Dietary Supplements Essay

1518 Words 7 Pages
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
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A new dietary ingredient is a dietary ingredient that was not sold in the United States in a dietary supplement before October 15, 1994. The FDA requires specific safety information from a manufacturer intending to market a dietary supplement containing a new dietary ingredient. This information is not required for older dietary supplement ingredients.

The companies, who manufacture, package, label or hold dietary supplement products should follow cGMP in following aspects: Quality control procedures, designing and constructing manufacturing plants, testing ingredients and finished product, record keeping and handling consumer product complaints.

There are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. FDA has to prove the product is not safe in order to restrict its use or remove it from the market once it is marketed.

1. General information
It includes: Name of product (including the word "supplement" or a statement that the product is a supplement), net quantity of contents, name and place of business of manufacturer, packer, or distributor, directions for use.
2. Supplement Facts Panel It includes: Serving size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value (%DV), if established, if botanical, scientific name of plant and

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