FDA WARNING_LETTER - Naturally For Her

On December 10, 2010, the FDA issued a Warning Letter to Naturally For Her regarding the marketing of Lady-Comp USA and Petit Sophia fertility monitors. The FDA learned the firm was marketing these devices in the U.S. without proper marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The FDA's Office of Compliance reviewed Naturally For Her's website, www.naturallyforher.com, which advertised Lady-Comp and Petit Sophia. While the FDA had cleared premarket notifications (510(k)) for Lady-Comp USA (K050094) on April 20, 2006, and Petit Sophia (K021978) on April 8, 2003, for "measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception)," the website promoted these devices for contraceptive uses.

Specific violations included website statements suggesting contraceptive use, such as "preventing pregnancy naturally," "Lady-Comp For Preventing Pregnancy," and descriptions of the devices supporting fertility awareness to "avoid pregnancy."

These new intended uses render the Lady-Comp USA and Petit Sophia devices adulterated under Section 501(f)(1)(B) of the Act, as the firm lacks approved Premarket Approval (PMA) applications or Investigational Device Exemption (IDE