Drug and Dietary Supplement Maker Signs Consent Decree Sought by FDA
PUH, which markets products under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy, and its president, Stephen J. Poindexter, have entered into a consent decree of permanent injunction sought by the Food and Drug Administration for allegedly distributing unapproved new drugs and adulterated dietary supplements.
PUH and Poindexter claimed that the dietary supplement products treated serious medical conditions such as prostate cancer, high cholesterol, hypertension, and congestive heart failure, conditions which cause the products to be considered drugs and for which they had not been approved by the FDA.
In addition, during a 2012 inspection, the FDA also found that the company distributed dietary supplements that were not manufactured in accordance with the current good manufacturing practice requirements.
The products 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.