How is GPACT Regulated

GPACT is a global association requiring its members to be responsible to ensure their compliance with all applicable laws and regulations regulating Colon Hydrotherapy in their area. GPACT advises colon hydrotherapists to check their local health authority, health ministry, medical board, licensing body, or health department to learn what restrictions may apply to the use of a colonic device in your area. You may find a prescription is required before the client can receive a colonic. Health and safety codes will have other information you will find useful.

GPACT is not responsible for providing any legal information; however, as information is provided GPACT will expand this list to help colon hydrotherapists know what is required for their clinic.

In the United States of America (USA), Colon Hydrotherapy is governed by the Food and Administration (FDA) and the Code of Federal Regulations (CFR).

COLONIC IRRIGATION SYSTEM

[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2011]
[CITE: 21CFR876.5220] (source)

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES
PART 876 — GASTROENTEROLOGY-UROLOGY DEVICES

Subpart F–Therapeutic Devices

Sec. 876.5220 Colonic irrigation system.
(a)Identification. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (876.5210).

(b)Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.

(c)Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, 1996]

PRESCRIPTION DEVICES

[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2011]
[CITE: 21CFR801.109] (source)

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES
PART 801 — LABELING

Subpart D–Exemptions From Adequate Directions for Use

Sec. 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met:

(a) The device is:

(1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or

(ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and

(2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.

(b) The label of the device, other than surgical instruments, bears:

(1) The statement “Caution: Federal law restricts this device to sale by or on the order of a ____”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device; and

(2) The method of its application or use.

(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented:Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.

(d) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder–piece labeling which calls attention to the name of the device but does not include indications or other
use information.

(e) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.

The Following are Known Governing Agencies for the Following Countries:

Canada
Dubai

Health Authority

European Countries (EU)
Regulated by standards set forth by CE mark
Mexico

Control by the COFEPRIS

United Kingdom (UK)
United States of America (USA)
Regulated by the Food and Drug Administration (F.D.A.) and by state.

  • Alabama
  • Alaska
  • Arizona (Revised Statues Sections 32-2911 Amended Protects homeopathy and Native American Healing Arts)
  • Arkansas
  • California
    • 2012 SB-667 Naturopathic doctors.
    • 2012 SB-1446 Naturopathic doctors
    • 2001 SB577 Complementary and Alternative Health care Practitioners
  • Colorado
    • 2013 SB-215 Colorado Natural Health Consumer Protection Law enacted.
    • 2011 HB1173 License Naturopathic Doctors requires naturopathic doctors to obtain a license to practice in Colorado on or after July 1, 2012
  • Connecticut
    • Naturopathic board regulates colon hydrotherapy
    • 2013 SB00873 An Act Concerning Colon Hydrotherapy Services
    • 2013 HB0544 An Act Concerning Licensure for persons who provide Colon Hydrotherapy Services
  • Delaware
  • Florida
    • Rule No: 64B7-31.001 Passed in 1975. Florida Massage Board regulates and licenses colon therapy and requires National Board Exam for licensing.
  • Hawaii
    • 2015 SB-1216. Colon Hydrotherapy; Naturopathic Medicine; Naturopathic Physicians; Scope of Practice
    • 2014 SCR11 Colon hydrotherapy auditor study
    • 2014 SB2750 Colon hydrotherapy licensure
    • 2012 SCR38 Colon hydrotherapy auditor study
    • 2012 SB2334 Colon hydrotherapy licensure
  • Georgia
  • Idaho
    • 1976 Statute 54-1804 look at section(j) A person who administers treatment or provides advice regarding the human body and its functions that: …
  • Illinois
    • 2015 SB1651 Colon hydrotherapy licensure Session Sine Die
    • 2014 HB3368 Colon hydrotherapy licensure Session Sine Die
    • 2013 H.B.3645 concerning Licensing of Naturopathic Doctors
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
    • 2005 SB189 Signed by the Governor. Becomes Act No. 334.
  • Maine
  • Maryland
    • Passed; signed into law by Governor. Senate Bill 314, House Bill 402. Naturopathic licensing bills.
  • Massachusetts
    • 2015 HB1892 An Act relative to naturopathic medicine coverage
    • 2015 HB1992 An Act establishing a board of registration in naturopathy
    • 2014 Did not pass; formal legislative sessions ended. House Bill 4304 (amends House Bill 3674 by substitution of a new draft; HB 3674 itself amended House Bill 2003 & Senate Bill 1091 by substitution of a new draft). Naturopathic licensing bill.
  • Michigan
  • Minnesota
    • 1999 149A Freedom of Access to Complimentary and Alternative Health Care Practitioners
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
    • 2014 S1190 Naturopathic Doctors Licensing Act
    • 2014 A814 Naturopathic Doctors Licensing Act
    • 2013 A4046 Naturopathic Doctors Licensing Act
  • New Mexico
    • 2009 HB0664 Unlicensed Health Care Practice Act
  • New York
    • Passed Senate; failed in Assembly. Legislature adjourned. Naturopathic licensing bill, Senate Bill 4878, passed the Senate on 6/17/13. Assembly Bill 7860.
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
    • 1994 Oklahoma Statue 59-480
  • Oregon
  • Pennsylvania
    • 2015 HB516 Naturopathic licensing bill; Passed House now in Senate SB621 but not passed; Legislature adjourned. May 1, 2015: Referred to Consumer Protestion and Prodessional Licensure
    • 2014 HB216 Naturopathic licensing bill
  • Rhode Island
    • 2003 Statue 23-74-1 Unlicensed Health care Practices
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
    • A colon hydrotherapist must use of a colon irrigation device under the supervision of a physician licensed by the Texas Board of Medical Examiners. You must have a written order on file for each procedure from the Texas licensed physician.
    • Admin Code RULE §193.17 Nonsurgical Medical Cosmetic Procedures
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming

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