Washington, D.C.–The Natural Products Association has dropped its lawsuit against the Food and Drug Administration for N-Acetyl-Cysteine (NAC) following guidance issued last month and subsequent market stabilization. FDA’s final guidance, issued in August, described enforcement discretion for the sale and distribution of NAC as long as the product does not make claims to diagnosis, cure, mitigate, treat, or prevent disease. This guidance responded to Citizen’s petitions and the NPA lawsuit. It institutes the process for export certificates, which was a main goal of the trade association. NPA’s Citizen petition and lawsuit can be viewed here and here. The final guidance was issued following FDA warning letters stating NAC was excluded from the definition of a dietary supplement because of its approval as a drug.
“When the industry suffered significant economic harm as a direct result of the Agency’s long and inexplicable delays on a NAC regulatory path, NPA and its leadership led the way forward because of our commitment to the industry and holding FDA accountable. We hope the agency uses this as a learning experience and handles other outstanding issues like CBD more appropriately,” said Daniel Fabricant Ph.D., President, and CEO of the Natural Products Association. “This preserves our legal rights and demonstrates that we achieved our domestic objective through the enforcement discretion announcement, which is an unprecedented move for the agency. For exports, FDA has initiated a process and we continue to work directly with the agency and foreign governments to ensure exports on NAC return to levels prior to this series of events. Thankfully, as a direct result of our lawsuit, the industry can sell domestically and internationally once again, maintain insurance, and ensure the FDA is consistent and meeting its basic regulatory obligations. As far as lawsuits go, while this was contentious at the start, as lawsuits can be, we were able to work cooperatively with the agency to bring NAC back via final guidance enforcement discretion. Legally, dismissing the case in this way enables us to preserve our standing, and refile this should FDA change their position on NAC in the future or take steps to inhibit commerce on NAC in the future.”