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Feds order California company to stop selling its probiotic vaginal products

The Department of Justice has filed a permament injuction in U.S. District Court for the Central District of California against Rancho Domigues based Laclede, Inc. and its president Michael A. Pellico after the company was found guilty of violating the Federal Food, Drug, and Cosmetic Act by introducing unapproved and improperly labeled (misbranded) drugs for sale across the country and afterwards ignoring repeated requests by the e U.S. Food and Drug Administration to stop marketing over-the-counter vaginal products without their approval. The products include Luvena Prebiotic Vaginal Moisturizer and Lubricant, Luvena Prebiotic Enhanced Personal Lubricant, Luvena Prebiotic Feminine Wipes, and Luvena Prebiotic Daily Therapeutic Wash.

For the past 4 years, the FDA has repeatedly told Laclede, Inc. and Pellico that it must obtain the FDA’s approval before selling its drug products, only to be ignored. As a result, the court has issued an order forcing the company to cease all distribution of the above named products until it complies with the Food and Drug Administration’s requirements, or until “all drug claims have been removed from the products’ labels, marketing materials, and any websites controlled by or related to Laclede.”

According to the company’s website, Laclede Inc. has been “manufacturing products for both humans and pets at their “FDA approved facility (at 2103 E. University Dr.) in Racho Domingues, CA, for Fortune 500 CPG corporations, up-and-coming- entrepreneurs and leading retailers around the world for the past 25 years including toothpaste, mouthwash, teeth Whiteners, fluoride delivery systems; oral care and pain relief drugs, as well as oral moisturizers and Dr. Pasternak's Ear Rescue. Services also include “house product development, research, design, marketing, raw ingredient and component procurement.” Although the company has been ordered to cease marketing for its vaginal product line, the injunction does not include any of the other products named above.

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