FDA Finds Hillestad in Violation of Injunction

FDA Finds Hillestad in Violation of Injunction

WOODRUFF, Wis.--The Food and Drug Administration (FDA) found Hillestad Pharmaceuticals USA Inc., located here, to be in violation of a 2000 court order enjoining the company from making drug claims in promotion of its dietary supplement products. According to FDA, claims that certain dietary supplements from the company can prevent viral or bacterial disease or treat medical conditions such as diabetes or depression are being made in company promotional materials.

FDA delivered a warning letter to the company ordering it to cease the illegal practices or face further action, including a possible contempt of court order. In addition, FDA ordered Hillestad to pay liquidated damages of $23,000, reflecting sales of Opti-Cran, Hi-C Level, Ginkgo Biloba and St. John's Wort that were made in violation of the 2000 court order.

When reached for comment, Dan Hillestad, company president, said Hillestad Pharmaceuticals was in negotiations with the agency to settle the case.