe toxic effects at this level. This exercise in self-questioning led me to the following con­ clusions which help us understand toxicological insignificance: Some hum an exposure m ust take place before anim al toxicologic studies can be conducted. Every hum an exposure from the m oment a chem ist synthesizes the first molecule constitutes a toxicologic experim ent in itself, which tells us som ething about the compound. The degree of hum an exposure which can be allowed w ithout formal anim al toxico­ logic studies is based entirely on experience. The only alternative is to prohibit the synthesis of any new chemical. Review of Chronic Toxicity Studies Because experience is the only basis for deciding w hat can be considered toxicologically insignificant for m igrants from food pack­ aging, I decided to examine our experience as thoroughly as possible. Since m ost of our decisions on safety of consum er products are based on long-term toxicity studies, I decided to search the biological liter­ ature for every chronic toxicity study which has ever been conducted and to tabulate the safe or “no toxic effect” level for each compound. I restricted my tabulation to chronic studies because most shorter term studies are not published and “no toxic effect” levels from shorter studies are not considered conclusive by some toxicologists. After my initial effort on this project became known, other toxicolo­ gists in industry, governm ent and universities helped by furnishing me obscure references and unpublished reports. I can make no claim that I have found every tw o-year chronic toxicity study which has been conducted. I can only claim that I have tabulated the “no toxic effect" levels from every chronic study which I could find, w ithout any selection or rejection. In total, I have been able to locate tw o-year chronic toxicity studies on 245 different substances, and although this may seem like a m odest num ber, it represents between 15 and 20 million dollars in toxicological research. I estim ate that I now have collected over 90r/ of all such studies PAGE 264 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 which have ever been conducted. I have presented these tabulations at two scientific sym posia on food packaging and the com plete details and docum entation have been published in the journal of Food and Cosmetics Toxicology.1 In brief, this review of our toxicological experience, based on the most stringent test available, revealed a m arked difference between the toxicity of the class of chemicals developed as pesticides and heavy m etals (which indeed were also used as pesticides at one time) and the class I refer to as “all others.” T his is an im portant observa­ tion, even though it is alm ost self-evident, because it points out that w hat is toxicologically insignificant for one class of com pounds need not be toxicologically insignificant for another. For the “all other” category, which excludes pesticides and heavy metals, every com­ pound was w ithout toxic effect in experim ental animals when fed for a lifetime at a dietary concentration of 40 parts per million. M ost compounds were safe at considerably above 100 parts per million. The Margin of Safety Therefore, if we apply the conventional 100-fold m argin of safety advocated by the FD A to protect against unpredictable hum an sensi­ tivity and make the standard adjustm ent for the greater intake per unit of body weight of experim ental animals, every compound which has been studied is safe for man at a total dietary concentration of 1 part per million. The analysis reveals that if we had perm itted all of these compounds in m an's diet at a level of 1 part per million w ithout conducting any toxicological studies, public health would have been protected just as well at a saving of from 10 to 20 million dollars in toxicological expenses alone. A lthough this experience indicates that we could accept 1 part per million as a level of toxicological insignificance, I recognize that my tabulation is only 90% complete. I also recognize th at chronic toxicity studies, although m ost suitable for calculation of safe levels, m ay not give a com pletely unbiased cross-section of chemicals. It is for this reason I have proposed that we protect ourselves by another factor of ten and adopt 0.1 parts per million as a level of toxicological insignificance for all m aterials other than pesticides and heavy metals. This is w hat experience has taught us. But at this extrem ely low level of insignificance, we need not rely solely on toxicological expe­ rience for protection. As I m entioned earlier, during the time th at a new com pound is synthesized, its usefulness explored, a pilot plant 1 “Scientific Evidence and Common R egulations,” 5 Foods and Cosmetics Sense as a Basis for Food Packaging Toxicology Journal 293, 1967. A REASONED APPROACH PAGE 265 operated, while it is being m anufactured, packaged and used in the food packaging industry, some degree of hum an exposure has taken place and som ething has been learned about its toxicity. Responsible m anufacturers conduct toxicologic studies routinely to protect their workm en, but even if no formal toxicologic studies have been con­ ducted, a com pound which could be toxic to man at 0.1 parts per million would have revealed its extrem ely high toxicity in these ex­ posures and it would have been rejected as incom patible for the food packaging industry. It m ight be suitable as a chemical w arfare agent, or perhaps a pesticide, but it could not be sold or used in the food packaging industry because this industry does not practice a level of industrial hygiene com patible w ith handling this type of compound. If employes in this industry wore fresh-air masks and full skin cov­ erings, we could not make this statem ent. Again w hat is toxico- logically insignificant for one industry or use of a compound, is not necessarily toxicologically insignificant for another. This proposal that we consider 0.1 parts per million as a toxico­ logically insignificant level for food packaging components was made originally at an American Chemical Society sym posium alm ost IS m onths ago. Since then I have not learned of a single commercial chemical which m ight be used in food packaging which would be an exception. As m any of you know, this proposal has received over­ whelm ing support from my profession. Tw enty-four other toxi­ cologists from universities and industries have supported this pro­ posal in w riting to the FDA. Alm ost as m any others have privately supported it. I believe the body of scientific fact and opinion justifies im m ediate adoption of this concept by FDA. Relating Insignificant Level with Specific Uses Now for a few m inutes, let us address ourselves to the problem of relating this insignificant level in the diet with specific uses of chemicals in food packaging. Quite obviously, if it can be dem on­ strated that a given use of a chemical in food packaging will contribute no more than 0.1 parts per million to the diet of man. it should be considered to be safe w ithout anim al toxicologic studies. M ajor com ponents of a food container certainly possess the capability of m igrating to food at a level in excess of 0.1 parts per million and the degree of m igration and dietary contribution m ust be determ ined. However, there are some levels of use which do not possess this capability. O ur initial problem is to establish a dividing line helow which significant m igration to food cannot occur. W e have attem pted to develop such a dividing line. p a g e 266 FOOD DRUG COSMETIC LAW JOURNAL----MAY. 1968 U ndoubtedly, this dividing line is different for each type of sub­ strate, as plastic, paper, cellophane, etc. However, for the purpose of establishing a level which would allow insignificant m igration to food and which would be applicable to all substrates and additives, we selected for study the substrate which is well known to be the most permeable and susceptible to extraction; nam ely paper, and we selected an additive which is very readily extracted from this sub­ strate : namely, rosin size. T his com bination of substrate and additive represents the m ost extrem e example of m igration, and values deter­ mined from rosin sized paper should represent a maximum for any com ponent of any packaging media. Indeed, such data would be ex­ cessive for most uses of packaging components. In our initial efforts to study the m igration of rosin size from paper, we used typical sim ulated solven ts: various aqueous solutions, hexane, vegetable oil, etc. This type of extraction test was wasted effort because, in w ater and oil. the extraction was a direct function of tim e and tem perature and did not plateau until essentially 100% of the rosin size was extracted and the integrity of the paper sheet was destroyed. Although these extraction studies clearly demonstrated that rosin sized paper would be an appropriate choice for developing maximum m igration data, they contributed nothing to the evaluation of safety of rosin size. As a consequence of this failure of the sim ulated solvents test to help define the am ount actually m igrating to food, we prepared radio­ active samples of rosin size, incorporated them into typical com­ m ercial paper and paperboard, packaged a wide variety of food in contact w ith these paper sam ples at typical package ratios, stored them at typical storage tem peratures for typical storage tim es and determ ined the rosin size content of each food by counting the radio­ activity. In effect, we conducted an experim ental m arket basket sur­ vey to determ ine the maximum am ount which could be contributed to the total diet. The study was far more extensive than I have time to describe today, because we used several types of paper (greaseproof, waxed, unwaxed, etc.), containing three different levels of rosin size, 24 different types of food (w ater, ice-cream, oysters, apricots, green beans, dry break­ fast food, sugar, doughnuts, ground beef, butter, bacon, sausage, to name ju st a few) and analyzed each sam ple at several different stor­ age intervals and tem peratures. For our purpose of developing data on a dividing line, we selected only the uncoated and unwaxed paper and only the m aximum m igration levels obtained for the 18 commodi­ A REASONED APPROACH page 2 6 7 ties packaged in these uncoated papers under typical commercial storage conditions. A dm ittedly this gives unrealistically high values for rosin size which are not typical of industry practice, but for our objective, the w orst case had to be selected. I shall not present these data in detail, since they also have been discussed thoroughly at two scientific sym posia and published in scientific journals.2- 3 However, these studies represent the most extensive effort that has been made to correlate levels of use of a packaging m aterial with dietary contributions and represent a valid experim ental basis for calculating maximum total diet contributions. Briefly, they dem onstrate that at a level of use of 1.0% the maximum dietary contribution will be 0.5 parts per million and at a level of use of 0.2% an insignificant am ount or no more than 0.1 parts per million will be contributed to the diet. This conclusion by necessity m ust apply to the food contact surface. If a compound is used in a surface treatm ent, as in a coating or in an antistatic treatm ent, this surface treatm ent m ust be con­ sidered the food contact surface and to limit migration to the insignifi­ cant level of 0.1 parts per million, the compound cannot be present at a level in excess of 0.2% of that surface treatm ent. U ndoubtedly this dividing line is unduly restrictive for most uses of packaging components. M any m aterials used at higher levels in less permeable substrates than paper, will contribute less than 0.1 parts per million. For example, a more limited study of actual m igra­ tion to food has been conducted with a radioactive plasticizer used at 28%- in a polyvinyl chloride film.4 A sim ilar analysis of these data suggest that a 0.6% level of an additive in plastics will contribute no more than 0.1 parts per million to the diet. The data are insufficient for me to propose the adoption of this dividing line for plastics, but they clearly confirm that paper and rosin size are a suitable choice as the extrem e example of m igration to food. Perhaps some care­ fully directed research will perm it establishing other dividing lines in the future. This conclusion th at 0.2% of a com ponent in a food container was safe also received overw helm ing support from other experts. Because of this support I subm itted a formal proposal to the FD A to incorporate this concept in Regulation 121.2500, which would ex- 2 See footnote 1. 4 “Toxicity of 2-Ethylhexyl Diphenyl 3 “M igration of Rosin Components Phosphate,” 8 Archives of Industrial H y- from Sized Paper to Exposed Foods,” giene and Occupational Medicine 283, 48 T A P P l 8, 1965. 1953. pa g e 268 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 em pt from petitioning "substances used at a level of no more than 0.2% by weight of the container or no more than 0.2% by weight of the coating or other surface treatm ent, provided these substances are not heavy m etals.......... or pesticides. . . ." By proposing the inclusion of this statem ent in 121.2500 (d), the other good m anufacturing practice provisions of that regulation are autom atically applicable to these substances: namely, that the sub­ stance is used “in an am ount not more than reasonably required to accomplish the intended physical or technical effect in the food contact article” and that it is of "purity suitable for its intended use.” Also, it is understood w ithout stating it. that any such sub­ stance m ust comply w ith the Delaney Clause of the 1958 Am endm ent which prohibits use of known carcinogens. As I m entioned earlier, two dozen experts have advised the FDA of their endorsem ent and have encouraged the A dm inistration to adopt this proposal. Several lawyers have advised me that this sup­ port from the scientific com m unity of and by itself confirms that these uses are generally recognized as safe or "gras” and that no action on the part of the FDA is necessary. I will not enter into a legal debate on this premise, but I think the evidence is clear that uses at or below this level of 0.2% offer no significant hazard to health, that they are unw orthy of the scientific and adm inistrative effort of industry and governm ent required to study, petition and regulate these m aterials. The Validity of the Reasonable Assumption So far I have tried to present a scientific basis for selecting some level of use of a com ponent in a food container which can be assum ed to be safe w ithout m igration data and w ithout toxicologic data. One additional guideline is needed to help prevent the continued waste of effort and that is a level of m igration for com ponents used at levels above 0.2% which also can be considered safe w ithout toxicologic studies. W e frequently refer to this type of com ponent as “non- m igratory.” It is a logical extension of mv previous proposal that we adopt the same level of 0.1 parts per million as a level of no significant m igration. If a use of a m ajor com ponent can be confirmed by suit­ able analytical studies to contribute no more than 0.1 parts per million to the diet, it also should be considered safe. An im portant point in the interpretation of the data from such studies, is that reasonable assum ptions of food contact and consum ption should be allowed rather than the arbitrary assum ptions that all food is packaged in A REASONED APPROACH PAGE 269 small one ounce containers, and that the entire diet is composed of the type of food to which greatest m igration occurs, even if it is vinegar. No-effect levels and acceptable daily intakes by definition are intake levels and they m ust be com pared w ith intake levels in man—-not with theoretical maxima which have no relationship to in­ take or total diet levels. Conclusion To conclude this discussion very briefly. I and many of my col­ leagues in the toxicology profession propose that we accept 0.1 parts per million in the total diet of man as a toxicologically insignificant level of a food packaging com ponent—with the exception of pesticides and heavy metals. W e have also proposed th at a level of 0.2% by weight of such a com ponent in a finished container or food contact surface be recognized as safe in the regulations because it cannot contribute more than 0.1 parts per million to the diet. Thirdly, we propose that m ajor com ponents which can be shown by suitable m igration studies to contribute no more than 0.1 parts per million to the diet should be considered nonm igratory. The other uses, and only these other uses which m igrate at a significant level are w orthy of toxicologic study and governm ent regulation. Thus we propose three categories of food packaging com ponents: 1) those used at 0.2% or less which cannot “reasonably be expected" to become com ponents of food, and these should be exempt. 2) those used above 0.2%c which way “reasonably be expected” to become a com ponent of food. “but in fact do not." and these should he considered nonm igratory, and 3) those used above 0.2%c which arc indeed food additives and should be subject to appropriate exam ination for safety and regulation under the law. Only by accepting some level of insignificance and recognizing the relative risk to public health from different uses can we avoid w asting our resources on predictably unprofitable research. It is our moral responsibility as scientists and it is the vested responsibility of governm ent to invest our tim e and money in research which is likely to provide the greatest protection to health. Ten years ago. we lacked the scientific basis to evaluate the relative hazard associated with indirect additives. Today, after investing tens of millions of dollars and man hours, we know that the relative risk is small. I propose that we benefit from this knowledge and restore an equitable balance to our environm ental health program . I have tried to suggest a few ways to achieve this objective. [The End] pa g e 270 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 196S Report of the Fifth Session of the Joint FAO/W HO Codex Alimentarius Commission By FRANKLIN M. DEPEW Mr. Depew Is President of The Food and Drug Law Institute, Inc. H E F IF T H SE SSIO N of the Food and A griculture Organiza- tion ( F A Q (/W orld H ealth O rganization (W H O ) Codex Ali- m entarius Commission was held at FAO H eadquarters. Rome. Italy. February 20 to March 1. 1968. The session was attended by about 150 registrants made up of delegates and observers from some 42 countries and 20 international organizations, as well as other interested observers. The total Commission m em bership as of the time of the m eeting was 52 countries — 25 in the European region, 2 in North America. 7 in Latin America. 8 in Africa. 2 in the South W est Pacific and 10 in Asia. The session was opened in behalf of the Directors-General of F'AO and W H O with a welcom ing speech by Dr. A. H. Boerma. Director-General of FAO. Dr. Boerma specially welcomed the new members of the Commission and emphasized the im portance of the work of the Commission in helping remove noil-economic obstacles to international trade. He paid tribute to Professor Dr. M. J. L. Dols of the N etherlands, the retiring Chairman of the Commission. Composition of Fifth Session The U nited States Delegation consisted of 12 representatives including Mr. George R. Grange. Deputy A dm inistrator, Consum er M arketing Service. U. S. D epartm ent of A griculture (U SD A ). its Chairman. Mr. Grange was assisted by Mr. F. Robert Anderson of the Consum er M arketing Service, USDA. and by the following indus- trv representatives : CODEX ALIMENTARIUS COMMISSION PAGE 271 Irving A. Hoff. U. S. Cane Sugar Refiners A ssociation: Leonard K. Lobred, National Canners A ssociation; Jan J. Mer- tens. National Canners A ssociation; Michael F. M arkel. Escj.. W ashington A ttorney; Donald M. Mounce, Campbell Soup Com­ pany: Robert G. Ruark. Corn Products Com pany; H ow ard C. Spenser, Dow Chemical C o.; R. Malcolm Stephens. Institute of Shortening and Edible O ils; J. Bryan Stine. K raft Foods Divi­ sion of National D airy Products Corporation ; Robert J. Olson. Genera! Foods Corporation. D uring the session the Commission elected Mr. J. H. V. Davies of the U nited Kingdom as Chairman to serve from the end of the Fifth Session until the end of the Sixth Session. The Commission also elected Professor Dr. O tto Hogl of Switzerland, Mr. E. M ortensen of Denm ark and Mr. I. H. Smith of A ustralia as Vice-Chairm en for the same term . The Commission also elected the following m em ber countries of the Commission to represent the indicated geographical locations on the Executive Com m ittee: For Africa — Ghana ; For Asia — Japan ; For Europe — Poland ; For L atin America — A rgentina ; For N orth America — U .S.A .; For South W est Pacific — New Zealand. The following briefly reports the progress made and the other principal actions taken by the Fifth Session of the Commission. Important Progress Am ong the prom ising steps taken by the Commission was the approval at step 9 o: the Codex procedure of the standards for canned tom atoes, canned green beans, canned peaches, canned applesauce, canned sweet corn, glucose syrup, dried glucose syrup, dextrose m ono­ hydrate, dextrose anhydrose and lactose. Approval at step 9 leaves only the acceptance of the standards by governm ents before the Commission can take the final step of pub­ lishing them as Codex standards. The approval of the first standard at step 9 was greeted by spontaneous applause. Also approved at step 9 were Codes of Practice for general prin­ ciples of food hygiene and hygienic practice for canned fruit and vegetable products. The Commission agreed that these Codes were advisory only but that parts of these Codes, especially those dealing w ith end product specifications, would be included in Codex standards p a g e 272 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 and could then become m andatory. The Commission further con­ cluded th at the statutes of the Commission concerning the protection of health of consumers gave it sufficient authority to continue its work on Codes of Hygienic Practice, but sought the legal advice of counsel of FAO and W H O as to its authority relative to codes of practice generally. The canned fruit and vegetable standards include a provision that the listings of food additives are subject to endorsem ent by the Codex Committee on Food Additives. The Chairman of the Committee. Air. George R. Grange of the U nited States, explained that a num ber of countries felt there was no technological necessity for certain of these additives but th at the Comm ittee agreed in general that if an additive were used in one or more countries which are significant producers of the product, the additive should appear in the standard in order that it can be reviewed by the Codex Comm ittee on Food Additives and the Joint F A O /W H O E xpert Comm ittee on Food A d­ ditives. Mr. Grange had said earlier, in connection with a discussion of flour treatm ent agents which were objected to by m any European countries, that if food additives are recognized as safe by the technical experts there m ust be some give-and-take if we are to have standards. Those opposing their use must consider the differing food habits in the various countries which make it essential for some countries to use these flour treatm ent agents. H is forceful support of this point of view on both of these occasions contributed greatly to the final ac­ ceptance of these fruit and vegetable standards at step 9. The Com­ mission agreed that if a food additive is only “tem porarily” endorsed by the Food Additive Comm ittee at the tim e a com m odity standard which provides for its use is sent to governm ents for consideration, it would bear footnotes stating “tem porary pending toxicological evalu­ ation” or “tem porary pending assessm ent of the total food load.” Those who believe in the Codex program expect that the United States should have little difficulty in accepting the standards approved by the Commission at step 9. FD A has already established standards for canned tom atoes, canned green and wax beans, canned sweet corn and canned peaches and has proposed standards for applesauce and for canned grapefruit. The canned fruit and vegetable standards ap­ proved by the Commission are very close to the FD A standards. The food hygiene codes of practice, which are guidelines rather than standards, resemble closely the “good m anufacturing practice” regu­ lations proposed by the Food and D rug A dm inistration (F D A ). No standards have been proposed for sugars but it is anticipated that CODEX ALIMENTARIUS COMMISSION PAGE 2 7 3 FD A will propose such standards in the near future. If the Codex program is to be successful, the U nited States m ust establish such standards, for it cannot accept the Codex standards and enforce them here unless there are com parable U.S. standards. If the U nited States shows a willingness to give on some points now, there should be a better chance of other countries giving on provisions of later stan­ dards. Such action on our part will exem plify the policy of give-and- take so eloquently expressed by Mr. Grange at the m eeting and re­ ported earlier. The audience granted by H is Holiness, Pope Paul V I, should operate as an incentive to all delegations to work more effectively tow ard the goal of harm onization. The Pope commended and en­ couraged the work of the Commission and invoked on its delibera­ tions richest divine graces and favors. General Principles A t the third session of the Commission the Comm ittee on Gen­ eral Principles, chaired by France, had recom m ended three w ays of accepting a Codex standard: (1) Full A cceptance; (2) Acceptance with a D eclaration of More Stringent or Supplem entary R equire­ m ents; and (3) T arget Acceptance. These were approved by the Commission at th at time and have remained basically unchanged since. A t the Fifth Session this Comm ittee subm itted the wording of these three ways of acceptance for Commission review and sug­ gested that it would be possible to better achieve the objective of acceptance if a fourth m ethod of acceptance, namely, “Partial Ac­ ceptance,’’ were made available to cover cases where the circum stances peculiar to a country m ight require it to perm it less stringent provi­ sions for some parts of a Codex standard. The Commission adopted the texts as recom m ended for the first three ways of acceptance, al­ though a num ber of objections were made to Acceptance with a Declaration of More Stringent or Supplem entary Requirem ents. It was pointed out that if a standard fulfilled the purposes of the Codex A lim entarais then there should be no need for more stringent require­ m ents and that recognition of this form ula constitutes approval of differing standards since each country can establish stricter criteria than those appearing in the standards. The three Vice Chairmen of the Commission redrafted the text of the fourth m ethod of acceptance to make it clear that the “less stringent requirem ents concerned only m inor m atters” and to provide th at these “m inor” deviations would have to be accepted by the Commission. The Commission decided not to adopt the draft at this tim e but to ask governm ents for com­ PAGE 274 FOOD DRUG COSMETIC LAW JOURNAL----MAY. 1968 m ent, and it requested the Comm ittee on General Principles to reconsider the proposal after the governm ent com m ents are received. Food Labeling The Codex Comm ittee on Food Labeling, chaired by Canada, reported on the proposed General Standard for the Labeling of P re­ packaged Food. The Commission considered the standard and de­ cided to advance it to step 6. During the discussion questions were raised about the listing of ingredients in general, and, in particular, the listing of standardized products for which it was suggested an exception should be perm itted. The view was expressed by some that the declaration of ingredients w ithout proportion is more likely to confuse the housewife than inform her. Some countries queried the provisions of the standard requiring declaration of net contents on the label. It was also suggested th at it would be helpful if labels should, in addition to the units of m easurem ent used in the producing country, also show the m easurem ent according to the m etric system. Some delegates expressed the view th at the label should be dated. The Comm ittee report indicated there m ight be some foods which should bear an expiration date, but stressed the need for sound scien­ tific justification for such a procedure. The Comm ittee said the individual com m odity com m ittees should consider w hether it is neces­ sary th at the labels of any com m odity being reviewed by them for standardization be dated. The Comm ittee has not finally settled the question of specifying type sizes. The Commission is referring these m atters to governm ents for com m ents and they will be discussed again by the Comm ittee at its next m eeting, after receipt of these com m ents. The FA O Secretariat reported th at it is preparing a paper dealing with national legislation in regard to the exem ption of foods from ingredient listing and that this paper should be com pleted in tim e to be considered by the Com m ittee at its next meeting'. Standard for Margarine The Commission spent an entire day discussing the provisional m argarine standard. The standard was examined section by section. In view of the divergence of opinion regarding a num ber of basic provisions of the standard, it was decided to keep the standard at step 8, to instruct the Secretariat to redraft the standard in the Codex form at, to send the redrafted text to governm ents for comm ents, and to subm it the text and com m ents to the Executive Comm ittee which would decide w hether to refer the standard back to the Codex Com­ m ittee on Fats and Oils or to recom m end th at the Commission re- CODEX ALIMENTARIUS COMMISSION PAGE 275 examine it at step 8 at its next session. D isagreem ent on the standard involved use of milk products in m argarine, m oisture content, both maximum and m inim um fat content provisions, use of vitam ins and food additives, and the coloring and labeling provisions. Mr. Grange, for the U nited States, pointed out that a m aximum m oisture content of 16r/c could operate to discrim inate against unsalted m argarine. He also pointed out that the U nited States would have to change its stan­ dard to allow m arine oil if the standard were passed to step 9, but felt th at this could be done. Standard for Honey Also considered at step 8 was the provisional standard for honey drafted by the Coordinating Comm ittee for Europe. At the fourth session of the Commission this Comm ittee had been asked to study the proposal that this standard be worldwide rather than regional. In reporting on the standard the Comm ittee recommended th at it be approved as a regional standard. The Comm ittee further reported th at it had taken into account views of interested non-European countries w ith the result that differences between European and non-European countries had been considerably narrowed. T here was extensive debate as to w hether the text of the standard should be considered first or the question of w hether the standard should be regional or worldwide. France argued that procedurally the E uro­ pean region alone had the right to vote on w hether or not the standard should be regional. This view did not prevail but the Com­ mission m em bers voted 16 to 13. with four abstentions, th at the stan­ dard be considered as a regional one. The regional standard in its present form would set high levels for enzym e activity, preventing heat treatm ent of honey. In behalf of the U nited States, Mr. Grange reported that 55% of random samples tested did not conform to the proposed standard. He commended the efforts to secure a standard acceptable to all and said the U nited States would continue to work with the Comm ittee to that end. The standard was kept at step 8, to be sent to governm ents for com m ents and to be re-examined at the next Commission m eeting, having in the m eantim e been referred to the Coordinating Comm ittee for Europe for review, if the Executive Comm ittee decided this was advisable. Proponents of m aking it a regional standard said it could later be am ended to serve as a w orld­ wide standard. Regional standards such as this would be barred under a proposal m ade by Canada which would limit regional standards to “food pro­ duced exclusively and consumed m ainly w ithin the geographic region.” p a g e 276 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 The Canadian delegate said regional standards for comm odities which move in world trade m ight operate to restrain trade. The Canadian proposal will be sent to governm ents for com m ents and considered at the next session. The Commission requested the Executive Comm ittee to examine the desirability of introducing a greater degree of flexibility in the procedure for elaboration of standards, in particular, with a view to enabling a standard under consideration at step 8 as a regional standard to be considered as a worldwide standard at the same step. Packaging Materials A t the request of the F ourth Session of the Commission, the Secretariat prepared a paper on packaging m aterials, outlining the subject. The Commission noted th at the Council o: Europe had established a W orking P arty to deal w ith the control of packaging m aterials. The Commission agreed with the conclusions of the Codex Comm ittee on Food Additives that before packaging m aterials were considered, a large am ount of prelim inary work would have to be done on com piling inform ation for consideration by a Joint F A O / W H O E xpert Committee. The Commission then exam ined the priority which should be given to the consideration of the subject. Mr. Grange pointed out th at there were m any other additive problem s which are more urgent and recom m ended deferring for at least a year. In view of the fact th at the existing E xpert Comm ittees and the Codex Comm ittees still had a num ber of classes of food additives, contam inants and pesticide residues with high priority to consider, the Commission decided that no action should be taken at this time, and that the outcome of the investigations of the W orking P arty of the Council of Europe should be aw aited before further action was taken on this subject. The Com­ m ission was of the opinion that m eanwhile the Secretariat of FA O and W H O should collect data on the m igration of packaging m aterial com ponents into food and on their toxicity. Food Standards Work in Africa, Asia and Latin America A t the F ourth Session of the Commission the Secretariat w as requested to prepare a survey of the needs of African countries in respect of food legislation and standards. The Commission was in­ form ed that the Secretariat had obtained some inform ation from the various African countries and that a certain am ount of data had been received through the offices of the FA O Regional and Country CODEX ALIMENTARIUS COMMISSION page 2 7 7 R epresentatives stationed in Africa. The Commission was also in­ formed that the docum ent which the Secretariat had prepared had been found useful by other services in FAO whose function was to advise developing countries. The Commission was informed th at in the main the food legislation of these countries was based either on British or French legislation but some progress had been made re­ cently in draw ing up national food laws in some countries. The Com­ mission noted that this had apparently stim ulated an increase in the m em bership of African countries in the Codex A lim entarius Com­ mission from four to eight countries and again em phasized the im­ portance of the participation of these countries in the work of the Commission. Such m em bership was also useful to establish contacts w ith the authorities responsible in these countries for health, sani­ tary and other m atters connected with food legislation and to enable those authorities to receive useful inform ation from FAO and W H O on the activities of the Commission. It was emphasized th at m em ­ bership did not involve any financial contribution additional to th at which countries were already m aking to the Regular Program s and Budgets of both O rganizations, and that participation in the work of the Commission could also be carried out by way of correspondence. It was decided that a sim ilar survey of food standards needs in Asian countries should be carried out. W ith regard to L atin America, it was noted that A rgentina had for the last 40 years a national code and that a Latin Am erican Food Code has also been adopted by a num ber of the countries of this region. The A rgentine delegate inform ed the Commission that a new edition of the L atin American Food Code would be issued shortly. The Commission agreed th at in order to complete the picture of food standard needs in the main developing areas of the world, an appro­ priate survey should also be made for L atin America. Progress on Other Standards Also sent out for com m ents at step 6 were the standards for canned asparagus, canned pineapples, canned Pacific salmon, edible fats and oils, soya bean oil, maize oil, sesame seed oil, safflower oil, lard, rendered pork fat. prem ier jus. edible tallow, white sugar and powdered sugar. Cocoa products and chocolate were returned to the Comm ittee at step 4. Mr. Graham Kerm ode, in behalf of the Secre­ tariat, pointed out th at there was a wide divergence of opinion betw een producing countries and im porting countries, as well as m anufacturers, as to processes. He said the proposed standards for cocoa products and chocolate were the most highly controversial p a g e 278 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 standards being considered by the Commission. Mr. Grange stated that the high degree of diversity of chocolate products m ight make it undesirable to have standards for all of them. The Codex Comm ittee on Food Additives reported th at a defini­ tion of “food additives’’ would he discussed at its next session. The Codex Comm ittee on Foods for Special D ietary Uses reported that it had concluded th at its scope of activity included both special foods for certain categories of healthy persons and also dietary foods, the use of which was connected with m orbid conditions of the hum an body. Other Matters Considered The Commission was inform ed by the Swiss delegation th at it would be willing to assum e the chairm anship of a Codex Com m ittee on Soups and Broths. The significant expansion in international trade in soups and broths was noted by the Commission. However, it was pointed out th at there are innum erable ingredients in soups and that in some countries there was a preponderance of dried soups, while in others canned soups were the favorites. It was also pointed out that new products such as frozen soups were gaining an increased importance. It was concluded that these products could not claim a high position, particularly as they were at present of little interest to developing countries. Mr. Grange pointed out that the U nited States had reservations about the advisability of any standards for soups outside of those relating to additive and labeling requirem ents. The delegation of Sw itzerland undertook to prepare a study on the regulations for soups and broths in the various countries and the im portance of these products in world trade, in conjunction w ith the Secretariat. T his paper will be distributed to governm ents for com­ m ent and will be reviewed at the next session. The Commission also considered a paper prepared by the Secre­ tariat on the subject of Codex standards for edible ices. It was reported that the Comm ittee on Milk and Milk Products m ay consider standards for such products which contain milk ingredients at its next session. Mr. Grange reported that the United States felt that no standards for these products should be elaborated at this time. The Commission was generally of the opinion that on the basis of informa­ tion presently available to it. international trade in edible ices did not appear to be such as to w arrant consideration of Codex standards for these products. The European Economic Com m unity (E E C ) reported that it now has in force standards for colors and preservatives, th at the CODEX ALIMENTARIUS COMMISSION PAGE 279 standards for antioxidants will be issued soon, that it is working on food standards for additives and m ethods of analysis, and th at drafts are being proposed for packaging m aterials and labeling of preserved or canned foods and dietetic foods. Progress Made at Fifth Session As indicated by the foregoing, while m any disturbing problem s were disclosed at this session, it appears on the other hand th at much sound influence was brought to bear for the achievem ent not only of harm onization but also reasonable regulation as the basis for it. Intelligence, ability to give a little and the overriding requirem ent for agreem ent on standards prevailed in most instances over nationalistic or narrow-m inded interests. Mr. Grange, his assistant, Mr. F. Robert Anderson, and all the other members of the U nited States Delegation w orked faithfully and effectively to this end. They deserve the warm com m endation of Am erican industry. Those desiring a more detailed report on this m eeting may secure it by w riting to : U nited States FAO Inter-A gency Sub-Com mittee on Codex A lim entarius A griculture M arketing Service United States D epartm ent of A griculture W ashington, D. C. 20250 [The End] DR. GODDARD RESIGNS AS FDA CHIEF Dr. James L. Goddard, Commissioner of the Food and Drug Adminis­ tration for 28 months, resigned on May 21, 1968, effective July 1, 1968. Dr. Goddard stated that he was retiring for personal reasons after more than 21 years in public service, which had been "deeply satisfying.” H E W Secretary W ilbur Cohen accepted the resignation of “one of our finest public servants . . . with great reluctance.” Dr. Goddard, who is 45, will direct a regional office of E D P T ech­ nology, Inc., and specialize in the use of data processing and inform a­ tion system s in the area of medicine. A t press time, no successor had been announced. PAGE 280 FOOD DRUG COSMETIC LAW JOURNAL----MAY, 1968 Persuade Juries, Win More Cases with Applied Psychology ANATOMY OF A TRIAL By Alan E. Morrill H ere's sound advice to help you develop the unique quality of "persuade- ability." The quality that sets some lawyers apart as true professionals. 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