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.
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.
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, according to the FDA.
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.
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.