A federal court on Nov. 14 enjoined an Arizona CEO and its company, which distributed a product marketed as a contraceptive from selling and distributing unapproved new drugs in violation of the Food, Drug and Cosmetic Act (FDCA).
In a civil complaint for permanent injunction filed on Oct. 12 in the District of Arizona, the United States alleges that Smart Women’s Choice and its CEO, Jennifer A. Richard, sold and distributed “Smart Women’s Choice,” a cream marketed as a contraceptive, to consumers across the country. The complaint alleges that the defendants sold the product through a website that claimed the product was “hormone-free,” “formulated to be used as a stand-alone contraceptive” and “99.8% effective.” According to the complaint, however, the Food and Drug Administration (FDA) found no published, adequate and well-controlled clinical investigations or any other scientific literature demonstrating that the product was safe and effective for its intended use as a contraceptive.
In May 2021, the FDA issued a warning letter to Smart Women’s Choice, explaining that the sale and distribution of the product was prohibited under the FDCA. According to the complaint, the company continued to make the same unproven claims about the product after receiving the warning letter and took no corrective action. The product never received FDA approval.
“Drug distributors are obligated to comply with the FDCA, which is designed to protect consumers and to ensure the safety and effectiveness of the drugs they take,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work closely with the FDA to stop the distribution of unapproved new drugs.”
“Americans expect and deserve drugs that have been scientifically proven to be safe, effective and of high quality,” said Director Jill Furman of the Office of Compliance for 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 defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The order entered by the federal court permanently enjoins the defendants from violating the FDCA and requires them to comply with federal drug safety regulations before selling any drugs.
Trial Attorney Carolyn Rice of the Civil Division’s Consumer Protection Branch is handling the case with the assistance of Associate Chief Counsel Aravind Sreenath of the FDA’s Office of the General Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.
The claims resolved by the resolution announced today are only allegations. There has been no determination of liability.