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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico. The complaint claims that Laclede illegally distributes over-the-counter vaginal drug products without required FDA approval.
According to the complaint, Laclede is in violation of the Federal Food, Drug, and Cosmetic Act for introducing unapproved and improperly labeled (misbranded) drugs for sale across the country. The prebiotic vaginal products named in the complaint are:
- Luvena Prebiotic Vaginal Moisturizer and Lubricant
- Luvena Prebiotic Enhanced Personal Lubricant
- Luvena Prebiotic Feminine Wipes
- Luvena Prebiotic Daily Therapeutic Wash
The complaint requests, among other things, that the court issue a permanent injunction order requiring Laclede to cease distribution of these drug products until the company obtains an approved new drug application from the FDA or until all drug claims have been removed from the products’ labels, marketing materials, and any websites controlled by or related to Laclede.
For more information, please visit: Laclede
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