![]() Oleomargarine Act requires prominent labeling of colored oleomargarine, to distinguish it from butter.ĭelaney Committee starts congressional investigation of the safety of chemicals in foods and cosmetics, laying the foundation for the 1954 Miller Pesticide Amendment, the 1958 Food Additives Amendment, and the 1960 Color Additive Amendment.ĭurham-Humphrey Amendment defines the kinds of drugs that cannot be safely used without medical supervision and restricts their sale to prescription by a licensed practitioner. Therefore, a worthless remedy cannot escape the law by not stating the condition it is supposed to treat. U.S. , a court of appeals rules that the directions for use on a drug label must include the purpose for which the drug is offered. This guidance, "Procedures for the Appraisal of the Toxicity of Chemicals in Food," came to be known as the "black book." Miller Amendment affirms that the Federal Food, Drug, and Cosmetic Act applies to goods regulated by the Agency that have been transported from one state to another and have reached the consumer.įDA publishes guidance to industry for the first time. In 1983 such control was found no longer needed and was abolished. Later amendments extended this requirement to all antibiotics. Penicillin Amendment requires FDA testing and certification of safety and effectiveness of all penicillin products. ![]() Public Health Service Act is passed, covering a broad spectrum of health concerns, including regulation of biological products and control of communicable diseases. It need not be proven that the officials intended, or even knew of, the violations. Dotterweich, the Supreme Court rules that the responsible officials of a corporation, as well as the corporation itself, may be prosecuted for violations. Insulin Amendment requires FDA to test and certify purity and potency of this lifesaving drug for diabetes. ![]() Campbell appointed as the first Commissioner of Food and Drugs. The Harrison Narcotic Act requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.įDA transferred from the Department of Agriculture to the Federal Security Agency, with Walter G. The court also noted that the mere presence of such an ingredient was not sufficient to render the food illegal. It ruled that in order for bleached flour with nitrite residues to be banned from foods, the government must show a relationship between the chemical additive and the harm it allegedly caused in humans. Lexington Mill and Elevator Company, the Supreme Court issues its first ruling on food additives. Gould Amendment requires that food package contents be "plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count." Winslow's Soothing Syrup for teething and colicky babies, unlabeled yet laced with morphine, killed many infants. It prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove. Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems leading to the enactment of these laws.įirst Certified Color Regulations, requested by manufacturers and users, list seven colors found suitable for use in foods.Ĭongress enacts the Sherley Amendment to overcome the ruling in U.S. The Meat Inspection Act is passed the same day. It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs. The original Food and Drugs Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. Public support for passage of a federal food and drug law grows. Wiley's studies draw widespread attention to the problem of food adulteration. The Biologics Control Act is passed to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans.Ĭongress appropriates $5,000 to the Bureau of Chemistry to study chemical preservatives and colors and their effects on digestion and health.
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