A BRIEF LEGISLATIVE HISTORY OF THE FOOD, DRUG, AND COSMETIC ACT INTRODUCTION The Federal Food, Drug, and Cosmetic Act provides authority for the broad and varied regulation of food, drugs, cosmetics, and medical devices. The Act prohibits the adulteration or misbranding of all such products. In the case of certain drugs, pesticides, food additives, and color additives specific pre-marketing requirements are set forth in the Act. Cosmetics are subject to pre-marketing requirements with regard to color additives. The regulation of medical devices is limited largely to labeling and directions for use. This reviews, in historical sequence, the legislative development of the Federal Food, Drug, and Cosmetic Act. The Committee is grateful for the excellent assistance it received in developing this document from Ms. Mary Nell Lehnhard and other members of the Congressional Research Service of the Library of Congress. CONTENTS Page 56-782 O 75 21 A BRIEF LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 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 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 vege 134 Stat. 768, 59th Cong., 1st sess.; June 30, 1906. |