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Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form. See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.
The FD&C Act has nine chapters: 
The FD&C is perhaps best known by the consumer because of its use in the naming of food coloring additives, such as "FD&C Yellow No. 6." The Act made the certification of some food color additives mandatory. Some food colorings are generally recognized as safe (GRAS) by the FDA and do not require certification .
The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods in the United States, plus numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs or cosmetics. Color additives derived from natural sources, such as vegetables, minerals or animals, and man-made counterparts of natural derivatives, are exempt from certification. Both artificial and natural color additives are subject to rigorous standards of safety before their approval for use in foods.
Certifiable colors: (name/common name)
There are also "D&C" colors that are only approved for use in pharmaceuticals and cosmetics.
The FFDCA requires producers of food additives to demonstrate to a reasonable certainty that no harm will result from the intended use of an additive. If the FDA finds an additive to be safe the agency issues a regulation specifying the conditions under which the additive may be safely used.
Definition of Food Additive
The definition of "food additive" is "any substance, the intended use of which results directly or indirectly, in its becoming a component or otherwise affecting the characteristics of food". However, excluded from the definition of "food additive" are substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food before January 1, 1958, through either scientific procedures or through experience based on common use in food) to be safe under the conditions of their intended use. This is the so called generally recognized as safe (GRAS) exemption.
GM foods are regarded as containing food additives
These regulations apply to foods produced by genetic engineering and natural sources, if the protein added to the food by the genetic engineering process is not "generally recognized as safe" then genetically modified food is regarded as containing a "food additive" and is subject to pre-market approval by the FDA . All GM foods sold in the USA have been subject to this FDA pre-market approval process.
This Act defines cosmetics as products for "cleansing, beautifying, promoting attractiveness, or altering the appearance." In this sense the FDA can classify cosmetics without actually regulating them. This allows a manufacturer the ability to use ingredients or raw materials and market the final product without government approval.
Section 510(k) and the device approval process
Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device.
This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.
Any device that reaches market via a 510(k) notification must be "substantially equivalent" to a device on the market prior to May 28, 1976 (a "predicate device"). If a device being submitted is significantly different, relative to a pre-1976 device, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a pre-market approval, or PMA. This does not always happen.
As of 2007, this has been implemented by splitting devices into three classes:
A device that reaches market via the 510(k) process is not considered to be "approved" by the FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to these as "cleared" or "510(k) cleared" devices.
The Wheeler-Lea Act, also passed in 1938, granted the Federal Trade Commission the authority to oversee advertising of all products regulated by FDA, other than prescription drugs.
Significant amendments to FDCA and other laws related to FDCA
Descriptions of these can be found at the FDCA's web site.
Comparison to state laws
Some US states have adopted the FD&C Act as an equivalent state law and will by default adopt any changes to the Federal law as changes to the state law as well.
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Federal_Food,_Drug,_and_Cosmetic_Act". A list of authors is available in Wikipedia.|