Federal Food Drug, and Cosmetic Act of 1938

1627 WordsMay 12, 20147 Pages
Federal Food, Drug, and Cosmetic Act of 1938 According to, http://www.toxicology.org/gp/fda.asp, the Society of Toxicology website, in 1937 the Massengill pharmaceutical company dispersed Elixir Sulfanilamide. This drug was prescribed generally to anyone who had symptoms of strep throat. Elixir Sulfanilamide contains diethylene glycol, which is a chemical equivalent of antifreeze. There were 107 documented deaths, involving many children, because of the lack in regulations. The Pure Food and Drug Act was deemed to insufficient to protect the public. This tragedy was the critical motivation for the creation of the Federal Food, Drug, and Cosmetic Act. The Federal Food, Drug, and Cosmetic Act (FFDC) can be found in chapter 9 of title 21 in…show more content…
Since the amendment the technology that is capable of finding such small particles of substance has caused some reconsideration of the “at any level,” concept. The flavor industry requested for a "de minimis," which refers to a level of risk that is too small to raise concern. The Senate has propositioned bills that would improve the meaning of the Delaney Clause but nothing has passed yet (http://cnie.org/NLE/CRSreports/Pesticides/pest-1.cfm). 1996 Food Quality Protection Act In 1996 both houses of congress passed the quality protection act (FQPA) unanimously. This amendment particularly reformed regulations of pesticides. Eliminating the Delaney Clause from being applied to pesticide residues. The U.S. Environmental Protection Agency (EPA) website indicates that this new law sets a single health-based standard instead of the previous multiple standards. The general safety standard is considered to be, “a reasonable certainty of no harm.” When the EPA sets the standards it will have to take in consideration all sources, which include water, and other pesticides with a common “mechanism of toxicity” (http://www.epa.gov/pesticides/regulating/laws/fqpa/backgrnd.htm ). The website also mentions a special provision considering babies and children, where there is to be a clear determination that proves tolerance levels are in fact safe for children. Three Food Standards
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