Natural Medicines & Vitamins

Publication Date: 
Tue, 11/08/2011
By: Alere Staff

Dietary supplements have a unique relationship with the U.S. Food and Drug Administration (FDA). FDA regulates dietary supplements under a different set of regulations than those covering "conventional" food and drug products (prescription and over-the-counter).

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements (except when marketing a dietary supplement that contains a "new dietary ingredient"). Manufacturers must also make sure that product label information is truthful and not misleading.

FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

Must all ingredients be stated on the label?

Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. Review the ingredients listed for potential interactions with your warfarin medication, specifically vitmain K.

Are dietary supplement serving sizes standardized?

There are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. Dietary supplements are not intended to replace the balance of the variety of foods important to a healthy diet. While you need enough nutrients, too much of some nutrients can cause problems.

Can I get information about a specific dietary supplement from the FDA?

The FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell, so if you have questions about a specific product, you may contact the manufacturer directly.

Should I check with my doctor before using a supplement?

Yes, always check with your doctor before using a dietary supplement. Since some supplements may interact with prescription and over-the-counter medicines, taking a combination of supplements or using these products together with medications (whether prescription or OTC drugs) could under certain circumstances produce adverse effects. The lack of disclosure of drug interactions on these products also makes it hard to know if you are at risk.

Report Adverse Effects

Anyone may report a serious adverse event or illness directly to FDA if you believe it is related to the use of any dietary supplement product. Call the FDA at 1-800-FDA-1088, or fax at 1-800-FDA-0178 or you can report it online.