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Food, Drug, and Cosmetic Act

The United States Federal Food, Drug, and Cosmetic Act (FFDCA, FDCA, or FD&C) is a set of laws passed by Congress that give the Food and Drug Administration (FDA) authority to oversee the safety of food, drugs, medical devices, and cosmetics. The FDCA is located in the United States Code, beginning at 21 U.S.C. §301.

In Texas, as in all states, the Federal Food, Drug, and Cosmetic Act (FDCA) provides the framework for the regulation of food, drugs, medical devices, and cosmetics. This federal law, which is found in Title 21 of the United States Code starting at Section 301, grants the Food and Drug Administration (FDA) the authority to ensure that these products are safe for public use and consumption. The FDA's regulatory powers include the ability to approve new drugs and medical devices before they can be sold, to set standards for food safety, to regulate the manufacturing and labeling of products, and to take enforcement actions against entities that violate the FDCA. While the FDCA is a federal statute and applies uniformly across the United States, Texas may have additional state laws and regulations that complement the federal rules and address specific public health concerns within the state. However, when state regulations are in conflict with federal law, the federal law will typically preempt state law under the Supremacy Clause of the U.S. Constitution.


Texas Statutes & Rules

Federal Statutes & Rules

Federal Food, Drug, and Cosmetic Act (FD&C Act) - 21 U.S.C. §301 et seq.
This is the primary federal law regulating the safety of food, drugs, medical devices, and cosmetics in the United States.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a comprehensive statute that provides the Food and Drug Administration (FDA) with authority to regulate the safety and efficacy of food, drugs, medical devices, and cosmetics. Key provisions of the FD&C Act include: - Prohibition of interstate commerce of adulterated or misbranded food, drugs, medical devices, and cosmetics (21 U.S.C. §331). - Requirements for new drugs to be proven safe and effective before marketing (21 U.S.C. §355). - Authority for the FDA to establish standards for food safety, including setting tolerances for pesticide residues (21 U.S.C. §§341-350). - Regulation of medical device safety and effectiveness, including a premarket approval process for certain devices (21 U.S.C. §§360c-360k). - Authority to regulate cosmetic safety and prohibit the marketing of adulterated or misbranded cosmetics (21 U.S.C. §§361-362). - Establishment of Good Manufacturing Practices (GMP) that manufacturers must follow to ensure the quality of their products (21 U.S.C. §351). - Enforcement powers, including inspections, seizures, injunctions, and criminal penalties for violations of the Act (21 U.S.C. §§332-334). The FD&C Act has been amended multiple times to address emerging health concerns and to give the FDA additional authorities, such as the authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act.

Food Additives Amendment of 1958 - 21 U.S.C. §348
This amendment to the FD&C Act introduced the requirement for manufacturers to establish the safety of food additives before they can be used in food products.

The Food Additives Amendment of 1958 requires manufacturers to provide evidence that food additives are safe for their intended use before they can be approved by the FDA. The amendment established the concept of 'Generally Recognized as Safe' (GRAS) for substances with a long history of safe use. It also introduced the Delaney Clause, which prohibits the approval of any food additive shown to induce cancer in humans or animals, regardless of the concentration of the additive.

Dietary Supplement Health and Education Act of 1994 (DSHEA) - 21 U.S.C. §321
DSHEA is an amendment to the FD&C Act that establishes specific regulations for dietary supplements.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements and sets forth a framework for their regulation. Under DSHEA, dietary supplements are treated as a category of food, not as drugs. Manufacturers are responsible for ensuring that their products are safe and that any claims made about them are substantiated by adequate evidence. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. DSHEA also provides for the establishment of Good Manufacturing Practices (GMP) specific to dietary supplements.

Biologics Control Act of 1902
While not part of the FD&C Act, the Biologics Control Act laid the groundwork for the regulation of biological products, which are now covered under the FD&C Act.

The Biologics Control Act of 1902 was the first federal law to regulate the quality of drugs and biologics. It was enacted in response to public health hazards from contaminated vaccines and serums. Although it has since been superseded by the FD&C Act and other statutes, it established the precedent for federal oversight of drug safety and efficacy. Today, biological products are regulated under the Public Health Service Act (PHSA) in conjunction with the FD&C Act, and the FDA's Center for Biologics Evaluation and Research (CBER) oversees these products.