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117:(1965) – Control the manufacture and distribution of depressants, stimulants, and hallucinogens. Required wholesalers and jobbers of these drugs to register annually with the FDA. Gave FDA authorization to seize illegal supplies, serve warrants, arrest violators, and require all legal handlers of controlled drugs to keep records of their supplies and sales.
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issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.
32:(1906) – Also known as the Wiley Act, It was passed in response to public concern about food and drug safety. Administered by the Bureau of Chemistry, it required that food be pure and wholesome and drug ingredients to be listed and prohibited interstate commerce in food, drinks, and drugs that did not meet these requirements.
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are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that
99:(1960) – FDA regulation for the safe use of color additives in foods, drugs, and cosmetics. Required manufacturers to make necessary scientific investigations to establish safety. The Delaney proviso prohibits the approval of any color additive shown to induce cancer in humans or animals.
73:(1944) – Safety, purity, and potency of biologic products such as vaccines, sera, and blood for interstate sale. Safety of pasteurized milk and shellfish, along with the sanitation of food, water, food services, and facilities on trains, airplanes, and buses.
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93:(1958) – Prohibited used of food additives until the manufacturer established their safety. The Delaney proviso prohibits the approval of any food additives shown to induce cancer in humans or animals.
38:(1912) – Enacted to overcome the ruling in the 1911 United States v. Johnson, where the Supreme Court prohibited labeling medicines with false therapeutic claims intended to defraud the purchaser.
165:(1984) – Allows the FDA to approve generic versions of previously approved new drugs without requiring their sponsors to duplicate the costly human tests required for the original drugs.
111:(1962) – Was passed to ensure drug efficacy and greater drug safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products before marketing them.
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Commissioner. (2018, February 01). FDA's Evolving Regulatory Powers - Part I: The 1906 Food and Drugs Act and Its Enforcement. Retrieved April 20, 2018, from
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Office of the
Commissioner. (2018, February 01). Research Tools on FDA History - Selected Food, Drug, Cosmetic, Device and Tobacco Laws. Retrieved April 20, 2018, from
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Barrett, S., London, W. M., Kroger, M., Hall, H., & Baratz, R. S. (2013). Consumer health: a guide to intelligent decisions (9th ed.). New York, NY: McGraw-Hill.
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Commissioner. (2018, February 01). FDA's Evolving Regulatory Powers - Milestones in U.S. Food and Drug Law History. Retrieved April 20, 2018, from
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123:(1966) – Provided additional support for the FDA to ensure that food, drugs, medical devices, and cosmetics were honestly and informatively labeled.
129:(1968) – Protected the public from unnecessary exposure to radiation from electronic products such as televisions, microwaves, and x-ray machines.
177:(1990) – FDA power to Obtain earlier knowledge of serious device problems and order recalls to quickly remove defective products from the market.
141:(1976) – Supplemented the FD&C Act of 1938. Permitted action only if a defect in a product was discovered after the product was in use.
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147:(1976) – Prohibited the FDA from limiting the potency of ingredients of vitamin and mineral products that are not inherently dangerous.
206:(DSHEA) (1994) – Broadened the term “dietary supplements” to include herbs and many other substances that lack nutritional value,
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159:(1983) – Facilitated the development of new drugs for more than 5000 rare diseases affecting as many as 20 million Americans.
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153:(1980) – Required strict controls to ensure the nutritional content and safety of commercial baby foods.
171:(1988) – Allows selling, buying, trading, or offering to sell, buy, or trade prescription drug samples.
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Accelerate review of new drugs and devices. Increase patient access to experimental drugs and devices.
135:(1970) – Required special packaging to protect children from accidentally ingesting toxic substances.
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105:(1960) – Required labels to display warnings regarding household products with hazardous chemicals.
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Eliminating the
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Voluntary guidelines to retailers for nutrition information of raw fruits, vegetables, and fish.
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Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.
44:(1938) – Replaced the 1906 Pure Food and Drugs Act with new and stronger provisions including:
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Permit pharmacists to compound certain categories of drug products not commercially available.
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Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.
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Determination of whether disease-prevention claims can be made for various nutrients,
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Authorizing standards of identity, quality, and fill-of-container for foods.
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Providing that safe tolerances be set for unavoidable poisonous substances.
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The distinction between over-the-counter and prescription drugs was made.
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Allows statements of “nutritional support” under certain circumstances,
79:(1951) – Drugs cannot be safely used without medical supervision,
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Set standards for the distribution of their-party literature,
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More appropriate disclosure of fat and cholesterol contents,
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Specified the ingredient and nutritional label information,
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with a more flexible requirement that additives be safe.
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Extending control to cosmetics and therapeutic devices.
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242:(1997) – Extended regulations intended to:
204:Dietary Supplement Health and Education Act
127:Radiation Control for Health and Safety Act
36:Sherley Amendment to the Food and Drug Act
186:Mandatory labeling on most food products,
103:Federal Hazardous Substances Labeling Act
221:Required goods manufacturing practices,
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42:Federal Food, Drug, and Cosmetic Act
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175:Safe Medical Devices Act
91:Food Additives Amendment
183:(1990) – Provided for:
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232:(1996) – Replaced the
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133:Poison Prevention Act
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151:Infant Formula Act
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