- Colon Care Products of PA, LLC
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Food and Drug Administration|
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
May 28, 2015
Colon Care Products of PA
151 Hoffman Rd
Barto, PA 19504
Re: Colon Hydrotherapy Device (GRACE)
Refer to CMS 460342
Dear Ms. Ehritz:
The United States Food and Drug Administration (FDA) have learned that your firm is marketing the Open System Colon Hydrotherapy Device (Grace), 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 Act, 21 U.S.C. § 321(h), this product 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 to affect the structure or any function of the body.
FDA has reviewed a video on your website, http://www.coloncareproducts.com/ and determined that the Colon Hydrotherapy Device is being marketed with general wellbeing and medical claims. For example, your firm makes reference to one of several treatments from your Open System Colon Hydrotherapy Device (Grace), in which a person could see improvements in the following medical conditions:
- remove ‘autotoxins’ associated with the presence of fecal waste material
- multiple sclerosis
- chronic intestinal pseudoobstruction
- congenital dysautonomia
- ovarian cancer
- parasitic infections
A review of our records reveals that your firm has not received clearance or approval before offering this device for sale, which is a violation of the law. Therefore, the Open System Colon Hydrotherapy Device (Grace) is 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 device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its 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) 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 for the device is described on the Internet at
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps 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 (which must address systemic problems) 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.
Your firm’s response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Room 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS 460342 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: LaShanda Long, at 301-796-5770 or 301-847-8137 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and