Federal Court Reprimands Two Companies for Unlawful Drug Distribution
Two Tennessee companies were found to have distributed and prescribed unapproved new drugs, adulterated and misbranded supplements, and an adulterated and misbranded device.
A federal court has found two Tennessee-based companies—Basic Reset and Biogenyx—for failing to comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree. According to the filed complaint with the consent decree, the companies broke a number of rules including distributing unapproved drugs, misbranded dietary supplements, and a misbranded device.
The FD&C Act is in place to ensure the safety of consumers, explains FDA Commissioner Ned Sharpless, M.D. That’s why there are standards—so drugs and products are safe, regulated, and consistent.
This is the not the first time these companies have failed to comply with food and drug regulations, explains the FDA press release on the topic. The company had been given a warning by the FDA in 2016 for failing to comply with similar requirements. “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,” said Sharpless.
The FDA has not approved either company’s drugs or device for any use, even though the companies claim that these products could be used to diagnose, cure, mitigate, treat, or prevent conditions like inflammation, chronic diarrhea, bacterial infections, head lice, allergies, and pain.
The companies also broke the law by distributing dietary supplements that are adulterated and misbranded; during the FDA inspections of the facility, investigators found a number of violations of the CGMP requirements for dietary supplements, including failing to adequately label the failing to follow written procedures to review and investigate product complaints. The companies’ failure to follow CGMP regulations makes their dietary supplements adulterated. Furthermore, many of the supplements are also missing information on their labels required by law, making them misbranded.
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 proprietors, Fred R. Kaufman III, owner, and Kimberly Kaufman. The complaint sought a permanent injunction against the drug, dietary supplement, and device distributors and the companies’ most responsible individuals.
Until the companies take appropriate measures to ensure their drugs comply with regulations, the decree prohibits either company and other defendants from receiving, labeling, holding, or distributing dietary supplements, drugs, or devices. In addition to proving the compliance of all their products, the companies must also recall their drugs, dietary supplements, and device products.