The trade group Council for Responsible Nutrition (CRN) announced last week that it has opened up membership to companies that market hemp-derived CBD and whole spectrum hemp extract in food and dietary supplements.
CRN’s board of directors voted on the decision in March and accepted three new CBD specialists to its membership: CV Sciences, OLEO Inc., and Demetrix.
“Responsible marketers of hemp-derived CBD and whole spectrum hemp deserve to have a voice in the industry and in Washington, D.C., and CRN is proud to provide a platform for these companies to join us as we work to create a regulatory path forward to market CBD in food and dietary supplements,” said the trade group’s CEO and president Steve Mister in a press release.
The trade group’s announcement, emailed to members of the press last week, admitted that the FDA does not recognize CBD as a legal dietary ingredient, notwithstanding the passed Farm Bill, because it was the subject of an Investigational New Drug application by British biopharma company GW Pharmaceuticals.
Under the current set of regulations for supplements, once an ingredient is approved for development in drugs, it cannot be used in dietary supplements (although ingredients that have been approved for dietary supplements first may eventually make its way to drug development).
“CBD is an explosive category,” CRN’s Shao told NutraIngredients-USA. “Right now, there are a lot more questions then there are answers.”
He thinks that having CBD companies that are “trying to go about this the right way, trying to find the proper pathway to market” join the ranks of CRN members (which includes giants like BASF and The Clorox Company) will help the association as it lobbies for CBD’s legality in food and supplements.
“It will help us as an association as we look to help FDA craft those regulations, or Congress to craft the legislation,” he said.
CBD companies will go through an extra step in vetting process
“Nothing about FDA’s acknowledgement of enforcement discretion exempts a CBD manufacturer from good manufacturing practices, the prohibition on making disease claims, the requirement for claim substantiation, serious adverse event reporting, and all of the other aspects of our comprehensively regulated industry,” said CEO Mister said in the press release.
Attorney: ‘I see all these emails saying once the Farm Bill passes, CBD is legal in all 50 states; that’s just not true’
11-Dec-2018 By Elaine Watson
There is good news in the impending* Farm Bill for industrial hemp – which will be removed from Schedule I of the Controlled Substances Act - but this does not suddenly make the on-trend ingredient CBD (cannabidiol) legal in foods, beverages and supplements, stress attorneys.
“Our board sees wisdom in admitting as CRN members those CBD companies who are playing by those rules. Unfortunately, many companies marketing products as containing CBD are not observing these compliance obligations, to put it mildly.”
The association believes that CRN’s stringent vetting process for compliances with the industry’s full regulatory regime will demonstrate to consumers that companies which seek the group’s membership have a commitment to “bringing safe, quality products to the market,” and “also a commitment to being part of the responsible, mainstream dietary supplement marketplace.”
CRN will subject all potential CBD members to some additional requirements that their products or ingredients be derived from hemp, not marijuana, since only hemp has been de-scheduled as a controlled substance; and that the ingredients and products must contain less than 0.3% THC.
Hearing on May 31, what comes next?
CRN said in a statement that it is working with allies in Congress and other influencers to bring a clear regulatory path forward for CBD as quickly as possible.
It will be participating in FDA’s public meeting on CBD on May 31. What’s to come after the meeting?
“The public meeting is just the start of the conversation. It’s the starting process to answer questions that the agency has,” Shao said.
“We’re not going to get an answer from the agency anything different on June 1st than we do on May 31st, because the public meeting is really just the starting point. It may take quite a bit of time.”