Washington—Following FDA Deputy Commissioner Jim Jones’s testimony before the House Subcommittee on Health, the Natural Products Association slammed the Commissioner’s mischaracterization of the dietary supplement market, in which he stated, “There are virtually no barriers to entry to the dietary supplement market.”
“NPA held out hope for new ideas, so it’s disappointing to see new leadership hold the same antiquated views on the dietary supplement industry. The notion that the industry’s size somehow impedes the agency from doing its job is irresponsible.,” said Daniel Fabricant, Ph.D. president and CEO of the NPA.
“The Commissioner is intimately familiar with the regulatory scrutiny dietary supplement manufacturers face, and to characterize the market as having ‘no barriers to entry’ is a slap in the face to our members who invest significant resources into bringing safe, effective, and well-researched dietary supplements to market. The agency can get labels now via inspection authorities and should know everyone who is out there already per the FSMA facility registration requirements. More concerning is that the agency seems more than happy to let the states run amok on developing new laws on the industry that are in contravention of the federal requirements. The agency remains silent; the ideal for them would be new authorities but no responsibility.
Mr. Jones also seems unaware of the significant burdens that manufacturers and brands of supplements have to meet to enter the industry and be compliant with not just the FFDCA but with the FTC and other state and federal authorities. The adverse event reporting requirements are the same for supplements and OTC medicines, yet I have never heard the drug program at the FDA bash the OTC industry for having ‘virtually no barriers to entry.’ It’s unfortunate but not surprising. For the supplement program to be more successful than it is currently regarded, better priorities would be to work with the industry and all stakeholders on State Preemption, drug preclusion interpretation, and targeted cGMP inspection.”
