TBN COMPANIES AGREE TO A PERMANENT INJUNCTION
In mid-December, a dietary supplement manufacturer -- doing business as Total Body Nutrition LLC, TBN Labs LLC and Loud Muscle Science LLC (“TBN companies”) -- consented to a permanent injunction in a case brought by the US Department of Justice alleging that the company had manufactured and distributed “adulterated and misbranded” supplements in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
Apparently, the TBN Companies neither tested nor verified their ingredients, nor tested to ensure that their finished batches met product specifications. Additionally, according to the Consent Decree, their product labels supposedly failed to provide the common or usual name of individual ingredients, failed to list the use of any artificial coloring, failed provide nutrition information in a “Supplement Facts” panel, failed to detail the part of any plant from which each botanical dietary ingredient was derived, and also failed to include a US-based address or phone number so that consumers could report a “serious adverse event.”
The Food and Drug Administration also inspected the companies’ facilities, over the course of several years, and found violations of the law, and the entities purportedly failed to heed several warning letters issued by the agency.
In the injunction, the TBN companies have agreed, among other things, to “comply with the dietary supplement current good manufacturing practice regulations and the dietary supplement labeling provisions of the FDCA and its implementing regulations.” They have also agreed to destroy all “adulterated dietary supplements.”
In a written statement, Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, observed, “Dietary supplement manufacturers and distributors have an important responsibility to ensure product quality and safety …. The Justice Department will continue to work closely with the FDA and take action against manufacturers and distributors who fail to abide by laws designed to protect public health.”
The claims resolved by the consent decree are allegations only, and there has been no determination of liability.
There’s no supplementing that.