ship, procedure, and publication. Each can change them at pleasure from time to time. To construe the bill as vesting for all time to come in such indefinite agencies authority to fix drug standards for the United States, subject to no official review or control, and to make even action by the Secretary of Agriculture wait on action by any such agencies, seems to be clearly obnoxious class legislation and moreover an unconstitutional delegation of legislative authority. Should the courts hold that Congress had enacted obnoxious class legislation and attempted to make an unconstitutional delegation of authority in undertaking to make volumes and supplements formulated after the passage of the act legal standards, then so much of the act as relates to the establishment of such standards would be held unconstitutional and void, and nothing would be left in the act clearly granting to the Secretary of Agriculture the right to define additional drug standards or to modify the drug standards legally established by adopting as statutory authorities the United States Pharmacopoeia, the Homepathic Pharmacopoeia of the United States, the National Formulary, and supplements thereto in force at the time of the passage of the act.

Only by holding that Congress had intended to adopt only the United States Pharmacopoeia, the National Pharmacopoeia of the United States, the National Formulary, and supplements thereto, that were in existence when the act was passed, could the entire act be held constitutional, and such would probably be the decision of the court.

The following decisions are authority for the statement that a statute is void to the extent that it undertakes to vest in the editors and authors of the United States Pharmacopoeia, the National Formulary, or any similar publication, the right to change established standards, after the statute is passed: State v. Emery (Ohio) (1896, 45 N.E. 319); State v. Holland (Maine) (1913, 104 A. 159); Commonwealth v. Costello (Pa.) (1908, 18 Pa. Dist. 1067).

The same principle is laid down in the following decisions: State v. Crawford (Kans.) (1919, 177, p. 360); Spencer v. Hunt (Fla.) (1933, 147 Co. 282); State v. Bonham (Wash.) (1916, 161 p. 377).

In one State, California, a different rule of law has been adopted. See Ex parte Gerino (Calif.), (77 p. 166.); Arwine v. Board of Medical Examiners (91 p. 319); Beard v. State Board of Embalmers and Funeral Directors (295 p. 1052).

The enactment of the pending bill in its present form will probably fix as permanent legal standards for drugs the very standards stated in the United States Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, the National Formulary, and supplements to all of them, on the day the bill becomes a law. To avoid such an unfortunate outcome of the enactment of this bill, it would seem to be wise, frankly, to adopt as provisional standards for drugs those standards that are embodied, at the time of the passage of the act, in the United States Pharmacopoeia, the National Formu lary, and supplements thereto. If there is any outstanding pharmacopoeial authority that shows what homeopathic drugs standards are, at the time of the passage of the act, there can hardly be serious objection to the adoption of those standards in like manner but it would hardly seem desirable to pass an act now, fixing as law the standards in the Homeopathic Pharmacopoeia of the United States, the most recent edition of which was published in 1914. In addition to establishing provisional drug standards in the manner stated above, the bill should confer on the Secretary of Agriculture, with the aid and advice of a committee on drug standards, authority to fix permanent standards and to change them from time to time. The matter of a committee on drug standards is discussed elsewhere in connection with the discussion of the auxiliary advisory committees with which the bill proposes to provide the Secretary of Agriculture.

MISBRANDED DRUGS

Narcotic and other habit-forming and cumulative drugs.-Section 8 (p. 10, line 18 to p. 12, line 15) prescribes certain labeling requirements for certain narcotic, hypnotic, stimulant-depressant, sedative, and cumulative drugs. A proviso should be added exempting from these requirements physicians' prescriptions when the labels contain explicit directions for use. Authority should be given to the Secretary of Agriculture or some other proper agency of the Government to add to the lists of drugs covered by this section, as circumstances may require.

Patent and proprietary medicines.-S. 2800, the bill now under consideration. has been developed in the process of evolution from S. 1944, commonly referred to as the Tugwell bill. S. 1944, section 8, subsection (e) (p. 11, lines 1-8) provided that if a drug was not subject to the provisions of the bill relating to drugs recognized by the United States Pharmacopoeia or the National Formulary or by any supplement to either of them, its label should bear

"(1) the common name of the drug, if any there be, and (2) the name and quantity or proportion of each medicinal or physiologically active ingredient thereof."

Unfortunately, in the course of the development of the later bill, the requirement that drugs not coming within the purview of the United States Pharmacopoeia or National Formulary be labeled so as to show the name and quantity or proportion of the medicinal or physiologically active ingredients contained therein, has been omitted.

The objections of the manufacturers of patent and proprietary medicines to the disclosure of the active ingredients in their products is without sound ethical or legal basis. A manufacturer who does nothing more than prepare some common drug in an attractive form and exploit it under a fancy name at an exorbitant price should not object to his customers knowing what he has done, for if the attractiveness of the form in which he markets his product is sufficient to justify the increased price, a knowledge of its medicinal basis will not hinder sales. The sale of such a product without a disclosure of its medicinal basis amounts to little less than downright fraud. A manufacturer who discovers or invents a new drug, or a new combination of drugs, or a new way of preparing and marketing already known drugs and mixtures, that will mitigate or cure disease in a manner or to an extent not effected by other remedies. owes it to humanity. as a moral duty to disclose its formula and method of preparation.

This does not mean that an inventor or discoverer of a medicinal agent or compound that will prevent, relieve, or cure disease, may not be entitled to a just monetary return for his ingenuity, knowledge, or skill. It does mean, however, that he should obtain that monetary reward through the channels provided by law for that purpose.

"Any person who has invented or discovered any new and useful art, machine, manufacture, or composition of matter, or any new and useful improvements thereof, not known or used by others in this country, before his invention or discovery thereof, and not patented or described in any printed publication in this or any foreign country, before his invention or discovery thereof, or more than 2 years prior to his application, and not in public use or on sale in this country for more than 2 years prior to his application, unless the same is proved to have been abandoned, may, upon payment of the fees required by law, and other due proceedings had, obtain a patent therefor." (U.S.C., title 35, ch. 2, sec. 31.)

By obtaining a patent, a manufacturer of a patent or proprietary medicine is entitled to the protection of the patent laws over a period of years, in return for which protection he must disclose to the public the composition and manufacture of his product, to be available for public use after his patent expires. Of course, if one resorts to the patent laws for protection, he is not at liberty to vary the formula of his medicine from time to time to meet market conditions, a practice that may be followed in the marketing of unpatented nostrums. The patent and proprietary medicine makers' most serious objection, however, probably is that their products would not pass the scrutiny of intelligent criticism by patent office examiners, when the criteria by which they are judged are novelty and usefulness.

The manufacturer of a patented medicine who desires protection against trade competition can build up around his product, under his own trade mark, during the life of his patent, goodwill that will protect him for many years. A certificate of registration of a trade mark remains in force for 20 years, except that in the care of trade marks previously registered in a foreign country such certificates cease to be in force in such foreign country, but certificates of registration may be from time to time renewed on the request of the registrant, for like 20-year periods. (U.S.C., title 15, ch. 3, sec. 92.)

In addition to the protection that the manufacturer of a patent or proprietary medicine can obtain through patents and trade marks, he has his remedy in equity if his style of packaging and labeling be inequitably trespassed on.

In view of all these methods of protection that the law affords the manufacturer of a patent or proprietary medicine, there is no adequate reason why he should not be compelled to state on the label of his product "the name and quantity or proportion of each medicinal or physiologically active ingredient thereof." A knowledge of such ingredients would enable the person using the medicine more intelligently to adapt it to his supposed needs and to avoid the taking of overdoses and the coincident use of other medicines containing antagonists and antidotes. It is recommended that S. 2800 be amended by requiring the labels of packages containing patent and proprietary medicines to show the name and quantity or proportion of each medicinal or physiologically active ingredient.

GERMICIDES, BACTERICIDES, DISINFECTANTS AND ANTISEPTICS

While section 8, subsections (i) and (j) (p. 13, line 18 to p. 15, line 5) authorizes the Secretary of Agriculture to prescribe certain testing methods for germicides, bactericides, disinfectants and antiseptics, it fixes an arbitrary standard of efficiency, namely:

"The germicidal effect within the duration so prescribed (by the method of testing adopted) of a one to eighty dilution of phenol used by a standard testing method for 10 minutes at 37 degrees centigrade." (P. 14, lines 1-4.)

This standard has been criticized on the ground that it is not fairly applicable to all kinds of micro-organisms and all kinds of disinfectants. The remedy seems to be to authorize the Secretary of Agriculture to fix standard methods of testing and standard methods of efficiency for different classes of germicides, bactericides, disinfectants and antiseptics, and to require a manufacturer to elect the standard to which his product conforms, to state his election on the label and labeling, and to hold the manufacturer, distributor, or dealer accountable for any violation.

POISON-BEARING FOODS AND COSMETICS

Section 3, subsection (a), clause 1 (p. 4, lines 5-7) defines a food as adulterated

"If it bears or contains any poisonous or deleterious substance which may render it dangerous to health.”

Section 5, subsection (a) (p. 7, lines 2–7) defines a cosmetic as adulterated— "If it bears or contains any poisonous or deleterious substance in such quantity as may render it injurious to the user under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual."

The phraseology of these two excerpts from the bill can, with possible advantage, be standardized.

FALSE ADVERTISEMENTS

Definitions.-Section 9 (p. 15, line 7, to p. 16, line 25) defines false advertise

ments.

An advertisement of a food or cosmetic is to be deemed false if it is false or misleading in any particular relevant to the purposes of the act regarding such food or cosmetic (p. 15, lines 7-10).

An advertisement of a drug is to be deemed false

(1) If it is false or misleading in any particular relevant to the purposes of the act regarding such drug (p. 15, lines 7-10).

(2) If any representation concerning any effect of the drug is not supported by substantial medical opinion or by demonstrable scientific facts (p. 15, lines 10-14).

(3) If it contains the name of any disease for which the drug is not a specific cure but is a palliative, and fails to contain a plain and conspicuous statement, indicating that the drug is a palliative and how the palliation is effected (p. 15, lines 15-20); and

(4) If the drug is represented as having any effect in the treatment of certain-named diseases, except that such representations of effect in the course of treatment when made to members of the medical and pharmaceutical professions only are not to be deemed a violation of the law if not otherwise prohibited, nor are they to be false if they are disseminated for the purpose of public-health education by persons not commercially interested in the drug (p. 15, line 21, to p. 16, line 25).

Under the general definition of falsity in advertisement, it would be neces sary to prove, in case of prosecution, not only that the advertisement is false or misleading, but that it is false or misleading in some particular relevant to the purposes of the act with respect to the food, drug, or cosmetic advertised. It would seem better to omit the qualifying phrase (p. 15, lines 8-10) "in any particular relevant to the purposes of this act regarding such food, drug, or cosmetic," in order that the prosecution may not be hampered with a difficult and sometimes impossible burden of proof. The general definition of falsity (p. 15, lines 7-8) might then be rewritten so as to read: "An advertisement of a food, drug, or cosmetic shall be deemed to be false if it is untrue or by any reasonable inference deceptive or misleading."

The provision (p. 15, lines 10-14) that any representation concerning any effect of a drug shall be deemed to be false "if that representation is not supported by substantial medical opinion or by demonstrable scientific facts calls for special consideration, in view of the difficulty of establishing what is "substantial medical opinion." The phrase "by substantial medical opinion or by demonstrable scientific facts" is used also in section 6 (p. 7, lines 18-19), with reference to the misbranding of foods, drugs, and cosmetics. What is said here regarding the construction of that phrase is applicable to it wherever it is used.

The difficulty of defining the term " 'medical opinion" has been recognized by those who drafted this bill. They have undertaken to meet the difficulty by a definition in section 2, subsection (k) (p. 3, lines 18-22) as follows: "(k) The term 'medical profession' means the professions of physicians, pharmacologists, dentists, and veterinarians; and the term 'medical opinion means the opinion of physicians, pharmacologists, dentists, or veterinarians relating to the fields of their respective professions."

and "the opinion

This definition hardly serves to improve the situation. In the first place, the terms "the professions of physicians of physicians may be construed as requiring courts to accept the opinion of limited practitioners of the healing art, whose education has given them either no knowledge of the use of drugs or only a modicum of such knowledge, and who are assumed and in some cases required by law to forego the use of drugs in their practices. Certainly the introduction of the opinions of men and women belonging to this drugless group of healers would serve only to confuse the issue, and yet since they are sometimes classed as "physicians their opinions might be given weight by judges and juries not familiar with their educational and experiential deficiency. Not only are such cultists not qualified to speak with reference to the potencies of drugs, using here the word " drugs in its ordinary acceptation, but the same may be said of some practitioners of medicine. Some of them, it must be admitted, would hardly be qualified to express opinions, because of the lapse of time since their graduation and of their failure to keep abreast of current medical literature and practice. "Medical opinion with reference to the many devices now used for the cure, mitigation, treatment, and prevention of disease, all of which are drugs" within the meaning of this bill (p. 2, lines 9-13), would be even more difficult to establish than medical opinion with respect to the more limited and better known category of materials ordinarily covered by the term "drugs."

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The alternative proposed by the bill "demonstrable scientific facts as an alternative to “ substantial medical opinion", hardly improves the situation, because of the difficulty of establishing always diagnostic and therapeutic efficiency by demonstrable scientific facts."

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Probably the easiest way to meet the pending difficulty would be to establish as a criterion of falsity medical books and periodicals of good repute and the opinions of competent medical witnesses. Books and medical periodicals might be accepted as prima facie evidence, the weight of the evidence to be determined from them alone or from them and from such books and periodicals considered in connection with the testimony of qualified medical witnesses. While the admission of medical books and periodicals in evidence represents a departure from generally established legal procedure, yet it has been provided for by statute in Alabama, California, Idaho, Iowa, Montana, Nebraska, Oregon, and South Carolina. After all, the admission of medical books and periodicals for the purposes here under consideration would constitute only an extension of the present practice of receiving in evidence books of authority in other realms of knowledge, such as life tables, etc.

The provision (p. 15, lines 15-20) that an advertisement of a drug shall be deemed false if it contains the name of any disease for which the drug

is not 66 a specific cure but is a palliative" and fails to state that the drug is a palliative and “how the palliation is effected ", might well be modified by omitting the word “specific" and the clause "and how the palliation is effected." The word " specific" adds nothing of value to the definition and to state 'how the palliation is effected" would ordinarily be difficult and often be of no particular value to the patient. If the clause "how the palliation is effected" means "in what respect relief is afforded ", as by the relief of pain, there can be no objection to the use of the clarified language.

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The prohibition of advertisements representing drugs as haviny any effect in the treatment of certain named diseases is merely an extension of the principle of legislation now in force in many States, prohibiting the publication of advertisements of medicines for the treatment of venereal diseases. Such prohibition has been established by statutes in the following States: Alabama, California, Colorado, Idaho, Iowa, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Montana, Nebraska, Nevada, New York, North Carolina, North Dkota, Ohio, Oregon, Pennsylvania, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. In the present instance, some question arises as to the phraseology of the proposed legislation and, of course, question unavoidably arises as to the diseases to be named.

The phrase "to discourage the public advertisement (p. 15, line 21) leads to an inquiry as to the definition of “ public advertisement." Probably what might be termed private advertising is more dangerous than public advertising, even if it is not so extensively pursued, because of the secrecy with which it is carried on. Sometimes by the purchase of "sucker lists and sometimes by obtaining lists of "prospects by offers of free advice or free samples, the distributor of a quack nostrum is enabled to carry on a private corre spondence with his dupes and to endanger their health and to defraud them of their money in that way. A procedure of that kind can hardly be referred to as a "public advertisement." Certainly the bill should be phrased so as to check this dangerous practice.

In the pending bill, the phrases "especially dangerous" and "patently contrary" (p. 15, line 23) can with advantage be modified by the omission of the qualifying words ' especially' and patently." The phrase "any effect " (p. 15, line 25) can well be modified to read " any beneficial effect."

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To the list of diseases with respect to which supposedly curative medication is not to be advertised (p. 16, lines 1-10), the following additions are suggested: Arthritis; anemia; asthma; boils; dysentery, amebic and bacillary; drug addiction; eczema; epidemic influenza; hay fever; hookworm disease; jaundice; nephrolithiasis; nervous disorders; obesity; peptic ulcer; pinworms; psoriasis; round worms; tapeworms; and trachoma.

Exception has been taken to the provision that any public advertisement of drugs for the treatment of the diseases named shall not be deemed false if they are disseminated to members of the medical and pharmaceutical professions only or appearing in the scientific periodicals of those professions (p. 16, lines 11-15). Similar language appears in section 8, subsection (i) (p. 14, lines 7-12), and in the same section, subsection (j) (p. 14), line 25, to p. 15, line 5). It is obvious, however, that since the purpose of the prohibition here under consideration is to discourage self-medication that is dangerous and contrary to the interests of public health, the proviso that permits advertisements to be sent to the medical and pharmaceutical professions is proper.

The provision of section 9 (p. 16, lines 15-18) that permits advertisements regarding the use of drugs for the treatment of the diseases named in the act, to be disseminated "for the purpose of public-health education by persons not commercially interested, directly or indirectly, in the sale of such drugs", comes dangerously near to obnoxious class legislation, if it does not pass beyond the limits. To say that a given advertisement published by one person is unlawful and that identically the same advertisement published by another person is lawful, seems to call for some distinction between such persons other than a mere commercial interest in the sale of the drugs advertised. An advertiser or a group of advertisers might publish an advertisement seeking to promote the sale of their product, without giving their own names or the name of one of them, and under the bill as it is now phrased they would violate. the law, whereas someone else, say an insurance company, publishing identically the same advertisement, with its name affixed, would be innocent. More. apt phraseology must be evolved, it is believed, in order to render class differentiation a safe one if the integrity of the legislation is to be preserved.