The Food and Drug Administration ("FDA") recently required the manufacturers of two purported "dietary supplements" to recall their products because they contained unapproved drug ingredients. The products, Svelte 30 (manufactured by Svelte 30 Nutritional Consultants) and Extenze (manufactured by Biotab Nutraceuticals, Inc.), were found to contain sibutramine. Although sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss, it is a controlled substance, which was withdrawn from the market in October 2010 for safety reasons. Several lots of Extenze also were found to contain prescription drugs used to treat erectile dysfunction.
Products containing a drug ingredient must be approved by the FDA. As a result, manufacturers sometimes seek to market their products as "dietary supplements", even tough they contain a drug ingredient, to escape the expensive and rigorous FDA approval process. Unlike drugs, manufacturers may market dietary supplements simply upon giving the FDA notice within thirty days after they start marketing the product. If the FDA does not formally object, the manufacturer may continue to market the product without the FDA having made any determination as to its safety or efficacy.
Because the FDA has not approved Svelte 30 and Extenze, their safety and effectiveness are unknown. In fact, their drug ingredient, sibutramine, is known to substantially increase blood pressure or pulse rate in some people and may be especially risky for those with a history of heart problems or stroke. Additionally, drugs like sibutramine, which are used to treat erectile dysfunction, may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
The FDA product recall includes the following:
- Svelte 30 Orange & Gray Capsules: Svelte is marketed as a natural herb for weight loss and is packaged in plastic bottles containing 30 capsules per bottle. The recalled products have UPC numbers from 04-3000 to 04-5999, manufacturing date of 10/22/2010, and expiration date of 10/21/2012.
- Extenze Tablets: Two lots of counterfeit products sold nationwide are packaged as a card of four packs (lot 0709241) and a box of 30 tablets divided into two 15-tablet blister packs (lot 0509075). It is possible that there may be other Extenze counterfeit products on the market that have not yet been identified.
If you, or someone you know, has purchased or used Svelte 30 or Extenze containing sibutramine, please contact us to discuss your legal rights.