A federal court on Dec. 13 enjoined two New York companies, a Delaware company and the companies’ owner from distributing and manufacturing adulterated and misbranded dietary supplements in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
In a civil complaint filed on Dec. 11 in the U.S. District Court for the Eastern District of New York at the request of the U.S. Food and Drug Administration (FDA), the United States alleged that Total Body Nutrition LLC, TBN Labs LLC and Loud Muscle Science LLC (collectively TBN companies) and the companies’ owner, Mohammed Islam, violated the FDCA at the companies’ facility in Hauppauge, New York, and their previous facility in Edgewood, New York, by manufacturing and distributing adulterated and misbranded dietary supplements. The complaint alleged that Islam and the TBN companies violated the FDCA by manufacturing dietary supplements without establishing product specifications for the finished batches and without testing or examining the finished batches to verify that they met product specifications, and by using dietary ingredients in their dietary supplements without first testing or examining the ingredients to verify their identity. The complaint also alleged that the FDA inspected the TBN companies’ current and previous facilities four times, in 2017, 2018, 2021 and 2023, and found violations of the FDCA at each inspection. According to the complaint, FDA also issued Islam and the TBN companies warning letters in 2016, 2017 and 2019.
“Dietary supplement manufacturers and distributors have an important responsibility to ensure product quality and safety,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “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.”
“Consumers trust that dietary supplements they purchase are unadulterated,” said U.S. Attorney Breon Peace for the Eastern District of New York. “My office is working diligently with our partners at the Justice Department’s Consumer Protection Branch and the FDA to ensure that these products are what they purport to be and safe. When they are not, we will take all appropriate action to protect consumers.”
“It is imperative that dietary supplement manufacturers comply with the FDA’s regulatory requirements to help ensure product safety and protect consumers,” said Acting Associate Commissioner Michael C. Rogers, MS, of FDA’s Office of Regulatory Affairs. “When evidence of non-compliance is identified, the agency holds dietary supplement manufacturers responsible. The FDA is dedicated to exercising its full authority under the law to take action against adulterated dietary supplements, as part of our ongoing commitment to protect the health of U.S. consumers.”
Islam and the TBN companies agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins Islam and the TBN companies from violating the FDCA, and requires, among other things, that Islam and the TBN companies comply with the dietary supplement current good manufacturing practice regulations and the dietary supplement labeling provisions of the FDCA and its implementing regulations. Further, Islam and the TBN companies must destroy all of their adulterated dietary supplements.
Trial Attorney Kimberly R. Stephens of the Civil Division’s Consumer Protection Branch is handling the case with the assistance of Assistant U.S. Attorney Michael Blume for the Eastern District of New York and Associate Chief Counsel Roselle Oberstein of the FDA’s Office of the Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.
The claims resolved by the consent decree announced today are allegations only, and there has been no determination of liability.
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