FDA Decides Against Proposed Ephedra Restrictions

Twinlab Corp. (Hauppauge, NY) and other supplement manufacturers breathed a collective sigh of relief last week when the FDA announced its decision to withdraw the proposed restrictive consumption levels for products containing ephedra. Since the rule was proposed in 1997, Twinlab and others in the industry have maintained that there was no scientific justification for the proposed restrictions.

When it proposed the rule, the FDA said it was acting because of more than 800 adverse event reports it had received allegedly connecting ephedra to health problems. However, the Congressional Government Accounting Office (GAO) recently discovered that these reports offer little scientific support for the restrictions.

Now, the FDA has released approximately 70 other reports filed in the past three years (1997–2000), a period that witnessed a dramatic increase in the consumption of ephedra, for review by industry experts. Theodore Farber, a board-certified toxicologist who formerly served with the FDA and has spent considerable time reviewing previous reports, said that his preliminary evaluation of the new reports has not changed his conclusion that no compelling scientific case exists for a ruling that ephedra is unsafe.

The FDA is expected to hold another hearing on the subject in the coming months. Twinlab has announced its support of appropriate federal and state regulations, explicit product labeling, prohibitions on sales to minors, and consumer education that will allow its customers to make informed choices about the products.

Twinlab Corp. is a manufacturer and marketer of nutritional supplements, including a complete line of vitamins and minerals, nutraceuticals, herbs, and sports nutrition products.

For more information: Ross Blechman, President and CEO, Twinlab Corp., 150 Motor Pkwy., Hauppauge, NY 11788. Tel: 631-467-3140. Fax: 631-630-3474.

Edited by Jim Pomager