Drugs

Consent Decree with Two Tennessee Companies

Under terms of a consent decree entered by a Tennessee federal judge, Basic Reset and Biogenyx must stop distributing drugs, dietary supplements, and medical devices until they comply with the Federal Food, Drug, and Cosmetic Act and other requirements in the decree. According to a Justice Department complaint filed with the decree, the two Tennessee companies unlawfully distributed unapproved new drugs, adulterated and misbranded dietary supplements, and an adulterated and misbranded medical device.

Commenting on the action in an FDA news release, acting commissioner Ned Sharpless said that despite previous warnings, the companies “placed consumers at risk by distributing certain products in violation of current good manufacturing practice requirements and products that failed to adequately meet labeling standards.”

The release says FDA has not approved the companies’ products for any use, despite their claims that they could be used to diagnose, cure, mitigate, treat, or prevent conditions such as inflammation, chronic diarrhea, bacterial infestations, head lice, allergies, and pain. The agency also says the companies unlawfully distributed adulterated and misbranded dietary supplements.

FDA says the consent decree follows multiple agency inspections at the two firms between 2012 and 2017. A Warning Letter was issued in 2016 for similar violations. “Despite assurances that the violations noted in the Warning Letter would be corrected,” the release says, “follow-up inspections revealed that the defendant had failed to make the necessary corrections.”

The decree prohibits the companies from directly or indirectly receiving, labeling, holding, or distributing dietary supplements, drugs, or devices at or from their facility until they take certain steps to ensure that all of these products comply with the law including, among other things, recalling their drugs, dietary supplements, and device products; hiring qualified experts to ensure conformity with current good manufacturing practice and other requirements, and receiving written permission from FDA to resume operations.

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