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.^[1] 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.^[2] See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.

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Contents

The FD&C Act has nine chapters: ^[3]

I. Short Title

II. Definitions

-201(f) is the definition for a food, which explicitly includes chewing gum

-201(g) is the definition for a drug

-201(h) is the definition for a medical device

-201(s) is the definition of a food additive

-201(ff) is the definition of a dietary supplement

III. Prohibited Acts and Penalties

This section contains both civil law and criminal law clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. All violations of the FD&C Act require interstate commerce because of the commerce clause, but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act.

Notably, the FD&C Act uses strict liability due to the Dotterweich^[4] and Park ^[5] Supreme Court cases. It is one of a very small number of criminal statutes that does.

IV. Food

There is a distinction in food adulteration between "poisonous and deleterious" substances that are added and those that are naturally present. Substances that are added are held to a stricter "may render (it) injurious to health" standard, whereas substances that are naturally present need only be at a level that "does not ordinarily render it injurious to health"^[6]

V. Drugs and Devices

-505 is the description of the drug approval process

-510(k) is the section that allows for clearance of class II medical devices

-515 is the description of the (class III) device approval process

VI. Cosmetics

VII. General Authority

-704 allows inspections of regulated entities

VIII. Imports and Exports

IX. Miscellaneous

Food coloring

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 ^[7].

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.

Food Additives

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.^[8]

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 ^[9]. All GM foods sold in the USA have been subject to this FDA pre-market approval process.

Cosmetics

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:

• Class I: Devices that do not require premarket approval or clearance but must follow general controls. Dental floss is a class I device.
• Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, and amalgam alloys used to fill cavities are all class II devices. The "predicate device" in question is often quite different, and this process is largely used to clear devices for marketing which do not meet the criteria to be considered class III. Hearing aids are class II devices.
• Class III: Devices that are approved by the Premarket Approval (PMA) process, analogous to a New Drug Application. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. An artificial heart meets both criteria. The most commonly recognized class III device is an Automated External Defibrillator. Devices that do not meet either criteria are generally cleared as class II devices.

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.

Related legislation

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.^[10]

Amendments

• Infant Formula Act of 1980, Public Law (PL) 96-359 (Oct. 26, 1980)
• Orphan Drug Act, PL 97-414 (Jan. 4, 1983)
• Drug Price Competition and Patent Term Restoration Act of 1984, PL 98-417 (Sept. 24, 1984)
• Prescription Drug Marketing Act of 1987, PL 100-293 (Aug. 18, 1988)
• Generic Animal Drug and Patent Term Restoration Act of 1988, PL 100-670 (Nov. 16, 1988)
• Nutrition Labeling and Education Act of 1990, PL 101-535 (Nov. 8, 1990)
• Safe Medical Devices Act of 1990, PL 101-629 (Nov. 28, 1990)
• Medical Device Amendments of 1992, PL 102-300 (June 16, 1992)
• Prescription Drug User Fee Act (PDUFA) of 1992, PL 102-571 (Oct. 29, 1992)
• Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, PL 103-396 (Oct. 22, 1994)
• Dietary Supplement Health and Education Act of 1994, PL 103-417 (Oct. 25, 1994)
• Food Quality Protection Act of 1996, PL 104-170 (Aug. 3, 1996)
• Animal Drug Availability Act of 1996, PL 104-250 (Oct. 9, 1996)
• Food and Drug Administration Modernization Act (FDAMA) of 1997, PL 105-115 (Nov. 21, 1997)
• Best Pharmaceuticals for Children Act, PL 107-109 (Jan. 4, 2002)
• Medical Device User Fee and Modernization Act (MDUFMA) of 2002, PL 107-250 (Oct. 26, 2002)
• Animal Drug User Fee Act of 2003, PL 108-130 (Feb. 20, 2003)
• Pediatric Research Equity Act of 2003, PL 108-155 (Dec. 3, 2003)
• Minor Use and Minor Species Animal Health Act of 2004
• Food Allergen Labeling and Consumer Protection Act of 2004, PL 108-282 (Aug. 2, 2004)

Other laws

• Federal Food and Drugs Act of 1906 (repealed; for historical reference)
• Federal Meat Inspection Act (March 4, 1907)
• Federal Trade Commission Act (Sept. 26, 1914)
• Filled Milk Act (March 4, 1923)
• Import Milk Act (Feb. 15, 1927)
• Public Health Service Act (July 1, 1944)
• Trademark Act of 1946 (July 5, 1946)
• Reorganization Plan 1 of 1953 (March 12, 1953)
• Poultry Products Inspection Act (Aug. 28, 1957)
• Fair Packaging and Labeling Act (Nov. 3, 1966)
• The National Environmental Policy Act of 1969 (Jan. 1, 1970)
• Controlled Substances Act (Oct. 27, 1970)
• Controlled Substances Import and Export Act (Oct. 27, 1970)
• Egg Products Inspection Act (Dec. 29, 1970)
• Lead-Based Paint Poisoning Prevention Act (Jan. 13, 1971)
• Federal Advisory Committee Act (Oct. 6, 1972)
• Government in the Sunshine Act (Sept. 13, 1976)
• Government Patent Policy Act of 1980 (Dec. 12, 1980)
• Federal Anti-Tampering Act (Oct. 13, 1983)
• Sanitary Food Transportation Act (Nov. 3, 1990)
• Mammography Quality Standards Act (MQSA) (Oct. 27, 1992)
• Bioterrorism Act of 2002 (June 12, 2002)
• Project BioShield Act of 2004 (July 21, 2004)
• Food and Drug Administration Amendments Act of 2007

^[11]

See also

• Food safety
• List of food additives
• Regulation of therapeutic goods
• Kefauver Harris Amendment

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.

References