SILVER SPRING, Md. — On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico. The complaint claims that Laclede illegally distributes over-the-counter vaginal drug products without required FDA approval.
The prebiotic vaginal products named in the complaint are: Luvena Prebiotic Vaginal Moisturizer and Lubricant, Luvena Prebiotic Enhanced Personal Lubricant, Luvena Prebiotic Feminine Wipes and 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.
“The drug approval process is critical to ensuring that drugs are safe and effective for their intended uses,” stated Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA will take swift action when companies bypass this important process established to protect consumers from harmful products.”
Since 2010, the FDA has repeatedly told the company that it must obtain the FDA’s approval before selling its drug products. According to the complaint, the company subsequently marketed and distributed the unapproved drug products, despite the FDA’s warnings.