Why doesn't the FDA regulate dietary supplements?

Nutritional supplements, otherwise known as "nutraceuticals" are classified as food products, not medicines or pharmaceuticals. Therefore, they are not regulated by the strict standards governing the sale of prescription and over-the-counter drugs.

How Nutraceuticals Are Regulated by the FDA

Nutraceuticals are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA) A dietary supplement is simply a product that is taken by mouth that contains natural ingredients intended to supplement the diet. The DSHEA places dietary supplements in a special category under the general umbrella of "foods."

As a result, the U.S. Food & Drug Administration (FDA) still has the responsibility to help regulate the industry in a lesser role.

The Center for Food Safety and Applied Nutrition (CFSAN), and the Federal Trade Commission(FTC) are both involved. As of 2011, all dietary supplement manufacturers must follow Current Good Manufacturing Practices (cGMPs), which means mandatory testing of all raw materials and finished products.

Flexicose ® is manufactured in the USA at a GMP facility and is subject to the statutes and regulations of the US Food, Drug and Cosmetic Act.



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