Inspections, Compliance, Enforcement, and Criminal Investigations
Naturally For Her
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
DEC 10, 2010
VIA United Parcel Service
Director of PR
Naturally For Her
578 Washington Blvd.
Marina Del Ray, California 90292
RE: Lady-Comp USA, Petit Sophia
Refer to GEN0901115 when replying to this letter.
Dear Ms. Mellinger:
The Food and Drug Administration (FDA) has learned that your firm is marketing Lady-Comp USA and Petit Sophia fertility monitors in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under Section 201(h) of the Act, 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body. The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website at www.naturallyforher.com, which advertises the products Lady-Comp and Petit Sophia. Your website promotes these devices for uses for which you have not obtained marketing approval or clearance, which is a violation of the law.
A review of our records indicates that we cleared a premarket notification (510(k)) for Lady-Comp USA, K050094, on April 20, 2006, and for Petit Sophia, K021978, on April 8, 2003. As indicated in the letters dated April 20, 2006, and April 8, 2003, we cleared these devices only “for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).” Your website contains the following statements which represent, or suggest that the Lady-Comp USA and Petit Sophia devices are intended to be used for contraception:
- On the homepage of your website there is a prompt that asks, “[w]hat do you want to do?” One of the clickable answers below this question is “preventing pregnancy naturally,” which if selected routes the user to a page describing the Lady-Comp.
- Under the Lady-Comp section of your website, there is a clickable option to learn more about “Lady-Comp For Preventing Pregnancy.” This section states that “Lady-Comp is the ‘intelligent’ fertility computer developed for Natural Family Planning.”
- The Lady-Comp FAQ portion of your website describes how the device supports fertility awareness, which according to the website “may be used to avoid pregnancy.”
- From your homepage, under the title “Natural Fertility Management & Contraception,” the user is presented with a number of product names that, when clicked, route the user to more information. The Petite Sophia is one of these products, and the information provided for this device explains that the Petit Sophia “provides an exceptional tool to assist with traditional Fertility Awareness / Natural Family Planning methods.”
(b)(4)The Lady-Comp USA and Petit Sophia devices are adulterated under Section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. 360(a), or approved applications for an investigational device exemption (IDE) under Section 520(g) of the Act, 21 U.S.C. 360j(g), for the new intended uses. The Petit Sophia device is also misbranded under Section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by Section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency (21 U.S.C. 807.81(b)). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
In addition, Lady-Comp USA is misbranded under Section 502(a), 21 U.S.C. 352(a), in that your website contains a statement that is misleading in accordance with 21 CFR 807.97, because such a statement creates an impression of official approval of a device due to clearance of a premarket notification submission. Specifically, your website states that “Lady-Comp is an FDA approved fertility monitor.” This device was not approved by the FDA, but was determined to be substantially equivalent within the meaning of Section 513(i)(1)(A) of the Act, 21 U.S.C. 360c(i)(1)(A).
The FDA requests that Naturally For Her immediately cease making claims, identical or similar to those described above for Lady-Comp and Petit Sophia. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for Lady-Comp and Petit Sophia the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Paul Tilton at the Food and Drug Administration, 10903 New Hampshire Ave., WO66-3540, Silver Spring, MD 20993, facsimile at (301) 847-8137. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Lady-Comp and Petit Sophia fertility monitors comply with each applicable requirement of the Act and FDA implementing regulations.
Steven D. Silverman
Office of Compliance
Center for Devices and