Consumers told not to use drugs recalled from Basic Reset and Biogenyx
The FDA has informed consumers not to use drugs recalled from Basic Reset and Biogenyx following consent decree for federal violations.
The US Food and Drug Administration (FDA) is alerting consumers of a recall of 25 drug product lines distributed by Basic Reset and Biogenyx. In September, a federal court entered a consent decree of permanent injunction between the US 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.
The FDA has said that Basic Reset and Biogenyx products that have been recalled include drugs such as Earth Wash and Ionyte. Given these products do not comply with appropriate standards, the FDA has advised that they have the potential to be unsafe or ineffective for their particular uses and could lead to adverse health impacts. It is also reminding consumers who may still have these products not to use them and distributors not to sell any of the recalled products.
“All companies must follow the appropriate standards and are given the opportunity to ensure their actions are in accordance with these laws,” said Melinda K Plaisier, FDA Associate Commissioner for Regulatory Affairs. “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, despite the companies’ claims that these products can be used to diagnose, cure, mitigate, treat or prevent a variety of conditions. The FDA has said that 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.
The FDA has explained that this action follows multiple inspections and a warning letter and 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 drugs 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, it said.
To date, the FDA has said it has not received any adverse event reports related to these products.