Marc Ullman, an attorney at counsel with the firm Rivkin Radler, will be one of the speakers at the upcoming American Herbal Products Association Hemp-CBD Supplement Virtual Congress. Last year’s in-person event was held in Colorado, one of the hotbeds of hemp innovation and production.
Ullman will take part in a panel during the event that’s scheduled for August 27. The panel will deliver a regulatory update for industry. In working with nascent brands in the space, he said this is one of the glaring shortcomings of this sector. A number of entrepreneurs have come into the space from other walks of life and are attracted by the opportunity. While many of these players might have energy and stamina, few seem to know what they’re getting themselves into, Ullman said.
“I lot of the players in this space are not familiar with a tight regulatory regime,” Ullman told NutraIngredients-USA.
History of industry plays into regulatory weaknesses
He added that the particular history of the hemp/CBD space has put its own imprimatur on the industry. It’s not too long ago when all aspects of hemp cultivation and use were illegal and all of the people involved (some of whom are still around) were operating outside the law. Just the tiniest dribble of above board activity, mostly through the National Center for Natural Products Research at the University of Mississippi, was taking place.
“I suspect some of them were not really traditional or mainstream business people,” Ullman said.
So Ullman and other industry observers say the hemp/CBD sector has a lot of growing up to do when it comes to regulatory compliance. However, with that being said, the ignorance of some of the new hemp players seems to be not all that different from that of new dietary supplement industry brand holders in general.
“Is it just a CBD-specific question, or is it a dietary-supplement-industry-in-general question?” asked Ivan Wasserman, partner in the law firm Amin Talati Wasserman.
“Across the industry this is still a problem, but especially so in CBDs. It is an area where investors wanted to be in desperately and they didn’t seem to care to do the due diligence you’d expect in normal investments. There is a potential to make a lot of money so people just jumped on in,” Ullman said.
These regulatory compliance gaps are one of the things that comes with a low barrier to entry for the industry, which is both blessing and curse. Blessing in that it allows for vibrant innovation that has helped the hemp sector and the dietary supplement industry as a whole consistently to outperform the general economy. And curse, in that some firms don’t seem to know what they don’t know, or actively try to skirt the rules.
One of the sessions at the AHPA event will be a three-hour primer on GMP compliance. The session will cover in detail the definition and use of master manufacturing records, the responsibilities and necessary qualifications for quality control personnel, testing and specifications and other topics.
And it seems as if such basic info in still in short supply in the industry. At another event in the sector last year, the NoCo Hemp Expo held in Denver, it was apparently that many of the attendees at a similar regulatory session where this reporter was in attendance were hearing for the first time what ‘GMPs’ stands for.
“It’s the general regulatory background that you need to understand,” Ullman said.
Wasserman said the still unsettled regulatory environment means that there is additional risk to running a CBD business.
“Anyone in the CBD business should ensure their dietary supplement product is 100% compliant as FDA requires so as not to give the Agency something easy to shoot at other the CBD question itself,” he said.
The keynote address at last year’s AHPA event was delivered by Colorado Gov. Jared Polis, a noted advocate both for hemp firms and products as well as for the dietary supplement industry as a whole. This year’s keynote will come from Oregon Sen. Ron Wyden. Oregon is another leader in the hemp industry.
To download a detailed agenda of the AHPA event or for more information about signing up visit the event’s website.