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 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 FDA’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. In the letter it states, “Even if your products did not have these therapeutic claims which make them drugs, your dietary supplement products are adulterated based on the following significant violation: You did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.”
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 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.
See the FDA Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability
See the Medical Law Perspectives May 18, 2015, Blog: Jury Instruction in Product Liability Case That Violation of the FDCA is Negligence Per Se; Preemption Considerations