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Pharmacist’s Ultimate Health of St. Paul, Minnesota agreed to a consent decree to cease their unlawful distribution of unapproved new drugs and adulterated dietary supplements. They have to stop distributing their products until all disease claims are removed from their websites and product labels and they comply with cGMP requirements for dietary supplements.
The company marketed products capsules, topical creams, and botanical extracts under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy. 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. The company 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 that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are considered to be drugs. Since the company offers products that to be used as drugs, but have not been approved by the FDA, the company is in violation of the law.
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. FDA inspections of dietary supplement manufacturer have found that at least half of them are not in compliance with cGMPs and 25% of them have received Warning Letters that failure to meet requirements could result in an injunction just like the one issued to Pharmacist’s Ultimate Health.
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