A federal court has ordered 2 Tennessee-based companies with the same owner to stop distributing drugs, dietary supplements, and devices until they are found to be in compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements.1

According to the FDA, Basic Reset and Biogenyx's drugs and devices have not been approved by the agency, despite the website's claims that they can diagnose, cure, mitigate, treat, or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies, and pain.1

Basic Reset's products include pH-FX, described as an alkalizing water enhancer; Dino-Min, marketed as 'Natural Prehistoric Humates'; and Energy FX pendants, which the website said protect against electromagnetic frequency.2

“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,” said Acting FDA Commissioner Ned Sharpless, MD, in a prepared statement.1 “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." 

In addition to distributing unapproved products, Basic Reset and Biogenyx also distributed adulterated and misbranded products, according to the FDA statement. Violations of the current good manufacturing practice (CGMP) requirements for dietary supplements included failure to establish specifications to ensure that the products they receive for labeling are adequately identified and consistent with the purchase order, and failure to establish and follow written procedures to review and investigate product complaints.1

As a result of the violations cited in the complaint filed by the US Department of Justice, US District Judge William L. Campbell, Jr. for the US District Court for the Middle District of Tennessee, entered a consent decree of permanent injunction against the companies. This decree prohibits them from directly or indirectly receiving, labeling, holding, or distributing dietary supplements, drugs, or devices at or from their facility until they take steps to ensure that their products comply with the law.1

The steps required by the FDA include recalling their drugs, dietary supplements and device products, hiring qualified experts to ensure conformity with CGMP and other requirements, and receiving written permission from the FDA before resuming operations.1


References
  1. Commissioner of the FDA. Federal judge enters decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decree-against-tennessee-drug-dietary-supplement-and-device. Published September 3, 2019.
  2. Products. Basic Reset. https://www.basicreset.com/products.