FDA Takes Action to Stop Distribution of Unapproved and Adulterated Products by Online Company

December 5, 2012 4:51 pm

FDA took action to restrain Pharmacist's Ultimate Health (PUH) from distributing any products into interstate commerce due to the Minnesota company’s distribution of unapproved new drugs and adulterated dietary supplements. The president of PUH has agreed to enter a Consent Decree of Permanent Injunction from distributing any products until the company complies with FDA regulations. The company marketed products under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy online at www.puhcorp.com and www.doc-nt.com and claimed that the dietary supplement products treated serious medical conditions such as prostate cancer, high cholesterol, hypertension, and congestive heart failure. 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. FDA notes that “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.” PUH is to stop distributing its products until all disease claims are removed from its Web sites and product labels. PUH also must comply with current good manufacturing practice requirements for dietary supplements. The Consent Decree also allows FDA to assess damages against the company for any future violations of the law or the Consent Decree. Additional details are available in an FDA news release.