Humana HealthBeat Transcript Archive

The Food and Drug Administration reversed a decision this week that allowed dietary supplement manufacturers to claim their products could treat morning sickness or pregnancy-related leg swelling.

The change in decision came after birth defects experts criticized the FDA for potentially putting pregnant women and their children at risk

It's not every day the FDA changes it's mind. But it does illustrate the fact that we all need to be careful when considering the use of dietary supplements.

A dietary supplement is any product taken by mouth that contains a so-called "dietary ingredient", such as vitamins, minerals, herbs, amino acids, and extracts, just to name a few. The label must state that the product is a dietary supplement.

The FDA does not regulate dietary supplements like they do medicines or medical devices. Companies that make the products don't have to register with the FDA or get FDA approval before producing or selling them.

Last month the FDA ruled that certain types of claims could be made that don't relate to specific diseases. For example, a product can claim it promotes health, or relieves common minor symptoms associated with life stages, such as hot flashes, and PMS. But the effects of the product don't need to be proven.

Manufacturers do have to provide information about the contents of the product on the label. The maker also has the responsibility to make sure the ingredients are safe.

The FDA does get involved if people are harmed by any products. If someone feels they have had a harmful effect from a dietary supplement, they should tell their doctor so they can get proper treatment. The doctor should then notify the FDA.

February 11
Dietary Supplements
	The Food and Drug Administration reversed a decision this week that allowed dietary supplement manufacturers to claim their products could treat morning sickness or pregnancy-related leg swelling. The change in decision came after birth defects experts criticized the FDA for potentially putting pregnant women and their children at risk It's not every day the FDA changes it's mind. But it does illustrate the fact that we all need to be careful when considering the use of dietary supplements. A dietary supplement is any product taken by mouth that contains a so-called "dietary ingredient", such as vitamins, minerals, herbs, amino acids, and extracts, just to name a few. The label must state that the product is a dietary supplement. The FDA does not regulate dietary supplements like they do medicines or medical devices. Companies that make the products don't have to register with the FDA or get FDA approval before producing or selling them. Last month the FDA ruled that certain types of claims could be made that don't relate to specific diseases. For example, a product can claim it promotes health, or relieves common minor symptoms associated with life stages, such as hot flashes, and PMS. But the effects of the product don't need to be proven. Manufacturers do have to provide information about the contents of the product on the label. The maker also has the responsibility to make sure the ingredients are safe. The FDA does get involved if people are harmed by any products. If someone feels they have had a harmful effect from a dietary supplement, they should tell their doctor so they can get proper treatment. The doctor should then notify the FDA.

	Are there any dangers in taking these supplements with other medications? There certainly can be. For example, one should not take chondroitin sulfate if taking blood thinners; or St John's Wort if taking other antidepressants. If you are taking other medications, talk with your doctor before using any supplements. Also, some pharmacies have software that can check for interactions. References and Resources: FDA Statement Concerning Structure/Function Rule and Pregnancy Claims www.fda.gov/bbs/topics/news/new00715.html FDA Finalizes Rules For Claims On Dietary Supplements http://vm.cfsan.fda.gov/~lrd/ Overview of Dietary Supplements U.S. Food and Drug Administration http://vm.cfsan.fda.gov/~dms/