FDA Announces Federal Court Enters Consent Decree Against Arizona-Based Company for Distribution of Unapproved Contraceptive Drugs

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Nov 15, 2023, 15:43 ET

SILVER SPRING, Md., Nov. 15, 2023 /PRNewswire/ -- Today, the U.S. District Court for the District of Arizona entered a consent decree of permanent injunction ordering Smart Women's Choice, Inc., an Arizona-based company, and Jennifer A. Richard, its chief executive officer, to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in the consent decree. According to the complaint, which was filed with the consent decree by the U.S. Department of Justice, Smart Women's Choice and Richard unlawfully distributed unapproved new drugs within the U.S. marketplace.

"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. "The FDA remains fully committed to taking enforcement action against companies and executives responsible for marketing unapproved drugs in violation of federal law."

The FDA has not approved Smart Women's Choice's drug, a vaginal cream the company has marketed as a safe and effective contraceptive. Smart Women's Choice has disseminated these claims on its website and social media accounts, among other sources. According to the complaint, despite the FDA's issuance of a warning letter in 2021 advising Smart Women's Choice that the distribution of its contraceptive drug product is unlawful under the FD&C Act, the company and Richard continued to violate the law.

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 the FDA that they appear to be in compliance with these requirements.

Media Contact: Audra Harrison, 301-908-6101
Consumer Inquiries: Email or 855-543-3784

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration