The Dietary Supplement Health and Education Act of 1994 (DSHEA) aimed to preserve incentives for the pharmaceutical industry by excluding researched or approved drugs from being marketed in supplements. That…
Tag: NAC
FDA, marketers of NAC may have motives to seek NAC rulemaking
A first-of-its-kind FDA rulemaking legalizing NAC (N-acetyl-L-cysteine) in dietary supplements could provide a “proof of concept that this authority works and that the agency can use it appropriately and effectively,”…
FDA formally announces NAC enforcement discretion, but legal hangover remains
The NAC draft guidance issued today by FDA was seen as a victory for industry. But observers say it leaves central legal questions regarding the interplay between supplement and drug…
FDA denies NAC petitions, signals it won’t enforce
FDA on Thursday denied requests by two trade associations that the agency reverse its position that NAC (N-acetyl-L-cysteine) is excluded from the definition of a dietary supplement. The agency, however,…
NPA files amended complaint against FDA in NAC fight
The Natural Products Association (NPA) on Monday filed an amended lawsuit against FDA in an ongoing fight over the legality of NAC (N-acetyl-L-cysteine) in dietary supplements. FDA has stated the…
Consumers cite health benefits of NAC in FDA comments
Many consumers have asked FDA to keep NAC (N-acetyl-L-cysteine) on the market in the U.S. as a dietary supplement, citing its health benefits including the ability to help with breathing…