On July 20, 2023, the FDA issued a warning letter to Wise Women’s Choice following a review of the company’s website and social media, which found statements about the company’s Wise Women’s Choice products to be drug claims because products were intended to affect the structure or function or the body.

According to the product website, Wise Woman’s Choice does not contain hormones or spermicide, and is promoted as a safe, organic, and all-natural alternative to other forms of contraception. It contains plant extracts and other ingredients, including potassium citrate, potassium castorate, and tocopherol.

It is promoted with statements such as, “Wise Women’s Choice works entirely differently from all other contraceptives; it immobilizes sperm (video #2) on our website . . . on contact, in the vagina, where it is deposited during intercourse. Being immobilized, it cannot travel into the Fallopian tubes, where fertilization occurs. NO FERTILAZATION = NO PREGNANCY.” The company’s website promoted Wise Women’s Choice with statements such as, “There exists a natural birth control cream that’s effective and safe[,] Wise Women’s Choice, formerly known as Smart Women’s Choice contraceptive cream is 99.8% effective.”

Additionally, the FDA stated in its letter that it considers Wise Woman’s Choice to be a “new drug” because products are not recognized as safe and effective for their intended use.

Wise Women’s Choice must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address any and all violations.

For more information, use the link below.

Warning: Wise Women’s Choice