Besides being unwise, useless, and unnecessary, and to the manufacturers of package medicines absolutely destructive of their legitimate business and unjust, it would hurt publications which derive revenue from drug advertising very much. Why should a manufacturer spend thousands of dollars to create demand for his package medicine product when every little human parasite who wished to do so could put out the identical product at no cost for development or advertising and hence at much lower price and could prove by the published formula that the two products were identical? It is apparent that the necessary result of such a law requiring full formula disclosure would be to reduce tremendously all drug advertising. Of course, that is a very real purpose of the provision for complete formula disclosure (and is the reason why the A.M.A. lobby even agitated for a requirement that every drug advertisement must carry a publication of the complete formula of the product and also for one forbidding the use of any trade name for a proprietary product). The most effective way to destroy the package medicine industry and to secure a sort of monopoly for the doctors, is to effectively stop the advertising on which that industry depends. Other provisions in the bill which would "discourage" the advertising of drug products in publications are one defining "false advertising" in such a way that even the most prudent and ethical advertiser could not reasonably expect not to inadvertently violate the law and go to the penitentiary (see sec. 9), those fixing grossly excessive penalties and inhuman penitentiary imprisonments to which he would be subjected whenever he violates it by disseminating any "false advertisement" regardless of honest and diligent effort to obey its provisions (see sec. 17 (a) 3 and 4, and (b) and (c) of sec. 17), and the provisions making the publishers, advertising agencies, and radio broadcast licensees subject to the same penalties for all such violations on the part of any of their advertisers (see sec. 17 (a) 3 and 4, (b), (c), and (d)). The bill surely and effectively "discourages" drug advertising.

As if the provision for complete formula disclosure were not enough, another "omnibus" provision is tacked on authorizing the Secretary to require any further information on the label as he may deem necessary to protect the public health, and here again there is no such limiting word as "reasonable" or "reasonably."

Paragraph (f) of section 8 simply provides that if the name of the product is the same as, or simulates a name recognized in the United States Pharmacopoeia or National Formulary or any supplement thereto, it shall be deemed misbranded unless it is packaged and labeled as prescribed therein. There is probably nothing objectionable about this provision.

Paragraph (g) of section 8 relates to products likely to deteriorate and provides that they must be packaged in such manner, and that the label must bear such statements for precautions, as the Secretary may prescribe for the protection of the public health and authorizes him to designate such drugs as he may find to be liable to deterioration, without any qualifying word or words to limit his authorization to reasonable findings or reasonable regulations.

Paragraph (h) provides that a drug product shall be deemed misbranded if its container is so made or shaped or filled as to mislead the purchaser or if it is an imitation of another drug or if it is offered for sale under the name of another drug. This last provision extends into the field of infringements of trade marks, trade names, and of unfair competition, and it would confer upon the Secretary jurisdiction in a broad field in which heretofore jurisdiction has been exercised only by the courts.

Paragraph (i) of section 8 is very serious and objectionable to manufacturers of drug products which can be designated as germicides, bactericides, disinfectants or antiseptics. It provides that any such product is misbranded if it is represented to be of such character and for any use on or within the human or animal body unless its labeling bears a statement of each such use and conspicuously "and in juxtaposition therewith, the method and duration of application necessary to kill all microorganism" with which it comes in contact when so used (unless it is represented as a germicide, bactericide, disinfectant, or antiseptic for only specific kinds of microorganisms and gives that information in respect of killing all of such specific organisms). Only germicides, bactericides, and disinfectants are supposed to kill micro-organisms; antiseptics may only inhibit the growth or multiplication of such organisms. I don't know how antiseptics are to be labeled and sold. If this becomes law it is going to be almost impossible to guarantee, as required, the conditions and time under which even germicides, bactericides, and disinfectants will kill 100 percent of the microorganisms with which they come in contact. One-hundred-percent efficiency should not be required of any medicine or drug product any more than any member of the American Medical Association should be required to have 100-percent success in treating disease cases. Some better, more practical and reasonable



provision should be written, such as that a drug product should not be represented, in labeling or advertising, to have germicidal, bactericidal, disinfectant or antiseptic properties unless, when used according to directions, it does in fact exercise such properties to an appreciable and reasonable extent that is of real benefit as an aid in the treatment of conditions for which the product is therein recommended, if any such provision is needed. But there is no sufficient reason for any provision referring specifically to germicides, bactericides, disinfectants and antiseptics; they are sufficiently covered by the other provisions of the bill applying to misbranding in general and to misbranding of drug products in particular. (See sec. 8 (d).)

Section 9: We come now to "false advertising" and paragraph (a) provides that any advertisement of any food, drug or cosmetic shall be deemed to be false if it is, in any particular, untrue or creates, either by ambiguity or "inference" (implication?), any misleading impression regarding the product advertised. What I have said under section 6 with reference to its first provision pertaining to labels and labeling is applicable to this one relating to advertising. (See sec. 6 (a).)

It should be noted that in order to amount to "false advertising," neither the manufacturer or advertiser, the publisher of the periodical or the radio broadcast licensee nor the advertising agent (with whose assistance the "false advertisement" is disseminated) need know or suspect or even have reasonable grounds to suppose that "in any particular it is untrue" or "by ambiguity of inference creates a misleading impression regarding" the product. All such words as "knowingly," fraudulently" and "intentionally" are omitted. The omission is intentional; that is clear from the fact that all such words are also omitted from section 17 (a) 3, and 4, which make "the dissemination of any false advertisement" by any means (and whether by manufacturer, wholeslaer, distributor, advertiser, publisher, radio station or advertising agency) a criminal act, and from section 17 (b) which fixes the penalties, fines up to $3,000 and imprisonment in the penitentiary up to 2 years, for "Any person who violates or causes to be violated any of the provisions of paragraph (a) of this section," and especially from (c) of section 17, which provides that "Notwithstanding the provisions of paragrah (b) of this section, in case of a willful offense the penalty shall be "imprisonment for not less than 6 months nor more than 3 years (a felony), or a fine of not less than $1,000 nor more than $10,000, or both such imprisonment and fine" for each such willful or intentional or knowing offense (with no discretion in the court to impose less than the prescribed minimum fine or imprisonment).

No matter how cautious or prudent a manufacturer or advertiser might be and regardless of all bona fide efforts on his part to scrupulously obey the law, he would be guilty and could be thrown into the penitentiary and heavily fined in any case where the Administration could succeed in convincing the jury that "by ambiguity or inference" any "misleading impression" even regarding the product could be drawn from the language of the advertisement. say in all sincerity that no regular monthly advertiser could publish advertisements that could begin to pay for their cost and reasonably expect to stay out of the penitentiary.

And if the danger to the advertiser is great the risk of the publisher or radio broadcast licensee is greater. Because the advertiser can reasonably be expected to know much more about his own one drug product, what it will do and what it will not do, than such publisher or licensee can possibly know regarding all such advertisements "disseminated" in the pages of his publication or over his radio station; if the publisher or licensee knows or has reason to think that a particular advertisement is "in any particular" false or that it could "by ambiguity or inference (implication) create a misleading impression" he is guilty "of a willful offense" and subject to the heaviest penalties

In press releases officials of the Food and Drug Administration have a number of times referred to this omission of any requirement for intention or criminal intent (that is, knowledge of falsity) in the bill as the removing of one of the "jokers" of the old law. The wording of the existing law under which a manufacturer cannot be thrown into prison for an unintentional violation of the law may be a "joke" to those officials but is no joke to the manufacturer; to him it is a matter of his good name and liberty and the honor of his family. Manufacturers, advertisers, publishers, or radio broadcast licensees cannot but regard as tragic the provisions of this bill under which they could reasonably expect to be branded as criminals and even felons and thrown into the penitentiary without having had any reason to think they were committing a crime. This feature of the bill is too serious to them to be termed a "joker"; it is for them a “hook"inserted to give the chief of the food, drug, and cosmetic control despotic power



in enforcing the law and "to discourage the public advertisement for sale in interstate commerce of drugs" (in the language of paragraph (c) of this same section) for the benefit of a small professional class.

The provisions of paragraph (b) of section 9 are analagous to the provisions (1) and (2) of paragraph (a) of section 8, but apply to any advertising (see definition of "advertisement" in sec. 2) instead of to labeling, and what I have said regarding paragraph (a) of section 8 applies to these provisions (1) and (2) of paragraph (b) of this section 9.

Consider the sales persuasion, "pulling power" or "punch", of an advertisement for a drug product which, although not an absolute "specific cure" for any disease, "is a palliative" (that is, of real value as an aid in the treatment of some disease condition-a product which is now often prescribed by physicians for such condition and is just as valuable as 99.9 percent of their prescriptions) if every time the advertisement mentioned the disease it had "to state with equal prominence and in immediate connection with such name the statement: "This product is not a cure for" such disease. Who could have thought of a more clever provision to kill drug advertising? That is what (1) of this paragraph (b) provides, and (2) extends to all advertisements of drug products the provision regarding labeling, that they are "false" if they represent, however truthfully, either "directly or by ambiguity or inference (implication?) anything concerning the effect of the product" which is contrary to the general (i.e., majority-not universal) agreement of medical opinion. (See sec. 8 (a) (1) and (2).) No one knows better than the medical men themselves how frequently the concensus of medical opinion has been, is, and will be false. The standard of truthfulness should be truth, and no man should be thrown into prison for the false opinion of others.

The next provision, paragraph (c) of section 9, prohibits the representation in any advertisement, "directly or by ambiguity or inference (implication?)" that any product has "any effect" in the treatment of a long list of specified diseases. A number of the discases listed in this paragraph are, no doubt, recognized as incurable at the present time and no member of the American Medical Associa tion can cure such diseases any more than any package medicine could cure them. But frequently doctors give or prescribe drugs or package medicines in such cases which give blessed relief to the sufferer and which, while not a specific or cure, are of sufficient assistance in the proper treatment of the incurable disease or in its proper care, to be worth while. Many members of the medical profession do not hesitate to accept fees for "treating" such diseases. Some of the diseases mentioned, such as measles or mumps, probably do not require anything more than palliative measures and proper nursing.

Certainly no package medicine should be permitted to be advertised or labeled as a specific, or cure, for any incurable disease nor should it be permitted to be represented as of any value as an aid in the treatment of any particular disease or condition unless it is of real value for the purpose. But under the provision of paragraph (a) of section 8, even if it is of value as a palliative, every time its labeling mentions any of the diseases listed in section 9 or mentions any other disease by name the label and labeling must "bear in juxtaposition with such name and in letters of the same size and prominence a statement that the drug is not a cure for such disease." That provision in section 8 ought to be enough, together with the analagous provision applying to the advertising of every drug product in paragraph (b) of this section 9, and together with the provision in paragraph (a) of section 6 and the provision in paragraph (a) of section 9 that an advertisement or label of a drug product shall be deemed false "if in any particular it is untrue, or by ambiguity or inference creates a misleading impression' regarding it. Those provisions should be sufficient. But this provision in paragraph (c) of section 9 provides that, even though a product is of very real value as an aid in the treatment or care of any of the named diseases, it cannot be advertised even as of "any effect in the treatment" of any of the diseases listed in that paragraph. It would forbid the advertisement of what is truthful. Have we come to this in legislation for the benefit of a professional class?

The effect of the provisions of this paragraph (c) of section 9 would clearly be to drum up business for members of the medical profession and advertising for the Journal of the American Medical Association, to drive people away from the druggists and to the doctors for prescriptions (which are very frequently for proprietary or package medicines). Where now the individual can get such package medicines from his druggist, the purpose of the paragraph is to make it necessary for him to first go to a physician, pay the physician his one or several dollars for the prescription and then pay the druggist a "prescription fee" for the same prod




uct with its label removed or dumped into a different container. The very language of this paragraph indicates these purposes; it states: "To discourage the public advertisement for sale in interstate commerce of drugs for diseases wherein self-medication may be expecially dangerous, or patently contrary to the interests of public health, any advertisement of a drug representing it * to have any effect * *" etc. After listing the specific diseases the paragraph then goes on to provide that such advertisements shall not be deemed to be false if disseminated only to members of the medical and pharmacological professions or if they appear "in scientific periodicals" such as the Journal of the American Medical Association, so that that Journal may get the bulk of all drug advertising and doctors may know of such products to prescribe them for a fee but so that lay people will not know of them and cannot get them without paying the doctor a fee for a prescription and the druggist a fee for "filling" the "prescription. The very language, "especially dangerous" and "patently contrary to the interests of public health” carries an implication which Congress should hesitate to make, namely that all or most self-medication is dangerous" and "contrary to the interests of public health."


Lest that implication might not be readily grasped, might be overlooked, the paragraph ends up with a provision that it shall not be construed as indicating that self-medication is safe or efficacious even for any other diseases that are not mentioned and with another "omnibus" provision authorizing the Secretary to add any other diseases to, or remove diseases from, the list, with no words to limit him to a reasonable discretion.

Section 10: This is the section which, in view of the definition of "food" in section 2, would make it possible for the Secretary, without going into court, to completely wipe out any business in medicated gums, medicated candies, medicated breakfast foods (such as laxative candies and gums, aspirin gum and the like) by simply "finding" that a child might possibly eat or chew up a whole carton of the candy or gum or that a person, intent upon suicide, might do that and by then, after notice and hearing, issuing his regulation that such laxative drug or apirin cannot be added to gum, candy, or breakfast food. The easiest way to prevent this would be to change the definition of "food" so that it would exclude medicated substances to be eaten or drunk by humans. For further comment along this line see remarks above under section 2.

Section 11: This section authorizes the Secretary to promulgate definitions of identity and standards of quality and fill of container for food products upon notice and public hearing and to amend or repeal such definitions or standards after notice and public hearing. I am not sufficiently familiar with the food industry and its problems to detect the objectionable features, if any, of this


Section. 12: Although this bill does not make it mandatory for all manufacturers of food, drug, or cosmetic products to obtain a license from the Secretary if they are to continue in business, it confers upon him such broad power that he can as a practical matter require any such manufacturer to go out of business unless the manufacturer accepts a license from him upon almost any conditions he may see fit to fix regarding the operation of the plant. The Secretary need simply "find" that the distribution of any of the products may (not that they necessarily will or reasonably may) "by reason of conditions surrounding the manufacture, processing, or packing thereof, be injurious to health" and that such injurious nature cannot be "adequately" determined after such articles have entered interstate commerce; then he may "after notice and hearing" "make such regulations governing the conditions of manufacture, processing, or packing as he deems necessary to protect the public health" and require the manufac turers, processors, and packers "to hold a permit conditioned on compliance with such regulations. Since almost any food or drug product could possibly be injurious through mistakes in preparation or compounding and since the Secretary could decide that such mistakes could not be "adequately" determined or discovered after the product had left the plant, this provision practically gives him an unlimited discretion to license any food, drug, or cosmetic manufacturers.



The next paragraph (b) of this section authorizes him to issue such permits for any such periods of time as he may by regulation prescribe and to make any regulations regarding their issuance and renewal. He is authorized "to suspend immediately upon notice' any permit that is without any warning, hearing, or opportunity for defense and without going into court; he can do this whenever he "finds" that any of the conditions of the permit have been violated", regardless of how slight the danger to health might be as a result of the violation of



some condition of the permit. No manufacturer could afford to try to question or resist even an unreasonable regulation or condition. If, after his permit has been thus revoked, the manufacturer shipped one package he could be jailed for 1 year and fined $1,000 or both; if he shipped a second package he could be fined $3,000 and put in the penitentiary for 2 years and if the court found that he did this willfully or with knowledge that his permit had been revoked the court must imprison him for 6 months to 3 years or fine him from $1,000 to $10,000 or inflict both the fine and imprisonment. (See sec. 17, (b) and (c).)

Under these provisions of section 12 of this bill the Secretary could, by regula tions and licenses or permits, control just about everything concerning personnel, formulas, methods of manufacture, equipment, plant and of working conditions because they could possibly affect health and because no manufacturer could afford to dispute his authority or try to resist.

The last paragraph (3) of section 12 provides that "any officer or employee designated by the Secretary shall have access to" any establishment operating under permit, "for the purpose of ascertaining whether or not the conditions of the permit are being complied with." Such access or permission to examine anything the inspector cares to investigate, had better not be denied because such denial is "ground for suspension of the permit."

Section 13: It is not only such manufacturers, processors or packers of food, drug or cosmetic products, as have been put under permits or licenses by the Secretary, that are subject to "inspection" by inspectors on the pay roll of the Food and Drug Administration or of the Department of Agriculture. The first paragraph (a) of section 13 provides that any officer or employee commissioned by the Secretary, if he first obtains the permission of the management, may enter any plant in which "food, drugs or cosmetics are manufactured, processed, packed or held for shipment" and may inspect it "and all equipment, methods, processes, finished and unfinished materials, containers and labels." The expression "after first obtaining permission of the" management is a "joker”, intended to make the provisions read more innocently and to conceal, on casual reading, the full import and broad application of this provision. Because, to insure that the management will not withhold such permission, the second paragraph (b) provides that whenever such permission is withheld for an inspector to do any of those things the United States District Courts can issue an injunction, either temporary (that is, before any hearing) or permanent, to restrain the movement of any products from the plant into interstate commerce, until the permission is given, and to punish summarily for contempt any violation of such injunction.

Note that the Food and Drug Administration would have to provide out of its appropriations for the salaries of inspectors and expense of inspections under section 12 and section 13. Such inspections, conditions for licensing and cancellation of licenses or permits could be carried out in a most galling and oppressive fashion. Unless I entirely misunderstand human nature and the ways of bureaucrats and their desire to extend the operation of bureaucracic activities further than Congressional appropriations will usually permit, the powers under these two sections are very likely to be exercised in such a way that the average manufacturer will elect to "voluntarily" apply for the "Voluntary Inspection Service" cleverly provided for in section 22. This will relieve the administration of all expense in the matter of managing or "regulating" his business, so that it can, without increasing its expenses or need for heavy appropriations, enlarge its force of supervisory inspectors just as far as politics and bureaucratic policy or ambitions may dictate. (See section 22).

Section 14: By this section it is provided that any common carrier, railroad, express company, steamship or truck company shall upon request of any employee of the Department permit access to, and to copy, all records showing the movement in interstate commerce of the products of any food, drug or cosmetic manufacturer. It provides that it shall be unlawful for any such common carrier to fail to permit such access to and copying of records.

Section 15: Paragraph (a) of this section should be read in connection with section 23. Together they provide that the Secretary through any employees of his Department or through any food, drug, or health officer of any State, Territory, or county duly commissioned by him, may conduct examinations and investigations, like the Federal Trade Commission, anywhere in the United States and may compel the attendance of any witnesses and production of any documents just like that Commission and that, as in the case of the Federal Trade Commission, "The findings of fact by the Secretary shall be conclusive if in accordance with law", so as to make it impossible for the courts to reverse the decision of the Secretary or his underlings if there is any evidence by which their

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