Last week, FDA issued a notice to consumers to avoid any of the 25 dietary supplement, drug and medical device products distributed by Basic Reset and Biogenyx, two Hendersonville, TN companies operating under the same ownership. According to FDA, the companies and their owner, Fred R. Kaufman III, entered into a consent decree in which they must recall and stop distributing products until they comply with stipulations put forward in the decree.
The products that were recalled included products marketed as dietary supplements that FDA subsequently classified as unapproved drugs because of the claims being made on them. They included Earth Wash and Ionyte (classified as drugs) as well as dietary supplements including Mello-Tonin and Body Mass Reset.
The consent decree was approved by a judge in September, but at least one of the products—Mello-Tonin—is still for sale on Amazon. FDA said it is ‘reminding’ distributors who still have the products not to sell them and for consumers who have purchased them not to use them because as they do not comply with federal laws they may pose risks.
Warning letter first issued in 2016
The consent decree was part of a drawn-out enforcement action that began with a warning letter issued to the companies in 2016. In that lengthy warning letter, the agency listed numerous violations.
The violations included many impermissible drug claims. They including claims relating to the treatment or prevention of Alzheimer’s disease, arthritis, osteoporosis, multiple sclerosis, glaucoma, depression, and others.
In addition, the warning letter included a laundry list of GMP failures. Those included a failure to have written specifications, a lack of quality control procedures or trained personnel, labeling shortfalls and others.
"The FDA's laws are designed to protect the public health by ensuring, among other things, that drugs and medical devices are safe and effective for their intended uses and that dietary supplements are manufactured and distributed appropriately," said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs. "All companies must follow the appropriate standards and are given the opportunity to ensure their actions are in accordance with these laws. We will continue to prevent the distribution of products that do not comply with applicable FDA requirements and ultimately place the public health at risk."