FDA Again Flags N-acetylcysteine as a Drug Not a Supplement

While it’s great it’s being studied for COVID, N-acetylcysteine (NAC) is again being flagged by FDA as a potential drug not a supplement. Seven companies selling NAC for alcohol hangovers received warning letters from FDA stating NAC is an unapproved new drug that has not been evaluated to be safe and effective for their intended use. This is the second time FDA publicly challenged the legality of NAC in dietary supplements. Steve Mister, president and CEO of Council for Responsible Nutrition said FDA is essentially “encouraging the drug companies to go forward under the thought that they could get a monopoly on the ingredient if [clinical research] pans out.”