Pharmaceutical, Pills Source: TFP File Photo

Guilty Plea, $4.5 Million Forfeiture For Texas Company And Misbranded Dietary Supplements

Pharmaceutical, Pills Source: TFP File Photo
Pharmaceutical, Pills Source: TFP File Photo

Defyned Brands, a company based in Austin, Texas, also known as 5 Star Nutrition LLC, admitted to three counts of distributing misbranded dietary supplements in a guilty plea.

The company, in accordance with the plea agreement, acknowledged that between September 2018 and July 2020, it transported misbranded dietary supplements across state lines.

These supplements are classified as food under the federal Food, Drug and Cosmetic Act (FDCA). The company specifically confessed to shipping three products, namely Epivar, Alpha Shredded, and Laxobolic, which were found to be misbranded.

As per the plea agreement, these products contained ingredients that were either falsely labeled as dietary ingredients or not listed on the product label.

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The items in question were advertised as exercise supplements and distributed at various 5 Star Nutrition stores.

According to the plea agreement, the company has consented to relinquish $4.5 million and adhere to a compliance program, along with specific reporting obligations. Magistrate Judge Susan Hightower of the U.S. District Court for the Western District of Texas oversaw the plea.

“Consumers deserve to know what is in the dietary supplements they take,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “We will continue to investigate dietary supplement manufacturers and distributors who sell products that do not comply with the law, including through criminal enforcement where appropriate.”

“For almost two years, the defendant in this case misinformed consumers with inaccurate labeling on dietary supplements,” said U.S. Attorney Jaime Esparza for the Western District of Texas. “By requiring this company to forfeit its profits from this practice, we hope to reaffirm the public’s confidence in the safety of the products they purchase.”

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“U.S. consumers rely on FDA oversight of foods to ensure that they are safe and wholesome. Companies that produce, sell or distribute misbranded dietary supplements put the public health at risk,” said Special Agent in Charge Charles Grinstead of the Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI) Kansas City Field Office. “We will continue to investigate violators of our laws and work to bring them to justice.”

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