Former Employee of Medical Device Manufacturer Sentenced for Forging Two FDA Letters that Led to Illegal Sale of Medical Devices
Defyned Brands, an Austin, Texas, company also known as 5 Star Nutrition LLC, pleaded guilty today to a three-count information charging it with distributing misbranded dietary supplements.
Pursuant to the plea agreement, 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 (FDCA). The company specifically admitted that shipments of products known as Epivar, Alpha Shredded and Laxobolic were misbranded. According to the plea agreement, the products contained ingredients mislabeled as dietary ingredients or not listed on the product label.
The products at issue were marketed as workout supplements and sold at 5 Star Nutrition retail locations. As part of the plea, the company agreed to forfeit $4.5 million and comply with the terms of a compliance program and certain compliance reporting requirements. Magistrate Judge Susan Hightower of the U.S. District Court for the Western District of Texas presided over 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.”
“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.”
FDA-OCI investigated the case.
Senior Litigation Counsel David Sullivan and Trial Attorney Manu J. Sebastian of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Matt Harding for the Western District of Texas prosecuted the case.
Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.