FDA WARNING_LETTER - Colon Care Products of PA, LLC

On May 28, 2015, the FDA issued a Warning Letter to Colon Care Products of PA, specifically to Arleen Ehritz, regarding the Open System Colon Hydrotherapy Device (Grace). The FDA determined that the firm is marketing this device in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The device is being marketed with general wellbeing and medical claims, including for conditions such as psoriasis, lupus, multiple sclerosis, and ovarian cancer. The FDA found that the firm has not received clearance or approval for the device, rendering it adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). Furthermore, the device is misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) because the firm failed to notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) (21 U.S.C. § 360(k)). The FDA requires the firm to take prompt action to correct these violations and notify the agency in writing within fifteen business days of the specific steps taken, including documentation and a timetable for systemic corrective actions. Failure to comply may result in regulatory actions such as seizure, injunction, and civil money penalties.