The American Herbal Products Association (AHPA) and others have provided the FDA with details regarding NAC products sold before 15 October 1994. Additionally, NAC itself is found in a variety of foods (garlic, onions, asparagus, and others).In 2020 FDA sent warning letters to several companies regarding the use of NAC in dietary supplements. In those letters FDA noted that NAC could not be marketed as a dietary supplement because NAC had NOT been marketed as a food or dietary supplement prior to its approval as a drug. FDA had confirmed in response to two citizen petitions (CRN and NPA) that NAC is excluded from the definition of a dietary supplement. FDA had not yet reached a decision, however, regarding a petitioners (NPA) request to issue a regulation that would permit the use of NAC in dietary supplements. On April 21, 2022, the FDA announced the availability of a draft guidance on FDAs policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine. The draft guidance, when finalized, will explain the agencys intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. The FDA has asked for comments on its NAC Guidance and has stated that they will use enforcement discretion with respect to NAC supplements.
Tolazamide is an oral blood glucose lowering drug used for people with Type 2 diabetes. It is part of the sulfonylurea family (ATC A10BB). Synthesis
para-Toluenesulfonamide is converted to its carbamate with ethyl chloroformate in the presence of a base. Heating that intermediate with 1-amino-azepane leads to the displacement of the ethoxy group and the formation of tolazemide:Azepane proper would lead to [13078-23-4]. References
External links
"Tolazamide". Medline Plus. U.S. National Library of Medicine.