The Department of Justice today announced the filing of a civil lawsuit against Laclede Inc. and its president, Michael A. Pellico, seeking to stop the distribution of over-the-counter vaginal drug products that the company makes and sells nationwide.
The lawsuit, filed on June 25, 2014, in the United States District Court for the Central District of California, seeks a permanent injunction against the defendants for the sale and distribution of four drugs: Luvena Prebiotic Vaginal Moisturizer and Lubricant; Luvena Prebiotic Enhanced Personal Lubricant; Luvena Prebiotic Feminine Wipes; and Luvena Prebiotic Daily Therapeutic Wash (Luvena Products).
According to the allegations in the complaint, the sale and distribution of the Luvena Products, which are manufactured by the company in its Rancho Dominguez, California, facility, violate various provisions of the federal Food, Drug, and Cosmetic Act.
The Act generally prohibits the distribution into interstate commerce of any drug for which the U.S. Food and Drug Administration (FDA) has not given approval.
Moreover, the Act prohibits the distribution of drugs that are misbranded, including drugs that fail to comply with FDA labeling regulations for over the counter drugs.
According to the complaint, since 2010, Laclede has sold one or more of the Luvena Products without the required FDA approval.
Furthermore, the complaint charges that the company has made unapproved claims that the products treat or prevent vaginal infections, including claims that have appeared on the company’s web sites, Facebook page, and Twitter feed.
The complaint alleges that since 2010, the FDA has repeatedly warned the defendants ¯ including through letters, emails, inspections and meetings ¯ that they must obtain FDA approval before distributing one or more of the Luvena Products.
Nevertheless, according to the complaint, the products were being distributed illegally as recently as March 2014.
The lawsuit was filed by the Justice Department Civil Division’s Consumer Protection Branch, in Washington, D.C., and is being handled by David A. Frank.
Assistance for this matter is being provided by Yen Hoang of the FDA’s Office of Chief Counsel in Silver Spring, Maryland.