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of tolerances limiting the amount of poisons for the protection of the public health. Such regulations are obviously essential in the light of the increasing complexities of food production. The regulations here authorized will be subject to the same procedure of judicial review as that followed in reviewing standards of quality under the McNary-Mapes amendment to the present law. This procedure is expressed in this bill in section 702. Any regulations that might be administratively announced under the authority of this section and in accordance with the procedure outlined in section 703 would be held invalid by the courts if they were unreasonable, arbitrary, capricious, or otherwise not in accordance with law, as, for example, would be the case if there had not been taken into account the extent to which the poisonous substance is required or unavoidable in the production of the article.
Paragraph (b) of this section authorizes the certification of coaltar colors for food. The purpose of this was discussed in connection with paragraph (c) of section 301.
SECTION 305. EMERGENCY PERMIT CONTROL
Section 305 authorizes the Secretary of Agriculture to place food factories under temporary permit control in those infrequent instances where the commodity, by reason of contamination with microorganisms during manufacture or packing, may be injurious to health and the injurious nature cannot be adequately determined after interstate shipment. The provisions of this paragraph could be invoked only in those instances where public health could not be adequately protected by the other provisions of the bill. As an illustration may be cited certain highly perishable food of such character that it furnishes good media for the growth of typhoid or other fecal organisms with which it may become contaminated through insanitary factory conditions. Laboratory methods to detect such organisms are not only time consuming but, at best, are uncertain. Such food moves into consumption so rapidly that the other provisions of the bill could not be applied in time to safeguard the public. The permit control could not become permanent, but would remain in effect until the safety of the product could be assured. It would be applied only in those localities where the situation requires it, if the difficulty is localized rather than Nationwide.
Regulations requiring permits would be set up with the advice of the Public Health Committee. These regulations, as well as others authorized by the bill, would be subject to court review. In order to provide means for the effective operation of this section in its purpose to protect public health, the inspection of factories operating under permit is authorized.
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 its labeling or advertising. There are no useful drugs which would be banned from the market under this provision, since labeling with proper directions for use would remove any worth-while drug from this ban.
Under the present law, which contains no provision of this character, there have come on the market a number of dangerous drugs from the use of which many authenticated cases of death and impairment of health have been reported. So long as their labels bore no false or misleading statements, the public could not be protected from these menaces.
It will be noted that this provision in S. 5 differs from a similar provision in at least one of the bills considered by the last Congress, in that the words “ or may be ” have been deleted before “ dangerous to health.” This is for the reason that there are certain drugs whose employment is necessary in the treatment of some diseases which, none the less, may in very exceptional cases prove harmful to persons to whom they are administered. Their action in such circumstances is comparable to the allergic action of eggs and other common foods, which was discussed in connection with paragraph (a) of section 301. It is not intended that this provision should ban the sale of useful drugs of this kind when they are appropriately labeled. On the other hand, it is not intended that the existence of these drugs shall constitute a cloak under which may hide the manufacturers of unnecessary and dangerous medicaments; or even necessary medicaments with improper or insufficient directions for use that result in the death or injury of susceptible persons in any considerable number of instances, even though most persons could use them with safety.
Much criticism has been launched at this provision on the ground that it applies to innocuous drugs for which extravagant therapeutic claims are made and which thus indirectly impair the patient's chance of recovery through his postponement of proper methods of treatment. The language does not relate to such products. It applies only to potent drugs which are per se harmful unless properly administered.
Subdivisions (2) and (3) of this paragraph deal with filth, decomposition, and 'insanitary conditions, and are parallel with the similar provisions on food in section 301. Subdivisions (4) and (5) of this paragraph deal with poisonous containers and the use of certified coal-tar dyes.
Paragraph (b), concerning so-called “ official” drugs, is essentially the same as the present law, with the exception that drugs recognized in the Homeopathic Pharmacopoeia are subjected to the same control as that prescribed in the present law for those recognized in the United States Pharmacopoeia and National Formulary, This paragraph provides that the drugs recognized in these official compendia shall comply with the standards of strength, quality, and purity set forth in those publications unless they are labeled to show wherein they differ in these respects. Provision is also made for supplementing the official tests for strength, quality, or purity when such tests are not provided, or, as is infrequently the case, are inadequate for the purposes of regulatory control. Regulations prescribing such tests could be issued only after the official revision committee has failed to act, and would be under the control of the Public Health Committee.
Paragraph (c) requires merely that nonofficial drugs live up to their own professed standards of strength, quality, and purity.
Paragraph (d) is analogous to certain provisions with respect to food contained in section 301 (b), banning the use of substitutes and of adulterants which reduce strength or quality.
SECTION 402. MISBRANDED DRUGS
Section 402 (a) defines drugs as misbranded if their labeling is false or misleading in any particular. It then provides that a drug shall be deemed to be misbranded if any representation of effect is not sustained by demonstrable scientific facts or substantial and reliable medical opinion.
This paragraph is designed to apply to misrepresentations of every kind, whether couched in terms of fact or opinion and whether made directly or indirectly.
An explanation is called for concerning the special rule set up for judging the truth or falsity, of claims of effect. There exist now, and perhaps always will exist, differences of medical opinion with respect to the effect of drugs. Any attempt to regulate by law in those fields where honest differences of opinion exist between groups of qualified practitioners is contrary to public interest. The bill, therefore, avoids entry into these controversial fields and places upon the Government the burden of proving that there is neither substantial and reliable medical opinion nor demonstrable scientific fact in support of the claims made. Certainly, before a manufacturer undertakes the grave responsibility of offering preparations for the prevention or treatment of disease he should determine that his preparations have at least the foundation here required.
This requirement of the bill will not discourage research for new remedies or new uses of old remedies since any valid claim can be substantiated by demonstrable scientific facts revealed by the research. In the phrase “ demonstrable scientific facts ", the word “ demonstrable" is perhaps redundant, but it is used for the sake of emphasis. The establishment of a truth by scientific means is in itself a demonstration of that truth. A fact so established can be demonstrated again at will by competent scientific workers. It is not intended that the mere speculative theories or working hypotheses of certain scientists or groups of scientists shall serve as the basis for claims for the effect of drugs, except insofar as those theories and hypotheses have become embodied in substantial and reliable medical opinion.
The expression substantial and reliable medical opinion” is intended to mean contemporary opinion shared by some numerically significant group of competent and reliable practitioners, including recognized experts in the field in question. A drug labeled with claims in accord with the views of such a group would not be actionable under this provision, even though other and larger groups believed the claims to be false. It is not intended that the unscrupulous may shield themselves through bringing up in support of their claims the opinion of a few practitioners, employed for the occasion, whose expressed views are at variance with either demonstrable scientific facts or the consensus of medical opinion in the field in issue. It is likewise not intended that there shall be cited in support of claims, opinions expressed in archaic medical literature but no
jonger held by any substantial medical group. If medical opinion is the sole criterion of the truth or falsity of a claim, that claim, in all fairness to the prospective users of a drug, should be sustained by the honest views current in a numerically significant group of competent and reliable practitioners, among whom are experts in the field in question.
Your committee has stricken out the phrase “ in every particular” from the sentence "Any representation concerning any effect of a drug shall be deemed to be false under this paragraph if in every particular such representation is not sustained by demonstrable scientific facts or substantial and reliable medical opinion.” The words“ in every particular" are redundant. Their deletion does not lower the standard required. If a representation concerning any effect of a drug is true, it is true in every particular. If the representation is not true in every particular, it is false. The language here used is intended to be comprehensive in order to avoid abuses arising out of decisions under the present law, under which it has been held that broad claims of therapeutic effect are justified where the drug has any palliative action whatever, even though the drug exercises no influence on the progress or duration of the disease. For example, in one outstanding case it was held that the words " for pneumonia” were justified, even though witnesses both for the Government and for the defense agreed that the drug had not the slightest remedial effect, but merely made the patient momentarily more comfortable. A hot-water bottle applied to the feet or a draft of fresh air would, perhaps, contribute the same result. Such broad claims where only a palliative result can be accomplished are grossly misleading to the lay public. Consumers construe such expressions as indicating that the article is an effective treatment for the disease itself. Half-truths may be more dangerous than outright falsehoods.
The language of the bill is designed to prevent the use of claims of misleading breadth and to require that all representations be limited to the actual value of the drug. If a drug has valuable remedial effect for a disease but cannot be relied on to cure it, any reference to the disease in the labeling must be so definitely and specifically qualified that the lay public, unfamiliar with the cause and treatment of disease, can fairly appraise the limits of the remedial action and will not be induced to believe that a cure can be had by using the medicine. With claims for drugs thus limited to what they will actually accomplish, and free from all representations which may mislead those who are untrained in the healing art, consumers will not be induced to rely too extensively on medicaments which are merely palliative, with the loss of valuable time in the adoption of more effective treatment where such is needed. A provision of this kind is essential if the public health is effectively to be protected and if the consumer is to be afforded an opportunity for, and encouraged in, the intelligent and effective use of drugs.
From the public health standpoint this paragraph of section 402 is perhaps the most notable improvement in the whole bill over comparable provisions of the present law. The law now imposes on the Government the responsibility of showing that unsupported claims of effect of drugs were made fraudulently by the manufac
turer; that is, with a willful knowledge of their falsity or, at least, with a wanton and reckless disregard of the truth. This burden is a serious handicap to the effective protection of the public against fake nostrums because it involves proof of the manufacturer's state of mind. It is of no consequence to the victim of such nostrums whether the representations were made in good faith or not. Furthermore, the present law places a premium upon the ignorance of those who assume the responsible role of treating disease. The more ignorant the individual who makes unsupported claims the more difficult it is to show that he did so with a knowledge that they were unsupported
Section 402 (b) requires packaged drugs to bear the name and place of business of the manufacturer, seller, or distributor, and an accurate statement of the quantity of contents. These provisions are identical with those made for food in section 302 (e).
Paragraph (c) of this section prescribes that information required on the label by the act be prominently placed thereon in intelligible terms. It is identical with section 302 (f) on food.
Paragraph (d) of this section requires that drugs containing habitforming narcotic and hypnotic substances be labeled with a statement showing the quantity or proportion of such drugs and with the legend, "Warning-May Be Habit-Forming.” Exception is made for drugs dispensed on physicians' prescriptions. Under the present act merely a label declaration of the names and quantities of certain narcotic substances is required. This has proved insufficient to give fair information to consumers, since the habit-forming properties of many such articles are not commonly known. Many drug addicts have innocently acquired the habit because drug labels did not give sufficient warning of the habit-forming properties of the article. The drugs listed in this paragraph, together with their chemical derivatives, include all habit-forming narcotics or hypnotics listed in the present law and other such drugs which have come into more or less general use since the law was passed. The language used in regard to narcotic or hypnotic drugs, chemically derived from those specified in the paragraph, is based upon an opinion of Attorney General Bonaparte rendered January 15, 1909, interpreting the present Food and Drugs Act. It is intended to bring within the operation of this paragraph all substances, other than those clearly not habit-forming, which are closely related chemically to the specified drugs, even though in actual manufacturing practice they may not be directly derived from such drugs. In this respect the bill embodies an administrative practice of long standing. It would be impracticable to name in the bill all the chemical derivatives of these substances, and new derivatives, which are frequently perfected, should be subject to the same control as that provided for the parent substances unless they are clearly not habit-forming.
Faragraph (e) of this section requires that drugs sold as other than pharmacopoeial or formulary preparations be labeled with their common or usual name, if they have such names, and if they are fabricated from two or more ingredients, the name of each active ingredient, including any alcohol. Since this does not require a disclosure of the quantities or proportions of the active ingredients, or