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The NAC draft guidance issued today by FDA was seen as a victory for industry.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 uses up in the air.

The major caveat for the use of NAC (n-acetyl-L-cysteine) in supplements is that such products are ‘legal,’ ie, that they are not making noncompliant disease claims. In other words, FDA is not coming after you just because you’ve got NAC in the bottle, but today’s draft guidance does not grant carte blanche for the marketing of NAC for indications outside the supplement realm.

FDA stated that today’s draft guidance​ was in response to two citizen’s petitions, one filed by the Council for Responsible Nutrition and the other by the Natural Products Association. Both petitions asked that FDA rule that NAC was a legal dietary ingredient because it was clearly on the market as a supplement prior to the DSHEA grandfather date of Oct. 15, 1994. The NPA petition also included an option for a formal rule that would grant an exception for NAC. FDA rejected the grandfather date approach but said it intends to move in the rule-making direction suggested in the NPA petition.

“[I]f, among other considerations, FDA does not identify safety-related concerns as we continue our review of the available data and information, we are likely to propose a rule providing that NAC is not excluded from the definition of dietary supplement,” the draft guidance states. (For its part the industry maintains that NAC has proven to be very safe over many decades of use.)

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