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FDA enforcement: Consent decree for GMP violations and an injunction for disease claims

By Stephen Daniells , 26-Oct-2012

An Oregon herb and supplement manufacturer has been slapped with a permanent injunction for disease claims on products, while a NY supplement manufacturer has agreed to stop activities following repeated cGMP violations, as the FDA continues to use the full extent of its enforcement powers.

Truman J. Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., was served with a permanent injunction for selling products represented as herbs and supplements with claims for treating diseases.

According to the FDA, Berst markets the products on his website, www.healthherbs.com, as alternative herbal medicine for serious disease conditions, such as cataracts, viral and bacterial infections, and cancer.

“This company has ignored previous FDA warnings and has continued to produce and distribute products in violation of federal law,” said Melinda Plaisier, FDA’s acting associate commissioner for regulatory affairs.

“The FDA continues to protect public health by seeking enforcement action against companies that are identified as violating our manufacturing and drug approval requirements.”

Under the Federal Food, Drug, and Cosmetic Act, a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Berst’s products are drugs which have not been approved by FDA for their claimed uses.

GMP violations

FDA also announced that it has entered a consent decree with New York dietary supplement manufacturer, Venus Pharmaceuticals, following repeated violations of current good manufacturing practice (cGMP) regulations.

Venus Pharmaceuticals International Inc., of Hauppauge, NY, and Bharat Kakumanu, its CEO, have agreed to stop production and distribution of dietary supplements into US commerce and recall and destroy affected product produced prior to January 2012, due to repeated violations of cGMP regulations.

“When a company violates public health protections, they put consumers at risk,” said Plaisier.

“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.”

US District Judge Arthur D. Spatt of the US District Court for the Eastern District of New York signed the consent decree on October 15, 2012.

Final products specifications

The Agency states that its investigators noted a number of violations, including a lack of controls to ensure its final products met established specifications. Follow-up inspections revealed that the firm failed to take adequate corrective action to ensure the manufacturing process complied with cGMP requirements. Failure to follow cGMP requirements made Venus Pharmaceuticals’ products adulterated under the Federal Food, Drug, and Cosmetic Act.

The company must hire an outside auditor to oversee and review progress in implementing the needed changes. For the next two years, the auditor must send quarterly reports to the FDA concerning the company’s progress with compliance, and additional reports every six months, thereafter. Venus Pharmaceuticals will be held to strict compliance deadlines for implementing the changes identified in the auditor’s reports.