The U.S. Department of Justice announced Friday that it has stopped a Rancho Dominguez firm from selling unapproved over-the-counter vaginal drug products made by the company.
A consent decree, approved Thursday by U.S. District Judge Percy Anderson, permanently enjoins Laclede Inc. and its president, Michael A. Pellicoe, from interstate distribution of unapproved drug products sold under the name Luvena Prebiotic, unless and until the products are approved by the U.S. Food and Drug Administration.
The products include: Luvena Prebiotic Vaginal Moisturizer & Lubricant; Luvena Prebiotic Feminine Wipes; Luvena Prebiotic Enhanced Personal Lubricant; and Luvena Prebiotic Daily Therapeutic Wash.
Attempts to reach a Laclede representative for comment were unsuccessful.
Among other things, the decree also authorizes the FDA to order Laclede and Pellico to stop manufacturing products or to recall distributed products should the FDA determine that there is a violation of the terms of the decree.
For the next five years, Laclede must notify the FDA before the company markets any new Luvena product or modify product labeling, and the company may not legally market such products until the FDA tells the company it may do so.
“We are pleased that the court has approved the consent decree,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division.
“The department will continue to partner with the FDA to vigorously enforce laws that protect women and other consumers against companies that make unapproved claims about health care products that are sold over the counter, as was the case with Laclede’s Luvena Prebiotic products,” she said.
The consent decree resolves a lawsuit brought by the department in June.
The sale and distribution of the Luvena Prebiotic products, manufactured by Laclede at its Rancho Dominguez facility, violated various provisions of the federal Food, Drug, and Cosmetic Act, according to the DOJ.
— City News Service