Supplement Manufacturer Gets Permanent Injunction
Dietary supplement manufacturer Confidence USA Inc., located in Port Washington, New York, its president, and its general manager received a permanent injunction on March 4, 2021 from the U.S. District Court for the Eastern District of New York that prevents them from manufacturing, holding, or distributing dietary supplements until further notified by FDA. Confidence USA manufactures and distributes more than fifty dietary supplements under several brands, including Confidence USA, American Best, USA Natural, and the Herbal Store, through Amazon, Walmart, and its own online retail store.
The court found that Confidence USA had violated the Federal Food, Drug, and Cosmetic Act by failing to follow the Current Good Manufacturing Practices (CGMPs) for dietary supplements including repeat violations of rules requiring defendants to verify the identity of each dietary ingredient used in their products and verify that their products met certain purity, strength, composition, and contamination limits. To be able to continue their dietary supplement business, Confidence USA must hire an independent expert to assist in remedying the causes for the repeat violations, pass an inspection, and receive FDA’s specific approval to resume operations.
By way of background, FDA regulates the packaging and preparation of dietary supplements and their ingredients. The Dietary Supplement CGMPs include rules on quality control, sanitation, and product testing that ensure dietary supplements are processed in a sanitary and safe manner and meet quality standards. Keller and Heckman is experienced in assisting dietary supplement manufacturers with CGMP compliance.