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What do sibutramine, rimonabant, phenytoin and phenolphthalein have in common? You can find them spread among the 69 brands of weight-loss pills identified by the FDA. The weight-loss segment of the industry will likely see even more scrutiny of its manufacturing practices now that the FDA has targeted products that it considers harmful or illegal. Among the name-brand products were StarCaps, which has all but shut down its Web site.

Of the four ingredients, the FDA says that sibutramine is a Schedule IV controlled substance, rimonabant is a pharmaceutical ingredient not approved in the United States, phenolphthalein has also been found to be genotoxic, and phenytoin poses a risk to consumers who are allergic or hypersensitive to the pharmaceutical ingredient.

Just how seriously does the FDA take this matter? In a release, the agency says, “More and more products tainted with prescription drugs, including drugs for erectile dysfunction, diabetes, and obesity, are finding their way into the U.S. marketplace.  Many are labeled as dietary supplements or supplements.  FDA takes this escalating issue very seriously, and is committed to doing all that it can to identify and remove these dangerous products from the market.”

Distributors and sellers would be well advised to stay ahead of the FDA. The first step is to review your good manufacturing practices. The federal rule that went into effect in June 2007 describes in detail the required steps. An overview can be found at the FDA Web site. Amendments were published in September of last year.

As you might expect, manfacturers are required to check their products so that they are not mislabeled. In the case of the 69 supplements, there were undeclared products. Discovery of those ingredients in part prompted agency action.


Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.