SECTION 713. DUTIES OF THE UNITED STATES ATTORNEYS

Section 5 of the existing law requires United States attorneys to accept the results of investigations by the Secretary of Agriculture and to commence appropriate proceedings in the proper courts of the United States for the enforcement of the law. It also authorizes United States attorneys to institute proceedings upon the presentation of satisfactory evidence by State health, food, or drug officials. This procedure has proved both effective and satisfactory. This section of the bill would continue the same procedure in all civil actions and in criminal actions where the proceeding is upon a misdemeanor. Felonies would necessarily have to be investigated by a grand jury before a proper indictment could be returned.

SECTION 714. IMPORTS AND EXPORTS

Section 11 of the Food and Drugs Act confers authority on the Secretary of the Treasury and the Secretary of Agriculture to apply jointly the provisions of the law to articles of food and drugs offered for import into the United States, and to effect the exclusion of such food and drugs where they are found to be in violation of the law. This provision has worked satisfactorily and hence it would be continued in effect by paragraphs (a), (b), and (c) of section 714 of

this bill.

Section 2 of the existing law contains a proviso setting up exemptions for articles offered for export to foreign countries. Substantially the effect of this provision would be continued by paragraph (d) of this section. It should be noted that this paragraph would require only those goods to be marked "For export" which did not conform with the requirements of the law applicable to domestic trade.

SECTION 715. PUBLICATION

Section 4 of the present law directs the Secretary of Agriculture, after judgment in each case, to give notice of such judgment by publication. This provision has proved satisfactory within the limits of its scope, and hence will be continued in effect by the provisions of section 715 of this bill. Further specific authority would be conferred upon the Secretary to disseminate information regarding food, drugs, or cosmetics which are imminently dangerous to public health or grossly deceptive. When a product is inimical to public health or a fraud on the consumer, it is highly important that such knowledge be immediately disseminated to the public. The bill would continue the authority the Department of Agriculture has had for 30 years or more to collect, illustrate, and report the results of its investigations.

SECTION 716. SEPARABILITY CLAUSE

In the event any provision of the bill should be held unconstitutional, or its applicability to certain persons or circumstances held invalid, section 716 would serve to preserve the remainder of the act insofar as it might continue to be applicable.

SECTION 717. EFFECTIVE DATE AND REPEALS

The bill would become effective 1 year after its approval. The existing law would remain in force and effect until that date and would then be repealed. Violations of the existing law occurring prior to its repeal would be subject to its provisions after repeal so long as they are not barred by limitation statutes. The repealing provision would except from its operation the act of March 4, 1923, defining butter and providing a standard therefor; the act of July 24, 1919, defining wrapped meats as in package form; and the act of June 22, 1934, authorizing the inspection of establishments packing sea food upon application of the packers. These acts have similar application to this bill and should be preserved.

The committee suggests the amendment of the title of the act, to be found at the end of the bill, with a view to stating its purpose more accurately and comprehensively.

74TH CONGRESS 1st Session

SENATE

REPT. 361
Part 2

FOODS, DRUGS, AND COSMETICS

MARCH 13 (calendar day, APRIL 4), 1935.-Ordered to be printed

Mr. BAILEY, from the Committee on Commerce, submitted the

following

MINORITY VIEWS

[To accompany S. 5]

The undersigned members of the Committee on Commerce submit a minority report on the subject of S. 5.

In submitting this report, each of the subscribers desires to say that he is in full accord with every proper effort to protect the American public against injurious and fraudulent practices in respect to foods, drugs, and cosmetics, and further that he is in sympathy with the principles laid down by the President in his message to the Congress. There is no disposition to prevent the passage of proper and well-considered legislation. On the other hand, we are submitting this report with the view to constructive improvement of the bill, with the view to preventing undue hardships upon the innocent and at the same time providing a proper law to restrain wrongdoers and protect all consumers. Notwithstanding that the legislation has been before the Congress a considerable period, we feel that a careful review of the bill now before the Senate is necessary and that it should be extensively revised and amended. The bill expands the existing law so as to include not only cosmetics, but also the broad field of advertising drugs, foods, and cosmetics.

When the original act, known as the "Wiley Act", was adopted in 1906, the administration of it was committed to the Department of Agriculture for the reason that it dealt with foods principally, but now that it is proposed to deal not only with foods and drugs, but also with cosmetics and advertising, we suggest that it might be well to consider that we now have a Department of Commerce and a Trade Commission to which matters relating to commerce and trade might well be committed.

The undersigned call attention to the fact that a great deal is involved in the way of commerce. We are informed that the value of manufactured food and kindred products in the year 1931, accord

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ing to our census reports, at wholesale prices was $8,247,000,000; that the value of cosmetics, perfumes, and toilet articles was $158,000,000; that the value of drugs was $373,000,000, of which amount proprietary medicines account for $254,000,000.

For the year 1934 the volume of national advertising of drugs and cosmetics amounted to $55,000,000 and of foods to $52,000,000. Sales of retail drug stores, according to the census reports in the year 1933, amounted to $1,066,000,000.

It is agreed that the principal consideration is the public health, but the commercial considerations are entitled to be weighed, and while the legislation ought to protect the public health to the fullest extent, it ought at the same time to be so contrived as to help, rather than handicap, legitimate commerce.

No exception is taken to strengthening and extending the Federal Food and Drugs Act of June 30, 1906, as amended (U. S. C., title 21, secs. 1-5), popularly known as the "Pure Food Law", for which Dr. Harvey W. Wiley labored so long and valiantly. That is the appropriate approach to improved food and drug legislation. The bill S. 5, however, does not strengthen and extend that act. It repeals it.

It is the latest of numerous revisions of S. 1944, introduced in June 1933, which was revised as S. 2000 and again as S. 2800. A storm of protest arose against stringent provisions of that measure which would place undue restrictions upon legitimate commercial operations. And many provisions which aroused the apprehension of honest manufacturers have not been rejected or appropriately altered in the current revision (S. 5). Instead, practical and sound objections to provisions of the bill have been consistently ignored in the various revisions and now remain in the present one.

In hearings held by a subcommittee on March 2, 8, and 9, 1935, witnesses from the regulated industries disclosed a liberal and cooperative attitude. The record, and the public prints, disclose that representatives of the industries have endorsed practical improvements in the law. They have merely asked for a free opportunity to carry on business according to, and within, clearly defined limits that neither penalize the worthy nor allow the unworthy to practice evil ways. They have asked that courts of law and not the whims of changing Federal officials should judge whether or not alleged violators are guilty or innocent; that prohibitions be stated in the law rather than in regulations of the enforcement officers' making; that, as the potential offenses under the new legislation are increased and the scope of the enforcement officers' policing is widened, the accused be assured (actually, and not theoretically) of his day in court. Congressional authority for this legislation must be found in the "commerce clause" of the Constitution. The construction of statutes based upon that clause invariably involves intricate legal questions. The form, structure, and text of the existing law have been examined in all particulars by the highest Federal and State courts. The United States Code, Annotated, title 21, sections 1-15, discloses that practically every section of the existing law has been adjudicatedsome of the sections many times. Approximately 229 decisions and 22 opinions of attorney generals are digested in those annotations.

It is not disputed that the present law is an effectual statute in its existing scope and extent. The criticism of it, advanced in support

of new legislation, is that it requires strengthening and extension, or, in the President's words, "practical improvements." That is quite possible without discarding the statute in its entirety and, with one stroke, wiping out the clarity and certainty that exist under the court decisions and the uniformity in Federal and State statutes. It appears from the testimony at the hearings that most of the States (sometimes estimated at 46) have used the Federal statute as a model for State laws and that regulations promulgated under the Federal law are adopted, where appropriate, in the States.

It has required years to effect the clarity and authority of this statute. To discard it entirely and replace it by a new statute, differing in form, structure, and text, means years before the authority and text of a new statute can be established.

Further legislation on this subject should be directed, through revision of the existing law, to preventing adulteration, misbranding, and false advertising of foods, drugs, and cosmetics in interstate commerce and not to regulatory control of the food, drug, and cosmetic industries. The bill is directed to the latter, and, accordingly, authorizes inordinate bureaucratic control, fostered and enforced by elaborate provisions for Federal inspection and licensing, severe punitive penalties, delegations of wide authority, establishment of extralegal committees, and discretionary exercise of drastic and extraordinary legal processes.

SECTION 401. ADULTERATED DRUGS

Section 401 (a) (1) defines a drug as adulterated if it is dangerous to health under the conditions of use prescribed in the labeling or advertising thereof. For administrative purposes, of course, that means if the enforcement officer considers that the drug is dangerous to health under the conditions of use prescribed in the labeling or advertising. Violence is done to the English language and, potentially, to legitimate industry by such a provision.

Adulteration is wholly a matter of composition, not of description. However commendable the purpose of this provision, it does not justify an attempt to pervert the accepted meaning of common words and to distort misbranding into adulteration. Obviously, the offense is one of labeling or advertising-branding-and the provision should be transferred to section 402 on misbranding. The importance of the transfer of the provision to the misbranding section is emphasized later in connection with the extraordinary seizure powers. The bill makes no distinction in that connection between misbranding and adulteration, subjecting both to multiple seizures. Some distinction is not only reasonable but highly important in a bill with so many potential offenses of an academic or technical nature, including differences of opinion and administrative attitudes.

Section 401 (b) provides that the tests or methods of assay set forth in the United States Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, or the National Formulary shall be the tests or methods of assay for determining the standards of strength, quality, and purity of drugs whose names are recognized in those compendiums. However, the Secretary is authorized by the bill to prescribe changes in such tests or methods of assay or to prescribe added tests and methods of assay by regulations if the body charged