Recalls & Warnings
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Posted June 7, 2017
FDA Warns Seller of Probiotic and Omega-3 Supplements for Manufacturing Violations
On May 22, 2017, the FDA issued a warning letter to BioTE Medical, LLC following a facility inspection which found its products, including BioTE DIM, BiotTE Probiotic, BioTE Iodine Plus, and BioTE Omega 3 to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.
These violations include failure to establish and follow written procedures for the responsibilities of the quality control operations and failure to establish and follow written procedures to fulfill the requirements relating to product complaints, as required by federal regulations.
In addition, statements made on product labels were found to be drug claims. For example, BioTE Probiotic was promoted with statements such as "Probiotics aide in the prevention of tooth decay and other oral health problems."
(See ConsumerLab.com's Review of Probiotic Supplements for tests of related products.)
BioTE Iodine Plus was promoted with statements such as "Adequate Iodine supplementation can control and reduce: ADD/ADHD, Atherosclerosis, Breast Diseases ..."
BioTE Omega 3 was promoted with statements such as "[B]lood clotting prevention... ." and was promoted with statements such as "[A]rthritis relief."
(See ConsumerLab.com's Review of Fish Oil and Omega-3 Fatty Acid Supplements for tests of related products.)
See Related Warnings:
To read the FDA's warning letter, use the link below