GHB's unique attributes have some legitimate uses. In Europe, it is still used as an anesthetic, for alcohol and opiate addiction therapy, and for narcolepsy therapy. Only this last indication of narcolepsy is recognized by the US Food and Drug Administration, which recently approved GHB (ie, sodium oxybate [Xyrem]) to treat a small subset of patients with narcolepsy who have episodes of weak or paralyzed muscles (ie, cataplexy). Because of sodium oxybate's history of abuse as a recreational drug, the FDA approved it as a Schedule III Controlled Substance. A limited distribution program that includes physician education, patient education, a patient and physician registry, and detailed patient surveillance has been established. Under the program, prescribers and patients will be able to obtain the product only through a single centralized pharmacy.
This Food Additives Status List, formerly called Appendix A of the Investigations Operations Manual (IOM), organizes additives found in many parts of 21 CFR into one alphabetized list. Additives included are those specified in the regulations promulgated under the FD&C Act, under Sections 401 (Food Standards), and 409 (Food Additives). The Food Additives Status List includes short notations on use limitations for each additive. For complete information on its use limitations, refer to the specific regulation for each substance. New regulations and revisions are published in current issues of the Federal Register as promulgated. Also refer to the Food Ingredient and Packaging inventories in the Foods section of the FDA web site to review several FDA databases of additive categories. For example, the EAFUS list (Everything Added to Food in the United States), is a helpful reference within the limitations described at the beginning of the database.