It has been a busy couple of weeks for the Food and Drug Administration, with the Agency filing another injunction, and sending warning letters for GMP violations and product claims.
Minnesota-based Pharmacist’s Ultimate Health (PUH) and its president, Stephen J. Poindexter, agreed to enter into a Consent Decree of Permanent Injunction 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.
The St Paul company 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.
“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.”
Myogenix pleads guilty
In further regulatory enforcement action, California-based Myogenix Corp. pleaded guilty to knowingly manufacturing and distributing in interstate commerce, the purported dietary supplement, “Spawn,” which contained the synthetic steroid “Estradienedione/Estra/Tren,” also known by the chemical name, “4,9(10)-estradiene-3, 17-dione,” – a drug that was not approved by the Food and Drug Administration.
Myogenix was fined $50,000, and a criminal forfeiture of $100,000, which the defendant paid immediately.
The plea agreements require that Myogenix, and any other continuing entities involved in the manufacture and distribution of dietary and nutritional supplements operated or controlled by Myogenix or its principals, monitor and test, at its own expense, all products distributed by those companies for a period of five years.
The testing must be done by an independent testing organization agreed upon by the parties.
FDA also sent a warning letter to Atrium Inc for cGMP violations, human food products allegedly containing material from cattle, and for products allegedly containing unapproved new drugs.
Minnesota-based CocoKefir, LLC , received a warning letter dated November 6, for labeling dietary supplements as "beverages," "nature's sports drink," and "probiotic drink". The Agency claimed that these terms may cause the products to be foods.
The agency also warned the company over 10 different cGMP violations.