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An assurance of safety: Treat supplements like drugs

Physicians call for better federal regulation of dietary supplements.

Editorial. Nov. 11, 2002. Additional information

When it comes to concerns about dietary supplements, ephedra has become a lightning rod. Physicians have long expressed worry about their patients' use of this product for weight-loss and energy-boosting purposes. And their fears now appear to have been borne out.

It was recently revealed that consumers made more than 13,000 complaints to the largest maker of ephedra-containing diet supplements, Metabolife International Inc. Nearly 2,000 of those reports represented "significant adverse reactions," according to congressional investigators. Metabolife insists that its products are safe.

There are others using irresponsible, and possibly illegal, marketing tactics, targeting teens looking for an energy boost or promoting ephedra-containing cocktails as alternatives to street drugs.

The health consequences of various ephedra-containing products reported by consumers are severe: death, cardiac arrhythmia, myocardial infarction, seizure and stroke.

Consumer complaints alone don't prove that ephedra, also known as ma huang, caused their ills. But until there is adequate scientific research into the benefits and risks of these products, federal regulators should err on the side of caution.

Worries about ephedra-containing supplements prompted the AMA to encourage the Food and Drug Administration to begin proceedings to remove products containing ephedrine alkaloids from the U.S. market. The FDA has not yet responded.

But the AMA's concerns about this substance can be applied to all supplements.

At a recent congressional hearing on ephedra's dangers, the AMA opened its testimony with a series of common-sense questions that should be asked about all such products:

• Do they actually contain the active ingredients at the strengths posted on their labels?
• Are they as safe as their manufacturers' promotional materials say?
• Does the degree of safety change for individuals with preexisting diseases or conditions or for those taking prescription drugs?
• Are the claims of the products' effects accurate and based on science?
• Are these products used inappropriately to treat diseases, thus delaying people from obtaining effective care?

The scary answer to all these questions is: No one knows.

That's why the government must act.

The biggest obstacle to effective regulation is the Dietary Supplement Health and Education Act of 1994. The AMA has urged Congress to amend this law so that dietary supplements are regulated as drugs, rather than as food. That means that ephedra-containing substances and other dietary supplements would have to undergo FDA approval for evidence of safety and efficacy; meet standards established by the U.S. Pharmacopoeia for identity, strength, quality, purity, packaging and labeling; and meet FDA postmarketing rules on reporting adverse events, including drug interactions.

A second step toward improved regulation would be FDA publication of standards for good manufacturing practices for supplements to ensure their quality, purity and consistency. The agency has made progress toward that end. In October, it forwarded a proposed manufacturing practices rule to the Office of Management and Budget for a 90-day review.

The government has taken some action to rein in supplement makers' abuses. In the case of ephedra, for example, it has cracked down on two U.S. firms for false labeling and other infractions. In October, the FDA informed the Netherlands-based distributor of Yellow Jackets that the product's continued sale as a substitute for controlled substances in the United States may be illegal.

But ephedra is just one supplement. And these steps fall short of effective protection.

More must be done. The answer is clear: Amend the dietary supplement law and institute manufacturing standards so these products receive the same scrutiny as other drugs. The American consumer deserves these assurances of safety.

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 ADDITIONAL INFORMATION: 

Hearing, "Ephedra: Who is Protecting American Consumers?" Senate Subcommittee on Oversight of Government Management, Restructuring, and the District of Columbia, Oct. 8 (http://www.senate.gov/~gov_affairs/100802witnesslist.htm)

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Copyright 2002 American Medical Association. All rights reserved.