Metagenics Comments on FDA Ephedra Proposal

Metagenics Files Response to FDA Request For Comments On the Agency’s Need For Additional Legislative Authority to Regulate Dietary Supplements Containing Ephedrine Alkaloids

Comments Urge FDA To Enforce Existing Food and Drug Laws Rather than Seek Additional Legislative Authority to Regulate Dietary Supplements.

Rockville Maryland (April 4, 2003) - Today, Metagenics, Inc., a health sciences company that manufactures and distributes research-based nutritional products and medical foods worldwide, filed detailed comments with the Federal Food and Drug Administration (“FDA”) in response to FDA’s request for comments in connection with new proposed warnings for dietary supplements containing ephedrine alkaloids. Metagenics also commented on FDA’s request for additional legislative authorities that “would be necessary or appropriate to enable FDA to address this issue most effectively.” According to Metagenics CEO, Jeffrey J. Katke, “FDA currently has all the power it needs to protect the public health in the area of dietary supplements. We strongly urge FDA to use that enforcement power rather than seeking revisions under the Dietary Supplement Health and Education Act which are wholly unnecessary at this time. While Metagenics does not currently sell any ephedra products, we also urge FDA to carefully review the Rand Report and take note that ephedra has been shown to be safe when used as directed.”

Marc S. Ullman, who submitted the comments on Metagenics’ behalf and is partner of the firm Ullman, Shapiro & Ullman, LLP in New York, stated that FDA’s request for additional powers is disingenuous as the agency currently has all the necessary legislative authority to ensure that dietary supplements are neither adulterated nor misbranded. “FDA’s failure to utilize the vast enforcement powers available under the Federal Food, Drug and Cosmetic Act (FDCA) as amended by the Dietary Supplement Health and Education Act (DSHEA) is a complete abdication of the Agency’s responsibility to protect the public health.”

In its comments, Metagenics noted that FDA currently has all the necessary enforcement power at its disposal to protect the public from unsafe and/or illegal dietary supplements. FDA’s enforcement power under existing Food and Drug laws include seizure, condemnation, and destruction as well as the outright removal of products from the market if they present an unreasonable risk of harm or if their labeling is false or misleading. FDA currently regulates the types of ingredients that can be used in dietary supplements, the potency and purity of those ingredients, and the claims that can be made on behalf of these products. Metagenics urges FDA to utilize those powers to ensure that all dietary supplements are safe.

Metagenics also noted that FDA’s current proposed warnings for dietary supplements containing ephedrine alkaloids are not supported by scientific evidence. The Rand Report released by FDA on February 28, 2003 established that ephedra was safe and effective for weight loss. Yet, FDA continues to misrepresent scientific data on ephedra in an effort to unduly restrict the sale of these products. Metagenics supports the use of science-based warnings for dietary supplements (including ephedra supplements), but does not believe that FDA’s current proposal is reasonable or necessary to protect the public health.

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Ullman, Shapiro & Ullman, LLP
299 Broadway
Suite 1700
New York, NY 10007

Jeff Katke, CEO
Susan Campbell, Esq., General Counsel
Metagenics, Inc.

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