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Food and Drug Administration and Compliance Issues
Monday, September 28, 2015
Federal judge enters permanent injunction against Florida dietary supplements maker, Sunset Natural Products Inc.
U.S. Magistrate Judge Edwin G. Torres for the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction on Sept. 25, 2015, against Sunset Natural Products Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements at its facility located in Miami, Florida.
The complaint filed by the U.S. Department of Justice sought the permanent injunction against the company and its owners for manufacturing dietary supplements under conditions that do not meet the U.S. Food and Drug Administration’s current Good Manufacturing Practice (cGMP) requirements. 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 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,” said 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.”
The FDA issued Sunset Natural Products a Warning Letter on March 19, 2013, for similar violations of the cGMP requirements 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 consent decree prohibits the company and its owners 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.