Inspections, Compliance, Enforcement, and Criminal Investigations
PC Tan 10/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
OCT 10, 2012
VIA United Parcel Service
Ms. Susan Miller
Chief Executive Officer
1040 Wilt Avenue
Ridgefield, New Jersey 07657
RE: KBL Brand Devices - Mon Amie, Optima, and pureCollagen
Refer to CPT1200104 when replying to this letter
Dear Ms. Miller:
The Food and Drug Administration (FDA) has learned that your firm is marketing KBL brand devices including the Mon Amie, Optima, and pureCollagen in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (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 to affect the structure or any function of the body.
The Office of Compliance, in FDA’s Center for Devices and Radiological Health, reviewed http://www.pctan.com/eguipment.php, which shows that the Mon Amie, Optima, and pureCollagen products contain the following claims:
“mon amie . . . • Tanning & Red Light Lamp Combination”
“Optima . . . •Tanning & Red Light Lamp Combination”
“pureCollagen . . . There are 3 different programs: body forming, health training or target muscle formation.”
The addition of red LED light to UV tanning booths constitutes a new technology for the tanning devices. UV tanning beds are regulated under 21 CFR 878.4635 as exempt devices when they are used with only UV light bulbs. Once additional wavelengths are added, in this case red light bulbs, the tanning bed is no longer exempt and would require a premarket submission. Also the pureCollagen device, in addition to using red light bulbs, is advertised to perform body forming, health training, or target muscle formation. The device has not been proven safe and effective for these claims.
Therefore, the Mon Amie, Optima, and pureCollagen devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are 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 sections 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 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance of its devices 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.
Your firm should take prompt action to correct these violations, including immediately ceasing distribution of these devices and disseminating promotional materials for the for the Mon Amie, Optima, and pureCollagen products that are the same as or similar to those materials described above. Failure to promptly correct these violations may result in regulatory action by the FDA without further notice. These actions include, but are not limited to seizure, injunction, and /or civil money penalties.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2012.
Therefore all of your firm’s devices are also misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(0), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps that your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Please direct your response to Ms. LaShanda Long, Branch Chief, General Surgery Devices Branch, Division of Enforcement A, Office of Compliance, Food and Drug Administration, 10903 New Hampshire Avenue, WO66-3520, Silver Spring, MD 20993, facsimile at 301-847-8137. We remind you that only written communications are considered official.
Finally, you should know that the violations discussed in this letter do not necessarily constitute and exhaustive list. It is your firm’s responsibility to ensure compliance with each applicable requirement of the Act and related regulations.
Steven D. Silverman
Office of Compliance
Center for Devices and