FDA NEWS RELEASE
For Immediate Release
: November 20, 2012 Media Inquiries:
Tamara Ward, 301-796-7567, firstname.lastname@example.orgConsumer Inquiries:
Federal judge approves consent decree with Minnesota drug and dietary supplement company
FDA: Firm distributed unapproved and adulterated products online
A Minnesota company and its president have agreed to enter into a Consent Decree of Permanent Injunction sought by the U.S. Food and Drug Administration for unlawfully distributing unapproved new drugs and adulterated dietary supplements.
A consent decree for permanent injunction restrains a company from distributing any products into interstate commerce, until they comply with FDA regulations and allows the FDA to assess damages against the company for any future violations of the law or the Consent Decree.
PUH is to stop distributing its products until all disease claims are removed from its websites, product labels, and all other products and websites under PUH’s or Poindexter’s custody or control. PUH and Poindexter also must comply with cGMP requirements for dietary supplements.
U.S. District Judge David S. Doty of the U.S. District Court for the District of Minnesota signed the injunction filed by the Justice Department against Pharmacist’s Ultimate Health (PUH) of St. Paul, Minn., and its president, Stephen J. Poindexter, on Nov. 6, 2012.
“The FDA works with companies to ensure that their processes comply with the public health requirements in our laws and regulations,” said Melinda Plaisier, the FDA’s Acting Associate Commissioner for Regulatory Affairs. “But when a firm refuses to comply, we will take aggressive enforcement action.”
The company marketed products online at www.puhcorp.com
. PUH and Poindexter claimed that the dietary supplement products treated serious medical conditions such as prostate cancer, high cholesterol, hypertension, and congestive heart failure. Under federal law, products offered for such use are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The company’s products are drugs that have not been approved by the FDA for their claimed uses.
During a 2012 inspection of PUH, the FDA also found that the company distributed dietary supplements that were not manufactured in accordance with the current good manufacturing practice (cGMP) requirements for dietary supplements.
The products, marketed under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy, include capsules, topical creams, and botanical extracts. The product names include Allergy Relief Complex, Lycopene Standardized Extract, Co Q-10, Cold and Flu Defense, Cholesterol Homocysteine, Prostate Companion, Ginger Root Standardized Extract, and Progesterone Cream, among others.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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