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table substance, or any portion of an animal unfit for food, or if the food was the product of a diseased animal, or one that had died otherwise than by slaughter.

Misbranding

A drug was deemed "misbranded" where the label bore any statement, design, or device regarding the contents which was false or misleading, or where the drug was falsely branded as to the State, Territory, or country in which it was manufactured. Drugs would be misbranded if they were an imitation of, or offered for sale under the name of another article (false name) or where the original contents had been removed in whole, or in part, and other contents added (false contents). Drugs would also be misbranded, if their labels failed to indicate any quantities of alcohol, narcotics, and certain other specified substances, which might be present in the product.

Food was to be considered misbranded if it was an imitation of or offered for sale under the name of another article. Labeling or branding so as to deceive or mislead the purchaser; purporting to be a foreign product when not so; partial or total replacement of the contents of the package as originally put up; or failure to state certain ingredients (narcotics, etc.) on the label also constituted mislabeling. If the food were in package form and the contents were stated in terms of weight or measure, they had to be plainly and correctly stated on the outside of the package. Any packaging or labeling bearing a statement, design, or device which was misleading in any particular rendered a food misbranded.

The Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce and Labor were to promulgate rules and regulations for carrying out the provisions of the Act, including the collection and examination of foods and drugs. The Bureau of Chemistry of the Department of Agriculture was to examine specimens of food and drugs for adulteration or misbranding. Any product which was adulterated or misbranded within the meaning of the Act was subject to seizure and libel for condemnation.

II. THE SHERLEY AMENDMENT OF 1912

Limitations in the scope of public protection provided by the 1906 Act soon became readily apparent. In 1911, the Supreme Court ruled that the drug labeling provisions prohibited only false statements about the identity of the drug product but not false therapeutic claims. A dissenting opinion said this would open the way for the sale of false cures for all manner of diseases.

President Taft at once called on Congress to eliminate the deficiency in the 1906 Act saying:

There are none so credulous as sufferers from disease. The need is urgent for legislation which will prevent the raising of hopes of speedy cures of serious ailments by misstatement of facts as to worthless mixtures on which the sick will rely while their disease progresses unchecked.

Congress responded by passing the "Sherley Amendment" which prohibited false and fraudulent curative or therapeutic claims on a

label. But this action created a new weakness in the law since it required proof that therapeutic claims were both false and fraudulent, a matter extremely difficult to prove, since fraud involves proving an intent to deceive.

III. THE FEDERAL FOOD, DRUG, AND COSMETIC ACT OF 1938

(THE COPELAND ACT)

The provisions of the 1906 Act were seriously inadequate in other areas of food and drug regulation. The conditions of the Depression and the occurrence of epidemics aggravated the situation and made the absence of proper safeguards even more apparent. False therapeutic claims were presented to the public via newspapers and radio. Inflated advertising and product cheapening were wide-spread, particularly in regard to cosmetics which were not mentioned in the 1906 Act.

In 1933, the Administration began drafting new legislation in an attempt to tighten the Federal regulation of food, drugs, and cosmetics. Such a move was prompted by a discussion between the Chief of the Food and Drug Administration. Walter Campbell, and Assistant Secretary of Agriculture, Rexford Tugwell, regarding the failure of the existing law to adequately protect the consumer.

When the FDA presented its proposed bill, strong opposition to it was expressed by business interests. Perhaps the proposed legislation's greatest handicap to acceptance by industry, and, to some degree, the Congress was the reputation of its sponsor, Rexford Tugwell, The Columbia University economics professor, who frankly admitted believing in a planned economy, was greatly feared in business circles.

During Senate consideration, the FDA's bill was somewhat modified by its Congressional sponsor, Royal S. Copeland. However, the proprietary lobbyists were still greatly opposed to the bill and were persistent in their attempts to: one, substitute the Federal Trade Commission for the Food and Drug Administration as the agency which would control food, drug, and cosmetic advertising; and two, reduce the multiple seizure authority given the FDA.

The attempt to weaken the multiple seizure provision was defeated. However, the FDA lost the battle to gain control over advertising; the regulation of advertising would be subject to the more lenient procedures of the FTC.

The chances of a food and drug bill passing the House were almost nonexistent until the 1938 Wheeler-Lea Act strengthened the FTC's authority in regard to food and drugs. The passage of this Act in conjunction with a drug disaster which resulted in over one hundred deaths, paved the way for enactment of legislation. The drug involved in the disaster was "Elixir of Sulfanilamide", sulfanilamide dissolved in diethylene glycol, a deadly poison. The chemist tested the solvent for flavor, appearance, and fragrance, but, unfortunately, not for safety.

Shortly after the sulfanilamide disaster, Congress adopted portions of the Copeland bill. The 1938 Food, Drug, and Cosmetic Act substantially revised the authority of the Federal Government to protect the

237 Stat. 416, 62d Cong., 2d sess.; Aug. 23, 1912.

public against adulterated and misbranded food and drug products.3 In addition, cosmetics, which prior to this time were unregulated, were placed under Federal supervision.

The major provisions of the 1938 Act are outlined below:

DRUGS AND DEVICES

Brought under FDA control devices intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, and (2) to affect the structure or any function of the body of man or other animals.

Prohibited traffic in new drugs unless they had been adequately tested to show that they were safe for use under the conditions of use prescribed on their labels. Exemptions to these requirements were provided for drugs intended solely for investigational use by qualified scientific experts.

Required the labels of official drugs-those recognized in official compendia-to reveal any differences of strength, purity, or quality from the official standard (the 1906 Act merely required that the label bear a true statement of the purity, quality, and strength of the product).

Required drugs intended for use in man to bear labels warning against habit formation, as in the case of narcotic or hypnotic drugs.

Required labeling of drugs and devices to bear adequate directions for use and authorized exemptions only where protection of the public health was not involved.

Required labels to bear warnings against unsafe use, where drugs or devices might be dangerous to health.

Required special precautionary labeling of drugs subject to deterioration.

Required official drugs to be packaged and labeled as prescribed by the official compendia.

Declared non-official drugs illegal if their standard of strength differed from the standard claimed.

Required the labels of non-official drugs to list the names of the active ingredients and to show the quantity or proportion of certain specified substances.

FOODS

Provided for the promulgation of a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of fill of a container. With certain exceptions, no definition and standard of identity and no standard of quality could be established for fresh or dried fruits, fresh or dried vegetables, or butter.

Prohibited traffic in food which was injurious to health. (The 1906 Act permitted regulation of injurious food only in the event. poison was added.)

Prohibited the addition of poisons to food. In the event the addition of a poisonous or deleterious substance was required in

3 52 Stat. 1040, 75th Cong., 3d sess.; June 25, 1938.

production or could not be avoided, the Secretary was required to promulgate regulations limiting the quantity of such substance in the food.

Prohibited the addition of any alcohol or nonnutritive article (with certain exceptions) to confectionery.

Required the label of nonstandardized food to bear: (1) the common or usual name of the food, and (2) in case it was fabricated from two or more ingredients, the common or usual name of each ingreditent. Spices, flavorings and colorings could be so designated without naming each.

Required the labels of food which purported to be or was represented to be for special dietary use to bear such information concerning its vitamin, mineral and other dietary properties as the Secretary determined necessary to inform purchasers as to its value for such uses.

Required any food containing any artificial flavoring, artificial coloring, or chemical preservative to bear a label stating that fact. Authorized emergency license control of food that might be dangerous by reason of contamination with micro-organisms. Such licensing was limited to operations in which the public health could not be otherwise protected.

COSMETICS

Prohibited traffic in cosmetics which contained any poisonous substance which might render them injurious to users under the conditions of use prescribed in the labeling or under such conditions of use as were customary or usual.

Required coal-tar hair dye to bear a warning label regarding use and preliminary testing.

Exempted from labeling requirements those cosmetics which were to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packed.

GENERAL

Deemed illegal any food, drug, or cosmetic whose labeling was false or misleading in any particular.

Required any food, drug, or cosmetic in packaged form to bear: (1) the name and place of business of the manufacturer, packer, or distributor, and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.

Prohibited traffic in food, drugs, or cosmetics which might have been prepared or handled under unsanitary conditions.

Deemed illegal any food, drug, or cosmetic whose container was made, formed, or filled so as to be misleading.

Forbade the use of uncertified and impure coal-tar colors in foods, drugs, and cosmetics.

Authorized factory inspection of establishments producing food, drugs, or cosmetics, subject to certain conditions. (See part VIII.)

Authorized the procurement of transportation records and other documents necessary to establish Federal jurisdiction.

Provided increased penalties for violations.

Authorized the Federal courts to restrain violations by injunc

tion.

With the exception of new drugs and coal tar dyes, the 1938 Act did not provide for automatic pre-market testing or approval of products. A manufacturer was not required to submit foods or cosmetics to the FDA to assess the safety of the chemical additives therein prior to their introduction into commerce. If the Federal government had reason to believe that a particular substance posed a hazard to the consuming public, it had to go to court to establish these hazards and the burden of proof of such fact rested with the Government, not with the manufacturer or user of the chemicals.

In an effort to prevent another disaster such as the sulfanilamide poisonings, the Act did provide for pre-market clearance of new drugs to assure safety. Prior to marketing, manufacturers had to submit to the Food and Drug Administration full reports of investigations which had been undertaken to establish safety. Unless the FDA, within a specified period of time, issued an order finding that such safety had not been established, the manufacturer could proceed to market the drug. The FDA was also authorized to act beyond the initial stages of drug development and was permitted to remove from the market any drug which it subsequently could prove unsafe. Old drugs, already on the market, were not subject to these requirements. They were allowed to remain on the market unless the FDA could prove in a court proceeding that they were dangerous.

It is important to note that the 1938 Act did not require that a drug had to be proven effective, as well as safe, in order to be cleared for marketing. But in making its judgments about safety, the FDA did consider effectiveness. The relationship between safety and efficacy is considered elsewhere. It is only significant to note that the manufacturer of a product did not have to prove that his product did the things it was reputed to do.

Because only a few coal tar dyes were safe for use in foods and drugs, and even these sometimes contained toxic impurities, a voluntary plan for Governmental testing of manufacturer's samples, started in 1907, was made mandatory by the 1938 Act. Not only were the dyes required to be found safe for use by the FDA, but "batch certification" was required to assure that each individual batch of the dye was properly manufactured.

The limitations imposed by the "false and fraudulent" provision of the Sherley Amendment were eliminated by prohibiting therapeutic claims that are "false or fraudulent".

IV. INSULIN AND ANTIBIOTIC CERTIFICATION AMENDMENTS

In December 1941, Congress added a section to the 1938 Act requiring the Food and Drug Administration to batch-certify drugs composed, in whole or in part, of insulin before they could be placed on the market. Each batch has to be tested for compliance with identity standards, and for the characteristics of strength, quality, and purity specified in official compendia. These tests were designed to assure safe and efficacious use of insulin products.

455 Stat. 851, 77th Cong., 1st sess.; Dec. 22, 1941.