Recalls & Warnings
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Posted September 3, 2019
Federal Court Shuts Down Two Supplement Companies Selling Weight, Joint Health and Other Supplements
On September 3, 2019, a U.S. District Court entered a consent decree of permanent injunction against Basic Reset and Biogenyx, two Tennessee-based companies that sell dietary supplements and other product promoted for health benefits.
The injunction bars the companies from receiving, labeling, holding or distributing dietary supplements drugs or devices until they take certain steps to ensure that all of these products comply with the law, including hiring qualified experts to ensure they are in compliance with cGMP and other requirements, and receiving written permission from the FDA to resume operations.
The companies were warned by the FDA in 2016 for multiple violations of Good Manufacturing Practices. However, the agency's new release about today's injunction noted, "Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the defendants had failed to make the necessary corrections."
Basic Reset and Biogenyx sell a variety of products, including weight loss supplements such as Trimup and Slimup, "water enhancers" such as pH-FX and IONYTE that are promoted for energy and muscle and joint pain, as well as Primo Java, a coffee, mangosteen and reishi drink blend, and Energy Fx pendant necklaces that are promoted to "protect against electromagnetic frequencies."
See ConsumerLab's Reviews of Joint Health Supplements and Reishi Mushroom Supplements for more information about ingredients found in these products. Also see CL's answer to the question: Which supplements help to improve energy and decrease fatigue?
See related recalls and warnings:
Seller of Mineral, Joint Supplements and More Warned for Manufacturing Violations, Drug Claims
Department of Justice Files Complaint to Shut Down Supplement Company Federal Court Shuts Down Maker of Sexual Enhancement Products
Federal Court Shuts Down Seller of Supplement Promoted for Herpes
Supplement Manufacturer Shut Down for Manufacturing Violations
Company Ordered to Stop Making and Selling Supplements
To read the full news release, use the link below.
The injunction bars the companies from receiving, labeling, holding or distributing dietary supplements drugs or devices until they take certain steps to ensure that all of these products comply with the law, including hiring qualified experts to ensure they are in compliance with cGMP and other requirements, and receiving written permission from the FDA to resume operations.
The companies were warned by the FDA in 2016 for multiple violations of Good Manufacturing Practices. However, the agency's new release about today's injunction noted, "Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the defendants had failed to make the necessary corrections."
Basic Reset and Biogenyx sell a variety of products, including weight loss supplements such as Trimup and Slimup, "water enhancers" such as pH-FX and IONYTE that are promoted for energy and muscle and joint pain, as well as Primo Java, a coffee, mangosteen and reishi drink blend, and Energy Fx pendant necklaces that are promoted to "protect against electromagnetic frequencies."
See ConsumerLab's Reviews of Joint Health Supplements and Reishi Mushroom Supplements for more information about ingredients found in these products. Also see CL's answer to the question: Which supplements help to improve energy and decrease fatigue?
See related recalls and warnings:
Seller of Mineral, Joint Supplements and More Warned for Manufacturing Violations, Drug Claims
Department of Justice Files Complaint to Shut Down Supplement Company Federal Court Shuts Down Maker of Sexual Enhancement Products
Federal Court Shuts Down Seller of Supplement Promoted for Herpes
Supplement Manufacturer Shut Down for Manufacturing Violations
Company Ordered to Stop Making and Selling Supplements
To read the full news release, use the link below.