Smart Women’s Choice, Inc, an Arizona-based company, has been ordered by the US District Court for the District of Arizona to halt distribution of drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as other requirements.
Takeaways
- The US District Court for the District of Arizona has issued a consent decree against Smart Women’s Choice, Inc, requiring them to cease the distribution of drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other regulations.
- The complaint, filed by the US Department of Justice, accuses Smart Women’s Choice of distributing unapproved new drugs unlawfully. The company marketed a vaginal cream as a safe and effective contraceptive without FDA approval.
- Despite receiving a warning letter from the FDA in 2021 stating that their distribution of the vaginal cream was unlawful under the FD&C Act, Smart Women’s Choice continued to violate these regulations.
- The consent decree not only prohibits Smart Women’s Choice from distributing any drug products but also extends restrictions to its CEO, Jennifer A. Richard, and affiliated persons or entities. These restrictions will remain until compliance with the FD&C Act, FDA regulations, and the terms of the decree.
- The FDA remains committed to taking enforcement action against companies and executives marketing unapproved drugs in violation of federal law, emphasizing the importance of ensuring drugs are scientifically proven to be safe, effective, and of high quality.
This complaint, filed by the US Department of Justice, statesSmart Women’s Choice was distributing unapproved new drugs unlawfully.
“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.”
Smart Women’s Choice distributed a vaginal cream marketed asa safe and effective contraceptive. However, this cream was not approved by the FDA. Despite this, Smart Women’s Choice has spread these claims on its website, social media accounts, and other sources.
In 2021, the FDA issued a warning letter to Smart Women’s Choice, stating the company’s distribution of the vaginal cream is unlawful under the FD&C Act. However, the company continued to violate the FD&C Act after this letter was issued.
The US District Court for the District of Arizona entered a consent decree, which prohibits Smart Women’s Choice, its chief executive officer Jennifer A. Richard, and any affiliated persons or entities from manufacturing, preparing, processing, packing, repacking, receiving, labeling, holding,or distributing any drug products.
These limitations will remain in place until the associated parties comply with the FD&C Act, FDA regulation, and the decree. They must also receive a letter from the FDA stating they are in compliance with these requirements.
Reference
Federal court enters consent decree against Arizona-based company for distribution of unapproved contraceptive drugs. US Food and Drug Administration. November 15, 2023. Accessed November 16, 2023. https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-arizona-based-company-distribution-unapproved?utm_medium=email&utm_source=govdelivery
