Earlier this year, Representative Jeff Duncan (R-SC) requested in a letter to the commissioner of the U.S. Food and Drug Administration (FDA)  that the agency hold a public hearing regarding its position that nicotinamide mononucleotide, a form of vitamin B3, is precluded from being used in dietary supplements.
 
Since FDA declared that NMN can’t be sold as a dietary supplement ingredient late last year, on the grounds that it was first approved for investigation as a new drug, the dietary supplements industry has widely taken issue with FDA’s lack of clarity regarding the evidence behind its position.
 
This week, the agency rejected Duncan’s request, claiming that a public comment period would be sufficient.
 
A Familiar Refrain
 
“FDA has completely abdicated its duty to transparency and appropriate regualtory practice for dietary supplements, and this is the latest proof,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association. “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 as the rationale for not holding a public hearing on NMN.”
 
In NPA and ANH’s petition, the two associations requested that FDA: determine NMN is not excluded from the definition of a dietary supplement; commit to exercising enforcement discretion in connection with the use of NMN in dietary supplements; and recommend the Secretary of Health and Human Services 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,” said Fabricant. “As we’ve seen with NMN, NAC, CBD, and others, 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 and 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.”