Federal Food, Drug, and Cosmetic Act of 1938, 1954, 1958


Draft Year: 1938
Amendment law: 1954, 1958

A national law, that helps the FDA to have more authority.

"Americans are avid consumers, and the Federal Food, Drug, and Cosmetic Act, covers products that represent nearly a quarter out of every dollar spent"- Theodore Ruger

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At the turn of the 20th century, there were no federal regulations to protect the public from potentially dangerous drugs.

Why was the law needed?
Under the new administration of FDR, the FDA began to fight for more regulatory powers, but not much happened until a shocking mishap. Massengill, a pharmeceutical company, released an antibacterial drug, named Elixir sulfanilamide. The drug had gone through safety checks, but when it was produced in liquid form, the company failed to test the solvent. This seemingly pleasant green shade of solvent, diethylene, better known as antifreeze, had deadly effects on the kidneys of those taking the drug. As a result 107 people, mostly children died before the product was quickly recalled. Within months of the tragedy, Congress passed the Food, Drugs, and Cosmetic Act of 1938.

This act gives authority to the U.S Food and Drug Administration, the FDA, to oversee the safety of food, drugs and cosmetics
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What the law does?
The Federal Food, Drug, and Cosmetic Act has two longing goals. The first goal is to protect the publics safety. The act regulates the safety, purity, and the effectiveness of some of the products, like drugs. The second major goal of the act is to disclose information. The product labeling must be truthful and accurate. The act prohibits inaccurate product labeling and provides civil and criminal enforcement if a company prints inaccurate labels on their products. The U.S. federal government is authorized to inspect, test, approve, and set safety standards to foods, drugs, chemicals and cosmetics. The Federal Food, Drug, and Cosmetic Act provides factory inspection for safety and purity standards. New drugs, medical devices, and food additives must receive the FDA's stamp of approval as safe before being marketed to the public. The drugs and devices must satisfy the added standard of effectiveness. Congress strengthened the Federal Food, Drug, and Cosmetic Act in 1958 with the Food Additives Amendment, precluding FDA approval of any food additive found to cause cancer in humans or animals.

How has the act impacted out health?chemicals.JPG
Before foods, drugs, or cosmetics are consumed they are first tested so that they are at a safe tolerance level of any pesticide residue or chemicals. This ensures that when people are using or consuming these products (specifically food) they are certain that there will be no harm the majority of the time. Also it forbids the use of any food additive if it is found to be potentially cancer causing. The act not only put restrictions on food and drugs, but it also banned cosmetics if they did not advertise exactly what was in them. This made sure that the buyer knew exactly what they were buying.


What is the agency/group responsible for regulation and enforcement?

Environmental Protection Agency (EPA) is responsible for implementing. FFDCA limits pesticide residues on food in interstate commerce (including imports). The FDA is responsible for $1 trillion a year worth of products and ensures safety and effectiveness of all foods (except meats and poultry), drugs, biological products, medical devices, animal drugs, animal food, and cosmetics.


Works Cited:

"Food and Drug Administration (FDA) (United States agency) -- Britannica Online Encyclopedia." Encyclopedia - Britannica Online Encyclopedia. Web. 05 Feb. 2010. <http://www.britannica.com/EBchecked/topic/212631/Food-and-Drug-Administration#ref=ref91826>.Ruger, Theodore W.. "Federal Food, Drug, and Cosmetic Act (1938)." Major Acts of Congress. 2004. Encyclopedia.com. 5 Feb. 2010 <http://www.encyclopedia.com>.http://www.epa.gov/lawsregs/laws/ffdca.html http://www.eoearth.org/article/Federal_Food,_Drug,_and_Cosmetic_Act,_United_Stateshttp:www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/ucm086299.htm
"Legislation."
Http:www.fda.gov/RegulatoryInformation/Legislation/default.htm. US Department of Health and Human Services, 15 Sept. 2009. Web. 5 Feb. 2010. <http://www.fda.gov/RegulatoryInformation/Legislation/default.htm>.

Pictures: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm
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