United States enters consent decree prohibiting illegal distribution of Luvena Prebiotic products January 30, 2015

For Immediate Release

January 30, 2015

Release

At the request of the U.S. Food and Drug Administration, a federal judge from the U.S. District Court for the Central District of California today entered a consent decree of permanent injunction against Laclede, Inc. of Rancho Dominguez, California, and its president, Michael A. Pellico. Laclede is the manufacturer of Luvena Prebiotic products.

The consent decree broadly prohibits Laclede from distributing unapproved or improperly labeled (misbranded) drugs and devices in interstate commerce. This action follows a complaint for permanent injunction that the U.S. Department of Justice filed at the request of the FDA on June 25, 2014. The complaint alleged that the company was illegally distributing over-the-counter vaginal drug products without required FDA approval, despite repeated warnings. The products in question were:

• Luvena Prebiotic Vaginal Moisturizer & Lubricant
• Luvena Prebiotic Feminine Wipes
• Luvena Prebiotic Enhanced Personal Lubricant
• Luvena Prebiotic Daily Therapeutic Wash 

The consent decree entered today specifies, among other things, that Laclede may not market any products that contain the term “prebiotic” or “actibiotic” on its labels or packages without obtaining the FDA’s approval. In addition, Laclede may not market any of its products currently the subject of premarket notifications submitted per section 510(k) of the Federal Food, Drug, & Cosmetic Act, including those referencing “lubrication.” 

“The FDA’s drug approval and device clearance processes are essential to ensuring that medical products marketed in the United States are safe and effective for their intended use,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will take strong enforcement action whenever companies attempt to bypass these critical processes.”

For five years following the consent decree, Laclede must also notify the FDA before it markets any new Luvena product and before it modifies any Luvena product labeling. Laclede may not market such products until the FDA notifies the company that it is in compliance with the law.

If the FDA determines that Laclede fails to comply with the consent decree, the agency may take appropriate measures to ensure compliance, including ordering the company to cease manufacturing and distributing its products, recall its products or pay liquidated damages.        

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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