Minnesota company barred from going to market for violations of drug and dietary supplement regs
SILVER SPRING, Md. — Pharmacist’s Ultimate Health of St. Paul, Minn., and its president, Stephen J. Poindexter, have been barred from distributing any "unapproved new drugs" that the company had distributed under the guise that they were dietary supplements.
The consent decree of permanent injunction that had been sought by the Food and Drug Administration was signed by U.S. District Judge David Doty of the U.S. District Court for the District of Minnesota on Nov. 6.
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 web sites, product labels, and all other products and web sites under PUH’s or Poindexter’s custody or control.
PUH and Poindexter also must comply with cGMP requirements for dietary supplements.
“The FDA works with companies to ensure that their processes comply with the public health requirements in our laws and regulations,” stated 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 and www.doc-nt.com claiming 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, the agency stated.
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 requirements for dietary supplements.
The products, marketed under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy, included capsules, topical creams and botanical extracts under the brand names 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.