Submitted by: Urmi Patel
The dietary supplements are regulated by FDA as “foods” but the regulations are different from drugs and other foods. The dietary supplements are known by various other names such as: Nutraceuticals, Phytaceuticals, Herbaceuticals, Nutrapharmaceuticals, Foodiceuticals, Phytomedicines, Therapeutic foods, Pharmafoods, Phytofoods and Parnuts (food of Particular nutritional uses).
FDA regulates food supplement safety and labeling and FTC i.e., Federal Trade Commission regulates food supplement advertising and marketing. Together, the agencies maintain cooperative relationship and coordinates enforcement and educational efforts.
The dietary supplements are regulated by following acts:
1. NLEA- Nutritional Labeling and Education Act of 1990
It specifies “national uniform nutrition labeling” provision which enacts food nutrition and content labeling requirements which varies from FDCA.
2. DSHEA- Dietary Supplements Health and Education Act of 1994
The act amended the FDCA to define dietary supplements as “foods” for most federal regulatory purposes.
Moreover, the company needs to register Bioterrorism Act with FDA before producing or selling supplements. It specifically involves the FDA to take steps to protect the public from threatened or terrorist attack on U.S. food supply.
DEFINITION OF DIETARY SUPPLEMENTS:
The dietary supplements as defined by Congress in the Dietary Supplement Health and Education Act, which became law in 1994, a dietary supplement is a product (other than tobacco) that
is intended to supplement the diet;
contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substan...
... middle of paper ...
...which were found to contain DMAA (dimethylamylamine).
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