The safety of dietary supplements is again in the spotlight as the FDA warns consumers not to take Strawberry Balance, a weight loss supplement. The FDA tested this product and found two unsafe ingredients, the drug Sibutramine and phenolphthalein. Sibutramine causes a life threatening reaction in some people and the FDA removed it from the marketplace. The FDA took phenolphthalein off the market for safety reasons.
This warning follows a continuing effort by the FDA to remove dietary supplements containing DMAA or dimethylamylamine from the marketplace. DMAA is a stimulant used in supplements for “weight loss and muscle building.” The FDA wants products containing DMAA off the market because “it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.”
REGULATION OF DIETARY SUPPLEMENTS
In the US, the FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (1994). This act requires manufacturers of dietary supplements to ensure their safety and gives the FDA the responsibility for taking action if an unsafe dietary supplement reaches the marketplace. DSHEA defines a dietary supplement as a product that:
- Is intended to supplement the diet
- Contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and certain other substances) or their constituents
- Is intended to be taken by mouth, in forms such as tablet, capsule, powder, softgel, gelcap, or liquid
- Is labeled as being a dietary supplement
Some examples of dietary supplements are fiber, St John’s wort and echinacea. Consumers purchase dietary supplements in a variety of places, including grocery stores, health food stores, and pharmacies.
DANGERS OF SOME DIETARY SUPPLEMENTS
Unlike over the counter medicines and prescription drugs, manufacturers of dietary supplements are not required to get FDA approval before placing these products in the marketplace. Therefore, manufacturers sell dietary supplements without proving the supplements are safe or effective.
The loose regulation of dietary supplements has led to numerous product recalls. The most common reasons for product recalls are:
- Drugs tainting dietary supplements
- Ingredients that are not dietary supplements are contained in products labelled as dietary supplements
These tainted supplements pose a real danger to consumers. “These products are masquerading as dietary supplements-they may look like dietary supplements but they are not legal dietary supplements,” says Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance. “Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.”
HOW TO PROTECT YOURSELF AND YOUR FAMILY
- Before deciding to take any dietary supplement, consult with your physician as even untainted supplements can pose a danger to consumers under certain circumstances.
- Look at the tainted supplements page on the FDA’s website and subscribe to its RSS feed to get direct information on contaminated supplements.
- Check the Natural Center for Complementary and Alternative Medicine at the National Institutes for Health for information on the safety of various dietary supplements and their uses as well as Medline.
- Finally, remember the old adage if it sounds too good to be true it probably is.
US Food and Drug Administration
Dietary Supplement Health and Education Act of 1994