FDA Petition Answer ‘Nonresponsive’: CRN

The Council for Responsible Nutrition (CRN) says an FDA 11/24/21 answer to the council’s 6/1/21 petition asking that the agency revert to its longstanding policy of allowing manufacturers to market dietary supplements containing NAC (N-acetyl-L-cysteine) was nonresponsive in failing to address the single legal issue raised by CRN. Instead, CRN says in a 1/4 letter, FDA “has attempted to deflect the facial legal defects of its position with a detour into safety concerns that do not exist and are not relevant to this inquiry. As such, the agency is now also in violation of its own requirement to respond to CRN’s citizen petition within 180 days of receipt.”

CRN also says FDA should not have combined its petition seeking legal clarity on policy reversal with a Natural Products Association (NPA) 8/18/21 petition on NAC. “It is inappropriate to review the CRN and NPA citizen petitions concurrently as they request different actions from the agency,” CRN says.