Guide to Dietary Supplements : Part 3

by Food and Drug Administration (FDA)

(Page 4 of 4)

Claims that the supplement has only benefits — and no side effects. A product "potent enough to help people will be potent enough to cause side effects," Barrett says.

Accusations that the medical profession, drug companies and the government are suppressing information about a particular treatment. It would be illogical, Barrett says, for large numbers of people to withhold information about potential medical therapies when they or their families and friends might one day benefit from them.

Though often more difficult to do, consumers also can protect themselves from economic fraud, a practice in which the manufacturer substitutes part or all of a product with an inferior, cheaper ingredient and then passes off the fake product as the real thing but at a lower cost. Varro Tyler, Ph.D., Sc.D., a distinguished professor emeritus of pharmacognosy (the study of medicinal products in their crude, or unprepared, form) at Purdue University in West LaFayette, Ind., advises consumers to avoid products sold for considerably less money than competing brands. "If it's too cheap, the product is probably not what it's supposed to be," he says.

Quality Products

Poor manufacturing practices are not unique to dietary supplements, but the growing market for supplements in a less restrictive regulatory environment creates the potential for supplements to be prone to quality-control problems. For example, FDA has identified several problems where some manufacturers were buying herbs, plants and other ingredients without first adequately testing them to determine whether the product they ordered was actually what they received or whether the ingredients were free from contaminants.

To help protect themselves, consumers should:

Look for ingredients in products with the U.S.P. notation, which indicates the manufacturer followed standards established by the U.S. Pharmacopoeia.

Realize that the label term "natural" doesn't guarantee that a product is safe. "Think of poisonous mushrooms," says Elizabeth Yetley, Ph.D., director of FDA's Office of Special Nutritionals. "They're natural."

Consider the name of the manufacturer or distributor. Supplements made by a nationally known food and drug manufacturer, for example, have likely been made under tight controls because these companies already have in place manufacturing standards for their other products.

Write to the supplement manufacturer for more information. Ask the company about the conditions under which its products were made.

Reading and Reporting

Consumers who use dietary supplements should always read product labels, follow directions, and heed all warnings.

Supplement users who suffer a serious harmful effect or illness that they think is related to supplement use should call a doctor or other health-care provider. He or she in turn can report it to FDA MedWatch by calling 1-800-FDA-1088 or going to www.fda.gov/medwatch/report/hcp.htm on the MedWatch Website. Patients' names are kept confidential.

Consumers also may call the toll-free MedWatch number or go to www.fda.gov/medwatch/report/consumer/consumer.htm on the MedWatch Website to report an adverse reaction. To file a report, consumers will be asked to provide:

• name, address and telephone number of the person who became ill
• name and address of the doctor or hospital providing medical treatment
• description of the problem
• name of the product and store where it was bought.

Consumers also should report the problem to the manufacturer or distributor listed on the product's label and to the store where the product was bought.

Today's Dietary Supplements

The report of the President's Commission on Dietary Supplement Labels, released in November 1997, provides a look at the future of dietary supplements. It encourages researchers to find out whether consumers want and can use the information allowed in dietary supplement labeling under DSHEA. It encourages studies to identify more clearly the relationships between dietary supplements and health maintenance and disease prevention. It urges FDA to take enforcement action when questions about a product's safety arise. And it suggests that FDA and the industry work together to develop guidelines on the use of warning statements on dietary supplement labels.

FDA generally concurred with the commission's recommendations in the agency's 1998 proposed rule on dietary supplement claims.

While much remains unknown about many dietary supplements — their health benefits and potential risks, for example — there's one thing consumers can count on: the availability of a wide range of such products. But consumers who decide to take advantage of the expanding market should do so with care, making sure they have the necessary information and consulting with their doctors and other health professionals as needed.

"The majority of supplement manufacturers are responsible and careful," FDA's Yetley says. "But, as with all products on the market, consumers need to be discriminating. FDA and industry have important roles to play, but consumers must take responsibility, too."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.