FDA WARNING_LETTER - Tiller MIND BODY, Inc. - June 26, 2014

On June 23-26, 2014, the FDA inspected Tiller Mind Body, Inc., manufacturer of the LIBBE Colon Hydrotherapy Irrigation System. The FDA determined the LIBBE System is an adulterated and misbranded device.

The device is adulterated because the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) for the device as marketed. It is misbranded because the firm made major changes to the intended use without submitting a new premarket notification (510(k)). The LIBBE System was cleared for colon cleansing before radiological or endoscopic examinations (Class II), but the firm promotes it for general well-being and other non-medically indicated uses (requiring Class III PMA). Examples include claims of being a "restorative procedure," improving hydration, cleansing tissues at a cellular level, promoting physiological flora, and use for children with difficult elimination, bowel telescoping, or constipation due to pheochromocytoma.

The device is also misbranded due to misleading promotional materials on the firm's website, which imply FDA approval by stating "FDA approved Colon Hydrotherapy Devices" and "FDA Approved" components, when the device was only found substantially equivalent. Additionally, the firm makes unsubstantiated claims about promoting well-being, being restorative, improving hydration, facilitating peristalsis, and obviating laxatives. The FDA expressed serious safety concerns regarding the device's use in children for the