U.S. Food and Drug Administration issued the following announcement on Sep. 3.
A federal court has ordered two Tennessee-based companies and their owner to stop distributing drugs, dietary supplements and devices until the companies comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree. According to the complaint filed with the consent decree, the defendants unlawfully distributed unapproved new drugs, adulterated and misbranded dietary supplements and an adulterated and misbranded device.
“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, M.D. “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.”
The FDA has not approved Basic Reset’s or Biogenyx’s drugs or device 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. Basic Reset and Biogenyx also unlawfully distributed dietary supplements that are adulterated and misbranded. During inspections at the facility, FDA investigators found numerous violations of the CGMP requirements for dietary supplements, including failing to establish specifications to ensure that the products they receive for labeling are adequately identified and consistent with the purchase order and failing to establish and follow written procedures to review and investigate product complaints. Because the defendants failed to follow CGMP regulations, their dietary supplements are considered adulterated. Several of the defendants’ dietary supplements are also missing information on their labels required by law, rendering those products misbranded. Additionally, defendants distributed a device that is adulterated and misbranded. According to the complaint, despite previous warnings from the FDA and repeated promises to correct deficiencies, defendants continued to violate the law.
As a result of these violations, today, 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, sole proprietorships, Fred R. Kaufman III, owner, and Kimberly Kaufman. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the Hendersonville, Tenn., drug, dietary supplement and device distributors and the companies’ most responsible individuals.
This action follows multiple FDA inspections conducted at Basic Reset and Biogenyx between 2012 and 2017. The FDA issued a warning letter to the companies in 2016 for similar violations. Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the defendants had failed to make the necessary corrections.
The consent decree prohibits Basic Reset and Biogenyx and the other defendants 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 CGMP and other requirements and receiving written permission from the FDA to resume operations.
Original source can be found here.
