Austin-Based Company Pleads Guilty to Distributing Misbranded Dietary Supplements; Agrees to $4.5 Million Forfeiture
Defyned Brands, also known as 5 Star Nutrition LLC, based in Austin, Texas, pleaded guilty to three counts of distributing misbranded dietary supplements. The guilty plea was made today in response to a three-count information charging the company.
According to the plea agreement, Defyned Brands admitted to distributing misbranded dietary supplements from September 2018 to July 2020. The products in question, including Epivar, Alpha Shredded, and Laxobolic, were marketed as workout supplements and sold at 5 Star Nutrition retail locations.
The company acknowledged that these products, classified as food under the federal Food, Drug and Cosmetic Act (FDCA), contained ingredients either mislabeled as dietary ingredients or not listed on the product label. As part of the plea deal, Defyned Brands agreed to forfeit $4.5 million and comply with a compliance program and reporting requirements.
Magistrate Judge Susan Hightower of the U.S. District Court for the Western District of Texas presided over the plea. Principal Deputy Assistant Attorney General Brian M. Boynton emphasized that consumers have the right to know the contents of the dietary supplements they take, and the Justice Department will continue to investigate and take action against those not complying with the law.
U.S. Attorney Jaime Esparza for the Western District of Texas stated that for nearly two years, Defyned Brands misled consumers with inaccurate labeling on dietary supplements. The decision to forfeit profits aims to restore public confidence in the safety of purchased products.
Special Agent in Charge Charles Grinstead of the Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI) Kansas City Field Office highlighted the importance of FDA oversight to ensure the safety of foods. Grinstead stated that companies producing, selling, or distributing misbranded dietary supplements pose a risk to public health, and investigations will continue to bring violators to justice.
The FDA-OCI conducted the investigation in this case.