In part one of this two part newsletter, I mentioned that the U.S. Food and Drug Administration (FDA) does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed. In general, FDA’s role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency’s first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) the FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.

The law defines dietary supplements in part as products taken by mouth that contain a “dietary ingredient.” Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Once a dietary supplement is on the market, the FDA has certain safety monitory responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotions.

The FDA has established good manufacturing practices (GMPs) that companies must follow to help ensure the identity, purity, strength, and composition of their dietary supplements.

If you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, WATCH OUT! Health fraud scams abound. Health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and effective information.

REFERENCES:

https://www.fda.gov