A Florida-based manufacturer of dietary supplements has been ordered to cease operations after the U.S. Food and Drug Administration (FDA) said it was manufacturing products under conditions that do not meet current Good Manufacturing Practice (cGMP) requirements.
In response to a complaint filed by the U.S. Department of Justice, a federal judge entered a consent decree of permanent injunction against Sunset Natural Products Inc. and its two owners for manufacturing and distributing adulterated dietary supplements at its facility in Miami, Fla.
Under the terms of the consent decree, the company will not be allowed to manufacture or sell dietary supplement products until the FDA has determined that it is in compliance with the Federal Food, Drug and Cosmetic Act.
“The FDA is committed to protecting the public health by ensuring dietary supplement makers operate in accordance with the law,” commented Melinda Plaisier, associate commissioner in the FDA’s Office of Regulatory Affairs. “Good Manufacturing Practice regulations are designed to safeguard consumers and violation of these requirements will result in enforcement action.”
Sunset Natural Products had previously received a Warning Letter from the FDA in March 2013, for similar violations of cGMP requirements as well as unapproved drug claims. Follow-up inspections in 2014 found that the company had removed drug claims from its products, but its manufacturing operations were still not in compliance with cGMP.
The company and its owners are now prohibited from marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from the FDA to resume operations.