Federal Judge Enacts Injunction against Dietary Supplement Firm

Federal Judge Enacts Injunction against Dietary Supplement Firm
September 28, 2015

A dietary supplement manufacturer has been ordered to cease operations.

US Magistrate Judge Edwin G. Torres, of the U.S. District Court for the Southern District of Florida, entered a consent decree of permanent injunction against Sunset Natural Products Inc. and its two owners, Teresa Martinez and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements.

Under the terms of the consent decree, the company will not be allowed to manufacture or sell dietary supplement products until the U.S. Food and Drug Administration (FDA) has determined that the business 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," Melinda Plaisier, associate commissioner in the FDA's Office of Regulatory Affairs, said in a written statement. "Good Manufacturing Practice regulations are designed to safeguard consumers and violation of these requirements will result in enforcement action."

Sunset Natural Products received a Warning Letter from the FDA in 2013, alleging that the company was operating in violation of current Good Manufacturing Process (cGMP) practices as well as unapproved drug claims. The FDA's follow-up inspections in 2014 found that although the company removed drug claims from its products, it failed to bring its manufacturing operations into compliance with cGMP.

The initial Warning Letter claimed that the establishment failed to follow appropriate testing procedures, establish the reliability of its suppliers, ensure batch uniformity, establish proper specifications in packaging, and record written procedures.

The consent decree prohibits the company and its owners from marketing dietary supplements until they 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.