September 21, 2019

Consent Decree Against Biogenyx and Basic Reset For FD&C Act Violations

A federal court has ordered two Tennessee-based companies to stop distributing drugs, dietary supplements, and devices until the companies comply with the Federal Food, Drug, and Cosmetic Act (FD&C). The companies are Biogenyx and Basic Reset.

Consent Decree Against Biogenyx and Basic Reset For FD&C Act Violations

The FDA has not approved these drugs or devices “for any use, despite the companies’ claims that these products could be used to diagnose, cure, mitigate, treat, or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain.” In addition, those companies have unlawfully distributed dietary supplements that are adulterated and misbranded, according to the decree.

During inspections at the facilities, FDA inspectors found numerous violations of the Current Good Manufacturing Practices requirements for dietary supplements, including failing to establish specifications to make sure the products are adequately identified and consistent with the purchase order, and failing to establish and follow written procedures to review and investigate product complaints. In addition, several of the dietary supplements are missing information on their labels, which render them misbranded under the law.

Acting FDA Commissioner Dr. Ned Sharpless said in a statement, “Americans expect and deserve products that meet appropriate standards for quality. To ensure safe use by consumers, it’s important that companies who sell products adhere to standards set forth by the FD&C Act, including product labeling and quality. Despite previous warnings, Basic Reset and Biogenyx placed consumers at risk by distributing certain products in violation of current good manufacturing practice (CGMP) requirements and products which failed to adequately meet labeling standards. The U.S. Food and Drug Administration remains fully committed to taking enforcement action against companies and owners who place unsuspecting American consumers at risk.”

U.S. District Judge William L. Campbell, Jr. for the U.S. District Court for the Middle District of Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx and their owners. Multiple inspections between 2012 and 2017 revealed these violations. The FDA issued warning letters to the companies in 2016 for similar violations. Follow-up inspections showed that the defendants did not make the necessary corrections, despite assurances that they would happen.

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