| U.S. Food and Drug Administration |
FDA Statement, Oct 1, 2004
FDA Finds Hillestad Pharmaceuticals, USA, to be Violating Permanent Injunction Against Promoting Unapproved Drugs
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.
This advisory was prepared by the FDA Office of Public Affairs.