FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

https://www.news-line.com/PH_news30087_enews

The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree.

Basic Reset and Biogenyx products that have been recalled include drugs such as Earth Wash and Ionyte, as well as dietary supplements Mello-Tonin and Body Mass Reset and device Energy FX among others. Basic Reset and Biogenyx issued recall notices by email to their customers on Sept. 23 and Oct. 18, requesting disposal or return to the place of purchase for products sold, purchased or distributed after Nov. 7, 2017. Given these products do not comply with appropriate FDA standards, they have the potential to be unsafe or ineffective for their particular uses, and could lead to adverse health impacts. The FDA is reminding consumers who may still have these products not to use them and distributors not to sell any of the recalled products as they do not meet FDA regulations.

“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.”

Basic Reset and Biogenyx have not received the FDA’s approval for the sale of their drugs and one device, despite the companies’ claims that these products can be used to diagnose, cure, mitigate, treat or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain. Consumer use of an unapproved product that claims to treat diseases may cause them to delay seeking appropriate medical care. Additionally, unapproved products have not been reviewed by the FDA for quality, safety or effectiveness. Basic Reset and Biogenyx also unlawfully distributed dietary supplements that are adulterated and misbranded.

This action follows multiple FDA inspections conducted at Basic Reset and Biogenyx between 2012 and 2017 and a 2016 warning letter. Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the companies failed to make the necessary corrections. Basic Reset, Biogenyx and the other defendants cannot receive, label, hold or distribute dietary supplements, drugs or devices until they take certain steps to ensure that all of these products comply with the law. Operations can only resume after receiving written permission from the FDA.

The FDA has not received any adverse event reports related to these products. The FDA encourages patients and health care professionals to report any adverse events to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

Filed under: General Problems