CRN and NPA Respond to FDA’s Enforcement Discretion Guidance on NAC
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Both the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have responded to the U.S. Food and Drug Administration’s (FDA) draft enforcement discretion guidance on the use of NAC (n-acetyl-cysteine).
Steve Mister, president and CEO of CRN, stated that “CRN appreciates FDA’s quick action following its March 31 response to our citizen petition with the announcement of this draft guidance today. We thank FDA for realizing that retailers and marketers of NAC need clarity and certainty in the market and assurance from the agency that there are no known safety concerns with these products.
“We hope today’s announcement by FDA provides retailers, payment platforms and product marketers with the assurance they have been asking for—that they may continue to sell NAC-containing dietary supplements without threat of FDA enforcement action. We are grateful for the agency’s statements that it is not aware of any safety-related concerns with NAC. CRN looks forward to working with our retail partners and other stakeholders in continuing to assure consumers have access to otherwise lawful dietary supplements containing NAC.”
Mister added, “CRN also continues to express our disagreement with FDA’s reasoning that led to this announcement. We believe FDA’s overly expansive interpretation of the drug preclusion provision in the federal Food, Drug & Cosmetic Act [21 USC § 321(ff)(3)(B)] and retroactive application of the clause are misplaced and set a dangerous precedent for the agency to remove other lawful dietary ingredients from the market based on assertions of pre-1994 drug approvals or clinical investigations.
“Without consideration of routes of administration, dosage/serving levels, biological mechanisms of action or the intended uses of the products, FDA would allow drug manufacturers to remove safe and beneficial dietary supplements from consumers using decades old research to get a monopoly for their pharmaceuticals. We continue to evaluate our options to revise the statute to clarify the original intent of the drug preclusion provision.”
NPA also filed a citizen’s petition and lawsuit against FDA. Danial Fabricant, president and CEO of NPA, stated “We’re glad we won this round but we’re not glad we had to go to such great lengths to secure this for American consumers and a functioning regulatory regime. FDA could have and should have reached this decision years ago, but I credit NPA’s members for realizing what was at stake and being committed to this extraordinary effort.”
“While this is a good first step, we still see dark clouds on the horizon. Citizens petitions and lawsuits should be the exception and not the rule, but FDA’s inaction on CBD is very similar to the NAC discussion. We also see greater risk of this happening on a widespread scale if efforts to pass unnecessary and unwise product listing requirements throw more sand in the gears of timely agency proceedings. The industry has experienced significant economic harm as a direct result to the Agency’s actions on NAC. Had mandatory product listing been in place at the time of FDA’s action, we are confident the economic harm would have been more significant than it already has been for industry stakeholders who provide millions of consumers with NAC. We have to find a remedy to other actions that have adversely impacted the NAC market, specifically the denial of export certificates and the delisting of NAC from certain e-commerce platforms.”
For more information, visit www.crnusa.org and www.npanational.org.
Both the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have responded to the U.S. Food and Drug Administration’s (FDA) draft enforcement discretion guidance on the use of NAC (n-acetyl-cysteine).
Steve Mister, president and CEO of CRN, stated that “CRN appreciates FDA’s quick action following its March 31 response to our citizen petition with the announcement of this draft guidance today. We thank FDA for realizing that retailers and marketers of NAC need clarity and certainty in the market and assurance from the agency that there are no known safety concerns with these products.“We hope today’s announcement by FDA provides retailers, payment platforms and product marketers with the assurance they have been asking for—that they may continue to sell NAC-containing dietary supplements without threat of FDA enforcement action. We are grateful for the agency’s statements that it is not aware of any safety-related concerns with NAC. CRN looks forward to working with our retail partners and other stakeholders in continuing to assure consumers have access to otherwise lawful dietary supplements containing NAC.”
Mister added, “CRN also continues to express our disagreement with FDA’s reasoning that led to this announcement. We believe FDA’s overly expansive interpretation of the drug preclusion provision in the federal Food, Drug & Cosmetic Act [21 USC § 321(ff)(3)(B)] and retroactive application of the clause are misplaced and set a dangerous precedent for the agency to remove other lawful dietary ingredients from the market based on assertions of pre-1994 drug approvals or clinical investigations.
“Without consideration of routes of administration, dosage/serving levels, biological mechanisms of action or the intended uses of the products, FDA would allow drug manufacturers to remove safe and beneficial dietary supplements from consumers using decades old research to get a monopoly for their pharmaceuticals. We continue to evaluate our options to revise the statute to clarify the original intent of the drug preclusion provision.”
NPA also filed a citizen’s petition and lawsuit against FDA. Danial Fabricant, president and CEO of NPA, stated “We’re glad we won this round but we’re not glad we had to go to such great lengths to secure this for American consumers and a functioning regulatory regime. FDA could have and should have reached this decision years ago, but I credit NPA’s members for realizing what was at stake and being committed to this extraordinary effort.”
“While this is a good first step, we still see dark clouds on the horizon. Citizens petitions and lawsuits should be the exception and not the rule, but FDA’s inaction on CBD is very similar to the NAC discussion. We also see greater risk of this happening on a widespread scale if efforts to pass unnecessary and unwise product listing requirements throw more sand in the gears of timely agency proceedings. The industry has experienced significant economic harm as a direct result to the Agency’s actions on NAC. Had mandatory product listing been in place at the time of FDA’s action, we are confident the economic harm would have been more significant than it already has been for industry stakeholders who provide millions of consumers with NAC. We have to find a remedy to other actions that have adversely impacted the NAC market, specifically the denial of export certificates and the delisting of NAC from certain e-commerce platforms.”
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