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advertising, and sale of drug products, and they ought not to be regulated under the provisions applying to foods.

The result of putting confectioneries (medicated as well as unmedicated) in the category food and in not excepting medicated foods from the classification is to give to the Food and Drug Administration the power to wipe out the business of manufacturers of laxative candies, medicated gums, laxative breakfast foods, medicated fruits, and the like. This is accomplished in the bill by including a proper provision that the Secretary of Agriculture may, by regulation upon notice, forbid the incorporation of any poisonous substances in foods (sec. 10) and by providing that, to do so, all he has to do is “to find” that the poisonous substance or drug is or may be injurious to health" (which means "may possibly be") "taking into account other ways (evidently ways other than according to the directions on the product) in which the consumer or user may (i.e., 'may possibly', not 'may reasonably') partake of or be exposed to" it. Without the inclusion of the unqualified "mays" and the latter provision (which enables the Secretary to base his findings upon what might happen if a person tried to commit suicide with the product or if he totally disregarded the directions) the section would not be unreasonable. There is more danger to human life in bichloride of mercury tablets and in many other drugs frequently kept in the medicine chest than there is in these medicated breakfast foods, gums, and candies. The definition of food-without reference to section 10-seems harmless enough, just as the threatening character of the power conferred by section 10 is not apparent unless read with reference to that definition.

The logical way to exclude this effect is to rewrite the definitions of "food" and "drug" so that the kinds of products I have referred to will be classified-as they should be classified-under "drugs".

The other definitions in this section do not require special comment except to point out that the term "drug" is defined broadly enough to include mechanical appliances used to correct body infirmities and that the term "cosmetic" is defined so that cosmetics can be brought under the operation of the new law. I think there is sufficient reason to bring such mechanical appliances and cosmetics under Federal regulation.

One other point. The definitions distinguish between "label", "labeling", and "advertisement". The term "label" is limited to the principal labels upon the immediate container and upon the outside of any container or wrapper of the retail package. The term "labeling" includes labels and extends to all written, printed or picture material enclosed in, or accompanying, the product, and thus clears up a point concerning which there has been some question, namely whether the Food and Drug Administration had jurisdiction over printed matter enclosed in the package but not specifically referred to on the label. The definition of the term "advertisement" is broad enough to include all written, printed or verbal representation of fact "or opinion" regarding the product whether in booklet, leaflet, poster, periodical advertising, letters, or statements made by salesmen, and includes a means of advertising that needs regulation badly, namely radio advertising. In my opinion, the definitions of "label" and "labeling" are satisfactory and I think that it is very desirable that the provisions applying to advertising be extended to radio advertising.

I have said that the definitions for "food" and "drug" should be rewritten. The following could be improved, no doubt, but as a suggestion I submit the following definitions for those two terms and for "cosmetic":

Section 2: As used in this act, unless the context indicates otherwise:

(a) The term "food" includes all substances and preparations other than drugs, designed, advertised, or represented in labeling thereof, to be eaten or drunk by man or other animal.

(b) The term "drug" includes (1) all substances and preparations then recognized in the United States Pharmacopoeia or National Formulary or supplements thereto; and (2) all substances, preparations, and devices represented in labeling or advertising thereof for use in or on the human or animal body in the cure, mitigation, treatment, or prevention of disease or to affect the structure or function of such body or of any part of it.

(c) The term "cosmetic" includes all substances, preparations, and devices other than drugs and foods represented in labeling or advertising thereof for use in cleansing or caring for the surface, or any part of the surface, of the human body including eyes, ears, nose, mouth, teeth, lips, throat, nails, scalp, and hair. Some such definitions as these would bring under the operation of the provisions applying to drugs anything to be eaten or drunk and all substances, preparations, and mechanical devices, for which any medicinal, curative, remedial, or therapeutic claim or representation for use in or on the human or animal

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body is made; anything to be eaten or drunk and for which no such claims are made, would fall under the classification "food" where it belongs; and any substances, preparations, or devices for which no such claims are made and which are not to be either eaten or drunk but which are for use in cleansing or caring for the surface of the body would come under the category "cosmetic". With this kind of definitions in section 2, section 10 would probably be quite proper. Section 3. It should be noted that the bill provides that a food shall be deemed adulterated if it is "or may be" dangerous to health or if it has been prepared, packed, or held under unsanitary conditions whereby it "may" (a) (4) have become contaminated; also if any substance has been mixed or packed therewith so as to increase its bulk or weight, "or" reduce its quality or strength "or" create a deceptive appearance. Inasmuch as almost any product which comes within the definition of the term "food", could possibly be "dangerous to health" if it has been prepared, packed, or held under conditions less than ideal, it is unfortunate that the bill does not include the word "reasonably" to make the sentence read that the food shall be deemed to be adulterated if it is or may reasonably be dangerous to health. Most, if not all, food products could become contaminated when prepared, packed, or held under unsanitary conditions, and the term "unsanitary" is relative and indefinite; hence this provision is very far reaching and capable of great extension by judicial and executive interpretation. Since "contaminated" and therefore "adulterated" foods "may", by reason of conditions surrounding the manufacture, processing, or packing thereof, be injurious to health and since frequently it could be plausibly argued that "such injurious nature cannot be adequately determined after such articles have entered interstate commerce" (section 12), this provision has an important bearing on section 12 covering licenses or permits and regulations by the Secretary, and strengthens the power of the Secretary to manage or "regulate" all manufacturers of such products and to close them up if they do not secure a license from him or if "any of the conditions of the permit have been violated" (section 12). It is difficult to anticipate fully how much trouble for manufacturers, advertisers, and publications may be implicitly contained in the provision that any food product is "adulterated" if any substance in it increases its bulk or weight, reduces its quality or strength, or creates a deceptive appearance; it clearly strikes at all fillers", at all substances that may be held to be fillers even though they may be of value, such as limestone and other minerals which may furnish needed calcium and phosphorus in poultry or animal foods.

The provision (a) (1) and (2) corresponds pretty closely to section 10 and both are very dangerous to manufacturers of medicated foods, gums, candies, and the like in view of the definition of the term "food." But this could be remedied by defining the term "food" so that it would exclude from that category any sub. stances for which medicinal or therapeutic claims are made. It does not appear to me, offhand, that (3), (5), or (6) under (a) of this section are objectionable. It is impossible to anticipate how broad effect may be given to (1) and (2) under (b) of section 3 which provide that any food products shall be deemed "adulterated" (and therefore subject to all provisions relating to adulterated foods) "if any valuable constituent has been in whole or in part abstracted therefrom or if any substance has been substituted wholly or in part therefor"; for example, in the manufacture of ordinary white flour the wheat embryo (which is a rich vitamin source) and other parts of the wheat, such as its bran, are removed and each of those certainly constitutes a "valuable constituent" of wheat flour. It is frequently desirable to incorporate some other substance in a food product, such as something like cornstarch in salt to prevent it from lumping or caking, and such incorporated substance might, by departmental construction, be held to be "substituted."

Provision (b), (2) and (4) of section 3 should be omitted or changed and a provision forbidding the use of "fillers" should be included in their place. Then in section 2 (definitions) the term "filler" should be defined. It could be defined somewhat as follows:

"Any substance or ingredient in any food which is of no substantial nutritious value and serves no reasonably useful purpose or, if it does serve a reasonably useful purpose, is in a proportion unreasonably in excess of what would be sufficient and adequate for such purpose or purposes."

I am not sufficiently acquainted with the confectionery industry to appreciate whether provisions (c) and (d) of section 3 are subject to reasonable criticism. Section 4: My observations on section 3 apply pretty much to section 4, which covers the adulteration of products falling within the category of drugs. But it is to be noted that they are not to be deemed adulterated simply because they "may" possibly be dangerous to health regardless of how taken or used (see

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supra, sec. 2, and infra, sec. 10); to be brought within this provision it must appear that they "may" be dangerous to health when used according to the directions in the labeling. Since most drugs could be dangerous if misused, this is a wise limitation, because medicated foods and confectioneries are really medicines or drugs and bear, or should be required to bear, proper directions for their use, the term "food" should be so defined as to exclude medicated foods and confectioneries and foods and confectioneries for which therapeutic claims are made, so that they would come within section 4 instead of under (a) (2) of section 3 and under section 10.

Section 5: This section prescribes under what conditions cosmetics shall be deemed to be adulterated; under its provisions a cosmetic is not adulterated simply because it "may be injurious to the user. such that "it is or may be injurious to the user under the conditions of use pre"" To be adulterated it must be scribed in the labeling thereof, or under such conditions of use as are customary or usual" or if it bears or contains any poisonous or deleterious ingredient prohibited or in excess of the limits of tolerance prescribed; this probably is as it should be. It properly takes into consideration directions for use of the product, just as such directions should be taken into consideration for medicated foods and confectioneries. (See, supra, secs. 2 and 4, and infra, sec. 10.)

Section 6: This section contains general provisions regarding misbranding that are applicable to all three kinds of products, foods, drugs and cosmetics. The provision (a) that a product is misbranded if it carries any false statement or by ambiguity or "inference" creates even any misleading impression regarding any food, drug or cosmetic is not limited to the label or labels; it extends to the "labeling" which includes all matter that accompanies the product. This provision omits all such words as "fraudulent" and "intentional," so that honest belief, upon adequate investigation, of the truth of a statement or possible implication is no defense. Instead of "by ambiguity or inference creates" the provision should read "by ambiguity or implication may reasonably create (The writer, label or labeling implics; the reader infers something that may or may not be implied. The manufacturer, packer or seller should not be held responsible for inferences that may be drawn unless they are reasonably implied.) Provision (a) is very broad and is very dangerous in view of the heavy penalties and penitentiary sentences provided in section 17 for selling in interstate commerce any "misbranded" product, and especially because of the indefiniteness of the term "false impression.

The second provision (b) of this section extends misbranding to a failure to state on the label (1) the name, place of business of the manufacturer, distributor, etc., and (2) an accurate statement of the quantity in terms of weight, measure or numerical count as prescribed by regulations of the Secretary, and provides that he can establish reasonable variations for small packages of foods and cosmetics (not drugs) and may make exceptions regarding canned foods labeled elsewhere than where packed. The third provision (c) is that such required information must be set out prominently and clearly on the label.

Section 7: This section relates to the misbranding of foods; it covers fill, name, imitation of other foods, identity, and quality. The last provision requires that if the product is represented as a food for which no definition of identity has been prescribed by regulations it is misbranded if its label fails to state the common or usual name of the food, if any, and the common or usual name of each ingredient in order of predominance by weight. This requirement for naming ingredients in order of weight is impractical. Finally, comes the customary "omnibus" provision authorizing the Secretary to prescribe by regulation any further information for the label as he may deem necessary to protect the public from deception, under which he could plausibly claim authority to require statements of all percentages and complete disclosure of formula; like the requirement for complete disclosure of the formulae on drug products (see comments under (e) of sec. 8), this would be unfortunate, as in the case of valuable trade secrets in the composition of perfectly harmless dressings, sauces, or in nice blends of seasoning and the like. to put any limitation on an otherwise arbitrary discretion. The word "reasonable" or "reasonably" does not occur

Section 8: In this section are the provisions prescribing what constitutes the misbranding of drug products. The first provision (a) (1) enacts that wherever the labeling (not label) mentions the name of any disease for which the product is not a "specific cure" although it is a "palliative" it must bear "in juxtaposition with such name and in letters of the same size and prominence," a statement that the product "is not a cure for such disease." This is unreasonable and is designed to hurt seriously the sale of package medicines which, although not "specified cures are of real value as aids in the treatment of diseases. When it

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is considered that there are only three or four drugs recognized as "specifics," the broad effect of this provision is more apparent. It would be much more reasonable and fair if this provision read: “If its labeling bears the name of any disease for which the drug is not a specific cure but is a palliative, unless the labeling, by appropriate language, clearly and fairly indicates or represents that the product is no more than a palliative or of value as an aid in the treatment of such disease." This would serve the proper purpose of any such provision and would not require such statements as This product is not a cure for" such disease, immediately following every reference to the disease. Inasmuch as the labeling must be truthful and adequate, the only effect of this provision would be to seriously interfere with sales of package medicines.

"

The next provision (a) (2) would seriously discourage the development of any new products for the alleviation of human suffering. It provides that the labeling cannot bear any representation "directly or by ambiguity or inference" (implication?) concerning any effect of the product "which is contrary to the general agreement of medical opinion", even though the statement may be absolutely truthful. If the research department of some company manufacturing drug products, say Merck, Eli Lilly & Co., Squibb, or Parke-Davis & Co., should develop a new product for the successful treatment of a condition or disease which has theretofore been generally regarded as incurable, or has not been generally recognized as susceptible to beneficial treatment by that new drug or combination of drugs, how can it market the product? Must it first make a complete disclosure of the secret formula (so that all who wish can imitate or duplicate the product) and, then by an expensive course of education, first teach members of the medical, dental, and veterinary associations what it has learned only at the expense of patient, constructive research work? And here, as elsewhere in the act the words "by ambiguity or inference" are very dangerous and susceptible to broad extension by judicial or departmental interpretation. This provision would effectively remove incentive for expensive, valuable research work by private institutions and individuals. The term "general agreement of medical opinion" is altogether too indefinite for a statute which is, like this one, criminal.

Provision (b) of this section provides that if a drug product is for internal use by man and contains any quantity of any of certain named narcotic or hypnotic substances it shall be considered misbranded unless it bears the name of such substances and the quantity or proportion of them with the statement, in juxtaposition, "Warning, may be habit-forming." And it provides that the Secretary may designate as narcotics and hypnotics such other substances as he may find to possess those properties. Probably some such provision is advisable; I am not sufficiently familiar with the properties of drugs to express an opinion whether some of those named should be omitted or whether others should be included in the list.

The next provision (c) of section 8 provides that any product is misbranded if it contains any quantity of ethyl alcohol, ethyl ether, or chloroform, and fails to bear on its label a statement, as prescribed by the Secretary, of the quantity or proportion of such substance. This is probably proper in respect of drug products for use by human beings but I do not appreciate why this provision should, any more than the preceding provision (b), be applied to products for veterinary use. But, unlike that preceding provision which is limited to drug products for interna! use by man", this one extends to all drug products whether for external use only or for only veterinary use, as well as to those to be taken internally by human beings. I do not think that the application of this provision to drug products which, according to the labeling, are for external use only or only for veterinary use, serves any good purpose unless the named drugs exist in such high proportion that it might possibly be dangerous for a human being to make use of them. A statement of quantity or proportion means but little to the ordinary layman. Probably this provision would be better if it required that when any drug product contained any of those substances in a quantity or proportion which might make its use dangerous when used as might reasonably be expected or according to directions, the labeling must bear a statement of the percentage of those ingredients and of precautions to be taken in its use. The next provision (d) of this section applies to all drug products not subject to provision (i) of this same section, that is to all except those represented as germicides, bactericides, disinfectants, or antiseptics for use on or in the human or animal body, for which that provision (i) makes other requirements regarding directions for use. Paragraph (d) provides that the labeling of all such other drug products must bear complete and explicit directions for use except as the Secretary may otherwise permit. That paragraph (i) is very objectionable and

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it would be much better if paragraph (i) were omitted and if paragraph (d) simply provided that all drug products must contain reasonably complete and adequate directions for use.

The next provision of this section, paragraph (e) applies to all drug products not subject to the provisions of paragraph (b) of section 4, therefore to all drug products except such as are, or purport to be, something recognized in the United States Pharmacopoeia, National Formulary or in any supplement thereto. Thus it hits all secret formulae. According to this provision "the name and quantity or proportion of each medicinal or physiologically active ingredient" must be given on the label. Here is the requirement for full, exact and explicit disclosure of all formulae.

In this connection I might quote one paragraph from the letter which I wrote on May 13 to Dr. Tugwell, Assistant Secretary of Agriculture, before this bill was introduced:

"I understand that there has been agitation for legislation requiring the complete formula for every drug product to be printed on the label. There is no justification for such requirement and it would be harmful. Such legislation is strongly advocated by the American Medical Association and the American Dental Association but those associations are not at all averse to governmental action that would injure the business of even ethical manufacturers of package medicines. I concede that when a product contains dangerous ingredients in quantities that might be harmful, it would be reasonable to require a statement of them on the label. There is no sufficient reason to require all ingredients to be listed, and to require publication of every formula would be absolutely vicious. There is very valuable property in many secret formulae of undoubted value. I do not think such legislation could be made to apply to existing products, because that would amount to depriving the owners of the formulae of property without due process of law. And for it to be enacted to apply to future products when a reasonable protection of the public does not require that, would simply injure the business of reputable manufacturers who now spend much in pure research work to develop valuable products, would discourage them from this constructive work and would make them common prey of trade pirates who would imitate their preparations and adopt identical statements of formulae. Legislation requiring statements of ingredients should go no further than is necessary to protect the public from physical injury. If a product is of no value or if its therapeutic claims are unwarranted it should be retired from the market by the Administration acting appropriately; but in a vain effort to prevent worthless products from appearing, legislation should not be enacted that would require the publication of all formulae and thereby injure and destroy legitimate business and deprive the public of the advantages flowing from the research and initiative of package-medicine manufacturers. There is a proper field for members of the American Medical Association and there is a proper and useful field for manufacturers of high-grade package medicines; neither should be permitted to force through legislation not required for the public welfare and designed to benefit that class of citizens to the injury of the other class and of the public." A provision requiring full disclosure of all formulae for drug products on their labels would be:

(a) Unnecessary for the protection of the life, safety or health of the publicexcept possibly in case of products containing dangerous ingredients in quantities that might be harmful, and in such cases there would be no need for complete disclosure of the formulae and a statement regarding such ingredients and precautions to be taken would be sufficient;

(b) Useless because a statement of formula means nothing to the ordinary user of package medicines, and just so that doctors can prescribe such commercial products by formulae, instead of by trade name, is no sufficient reason for such a provision;

(c) Unjust because it would uselessly and without reasonable necessity wreck the package medicine industry-just for the benefit of a professional class; and (d) Very unwise and impolitic because (1) I would deprive the public of many valuable package medicine products which are sufficiently meritorious to be commonly prescribed by doctors-just to compel people to go to a physician whenever there were need for such a preparation and to get it, or a prescription for it, from him for a fee; and (2) it would deprive the public of the undoubted benefits of private research on the part of commercial institutions since it would discourage such companies from that kind of expensive work by removing all incentive for it and compelling them to turn the fruits of their efforts, in the way of new and valuable formulae, over to trade pirates to be exploited at prices which woud be ruinous to the originators.