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Date: 01-01-2024
Case Style:
United States of America v. Mohammed Islam DBA Total Body Nutrition, LLC, TBN Labs, LLC, and Loud Muscle Science, LLC
Case Number: 23-CV-9073
Judge: Carol Bagley Amon
Court:
United States District Court for Eastern District of New York
Plaintiff's Attorney: United States District Attorney’s Office
Defendant's Attorney: Not Availab le
Description:
New York City, New York criminal defense lawyer represented New York and Delaware Companies from Manufacturing and Distributing Adulterated and Misbranded Dietary Supplements
Breon Peace, United States Attorney for the Eastern District of New York, Brian M. Boynton, Principal Deputy Assistant Attorney General of the Justice Department’s Civil Division, and Michael C. Rogers, MS, Acting Associate Commissioner, of the U.S. Food and Drug Administration (FDA)’s Regulatory Affairs announced today that two New York companies, a Delaware company, and the companies’ owner have been enjoined from distributing and manufacturing adulterated and misbranded dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
“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.” stated United States Attorney Peace.
“Dietary supplement manufacturers and distributors have an important responsibility to ensure product quality and safety,” stated Principal Deputy Assistant Attorney General 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.”
“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, for FDA’s 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.”
A civil complaint filed on October 18, 2023 at the request of the U.S. Food and Drug Administration (FDA), 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, Long Island, and their previous facility in Edgewood, New York, by manufacturing and distributing adulterated and misbranded dietary supplements. The complaint alleges 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 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.
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 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.
Assistant United States Attorney Michael Blume of the Eastern District of New York and Trial Attorney Kimberly R. Stephens of the Justice Department’s Consumer Protection Branch are handling the case with assistance from Associate Chief Counsel Roselle Oberstein of the FDA’s Office of the Chief Counsel.
In March 2022, Mr. Peace announced the creation of a Consumer Protection Team in the Office’s Civil Division. The Consumer Protection Team has focused on protecting the health, safety, economic security, and dignity of individuals in the Eastern District of New York and nationwide, including our most vulnerable residents.
The claims resolved by the consent decree announced today are allegations only, and there has been no determination of liability.
Outcome: Islam and the TBN companies agreed to settle the suit and be bound by a consent decree of permanent injunction.
Plaintiff's Experts:
Defendant's Experts:
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