Did FDA remove NAC from market?
Our NAC-containing products will remain available to consumers at this time while FDA continues to consider this matter.” Many consumers have asked FDA to keep NAC on the market in the U.S. as a dietary supplement, citing its health benefits including the ability to help with breathing problems.
Why is FDA against NAC?
Constituent Update As we discussed in a recent response to two citizen petitions, the FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food.
Is NAC approved?
NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.”
When was NAC FDA approved?
1963
FDA has concluded NAC cannot be lawfully marketed in dietary supplements due to its approval as a drug in 1963.
Did the FDA ban NAC 2021?
Additionally, FDA requested data, research results, and other information related to the safe use of NAC in products marketed as dietary supplements and any safety concerns. In a March 31, 2022 Constituent Update, FDA announced it has confirmed that NAC is excluded from the definition of a dietary supplement.
Are they banning NAC?
Though the FDA has not officially banned NAC supplements, the effect of its new position—and especially Amazon’s response to it—has definitely hobbled sales. Pavlick noted that in November 2020, there were 718 NAC-containing products listed on Amazon’s online shelves.
Is the FDA banning NAC 2021?
While FDA’s response to the citizen petitions confirms that NAC is excluded from the definition of a dietary supplement, the agency has not yet reached a decision on the NPA citizen petition’s alternative request that FDA undertake rulemaking to allow the use of NAC in dietary supplements.
Why is NAC off the market?
In a series of letters, the FDA asserted that NAC cannot be sold in supplements because it was first used as a pharmaceutical ingredient in 1963 and therefore is not a legal dietary ingredient. Since the FDA’s move, sales of NAC products have declined.
