Federal judge approves consent decree with New York dietary supplement maker (FDA)

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Federal judge approves consent decree with New York dietary supplement maker (FDA)

Published: Thursday, July 3, 2014

Editor's Note: New York dietary supplement manufacturer Mira Health Products Ltd. has entered into a consent decree for permanent injunction with the U.S. after FDA laboratory analysis allegedly found products contained drugs. The consent decree requires Mira to notify FDA of intentions to resume business at least 60 business days in advance, retain an independent expert to inspect its operations and certify to that necessary corrections have been made. Mira must also obtain written notice from the FDA that its operations are compliant with all applicable regulations and recall and destroy all unexpired drugs and dietary supplements manufactured since Aug. 1, 2010. Mira has informed the court that they are out of business and no longer manufacture, process, pack, label, hold, or distribute any dietary supplements.

Food and Drug Administration

Federal judge approves consent decree with New York dietary supplement maker  

A federal judge in New York has signed a consent decree for permanent injunction between the United States and Mira Health Products Ltd., a dietary supplement manufacturer located in Farmingdale, New York, and Michael S. Ragno and Michael S. Ragno, Jr.

On July 26, 2013, the FDA issued a warning to consumers not to use or purchase Healthy Life Chemistry By Purity First B-50, a dietary supplement manufactured by Mira. The FDA issued this warning after receiving numerous reports of illness associated with use of the product. An FDA laboratory analysis found that the product contained two drugs that are potentially harmful anabolic steroids-methasterone, a controlled substance, and dimethazine. These ingredients were not listed on the label and should not have been in a dietary supplement because they are illegal drugs and not dietary ingredients.

In August 2013, Mira recalled all dietary supplements manufactured between June 1, 2010 and May 31, 2013.

Mira's representatives have informed the court that they are out of business and are no longer manufacturing, processing, packing, labeling, holding, or distributing any dietary supplement, any product labeled as such, or any drug.

Under the terms of the consent decree, before Mira can resume operations, the company must first notify the FDA of its intentions at least 60 business days in advance of resuming operations and must retain an independent expert to inspect its operations and certify to the FDA that the necessary corrections have been made.

The company will not be able to resume operations until it receives written notice from the FDA that its operations are compliant with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. Pursuant to the consent decree, the company must, among other things, bring its procedures for manufacturing, packaging and labeling dietary supplements into compliance with federal regulations prior to resuming operations. The company must also recall and destroy, under the FDA's supervision, all unexpired drugs and dietary supplements manufactured since Aug. 1, 2010.

"By law, dietary supplements must be manufactured according to FDA regulations," said Melinda K. Plaisier, the FDA's associate commissioner for regulatory affairs. "This consent decree will ensure that this company cannot harm consumers by selling dietary supplements that do not comply with federal manufacturing requirements."

United States District Court Judge Joseph F. Bianco of the Eastern District of New York entered the consent decree for permanent injunction against Mira Health Products Ltd on July 1, 2014.

Any illnesses or adverse events related to use of these products should be reported to the FDA at https://www.accessdata.fda.gov/scripts/medwatch/ or by calling 800-322-1088.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring 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.

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