Mister, who is president and CEO of the Council for Responsible Nutrition, said during an interview at the recent SupplySide West trade show in Las Vegas, NV that critical issues are going mostly unnoticed by an industry captivated by glittering vistas of the hemp/CBD gold rush. While that part of the story is certainly worthy of attention, Mister said the industry may come to regret having neglected other issues in the meantime.
Amendment aimed at military personnel
Among those issues are the continuing attempts by Sen. Richard Blumenthal, D-CT, to put more regulations on the industry. Blumenthal’s latest effort is an attempt to attach a ride to an unlikely root piece of legislation, the Defense Authorization Bill that is currently making its way through congress.
Blumenthal’s amendment would require the Department of Defense to set up an adverse event reporting system that would in Mister’s view would seem to duplicate and operate in parallel to the one already written into law and managed by the US Food and Drug Administration. In the FDA maintained system companies are required to accept adverse event reports from consumers and forward on to FDA any that are serious. Blumenthal’s proposal appears to be more invasive, in that it would operate on an individual case basis.
“It also requires that supplement use to be written into the medical records of personnel who go to these doctors on base. It serves as a real disincentive for them to use our products and a disincentive for them to be candid with their healthcare practitioners about anything that might have gone wrong,” Mister said.
Mandatory product listing
Mister said another issue that has gotten swept under the rug to some extent is the question of proposed mandatory product listing. The idea is that requiring information about new products to be added to a central registry would add transparency to the industry and help FDA get a handle on the marketplace. It’s an idea that CRN has been advocating for. Mister emphasized the new listing would be more like a birth certificate than a driver’s license. In other words, any such proposal must include a hard line drawn in the sand to forestall its development into a form of premarket approval.
“It’s not a huge burden, but yes, it will require companies to have another step when they bring products to market. But we think the rewards of being open and transparent with FDA will far exceed the burdens it places on industry,” he said.