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NPA Issues Statement in Response to FDA’s Refusal to Hold Public Hearing Regarding NMN

On July 20, the U.S. Food and Drug Administration (FDA) rejected a request by Rep. Jeff Duncan (R-SC), a member of the House Energy and Commerce Committee, to hold a public hearing on the agency’s position on nicotinamide mononucleotide (NMN). FDA stated that a public comment period would be sufficient.

In response, the Natural Products Association (NPA) stated that “FDA has completely abdicated its duty to transparency and appropriate regulatory practice for dietary supplements, and this is the latest proof. A public comment period and a public hearing are entirely different, and the agency knows that. FDA continues to hide behind the ‘Administrative Iron Curtain,’ citing our joint citizen’s petition with the Alliance for Natural Health [(ANH)] as the rationale for not holding a public hearing on NMN,” said Daniel Fabricant, PhD, president and CEO of NPA.

In a Citizen’s Petition on March 7th, NPA and ANH requested that FDA:

1. Determine nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B);

2. Commit to exercising enforcement discretion in connection with the marketing and selling of NMN in or as a dietary supplement; or

3. In the alternative, recommend the Secretary of Health and Human Services (HHS) issue a regulation after notice comment, finding NMN would be lawful.

“This is yet another demonstration that the agency views the dietary supplement industry and the millions of Americans who use supplements every day as second-class citizens. As we’ve seen with NMN, NAC, CBD and others, its enforcement of the laws governing supplements is often inaccurate or inconsistent. It conveniently ignored conducting a performance review of the Office of Dietary Supplement Programs (ODSP) in the independent evaluation of the Human Foods Program, and now the agency is proposing the elimination of the ODSP altogether. FDA needs to face the facts that accept the fact that supplements can play a positive role in consumer health and start to embrace its role in regulating this important area as the law requires.”

For more information, visit www.npanational.org.

On July 20, the U.S. Food and Drug Administration (FDA) rejected a request by Rep. Jeff Duncan (R-SC), a member of the House Energy and Commerce Committee, to hold a public hearing on the agency’s position on nicotinamide mononucleotide (NMN). FDA stated that a public comment period would be sufficient.

In response, the Natural Products Association (NPA) stated that “FDA has completely abdicated its duty to transparency and appropriate regulatory practice for dietary supplements, and this is the latest proof. A public comment period and a public hearing are entirely different, and the agency knows that. FDA continues to hide behind the ‘Administrative Iron Curtain,’ citing our joint citizen’s petition with the Alliance for Natural Health [(ANH)] as the rationale for not holding a public hearing on NMN,” said Daniel Fabricant, PhD, president and CEO of NPA.

In a Citizen’s Petition on March 7th, NPA and ANH requested that FDA:

1. Determine nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B);

2. Commit to exercising enforcement discretion in connection with the marketing and selling of NMN in or as a dietary supplement; or

3. In the alternative, recommend the Secretary of Health and Human Services (HHS) issue a regulation after notice comment, finding NMN would be lawful.

“This is yet another demonstration that the agency views the dietary supplement industry and the millions of Americans who use supplements every day as second-class citizens. As we’ve seen with NMN, NAC, CBD and others, its enforcement of the laws governing supplements is often inaccurate or inconsistent. It conveniently ignored conducting a performance review of the Office of Dietary Supplement Programs (ODSP) in the independent evaluation of the Human Foods Program, and now the agency is proposing the elimination of the ODSP altogether. FDA needs to face the facts that accept the fact that supplements can play a positive role in consumer health and start to embrace its role in regulating this important area as the law requires.”

For more information, visit www.npanational.org.


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