Large Volume Enema Kits - Combinations of components sold for use as an enema. The FDA makes no mention of the size of an enema bag in their regulation. Currently, bags are on the market that are 1 gallon or more in capacity.
Legal Classification: A Class 1 Medical Device. Class 1 Medical devices like enema kits are legal for over-the-counter sales and for home use without the aid of a physician. Currently, the FDA is not interested in the size of an enema bag. Currently, bags are on the market that are 1 gallon or more in capacity. This is a small market with very few sales. It is not expected to see more regulation.
Manufacturing Requirements: Enema Kits do not require specific FDA approval and can be manufactured by many companies. Companies that make large volume enema bags tend to be small and specialized. If some regulation was introduced, we expect it would put all of them out of business.
Retail Requirements: Large volume enema bags are very hard to find. Only a few online retailers stock them. Try EnemaSupply.com or EnemaEquipment.com for one gallon or larger enema bags.