Inspections, Compliance, Enforcement, and Criminal Investigations
Bobalee Originals Manufacturing
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20993
FEB 17 2010
Bobalee Originals Manufacturing
4937 Rocky Vista Circle
West Jordan, Utah 84088
RE: Ear Candles
Dear Ms. Benson:
The Food and Drug Administration (FDA) as learned that your firm is marketing ear candles in the United States (U.S.) without racketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your web site www.bobalee-mfg.com for ear candles. The product is a device within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act. The ear candle is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from FDA before they may offer them for sale.
Your web site www.bobalee-mfg.com contains claims that this device is intended to eliminate chronic ear infections in children and adults, clean out embedded or excess wax, and remove fungus and Candida. Additionally, your web site implies additional claims of improved hearing, removes fluid from the inner ear of a child, treats sinus infections, relieves tinnitus, earaches and itching. FDA is aware that these devices may be promoted for use in children of any age, including babies, putting them at increased risk for injuries and complications.
Marketing your device for the intended uses listed above that have not been approved or cleared by FDA is a violation of the law. Specifically, the ear candle is adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). Your device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution for the intended uses discussed above, 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, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 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.
The Office of Compliance requests that Bobalee Originals Manufacturing immediately cease marketing and distribution of ear candles, including the dissemination of promotional materials for ear candles the same as or similar to those described above. 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.
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 ear candles the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Debra Demeritt at the Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 3546, Silver Spring, Maryland 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 ear candles comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and