5. FEDERAL FOOD, DRUG, AND COSMETIC ACT:1 A BRIEF LEGISLATIVE HISTORY TABLE OF CONTENTS I. The Food and Drugs Act of 1906 (the Wiley or Heyburn Act).. II. The Sherley Amendment of 1912.. III. The Federal Food, Drug, and Cosmetic Act of 1938 (the Copeland Act).. V. Regulatory Amendments of 1948.. VI. The Delaney Committee... VII. The Durham-Humphrey Amendment of 1951 X. The Pesticide Chemical Amendment of 1954 XV. Insecticide Amendments of 1959. XVII. The Drug Amendments of 1962 (the Kefauver-Harris Amendments). XIX. The Drug Listing Act of 1972. XXI. Medical Device Amendments of 1976. XXII. Saccharin Study and Labeling Act... Capsule Legislative History ...... 1 Prepared by the Congressional Research Service of the Library of Congress. Page 354 355 356 360 360 361 361 363 363 363 364 365 365 367 367 368 368 372 372 373 374 375 376 FEDERAL FOOD, DRUG, AND COSMETIC ACT: A BRIEF I. THE FOOD AND DRUGS ACT OF 1906 (THE WILEY OR HEYBURN ACT) The first Federal food and drug law, the Food and Drugs Act of 1906, was signed into law by President Theodore Roosevelt on June 30, 1906. The law banned from interstate commerce any traffic in adulterated or misbranded food or drugs. The statute also made it unlawful to manufacture adulterated or misbranded foods or drugs within any Territory of the United States and the District of Columbia. The Act defined "drug" to include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention, of disease in either man or other animals. The term "food" included all articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compounded. Definitions for adulteration and misbranding were set forth in the Act for both foods and drugs: Adulteration Drugs were to be deemed adulterated if they were sold under or by a name recognized in the official compendia, but failed to meet the standards set forth therein. An exception was provided-that a drug using a recognized name not meeting the official standard would not be deemed adulterated if it met its own standard of strength, quality, and purity plainly stated on the bottle, box, or other container. Any drug which failed to meet the professed standard under which it was sold would, however, be deemed adulterated. Confectionery was to be deemed adulterated if it contained any ingredient deleterious or detrimental to health or any poisonous color or flavor. It was also deemed unlawful for confectionery to contain any vinous, malt, or spirituous liquor or compound or narcotic drug. The Act set forth several conditions under which food would be deemed to be adulterated, including: (1) if any substance was mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength; (2) if any substance was substituted wholly or in part for the article; (3) if any valuable constituent of the article was wholly or in part abstracted; (4) if the food was colored, powdered, coated, or stained in such a manner as to conceal damage or inferiority; (5) if it contained any added poisonous or other added 1 34 Stat. 768, 59th Cong., 1st sess.; June 30, 1906. deleterious ingredient which might render it injurious to health; (6) if it consisted in whole or in part of a filthy, decomposed, or putrid animal or vegetable 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.2 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 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 widespread, 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. 2 37 Stat. 416, 62d Cong., 2d sess.; Aug. 23, 1912. |
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