FDA and Justice Department Clamp Down on Maker of These Supplements

Sunset Natural products may not be safe

Check the label on your dietary supplements. If they carry the brand of this manufacturer, you could be putting your health at risk.

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In a recent news release from the FDA, Sunset Natural Products, Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz were served this past week from the U.S. Department of Justice a consent of decree of permanent injunction for the offense of manufacturing and distributing adulterated dietary supplements at its facility located in Miami, Florida.

Basically, a consent of decree is a court order in which a person or company agrees to take specific actions without admitting fault or guilt for the situation that led to the lawsuit. 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. Failure to comply with the decree is considered contempt of court and would lead to further legal action against the company and its owners.

Following inspections of the dietary supplement maker’s facilities, the U.S. Food and Drug Administration’s found that the company failed to adhere to current Good Manufacturing Practices (cGMP), which are government-mandated regulations that are designed to protect consumers from potentially harmful manufacturing practices that can lead to dangerous products.

According to the FDA this has been an ongoing problem originating back in 2013 when Sunset Natural Products was issued a warning letter for making unapproved drug claims for its products and failing to use Good Manufacturing Practice during the manufacture of its supplements.

“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.”

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A search of the company’s online website reveals a rather rudimentary online presence that appears to provide the service of manufacturing and packaging of supplements upon order from another company. Who supplies the ingredients or where the ingredients come from is ambiguous at best.

For another recent warning from the FDA, here is one warning consumers that a weight loss drug advertised as “natural” is not so natural after all.

References:

FDA News Release “Federal judge enters permanent injunction against Florida dietary supplements maker, Sunset Natural Products Inc.”

FDA Warning Letter to Sunset Natural Products Inc.

Sunset Natural Products Inc.

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