FDA WARNING_LETTER - Natural Methods, Inc. - December 06, 2010

The FDA issued a Warning Letter to Natural Methods, Inc. regarding their Lady-Comp USA, Baby-Comp, and Pearly fertility monitors. The FDA's Office of Compliance reviewed the firm's website, www.ladycomp-babycomp.com, and found that the devices are being marketed in the U.S. without proper marketing approval for all stated uses, violating the Federal Food, Drug, and Cosmetic Act.

Specifically, while Lady-Comp USA (K050094) was cleared in 2006 for measuring basal body temperature as an aid in ovulation prediction to facilitate conception (not for contraception), the website promotes Lady-Comp, Baby-Comp, and Pearly for contraceptive uses. Examples include claims like "[Pearly] is 99.3% effective as a contraceptive," "With Baby-Comp you can ... even use it for contraception," and "Lady-Comp and Pearly are the smart choice for natural birth control!" These claims render the devices adulterated under Section 501(f)(1)(B) of the Act, as there are no approved Premarket Approval (PMA) applications or Investigational Device Exemption (IDE) applications for the contraception intended use.

Furthermore, Lady-Comp USA is misbranded under Section 502(a) because the website states it is "FDA Approved." This statement is misleading per 21 CFR 807.97, as