Labeling Federal Food, Drug

US legislation on food additives consists of the Federal Food, Drug, and Cosmetic Act (FD C Act), the Fair Packaging and Labeling Act, and other applicable laws including the Public Health Security and Bioterrorism Preparedness and Response Act. The FD C Act states that foods are adulterated if they contain color additives that have not been approved as safe to the satisfaction of the Food Drug Administration (FDA) for a particular use. ... 

Federal laws thus take precedence over state laws. Given the key role of the FDA in approving and regulating prescription drugs, states must follow the federal laws. Indeed, the Federal Food, Drug, and Cosmetic Act says that no state may establish requirements for labeling or packaging that differ from requirements of the federal law. 

FDA (Food and Drug Administration)—agency administered under the U.S. Department of Health and Human Services (formerly Health, Education and Welfare) "to enforce the Federal Food, Drug, and Cosmetic Act and thereby carry out the purpose of Congress to insure that foods are safe, pure, and wholesome, and made under sanitary conditions drugs and therapeutic devices are safe and effective for their intended uses cosmetics are safe and prepared from appropriate ingredients and that all of these products are honestly and informatively labeled and packaged."... 

Dietary Supplement Health and Education Act (1994) Amended the Federal Food, Drug, and Cosmetic Act of 1938 to establish standards with respect to dietary supplements. Required the establishment of specific ingredient and nutrition information labeling that defines dietary supplements and classifies them as part of the food supply. 

The regulation of Echinacea products in the United States would fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). In the United States, statutory 403 (a)(1) of the Federal Food, Drug, and Cosmetic Act prohibits labeling that is false or misleading. Under DSHEA, a structure/-function claim can be made, provided the claim meets the criteria set forth in statutory 403(r)(6). Structure/function claims are permissible if a specific disease is not targeted, unless reviewed by FDA. A structure/function claim such as supports the immune system would be acceptable whereas alleviates the common cold or flu would not be acceptable for Echinacea because the claim targets a specific disease state (i.e., cold or flu). 

Federal Food, Drug, and Cosmetic Act, Title 21 their effect on food and drug purity package labeling and marking. 

The USP and NF standards of strength, quality, purity, and packaging and labeling are recognized by the U.S. Federal Food, Drug, and Cosmetic Act and Amendments since 1906. These requirements are enforced by the Food and Drug Administration (FDA), a party in the harmonization of requirements for drugs. 

The USP Convention is the publisher of the United States Pharmacopeia and National Formulary (USPINF). These texts and supplements are recognized as official compendia under the Federal Food, Drug Cosmetic Act (FD C Act). As such, their standards of strength, quality, purity, packaging, and labeling are directly enforceable under the adulteration and misbranding provisions without further approval or adoption by the FDA (http //www.usp.org frameset.htm http //www. usp,org/standards/fda/jgv testimony.htm). 

---