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According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.
On Dec. 10, 2019, FDA released a statement regarding the recall of 25 drug, dietary supplement, and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, TN. According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until they comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.
The companies issued recall notices on Sept. 23, 2019 and Oct. 18, 2019 that directed their customers to dispose of or return products sold, purchased, or distributed after Nov. 7, 2017, according to an FDA press release. The products recalled include drugs Earth Wash and Ionyte, dietary supplements Mello-Tonin and Body Mass Reset, and device Energy FX, among others. Many of the recalled products claim to diagnose, cure, mitigate, treat, or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies, and pain despite not receiving FDA approval or complying with FDA standards.
“[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, in the press release. “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.”
The agency’s statement comes after several FDA inspections at the Basic Reset and Biogenyx locations from 2012 to 2017, which resulted in a warning letter in 2016, according to the release. Follow up-inspections showed the companies failed to make the necessary corrections outlined in the warning letter and can only resume operations after receiving written permission from FDA.
Currently, FDA has not received any adverse event reports related to the recalled products.