December 23, 2022—Foundation Consumer Healthcare (FCH), the maker of Plan B One‑Step® 1.5 mg levonorgestrel emergency contraception (Plan B), has been working with the U.S. Food and Drug Administration (FDA) to update the product label to accurately reflect how Plan B works.
Scientific data overwhelmingly shows that Plan B works by delaying or stopping the release of an egg from the ovary and will not prevent or interfere with the implantation of a fertilized egg.1,2
On December 23, 2022, the U.S. FDA approved the corrected label to reflect the accurate mechanism of action (MOA) for Plan B. Additional information from the FDA can be found here:
This is welcome news for the category. The misconception that Plan B works by interfering with implantation can present barriers to broader emergency contraception access. The Plan B labeling correction will help protect continued over-the-counter emergency contraception access and reduce confusion about how Plan B works and further clarify that Plan B does not affect implantation.1,2
FCH firmly believes that access to emergency contraception is critically important. It is our responsibility to equip people with the correct information on how Plan B works and ensure consumers know that Plan B remains available to them in every state across the country, without restrictions.
More About Plan B One‑Step
- Plan B One‑Step was approved as a nonprescription product by the FDA in 2013. Its proven safety and efficacy is supported by a large body of clinical studies and scientific literature.
- Plan B One‑Step is a backup emergency contraceptive pill to help prevent unintended pregnancy before it begins. It must be taken within 72 hours after unprotected sex or birth control failure.
- Plan B One‑Step is not an abortifacient. It will not affect a pregnancy that has already begun, and it will not impact a woman’s future fertility.
- Plan B One‑Step is available right off the shelf at all major retailers in every US state without a prescription or ID. There is no age requirement to purchase.
- Noé G, Croxatto HB, Salvatierra AM, Reyes V, Villarroel C, Muñoz C, Morales G, Retamales A. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception. 2011; 84:486-92.
- Ender M, Gemzell-Danielsson K. Effect of levonorgestrel emergency contraception on implantation and fertility: A review. Contraception, 2022; 109: 8-18.