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this pageFDA Bans Ephedra in Dietary Supplements
WASHINGTON, D.C. — January 9, 2004 — After spending years collecting data about the medical dangers caused by the dietary supplement ephedra, the federal Food and Drug Administration (FDA) has finally moved to ban the substance. This action comes only after one hundred fifty–five people have died and many more have suffered from ephedra–related heart problems, strokes, and increased blood pressure.
The FDA plans to issue a final rule prohibiting ephedra sales. It will be effective within 60 days. Meanwhile, the agency has informed ephedra manufacturers of the upcoming rule, and issued a public alert warning consumers that ephedra causes an “unreasonable risk of illness or injury, and should not be consumed.”
Is the FDA warning enough? According to recent reports, some people are actually stocking up on ephedra–based products at local health food stores (Los Angeles Times, January 1, 2004). Sales of ephedra products such as Speed Stack, Ripped Force and Kranker remain high, as some users believe that the supplements build muscles and increase stamina without causing any harm. Others use ephedra products for weight loss, and remain convinced of their usefulness. Yet another group is aware of ephedra side effects and avoids its use while stores quietly remove the products from their shelves.
The issue could be further complicated as manufacturers look for other substances to replace ephedra in dietary supplements. For example, bitter orange (citrus aurantium) contains synephrine, a chemical that is similar to ephedra and also raises the heart rate and blood pressure. Dietary supplement manufacturers have not demonstrated its safety, although it is now contained in products such as Staker 2 Ephedra–Free and Xenadrine EFX (Houston Chronicle, January 2, 2004).
Why Has the FDA Been Slow to Respond to Ephedra Risks?
Part of the ephedra problem may lie in the Dietary Supplement Health and Education Act of 1994. Under this Act, the FDA bears the burden of showing that a dietary supplement presents a “significant or unreasonable risk” to prevent it from being marketed. Therefore, ephedra is presumed to be safe when included in a dietary supplement. In contrast, for drug formulas, the manufacturers must prove that a product is safe and effective before it can be marketed.
To remedy this inconsistency, Sen. Richard Durbin (D–IL) introduced a bill that would require manufacturers of stimulants in dietary supplements to prove that they are safe (S.B. 722). They would also be required to report and investigate any serious side effects of the supplements. Rep. Susan David (D–CA) introduced a similar bill, H.R. 3377, although it excludes vitamins. (For the full text of these bills, see the Thomas Legislative Information site, scroll to Bill Number, and search on S.B. 722 and H.R. 3377 respectively.)
So far, neither of these bills have been adopted. “The supplement industry is a multibillion–dollar operation with an army of lobbyists, friends in the highest places in Washington and attack dogs straining at the leash,” Sen. Durbin commented. He wrote eight letters to U.S. Secretary of Health and Human Services Tommy Thompson urging the agency to prohibit sales of ephedra products. The last letter was sent in July—five months before the FDA’s announcement banning ephedra (Press Release, July 23, 2003).
The consumer group, Public Citizen, has been a vocal critic of both the FDA and the ephedra manufacturers. Dr. Sidney Wolfe, head of health research at Public Citizen, called the FDA’s delay in ordering an ephedra ban an “inexcusable dereliction of responsibility,” even considering the restraints of the 1994 dietary supplement law (Chicago Tribune, December 31, 2003). The group points to the vast amount of material about ephedra that has been available to the FDA over a twenty–year period. This includes complaints, medical literature, and a study by the RAND foundation analyzing ephedra side effects. For more details, see Ephedra Scientific Evidence Versus Money/Politics.
At Brayton Purcell, we are concerned with consumer health and committed to helping people avoid any injuries from unsafe medical drugs and dietary supplements. For more information about medical drugs, supplements, and your legal rights, please feel free to contact us.