Luvena Lawsuit by FDA Seeks to Curtail Sales
Audet & Partners, LLP reports that the U.S. Food and Drug Administration (FDA) has filed a lawsuit in the United States District Court for the Central District of California against Laclede, the manufacturer of Luvena vaginal moisturizer, to enjoin future sales of the Luvena product.
In taking this extraordinary action, the FDA has alleged that Luvena falls within the FDA designation as a “New Drug.” Because Laclede failed to seek and obtain necessary FDA approval for a “new drug,” the FDA asserts that the company has violated federal law by introducing Luvena into the marketplace. In addition to failing to obtain required approval, the FDA has alleged that the Luvena product has been misbranded in its packaging, in addition to affirmative statements on the company’s website and other marketing materials. More specifically, the FDA has alleged that Luvena lacks a “Drug Facts” panel required of all over-the-counter (OTC) drugs, and its packaging fails to present information on “active ingredients” of the product.
Perhaps most shocking is the FDA allegation that Laclede introduced Luvena into the marketplace without requisite approval even after warning letters issued back in 2010 and 2013 by the FDA to Laclede which clearly explained that Luvena must obtain FDA approval before being taken to market.
Audet & Partners, LLP is currently reviewing many complaints from women who have experienced physical problems associated with Luvena. If you have used Luvena and have suffered side effects that you believe are connected to the lubricant, you are urged to contact a false advertising attorney at Audet & Partners, LLP by calling (800) 965-1461, or by completing and submitting our confidential inquiry form on the right side of this page.