NAC dietary supplement regulatory policy update, some products are prohibited from sale

FDA updated its regulatory stance on N‑Acetylcysteine (NAC). Since NAC was previously approved as a pharmaceutical drug, FDA considers there are compliance barriers for selling NAC in the form of dietary supplements. Certain NAC‑containing health supplements are ruled unmarketable as dietary supplements.

FDA updated its regulatory stance on N‑Acetylcysteine (NAC). Since NAC was previously approved as a pharmaceutical drug, FDA considers there are compliance barriers for selling NAC in the form of dietary supplements. Certain NAC‑containing health supplements are ruled unmarketable as dietary supplements. Enterprises wishing to market NAC products shall follow pharmaceutical‑drug approval pathways only. Cross‑border sellers need to screen product lines and stop selling NAC as dietary supplements for the US market. Existing inventory faces risks of detention and recall. This policy generates notable impacts on cross‑border health‑product supply chains.