According to the Justice Department, Defyned Brands, also known as 5 Star Nutrition, distributed misbranded dietary supplements. The company pled guilty to a three count information charging it with that action.
The company admitted that from September 2018 to July 2020, it delivered into interstate commerce misbranded dietary supplements, which are considered a type of food under the Federal Food, Drug, and Cosmetic Act. The specific admission was that shipments of products known as Epivar, Alpha Shredded, and Laxobolic were misbranded. They allegedly contained ingredients that were mislabeled as supplements or were not listed on the product label.
The products were marketed as dietary supplements. They were sold at 5 Star Nutrition Retail locations. The company has agreed to forfeit $4.5 million and comply with the terms of a compliance program and reporting requirements. Magistrate Judge Susan Hightower of the U.S. District Court for he Western Division of Texas presided.
Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division said in a statement, “Consumers deserve to know what is in the dietary supplements they take. 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.”
U.S. Attorney Jaime Esparza for the Western District of Texas. said in a statement, “For almost two years, the defendant in this case misinformed consumers with inaccurate labeling on dietary supplements. 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.”
Special Agent in Charge Charles Grinstead of the Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI) Kansas City Field Office added, “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. We will continue to investigate violators of our laws and work to bring them to justice.”
