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T04-41 |
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The Food and Drug Administration has informed Hillestad Pharmaceuticals, USA, Inc., of Woodruff, Wisconsin, that the firm is violating a court order prohibiting the company from using drug claims in the promotion of its dietary supplement products. FDA took this action after an inspection of the firm revealed that it was promoting various dietary supplements with claims that they could treat, prevent, cure or mitigate disease -- even though none of these products has ever been shown to be safe or effective for these uses.
In a letter delivered to Hillestad Pharmaceuticals, FDA instructs the firm to cease these illegal practices or face further FDA action, including a possible contempt proceeding for failure to comply with the court order. The letter also directs the firm to pay liquidated damages in the amount of $23,000.00, which reflects sales of Opti-Cran, Hi-C Level, Ginkgo Biloba, and St. John's Wort that were made in violation of the court order.
In July 2000, the company agreed to a consent decree issued by the United States District Court for the Western District of Wisconsin as part of a settlement of a case FDA and the Department of Justice had brought against it for marketing unapproved new drugs -- products not shown to be safe or effective for their intended uses -- in violation of the Federal Food, Drug & Cosmetic Act. Under the terms of the decree, the firm was required to cease making such drug claims and destroy all promotional materials containing such claims.
An FDA inspection of the firm, however, revealed that such unapproved drug claims are being made in promotional materials such as monthly newsletters the company distributes. These newsletters contain claims that certain products can prevent viral and bacterial disease or treat medical conditions such as diabetes, depression, impotence and allergies.
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