On September 29, 2011, the FDA issued new guidance with regard to the DESI category. This effectively disallowed any new DESI formulations to enter the market. The FDA also has stated that DESI drugs do not have any therapeutic equivalent drugs listed in the “Orange Book”. In their description of therapeutic equivalence, the FDA specifically cites Donnatal®. Therefore, any so-called generic drugs on the market with similar formulation to DESI drugs, are considered illegal drugs as the FDA has not reviewed their composition or therapeutic equivalence. Donnatal, although containing phenobarbital, is exempt from the Controlled Substances Act due to the belladonna alkaloids present in the formulation. References
External links
"Donnatal Extended Release Tablet Information". Archived from the original on 2008-12-27.
The idea that its walls are coated with years-old hamburger residue is preposterous". Supplement effectiveness
The consumer advocacy news program Marketplace conducted a consumer trial with three women on the effectiveness of two colon supplements versus fiber. The results showed the supplements did not assist in weight loss and provided no additional benefit over a basic fiber supplement. According to the American Cancer Society, "Available scientific evidence does not support claims that colon therapy is effective in treating cancer or any other disease". Colon hydrotherapy
Colonic irrigation, also known as colon hydrotherapy, colonic hydrotherapy, or a "colonic", is a treatment which is used "to wash out the contents of the large bowel by means of copious enemas using water or other medication. "During a cleansing enema, liquid is introduced into the colon and retained for five to fifteen minutes. During a colonic, liquid is introduced into the colon and then it is flushed out and this is repeated until the entire colon is cleared.Colonic irrigation has been described as an "unwise" procedure as it carries the risk of serious harm and has no proven benefit. Regulation
In the United States, the Food and Drug Administration (FDA) regulates the production of equipment used in colon hydrotherapy but does not regulate their use, or the supplements used in oral colon-cleansing regimens. Manufacturer claims do not require verification or supporting evidence. The contents of the products are also not verified or tested.