| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
Warning Letter
DEC 06 2010
VIA United Parcel Service
Oliver Muhs
Natural Methods, Inc.
12 French Dr. RR5
Orangeville, Ontario L9W 2Z2
Canada
RE: Lady-Comp USA™, Baby-Comp, and Pearly
Refer to GEN0901115 when replying to this letter.
Dear Mr. Muhs:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Lady-Comp USA™, Baby-Comp, and Pearly fertility monitors in the United States (U.S.) without marketing 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.ladycomp-babycomp.com. which advertises the products Lady-Comp, Baby-Comp, and Pearly. Your website promotes these devices for uses for which you have not obtained marketing approval, 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. As indicated in the letter dated April 20, 2006, we cleared this device 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 that represent or suggest that the Lady-Comp, Baby-Comp, and Pearly are intended to be used for contraception:
• "[Pearly] is 99.3% effective as a contraceptive."
• "With Baby-Comp you can ... even use it for contraception."
• "Lady-Comp and Pearly are the smart choice for natural birth control!"
The Lady-Comp USA™, Baby-Comp, and Pearly 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 contraception intended use.
In addition, Lady-Camp USA™ is misbranded under Section 502(a), 21 U.S.C. 352(a), misbranding by reference, 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-Camp USA™ is "FDA Approved." 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 Natural Methods, Inc. immediately cease making claims, identical or similar to those described above for Lady-Camp, Baby-Camp, and Pearly. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Also, U.S. 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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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-Camp, Baby-Camp, and Pearly 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, Baby-Comp, and Pearly fertility monitors comply with each applicable requirement of the Act and FDA implementing regulations.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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