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Adulterated and Misbranded Dietary Supplements
A federal court on Dec. 13 enjoined Total Body Nutrition LLC, TBN Labs LLC, and Loud Muscle Science LLC, along with their owner Mohammed Islam, from distributing and manufacturing adulterated and misbranded dietary supplements in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
The U.S. Food and Drug Administration (FDA) filed a civil complaint against the companies and Islam on Dec. 11 in the U.S. District Court for the Eastern District of New York. The complaint alleged that the companies and Islam 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.
The FDA also alleged that the companies and Islam used dietary ingredients in their dietary supplements without first testing or examining the ingredients to verify their identity. The complaint further stated that the FDA inspected the companies’ current and previous facilities four times, in 2017, 2018, 2021, and 2023, and found violations of the FDCA at each inspection.
“Dietary supplement manufacturers and distributors have an important responsibility to ensure product quality and safety,” said Principal Deputy Assistant Attorney General Brian M. Boynton. “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 companies and Islam 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 the companies and Islam from violating the FDCA, and requires that they comply with the dietary supplement current good manufacturing practice regulations and the dietary supplement labeling provisions of the FDCA and its implementing regulations.
The consent decree also requires the companies and Islam to 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.
In a separate statement, U.S. Attorney Breon Peace for the Eastern District of New York said, “Consumers trust that dietary supplements they purchase are unadulterated. 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.”
Additionally, Acting Associate Commissioner Michael C. Rogers, MS, of FDA’s Office of Regulatory Affairs stated, “It is imperative that dietary supplement manufacturers comply with the FDA’s regulatory requirements to help ensure product safety and protect consumers. 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.”
Mandatory Facts:
Defendant/Respondent: Total Body Nutrition LLC, Mohammed Islam
Criminal Charges: Manufacturing and distributing adulterated and misbranded dietary supplements in violation of the Federal Food, Drug and Cosmetic Act (FDCA)
City and State: Hauppauge, New York
Date: December 13, 2023
Sentence/Outcome: Permanent injunction, required to destroy adulterated dietary supplements and comply with FDCA regulations
Dollar Amounts: N/A
Key Facts
- State: New York
- Category: White Collar Crime
- Source: DOJ Press Release â†â€â€
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