Ephedra Ban : Evidence of Harm, Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Whatever their form, the FDA regulates dietary supplements under a different set of laws than those covering "conventional" foods and drug products. Under DSHEA, manufacturers are responsible for ensuring that a dietary supplement is safe before it is marketed. They are not required to obtain FDA approval before producing or selling dietary supplements, but they must make sure that product label information is truthful and not misleading. Once a dietary supplement reaches the market, the FDA can take formal action against any dietary supplement shown to be unsafe, such as ephedra. The burden of proof for showing a dietary supplement is unsafe rests with the FDA.

Interim Measures

Based on the FDA's recent comprehensive evaluation of the science, as well as a review of adverse event reports associated with products containing ephedra, the agency alerted consumers to stop buying and using these products immediately. In December 2003, the agency notified firms manufacturing and marketing these products of its intent to issue a final rule prohibiting their sale.

Why a rule? A rule is the most efficient and powerful way to be sure that ephedra-containing dietary supplements stay off the market, as the FDA intends. The rule describes the scientific basis for the FDA's conclusion that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury, and are therefore adulterated under the FD&C Act, when used either as suggested in the labeling, or as they are ordinarily used if the labeling doesn't specify use.

"This final rule will protect consumers by ensuring that these dangerous products are removed from the market and never sold," says FDA Commissioner Mark B. McClellan, M.D., Ph.D.

If a firm continues to market dietary supplements that contain ephedra after the April 2004 effective date of the rule, the FDA can forbid the manufacturer or distributor from continuing to distribute the products, or the agency can initiate action to remove them from the market.

The February 2004 announcement of the FDA's ephedra ban continues a process that started in June 1997, when the FDA first proposed limits on its use, including a required statement on ephedra-containing dietary supplements warning that ephedra is hazardous and should not be used for more than seven days. In February 2003, the agency announced a series of measures that included strong enforcement actions against firms making unsubstantiated claims about their ephedra products. The agency has also taken action against dietary supplements containing synthetic ephedrine, since this material does not meet the definition of a dietary ingredient.

Immediate Action

While working on the final rule, the FDA was actively protecting the public health through a series of high-profile enforcement actions aimed at addressing the public health danger or false or misleading product promotion. Such actions included inspections that resulted in voluntary compliance, voluntary recalls, warning letters, seizures and injunctions, criminal enforcement, and joint enforcement actions with the Federal Trade Commission (FTC) and the Department of Justice.

For example, in 2003 the FTC brought four enforcement actions challenging deceptive claims about safety and side effects for ephedra supplements marketed as bodybuilding aids and energy boosters, and as alternatives to street drugs like Ecstasy. In these cases, the marketers both overstated the benefits and understated the risks of using the products.

In light of the FDA's actions, some ephedra products already have been removed from the market, and the demand for ephedra products has declined significantly. Many companies have reformulated their products to remove ephedra, while others pulled products from the market altogether.

The FDA says there is now concern over some of the alternative ingredients to ephedra, such as bitter orange, which contains synephrine, another form of stimulant with properties similar to ephedrine.

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.