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FDA News Release

United States enters consent decree with New York dietary supplement manufacturer

Repeated failure to follow current good manufacturing practice prompts government action

For Immediate Release

July 9, 2014

Release

Triceutical, Inc., of Farmingdale, New York, and Liqun Zhang, the company’s president, have agreed to stop production and distribution of dietary supplements under the terms of a consent decree because of violations of federal dietary supplement regulations, known as Current Good Manufacturing Practice (cGMP) requirements.

Triceutical, under the FDA’s supervision, is required to recall and destroy all dietary supplements that were manufactured, prepared, packed, repacked, labeled, held and/or distributed since February 6, 2012, in accordance with the procedures in the consent decree. The consent decree was entered by United States District Judge Leonard D. Wexler of the Eastern District on July 8, 2014.

The FDA issued Triceutical a warning letter dated November 8, 2012, that outlined serious violations of cGMP requirements, including failure to perform tests to verify the identity of dietary ingredients used to manufacture the dietary supplements.

Follow-up inspections by FDA revealed that Triceutical failed to take adequate corrective actions to correct that violation and to ensure the manufacturing process complied with cGMP requirements. Failure to follow cGMP requirements made Triceutical’s products adulterated under the Federal Food, Drug, and Cosmetic Act.

“When a company violates good manufacturing practice requirements, they put consumers at risk,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “Our goal at the FDA is to ensure that the dietary supplements consumers have access to meet federal standards for safety, effectiveness and quality."

As part of the consent decree, Triceutical must bring its procedures for manufacturing, packing, repacking and labeling dietary supplements into compliance with FDA laws and regulations before it can resume production and distribution.

The consent decree also requires Triceutical to hire an outside auditor to assess whether the company continues to comply with cGMP requirements. For at least the next five years, the auditor must send biannual reports to the FDA documenting the audit findings.

If Triceutical violates cGMP requirements in the future, the consent decree provides FDA with the authority to order the company to take appropriate measures to achieve compliance.

Any illnesses or adverse events related to use of these products should be reported to the FDA at https://www.accessdata.fda.gov/scripts/medwatch/or by calling 800-322-1088.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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