Washington- Following a Citizen’s petition and lawsuit filed by the Natural Products Association (NPA) against the Food and Drug Administration (FDA) for a dietary supplement issued enforcement discretion for N-Acetyl-Cysteine (NAC) has resulted in the agency issuing final guidance which can be viewed here. NPA’s Citizen’s petition can be viewed here and lawsuit here.
“This is a big win but it is bittersweet for sure. Although it was NPA’s leadership that secured this victory for American consumers, the FDA could have and should have reached this decision years ago. The dietary supplement industry is under attack from all levels of government, from shortsighted organizations pushing for unnecessary and costly new federal red tape to state lawmakers who are determined to block access to supplements and raise costs for consumers and retailers, but NPA’s members had the foresight and commitment to turn the tide.” said Daniel Fabricant, Ph.D. president and CEO of the Natural Products Association.
“Citizens petitions and lawsuits are extreme measures and should be the rare exception, not the rule. The industry experienced significant economic harm as a direct result of the Agency’s yearslong and inexplicable delays on NAC, but thankfully our actions held FDA accountable and forced their hand on issuing final guidance. We hope this is a teachable moment for the agency and that basic regulatory obligations in the future are handled in the timely and professional manner befitting of the world’s gold standard.”