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Federal Food Drug, and Cosmetic Act of 1938

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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 the United States Code. Congress passed the act in 1938, in effort to protect the well being of the country by controlling the food and medical supply at a federal level. The act permitted the Food and Drug Administration (FDA) to have the authority to carry out legislative obligations. Specifically, the FDA enforced standards that limited the maximum amount of residue levels for unavoidable poisonous substances on food due to pesticides. The FDA website claims to have established laws that provided three types of food standards. These standards include: standard of identity, standard of quality, and standard of regulating the fill of container. Any food that did not meet these FDA standards would be, “misbranded.” The Act also regulates the pharmaceutical industry to guarantee the safety and effectiveness of drugs manufactured and retailed in the United States. (http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ucm132818.htm)
1954 Pesticide Chemicals Amendment
In 1954 the Pesticide Chemicals Amendment was added to the FFDC, which formally set the restrictions for pesticide deposits on uncooked cultivated products. According to the University of California Press website, the amendment authorized the FDA and Department of Agriculture to prohibit the use of hazardous pesticides. Many grievances about the procedures oppressed effective action, therefore has been constantly amended. Each amendment reduced the process required to ban pesticides the agencies considered to be too risky.
1958 Food Additive Amendment
In 1958 the Food Additive Amendment was added to the Act of 1938. According to http://extoxnet.orst.edu/faqs/additive/laws.htm, the amendment created a security measure for the nation, by requiring verification of the safety in food additives. Before new food additives are allowed in the marketplace it is required to have approval by the FDA or USDA, depending on the type of food. The responsibility of providing the evidence of the safety is placed on the manufacturer who wants to sell the food additive. At the time, to be considered “safe” there only had to be a reasonable certainty that no harm would incur from the use of the additive. Later, The Delaney Clause stated, “no additive shall be deemed safe if it is found to induce cancer when ingested by man or animal.”
The list of Generally Recognized As Safe (GRAS) substances and substances that were approved before 1958 (prior sanctioned substances) were exempted from the safety obligation. Although, today all substances once listed as GRAS are being reexamined to reassure they meet current food safety standards. Therefore, if tests reveal that a substance is not considered safe it will be removed from the list.

In a CRS Report for Congress, Donna Vogt wrote about the Delaney Clause. Under this Delaney Clause any substance that has been proven to cause cancer at every level will not be permissible for food. 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 To avoid being misbranded manufactures must meet three standards set by the FDA. According to an article I read called, “Analysis of Food Product,” the standard of identity is the guideline that identifies the amounts of certain types of ingredients for which food products must include if they are going to be given a certain name on the label. There is also a maximum and minimum concentration of components that must be in particular foods. For example, ice-cream is required be more than 10% milk fat and peanut butter must be required to be less then 55% fat. Standards of Quality are the minimum requirement pertaining to the color, tenderness, and freedom from defects in canned fruits and vegetables. Standards of Fill-of-Container deals with avoiding consumer deception by establishing a minimum weight or volume on how full a container must be. If it does not meet standards the product must specify the degree of fill is measured on the label, for example, “Below Standard of Fill” (http://people.umass.edu/~mcclemen/581Introduction.html ). 1976 Medical Amendment The FFDC was amended to include requirements on medical devices as well as vitamins and minerals in 1976. The FDA website had an overview of the amendment, which included the requirement of controlled labeling standards of prescription drugs in order to be legally marketed. The amendment also forces a preapproval process for drug devices to be marketed placing them under one of three classifications. Class I devices are, “general control” these are low risk devices including oxygen masks, elastic bandages and tissue retractors. Class II devices are considered, “special controls,” which are performance standards. Finally the Class III devices are the highest risk, which are usually new technology items. This classification has the most rigorous controls and requirements including pre-market review. Devices under this classification include heart valves, computerized microscopes and implantable defibrillators.
(http://www.hhs.gov/asl/testify/t970430a.html)

The court case, Wyeth v. Levine, is a good example of the importance of the labeling laws included in the FFDC. In 2000 a woman named Diana Levine was given Phenergan, a drug given to ease the symptoms of nausea. The drug was allegedly administered incorrectly, which caused gangrene in Levine’s arm requiring it to be amputated. Levine sued the manufacturing company, in the state courts, claiming negligence and product liability because of inadequate warnings of possible risk to the consumer. Ultimately Levine won her case in both lower courts, but the manufacturer of Phenergan claims that federal law preempts the state law which conflicts with the requirements of the FFDC. Now it is up to the Supreme Court to better define the Federal preemption doctrine to refine labeling requirements set by the FDA. The outcome of this case will be interesting because it will have direct impact on the information included on drug labels both a federal and state level (http://www.law.cornell.edu/supct/cert/06-1249). Final Thought Today the FFDC is applied directly or indirectly in our everyday life. Consumers are more indirectly affected by the laws because just about anything bought from a local grocery store has already been required to meet the regulation standards set by agencies which enforce them. The fresh produce, milk, and even over the counter medicine all had to meet certain criteria to prove it is safe to be consumed by humans. The act was created in order to keep the public safe from harmful substances and misleading or unclear labeling. The Federal Food, Drug, and Cosmetic Act directly affect the manufacturers of the products created. Whether it is the food additive manufacturer, pharmaceutical producer, or the farmer who grows corn, they all have to conform to the rules and regulations set, for the ability to make it into the public market place. This is important to me as a consumer because knowing there are laws in place that require certain standards gives me a sense of security when I buy food to feed my family. The reality is some products will still make in into the market place even though it has been misbranded or somehow found a loophole in the law. Therefore, as consumers we have to do our part to protect ourselves and do some research on the products before purchasing them. Overall, the Federal Food, Drug and Cosmetic act of 1938 is not perfect but has come a long way and has made many improvements overtime. The amendments are steps that attempt to increase effectiveness of the laws created because of the act. Considering now days far less people are being harmed because of unsafe or mislabeled food or unsanitary medical devices, I would say this act has been one of the countries most positive and significant statutes for consumer safety.

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[ 1 ]. http://publishing.cdlib.org/ucpressebooks/view?docId=ft2k4004pp&chunk.id=d0e422&toc.depth=1&brand=ucpress
[ 2 ]. http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126288.htm…...

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