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 ..."

(See the "Iodine" section of ConsumerLab.com's Multivitamin/Multimineral Supplements Review and the Review of Kelp Supplements for tests of related products.)

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:

Seller of Heart, Senior and Teen Supplements Warned For Drug Claims

Seller of 5-HTP, Chromium, Curcumin and More Warned for Drug Claims

Seller of Omega-3, Ginkgo, Vision Supplements & More Warned for Drug Claims

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

Seller of Turmeric, Milk Thistle and More Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below