FDA Warns Consumers to Stop Using Hydroxycut Products; Action Demonstrates Strength of SAER Law

The Food and Drug Administration (FDA) announced today it is warning consumers to immediately stop using select Hydroxycut products (Iovate Health Sciences Inc.). According to FDA, some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall the products from the market.

FDA stated it received 23 adverse event reports of liver-associated damage and also reviewed four case reports published in medical journals. Based on the information available to FDA, the agency has not yet determined if any of the specific ingredients may be the cause of liver injury reports associated with the products.

During a morning conference call with industry, Dietary Supplements Division Director Vasillios Frankos, Ph.D, stated the agency’s expanded authority under “The Dietary Supplement and Non-Prescription Drug Consumer Protection Act” (“the SAER law”) was “of particular importance.” “These reports are helping FDA identify unsafe dietary supplements,” Frankos stated.

According to Frankos, the majority of the reports were submitted voluntarily over the past several years, and FDA exercised its inspection authority as granted by the SAER law.

“The Hydroxycut recall is another indicator that the SAER system is working,” said AHPA President Michael McGuffin. “This is a product-specific recall, and the dietary supplement industry looks forward to continuing to provide safe, health-promoting products to the public and supporting this good law we fought to see enacted.”

The FDA release, which includes a complete list of recalled products, is available on the agency’s Web site: http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html

[Note to Editors: Since Dec. 22, 2007, the dietary supplement and over-the-counter drug industries have been reporting all SAERs to the Food and Drug Administration (FDA) in accordance with Public Law 109-462, “The Dietary Supplement and Non-Prescription Drug Consumer Protection Act.” AHPA submitted a Citizen Petition to FDA in 2003 requesting the agency mandate such reporting, and the association was instrumental in the development and passage of “The Dietary Supplement and Non-Prescription Drug Consumer Protection Act.”]

The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.

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