Brattleboro, Vermont, January 3, 2004 --A December 30, 2003 FDA ban on dietary supplements that contain ephedrine alkaloids proves true what those in the natural products industry have been saying since 1994: that FDA has the authority to effectively regulate dietary supplements through existing law, the Dietary Supplement Health and Education Act of 1994 (DSHEA.) Through its action and forthcoming final rule on ephedra, FDA is now prepared to use the provisions found in DSHEA with respect to supplement safety, according to comments made by industry consultant Jay Jacobowitz, president of Brattleboro, VT-based Retail Insights.
“FDA has struggled with the ephedra issue since 1995 when it first began receiving reports of adverse events, initially reacting before gathering sufficient science,” Jacobowitz said. By commissioning a February, 2003 independent study from the Santa Monica, CA-based Rand Corp., FDA distanced itself from the scientific controversy surrounding ephedra, a necessary step to avoid criticisms of bias.
The Rand study adds an important independent assessment to the collective database on ephedra, according to Jacobowitz. While researchers at Rand found that the relationship between the total number of ephedra doses and the total number of adverse event reports (AER) was not out of line, the researchers concluded that the serious nature of some of these reports raised a level of concern that warranted further study.
According to Loren D. Israelsen, President of Utah-based LDI Group, “Because dietary supplements are regulated as foods, they do not enjoy the same risk/benefit rationale that applies to drugs. In other words, we expect that there will be adverse events with drugs, which by definition are toxic beyond a certain dose range, because drugs offer recognized benefits along with these known safety risks. Our society has agreed to accept these risks as part of our health care model. With foods, there is no such risk/benefit equation.”
Jacobowitz concurred, adding, “The ephedra ban highlights the difference between foods and drugs. Because drugs are intended solely to cure or mitigate disease, society accepts the risks that go along with that benefit. Foods, on the other hand, while they can mitigate or cure disease, are primarily used for nourishment and maintaining health. As a result, society does not associate foods with risk. This is why the serious AERs associated with ephedra, which FDA regulates as a food under DSHEA, are unacceptable to the public.
“It is clear that FDA, as well as certain members of Congress, would prefer to regulate dietary supplements under a drug-type pre-approval scheme, which would shift the burden onto supplement marketers to prove safety before coming to market. Under DSHEA, the burden currently rests with FDA to prove “significant or unreasonable risk” only after the products are on the market; the underlying assumption being that foods are generally safe.
“Ephedra marketers weighing the wisdom of a court challenge to the ban will understand that while the legal precedent has yet to be set, the verdict on ephedra has already been decided in the court of public opinion. The industry can’t have it both ways: benefit from the conventional food industry’s woes over food safety on the one hand, yet deliver unsafe product from its core offerings on the other. Conspiracy theorists pondering the media chorus calling for greater industry regulation need only understand this fundamental social contract: foods must be safe.
“It is my belief that lawsuits challenging the ban will provoke Congress to rescind DSHEA and force the entire industry into a crippling pre-approval regulatory scheme similar to that required for drugs. Such litigation would be both self-seeking and self destructive. Perhaps ephedra marketers should consider patenting their formulations and going through the drug approval process,” Jacobowitz concluded.