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FDA announced on Nov. 15, 2023 that the US District Court for the District of Arizona entered into consent decree of permanent injunction that orders Smart Women’s Choice and its CEO, Jennifer A. Richard, to stop distributing unapproved contraceptive drugs in the United States until it complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The company has promoted its vaginal cream product as a safe and effective contraceptive despite the drug not being approved by FDA. The agency sent a warning letter to the company in 2021 that it was unlawful to distribute the unapproved products; however, the company continued to distribute.
“The consent decree prohibits Smart Women’s Choice, Richard, and any persons or entities in active concert or participation with them who receive notice of the decree, from directly or indirectly manufacturing, preparing, processing, packing, repacking, receiving, labeling, holding and/or distributing any drug at or from their facilities unless and until they meet certain requirements to ensure they are operating in compliance with the FD&C Act, the FDA’s regulations and the decree, and they receive written notice from [FDA] that they appear to be in compliance with these requirements,” the agency stated in a press release.
“Americans expect and deserve drugs that have been scientifically proven to be safe, effective, and of high quality,” said Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in the press release. “lFDA] remains fully committed to taking enforcement action against companies and executives responsible for marketing unapproved drugs in violation of federal law.”