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By Carol Rados
The Food and Drug Administration has banned the sale of dietary supplements containing ephedra (ephedrine alkaloids) due to concerns over their cardiovascular effects, including increased blood pressure and irregular heart rhythm. The final rule, published Feb. 6, 2004, becomes effective on April 12, 2004.
"This FDA rule reflects what the scientific evidence shows--that ephedra poses an unreasonable risk to those who use it," Health and Human Services Secretary Tommy G. Thompson said. "The regulations prohibit the sale of dietary supplements containing ephedra, and we intend to take swift action against anyone who puts consumers at risk by continuing to sell such products after the prohibition takes effect."
The action banning ephedra, often referred to as ma huang, marks the first time that the FDA is taking formal action to halt the sale of a dietary supplement ingredient since passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994.
Ephedra is a naturally occurring substance found in plants. Its principal active ingredient is ephedrine, an amphetamine-like compound that potentially has powerful stimulant effects on the nervous system and heart. Like an amphetamine, ephedra increases both blood pressure and heart rate, decreases appetite, and makes the user feel energetic.
In synthetic form, ephedrine is regulated as a drug under the Federal Food, Drug and Cosmetic Act (FD&C Act), and is allowed as an ingredient in over-the-counter drugs to treat asthma, nasal congestion, and minor eye irritation. In recent years, however, dietary supplement products containing botanical ephedra, often in combination with caffeine, another type of stimulant, have been promoted to help people lose weight and enhance sports performance and energy. At the same time, ephedra has been suspected of causing unreasonable health risks or injuries.
There is strong scientific evidence of harm associated with the use of ephedra products. The FDA has been reviewing information for many years about ephedra's effects in the body, its safety and effectiveness, and the adverse event reports associated with its use. The agency found that supplements containing ephedra show little evidence of effectiveness, except for short-term weight loss. The agency also found that the herbal substance raises blood pressure and stresses the circulatory system. These reactions have been linked to serious health problems, including heart ailments and strokes.
One review sponsored by the National Institutes of Health concluded that ephedra is associated with higher risks of mild-to-moderate heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of hyperactivity of the autonomic nervous system, such as tremor and insomnia, especially when taken with caffeine and other stimulants. Another review showed that, for people taking more than 32 milligrams daily, the rate of hemorrhagic (bleeding) strokes among ephedra users was significantly higher than that recorded for non-users. Some ephedra-containing dietary supplement labels recommend daily doses of up to 100 milligrams.
Additionally, a study of calls to poison control centers revealed a disproportionate rate of reactions to ephedra relative to other herbal products. In short, the evidence shows that ephedra is associated with an increased risk of alarming side effects, possibly even deaths.
A dietary supplement is a product taken by mouth that contains a dietary ingredient, such as a vitamin, mineral, herb, other botanical, or amino acid. Substances intended to supplement the diet, such as enzymes, organ tissues, glandulars, and metabolites, also fall in this category. Dietary supplements can be extracts or concentrates, and may be found in many forms, such as tablets, capsules, softgels, gelcaps, liquids, or powders. People take dietary supplements for many reasons, including weight loss, energy, disease prevention and management, and health maintenance.
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.
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.
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.
All currently marketed dietary supplements are affected by the ban if they contain a source of ephedrine alkaloids, including:
The rule does not pertain to: