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The Department of Justice today announced the entry of a consent decree of permanent injunction involving pharmaceutical company, Laclede Inc. and its president, Michael A. Pellico, concerning the distribution of unapproved over-the-counter vaginal drug products made by the company.
The consent decree, approved by U.S. District Judge Percy Anderson for the Central District of California on Jan. 29, permanently enjoins Laclede and Pellico from interstate distribution of unapproved drug products sold under the name Luvena Prebiotic unless and until these products receive approval by the U.S. Food and Drug Administration (FDA). The drug products include: Luvena Prebiotic Vaginal Moisturizer & Lubricant; Luvena Prebiotic Feminine Wipes; Luvena Prebiotic Enhanced Personal Lubricant; and Luvena Prebiotic Daily Therapeutic Wash.
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.
Moreover, 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 for 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.”
The consent decree resolves a lawsuit brought by the department in June 2014. According to the allegations in the complaint, the sale and distribution of the Luvena Prebiotic products, which were manufactured by Laclede at its Rancho Dominguez, California, facility, violated various provisions of the Federal Food, Drug, and Cosmetic Act.
The act generally prohibits the distribution in interstate commerce of any drug for which the FDA has not given the required premarket 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.
The complaint alleged that since 2010, Laclede had sold one or more of the Luvena Prebiotic products without the required FDA approval. The complaint also alleged that Laclede and Pellico ignored repeated FDA warnings that the company must obtain FDA approval before distributing one or more of the Luvena Prebiotic products in interstate commerce.
Furthermore, the complaint alleged that the company had made unapproved claims on its websites, Facebook page and Twitter feed that the Luvena Prebiotic products balanced vaginal bacterial flora and/or treated or prevented vaginal infections. For instance, according to examples described in the government’s complaint, Laclede made numerous unapproved claims on its product labels or on the company’s websites, Facebook page or Twitter feed that its Laclede Prebiotic products would “rebalance” vaginal bacterial flora, correct pH and reduce or minimize vaginal infections.
For instance, the company’s Twitter feed posted: “If your vagina pH isn’t slightly acidic, correct it with Luvena Prebiotics and rebalance the flora for fewer infections.”
Moreover, Laclede’s Facebook page posted: “Yes, Luvena Prebiotics absolutely do help dryness, but their enzymes help with pH also . . . If you have frequent vaginal infections, use Luvena Prebiotics every two weeks — see if it stops your infections.”
The lawsuit was filed by the Civil Division’s Consumer Protection Branch in Washington, D.C., and was handled by Trial Attorney David A. Frank. Assistance for the lawsuit was provided by Yen P. Hoang of the FDA’s Office of Chief Counsel in Silver Spring, Maryland.