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of the identity of the inactive ingredients, it will not effect disclosure of the formula. But the consumer of drugs certainly has the right to know something of the identity of the active ingredients, particularly if he is undertaking to medicate himself and is thus acting the role of physician to himself. In such circumstances he has as much right, as does the physician, to know the identity of the drugs he is administering. Furthermore, with the revelation of the identity of the active ingredients on the label he will be able to avoid those substances to which he has found himself to be allergic. This provision will also restrict the practice, now all too prevalent, of selling a common drug such as bicarbonate of soda, or a common mixture like sulphur and molasses, under fanciful names at prices several times their actual value. A proviso, similar to that in the paragraph requiring disclosure of the identity of ingredients of undefined food, is added to this paragraph to permit exemption from declaring the active ingredients in appropriate cases.

Paragraph (f) requires that the labeling of drugs bear complete and adequate directions for use. Such information is usually necessary to the proper administration or use of drugs, but where it is not necessary authorization is provided for exemption from any requirement of this paragraph through the operation of the Public Health Committee.

This paragraph also defines a drug as misbranded if its labeling fails to bear such warnings, as may be prescribed by regulations set up through the operation of the Public Health Committee, against use in such pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application. There are many valuable drugs which must be administered with great care. They are just as potent for harm as for good. The mere giving of directions for use may not avert tragedy. For example, a patient suffering from asthma may take a potassium iodide preparation for the relief of the paroxysms, but if he has an arrested case of tuberculosis the drug may quickly render it dangerously active. Or the last doses of a bottle of worm medicine given without shaking before each dose may be fatal to children because the potent principle settles out on standing. Warnings against probable misuse are therefore essential to public health protection.

Paragraph (g) makes mandatory the packaging and labeling requirements of the Pharmacopoeias and National Formulary. These requirements are all designed to safeguard the integrity of drugs and the safety of their use.

Paragraph (h) deals with drugs which are liable to deterioration. Many of these drugs are of great value in emergency conditions, and reliance on them after deterioration may be fatal. Methods of packaging and storage or other handling are now known which will prevent or retard the rate of deterioration of a number of such drugs. Other methods will undoubtedly be developed. The regulations designating drugs for the operation of this paragraph will be formulated through the Public Health Committee, but no such regulation may be promulgated for a drug recognized in the official compendia until the matter has been brought to the attention of the appropriate revision committee and that committee

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has failed to act. In appropriate cases drugs can be exempted from this and other labeling and packaging requirements through the operation of paragraph (1) of this section.

Paragraph (i) deals with deceptive containers, with drugs which are imitations, and with drugs which are offered for sale under the names of other articles. The provision regarding deceptive containers is identical with that for foods under section 302 (d). The other provisions merely repeat requirements in the present law :

Paragraph (j) deals with products sold as germicides, bactericides, disinfectants, and antiseptics for use on the body. Articles of this character are widely used and are greatly relied on by the public as safeguards against infection. With the exception of inhibitory antiseptics covered by paragraph (k), discussed below, these articles are of little or no value to the user unless when used as directed they have at least the germicidal power set up by the phenol standard. It would be little consolation to the sufferer from blood poisoning to know that the antiseptic with which he had flooded the infecting germs had killed some of the weaker ones. There are many weak and impotent articles sold as antiseptics which cannot be reached under the present law. They would likewise be immune under the provisions of this bill without this paragraph because the word antiseptic is defined by dictionaries generally and has been defined by court decision under the present law as anything guarding against sepsis or that restrains the growth of putrefactive organisms. Under this definition a mouthwash which restrains the growth of bacteria during the 60 seconds it is in the mouth can be called an antiseptic, even though none of the germs is killed and all resume their growth and multiplication immediately after the wash is expectorated. Indeed, cold water is entitled to be designated as an antiseptic under this definition. It is therefore important to require that such articles, under the conditions of use the manufacturer prescribes, have a reasonably effective germicidal power. As an essential for accomplishing this result the provision requires the labeling to give adequate directions for use. The user will then be less likely to stop with a 30-second application when the drug would not be effective in less than 5 minutes, or to dilute the drug before use when it is effective only in full strength.

Paragraph (k) permits the sale as inhibitory antiseptics of those articles which are intended for prolonged contact with the body and which, during such contact, perform the useful function of preventing the growth or multiplication of germs so that the body forces have opportunity to effect repairs.

Paragraph (1) is identical with paragraph (1) of section 302 on food, and is offered for the same reason.

SECTION 103. CERTIFICATION OF COAL-TAR COLORS FOR DRUGS

This section sets up authorization for the certification of coal-tar colors for use in drugs.

SECTION 501. COSMETICS

Section 501 deals with adulterated cosmetics. Cosmetics are not encompassed within the scope of the present law. There are on

the market a number of preparations, notably hair dyes, eyelash and eyebrow dyes, complexion bleaches and depilatories, which have caused serious impairment to the health of users and, in a number of instances, have resulted in such injuries as blindness and paralysis. These injuries have been caused by such toxic substances as certain coal-tar dyes and metals like lead, arsenic, mercury, and thallium, upon which the “ beautifying ” action of the preparations depends. Paragraph (a) is intended to protect the user against such hazards to health.

It will be noted that in drafting this paragraph the same general form has been used, to avoid complications arising from allergic reaction to wholesome products, as was employed in dealing with food under section 301 (a) (2). A consideration of the language employed discloses the fact that only those products are considered as adulterated which contain poisonous and deleterious substances, and then only when those substances are present in such quantity which may render the product injurious. This would not prevent the marketing of a face powder or cream or any other cosmetic which did not contain poisonous or deleterious ingredients, even though such cosmetics might contain ingredients to which a certain class of unfortunate people are allergic. Obviously, no allowance should be made for poisonous or deleterious ingredients on the ground of allergy; a provision to that effect would perpetuate many shocking abuses.

Paragraphs (b) and (c), which deal with filthy products and insanitary conditions, are identical with provisions in the chapters on food and drugs.

Paragraph (d), concerning poisonous containers, and paragraph (e), requiring coal-tar products used in cosmetics to be certified, are self-explanatory.

SECTION 502. MISBRANDED COSMETICS

Paragraph (a) of this section is identical with the general misbranding provision on food, section 302 (a). The discussion under that paragraph is equally applicable here. Paragraphs (b) ind

(c) requiring name and address of the manufacturer and a statement of the quantity of the contents on packaged cosmetics, and providing that any required label statement be plain and conspicuous and in terms readily understood by the purchaser and user, are merely an extension to cosmetics of provisions in the food and drug chapters. The same is true of paragraph (d) authorizing exemption from labeling requirements of cosmetics while being shipped from the point of manufacture to the point of final processing, labeling, or repacking.

SECTION 503. CERTIFICATION OF COAL-TAR COLORS FOR COSMETICS

This section authorizes the certification of coal-tar colors which are harmess and suitable for use in cosmetics.

SECTION 601. FALSE ADVERTISEMENT

Section 601 defines false advertisements. Paragraph (a) covers all the commodity groups encompassed in the bill and defines the

advertisement of a food, drug, or cosmetic as false if it is false or misleading in any particular relevant to the purposes of the bill regarding such food, drug, or cosmetic. The language is similar in its import to that of the general misbranding provisions in sections 302 (a), 402 (a), and 502 (a). It imposes the same standard of truth.

The words “relevant to the purpose of this act regarding such food, drug, or cosmetic " have been added for the reason that it is not intended to apply to what is simply goodwill advertising and not an advertisement of the merits of the article, even indirectly. Such language is deemed unnecessary in the provision with respect to labeling, which does not lend itself to such representations.

This paragraph, as will be noted from the definition of advertising in section 201, paragraph (j), deals with representations of opinion as well as fact. This is to prevent the unscrupulous from expressing false representations by the simple expedient of couching their advertisements in the form of expressions of opinion. Clever copy writers would have no difficulty in conveying false representations in opinion terms. But the law has long recognized the privilege of "trade puffing", or the right of the advertiser to “put his best foot forward” in the sale of his wares. Section 601 is not intended to restrain the legitimate exercise of this privilege where it is in no particular misleading. Good advertising is not incompatible with truth in advertising, and there is nothing in this paragraph or in any other section of the bill to prevent the vivid and attractive advertisement of any and all meritorious properties of goods. The language of this paragraph dealing with representations of effect of drugs is identical with the proviso under paragraph (a) of section 402, which was discussed in connection with that section.

Paragraph (b) proscribes the advertisement of drugs for a short list of extremely dangerous diseases that cannot be effectively treated by self-medication with any drug. The purpose of the paragraph is to afford a means of summarily stopping such advertisements before victims of the diseases have been encouraged to waste valuable time in temporizing with ineffective treatment, during which the malady may progress to stages where the most skilled treatment will not avail. It is recognized that most advertisements of drugs for these diseases could be stopped under the preceding paragraph proscribing false advertising. It is nevertheless true that vendors of these outrageous “fakes", through resort to technicalities and legal delays, could continue to foist the nostrums on the public for considerable time if paragraph (a) were the sole instrument under which the Government could operate. The toll of suffering and death taken by such fraudulent preparations is so serious that authority should be provided for immediate and unquestionable action. An exception is made in the paragraph for advertisements appearing in medical and pharmaceutical journals if such advertisements meet the standard of truth imposed by paragraph (a) of the section.

SECTION 701. PROVISIONS AS TO REGULATIONS

Section 701 provides the rule-making power. The Secretary of Agriculture, to whom responsibility for enforcement is delegated, is authorized to promulgate regulations for the efficient enforcement of

the act in all cases except with respect to imports. The Secretary of the Treasury and the Secretary of Agriculture are empowered jointly to prescribe regulations for the enforcement of the provisions of the act dealing with imports, other than those phases of import procedure specifically delegated to the Secretary of the Treasury by section 714.

Section 701 also authorizes the Secretary to designate officers or employees to conduct hearings authorized or required by the act.

SECTION 702. COURT REVIEW OF REGULATIONS AND ADMINISTRATIVE

ACTIONS

In order to insure a safe and prompt review of any regulations promulgated under the act, section 702 confers jurisdiction on the District Courts of the United States, on petition of an interested person making a satisfactory showing that the enforcement of the regulation would cause him to suffer substantial damage, to review such regulation before action is instituted under it against such person or his goods. This would not abridge the right of any person to have a similar review of the regulation when defending against an action brought against him or his goods pursuant to sections 708, 711, or 712. This section likewise authorizes the courts to grant appropriate injunctive relief from any act or omission on the part of the Department or its officers, representatives, or employees in the administration of the act. The established rules of constitutional law governing judicial review of administrative action, as developed by the United States Supreme Court, would, of course, be applicable to proceedings under this section.

SECTION 703. PUBLIC HEALTH AND FOOD STANDARDS COMMITTEES

The nature of the committees provided by this section, the procedure of their operation, and some of their functions have been referred to in the discussion of sections 301 (a) (2) and 302 (g).

The chapters on food, drugs, and cosmetics authorize the establishment of regulations for the following purposes:

1. Limiting the quantity of added poison in food. 2. Certification of coal-tar colors for food, drugs, and cosmetics. 3. Establishment of definitions and standards of identity and standards of quality and fill of container for food.

4. Informative labeling as to nutritional qualities of infant and invalid food, and precautionary labeling against misuse of potent drugs which may be dangerous to infants or in pathological cases.

5. Prescribing sanitary conditions in food factories where there is danger to health because of bacterial contamination and the danger cannot be adequately controlled by other provisions of the act.

6. Prescribing methods of testing official drugs, when the official committees have failed to do so, and methods for the testing of antiseptics.

7. Prescribing appropriate methods of packing and precautionary labeling for deteriorating drugs.

While other regulations are authorized for the purpose of making exemptions or for purely administrative operations, the only regula

8. Repts., 74–1, vol. 1---29

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