Truman J. Berst, doing business as Alternative Health and Herbs Remedies, was ordered on Sept. 20, 2012, by permanent injunction in an Oregon Federal District Court, to stop selling its herbal supplement products, which were advertised as capable of curing disease, an illegal claim for a supplement label under the Federal Food, Drug and Cosmetic Act (FDCA).
“This company has ignored previous FDA warnings and has continued to produce and distribute in violation of federal law,” said Melinda Plaisier, FDA’s Associate Commissioner for Regulatory Affairs. “The FDA continues to protect public health by seeking enforcement against companies that are identified as violating our manufacturing and drug approval requirements.’
The company’s website, www.healthherbs.com, includes a box on the front page alerting consumers that, “the Food & Drug Adminsitration and the U.S. Department of Justice have declared war on health foods, alternative health care practitioners, and me personally.”
Under the Dietary Supplement Health and Education Act, companies selling supplements are not permitted to make disease treatment claims on their products or marketing materials. If a product is marketed as a cure, it must be approved by FDA as a drug.
Alternative Health and Herbs Remedies was found to have distributed unapproved and misbranded drugs. The company may be able to resume business after removing any treatment claims from its marketing materials, including its website.
On October 15, 2012, Venus Pharmaceuticals International, Inc. of Hauppauge, N.Y. signed a consent decree agreeing to halt production of its dietary supplements, and to recall and destroy certain products made before January 2012.
The consent decree, signed by US District Judge Arthur D. Spatt of the Eastern District of New York, came after multiple violations of current good manufacturing practice regulations.
A consent decrees is a regulatory tool FDA uses after investigations reveal violations by a food or drug producer.
“When a company violates public health protections, they put consumers at risk,” Plaisier said.
A warning letter from FDA to Venus Pharmaceuticals in May 2011 listed several violations including incomplete record keeping and an inadequate response showing improved records. The warning letter also asserted that Venus Pharmaceuticals “failed to verify [its] finished batch of dietary supplements [met] product specifications for purity, strength, and composition … .”
The consent decree requires Venus Pharmaceuticals to conform its procedures with CGMP before the company can start manufacturing supplements again. Those procedures will be reviewed by a third-party auditor. FDA reports no illnesses associated with Venus Pharmaceuticals’ products.© Food Safety News