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# Smart Women’s Choice Consent Decree
- URL: https://www.fdaweb.com/smart-womens-choice-consent-decree/
- Published: 2023-11-15T12:00:00.000Z
- Updated: 2026-09-14T14:16:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155801

FDA says the Arizona federal court has entered a consent decree of permanent injunction ordering Smart Women’s Choice and its CEO, **Jennifer Richard**, to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic Act and meets other requirements in the decree. According to a complaint filed with the decree, the company and Richard distributed unapproved new drugs within the U.S. marketplace.

In a [statement](https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-arizona-based-company-distribution-unapproved?ref=fdaweb.com), the agency says it has not approved Smart Women’s Choice drug, a vaginal cream the company has marketed as a safe and effective contraceptive. The complaint says FDA issued a 2021 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smart-womens-choice-614359-05192021?ref=fdaweb.com) advising the company that its distribution of an unapproved contraceptive was illegal, but Richard and Smart Women’s Choice continued to violate the law.