Colonic Regulation


Food and Drug Administration (FDA) regulates the production of equipment used in colon hydrotherapy in the USA. However, it does not regulate the use of colonic systems. The  manufacturer claims do not require verification or supporting evidence.

The FDA has issued several letters warning manufacturers and suppliers of colon hydrotherapy equipment about making false claims of effectiveness, safety issues and quality control violations.

Therapist can report information based on testimony, but cannot report any information as fact as it is currently not regulated.

At this time the FDA has “registered” the colonic irrigation systems into their appropriate class level. Note, this does not mean and therapists cannot say the equipment is “approved” by the FDA. That statement is implying something that is not true. The FDA is no regulation or approval on colonics themselves, or the process; only that the equipment has been registered at its appropriate class level. Within the class level, the equipment has meet the regulations standard. The terminology is everything when it comes to colonics.

Here’s the code for the FDA’s classification of equipment, click here

What are the classifications of FDA registered equipment?
– The FDA has 3 classifications of equipment to instill water into the colon
• Class 1 – Enema kits (over the counter)
• Class 2 – Colonic Irrigation System – Requires physician (or state defined individual) to purchase
• Class 3 (for general well being)  – Currently no equipment in this category

There are attempts to regulate the training and therapy process at the state level. This requires laws to be submitted and passed.  At this time only a few states have regulated colon hydrotherapy. Florida being one of them.

Note:  This means, there is no required-by-law training guide, process guide or standards for colon hydrotherapy. This means anyone, trained by their friend can open and perform a colonics. This comment is not meant to devalue any therapist, it is made so clients understand your health is in your hands.  Finding a therapist and practice is up to the standards of I-ACT (at a minimum) is the best (if not only) resource at this time to assure your therapist and facility have the training and experience to perform sessions.

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