Ephedra recall backed by industry
By Lorraine Heller
Last week's recall of nine dietary supplement products containing ephedra has again put the spotlight on the banned ingredient, and the importance of keeping it off the market. Ephedra, a once-popular herbal marketed for weight loss and sports performance, was banned by the US Food and Drug Association (FDA) in 2004 on the grounds that it does not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death.
Nevertheless, the ingredient still found its way into products marketed by dietary supplements company Herbal Science International, which were recalled Thursday on the grounds that "they may present a serious health hazard to consumers".
Dietary supplement industry organization Council for Responsible Nutrition (CRN) commented that this was an "isolated incident" and reiterated that consumers should buy products from "companies and sources you know and trust".
"This incident involves ingredients clearly not permitted by DSHEA for inclusion in dietary supplements. Companies abiding by good manufacturing practices and using only those ingredients permissible under DSHEA should not encounter these kinds of problems," Judy Blatman, CRN senior vice president, communications, told NutraIngredients-USA.com.
The Natural Products Association (NPA), another industry body, expressed its support of the recall. "Products that have been formulated with a banned ingredient just shouldn't be out there on the shelves," said Daniel Fabricant, NPA VP for scientific and regulatory affairs.
Bans and appeals
Ephedra is a source of ephedrine alkaloids, which are adrenaline-like stimulants that can have potentially dangerous effects on the heart. An FDA ruling in 2004 banned the use of the ingredient in dietary supplement products, although the move sparked a debate that has played out in US courts as companies have appealed against the FDA position.
In April 2005, the ban was successfully challenged by Nutraceutical Corporation, since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor.
However, this was then overturned by the federal appeals court decision in August of the same year.
Since then the pendulum has swung back and forth on appeal. The latest came in May last year when the US Court of Appeals rejected the Utah-based firm's challenge to the ban on the grounds that FDA's determination of "unreasonable risk" was itself unreasonable and meant virtually all dietary supplement ingredients stood the risk of being banned. The court rejected the appeal without comment.
At the time of the Nutraceutical appeal at Supreme Court, industry group Natural Products Association also filed an amicus curiae with the Supreme Court. This asked the court to give interested parties the opportunity to prove, on merits, that the FDA overreached and exceeded the bounds of Congress' regulatory scheme.
"We filed the amicus because there is a statutory distinction between food and drugs. We think the risk-benefit standard could cause a problem with that distinction," David Seckman, president of the NPA told NutraIngredients-USA.com at the time.
Herbal Science International is currently recalling nine products containing ephedra as an ingredient sold labeled under the following brands:
The company has ceased distribution of these products and is advising all consumers to immediately stop using them. It said it is working closely with FDA in the recall process.