A federal judge has entered a permanent injunction against a dietary supplements manufacturer for failing to meet current Good Manufacturing Practice regulations.
A federal judge has entered a permanent injunction against a dietary supplements manufacturer for failing to meet current Good Manufacturing Practice (cGMP) regulations.
Operations of Miami-based Sunset Natural Products Inc were halted under the ruling from US Magistrate Judge Edwin G. Torres.
According to an FDA press release, company owners Teresa Martinez and Elsy Cruz will not be allowed to resume business until the agency deems it in compliance with the Federal Food, Drug, and Cosmetic Act.
Sunset Natural Products will have to recall and destroy its adulterated products that were manufactured or distributed since April 2, 2014. The company will also have to hire a cGMP expert.
The company had received a warning in March 2013 for cGMP violations and unapproved drug claims. In 2014, an FDA inspection found that it had removed unapproved drug claims from its products, but still had cGMP violations.
“The FDA is committed to protecting the public health by ensuring dietary supplement makers operate in accordance with the law,” stated Melinda Plaisier, associate commissioner in the FDA’s Office of Regulatory Affairs, in a press release. “Good Manufacturing Practice regulations are designed to safeguard consumers and violation of these requirements will result in enforcement action.”
A federal judge also halted operations of another drug and dietary supplement maker called Iowa Select Herbs LLC on August 17, 2015,. The company had illegitimately been marketing their products as treatments for cancer, malaria, herpes, and heart disease.
Earlier that month, 3 dietary supplement makers in Wisconsin were also issued a permanent injunction for violating cGMP regulations, such as improperly labeling their products.