| Acronym | FFDCA, "FD&C Act" |
|---|---|
| Enacted by the | 75th United States Congress |
| Citations | |
| Public Law | 75-717 |
| Stat. | 52 US Stat. 1040 |
| Codification | |
| U.S.C. sections created | 21 U.S.C. § 301 et seq |
| Legislative history | |
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| Major amendments | |
| 1951 Food, Drug, and Cosmetics Act Amendments, PL 82–215, 65 Stat 648, 1962 Food, Drug, and Cosmetics Act Amendments, PL 87–781, 76 Stat 780, Fair Packaging and Labeling Act, PL 89–755, 80 Stat 1296, Medical Device Regulation Act, PL 94–295, 90 Stat 539, Radiation Control for Safety and Health Act, PL 90-602, 82 Stat 1173, Drug Price Competition and Patent Term Restoration Act of 1984, PL 98-471, 98 Stat 1585, Nutrition Labeling and Education Act (1990), PL 101-535, 104 Stat 2353, Safe Medical Device Amendments of 1990, PL 101-629, 104 Stat 4511, Food and Drug Administration Revitalization Act, PL 101-635, 104 Stat 4583, Dietary Supplement Health and Education Act (1994), PL 103-417, 108 Stat 4332, Food and Drug Administration Modernization Act of 1997, PL 105-115, 111 Stat 2296, Food and Drug Administration Amendments Act of 2007, PL 110-85, 121 Stat 823[1] | |
| Relevant Supreme Court cases | |
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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 U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York.[2] 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.[3] 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.[4] See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.
Contents |
The FD&C Act has twenty chapters:[5]
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.[9]
The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods in the United States, and numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs for external application 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.
| Name | Common name | Color | Comment |
|---|---|---|---|
| FD&C Blue No. 1 | Brilliant Blue FCF | bright blue | |
| FD&C Blue No. 2 | Indigotine | royal blue | |
| FD&C Green No. 3 | Fast Green FCF | sea green | |
| FD&C Red No. 3 | Erythrosine | cherry red | |
| FD&C Red No. 40 | Allura Red AC | orange-red | |
| FD&C Yellow No. 5 | Tartrazine | lemon yellow | |
| FD&C Yellow No. 6 | Sunset Yellow FCF | orange | |
| Orange B | Restricted to specific uses | ||
| Citrus Red No.2 | Restricted to specific uses |
There are also "D&C" colors that are only approved for use in pharmaceuticals for external application 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.
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"[10]. A food additive requires a premarket approval by the FDA unless excluded from this requirement as a substance that is generally recognized, among experts qualified by scientific training and experience to evaluate its 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 its intended use. This is the so called generally recognized as safe (GRAS) exemption.[11]
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.[12] All genetically modified foods sold in the USA have been subject to this FDA pre-market approval process.
Homeopathic preparations are regulated and protected under Sections 201(g) and 201(j), provided that such medications are formulated from substances listed in the Homeopathic Pharmacopoeia of the United States, which the Act recognizes as an official drug compendium.
Bottled water is regulated by FDA as a food. The Agency has published identity standards for types of water (mineral water, spring water), and regulations covering water processing and bottling, water quality and product labeling.[13][14] [15]
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)[16] 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 premarket 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 as "cleared" or "510(k) cleared" devices.
Some economists support pre-market approval of drugs and devices mainly based on the belief that imperfect information exists in the market.[17]
The Wheeler-Lea Act, passed in 1938, granted the Federal Trade Commission the authority to oversee advertising of all products regulated by FDA, other than prescription drugs.
Descriptions of these can be found at the FDCA's web site.[18]
Amendments:
Other laws:[19]
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.