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Regulatory Focus™ > News Articles > US Regulators Crack Down on Supplement Manufacturers

US Regulators Crack Down on Supplement Manufacturers

Posted 26 October 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has moved against three dietary supplement manufacturers for allegedly marketing their products using claims that would cause them to be drugs under the Federal Food, Drug and Cosmetic Act, as well as quality deficiencies.

The three announcements came between 23 and 25 October-an unusually high rate of enforcement activity against a particular sector.

The first action, taken against New York-based Confidence, Inc., related to a number of products that the company claimed could treat specific diseases, such as dementia, atherosclerosis, gangrene, depression and cancer. Under federal law, supplements may make supported claims indicating they support health in general, but may not make specific claims without first demonstrating the product's safety and efficacy to FDA or conforming to an established monograph.

As with many dietary supplement manufacturers whose products are deemed to be drugs by FDA, regulators also alleged that the company had failed to meet current good manufacturing practice (CGMP) standards. US Marshals, at the direction of FDA, seized the company's products, and the matter is likely to now move to the courts.

On 25 October, FDA entered into a consent decree with Venus Pharmaceuticals, another New York-based dietary supplement manufacturer, requiring the company to stop production and distribution of all dietary supplement products and to destroy existing stock manufactured before 1 January 2012. FDA said the company had repeatedly violated CGMP regulations, putting consumers at risk.

"Our goal at the FDA is to ensure that consumers have access to dietary supplements that meet good manufacturing practices, so that the products do not harm consumers," explained Melinda Plaisier, acting associate commissioner for regulatory affairs. The consent decree will also require Venus to hire an outside auditor, which will be charged with sending quarterly reports to FDA for the next two years, and every six thereafter.

FDA also announced the receipt of a permanent injunction against an Oregon-based dietary supplement manufacturer, which it said had marketed its products for the treatment of specific diseases. The company, Alternative Health & Herbs Remedies, had already been found guilty of violating federal law in September 2012, but FDA said the manufacturer had failed to comply with the court's order to cease distribution until certain conditions were met. The company is now appealing the permanent injunction in the 9th Circuit Court of Appeals, FDA said.

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