On Tuesday the Connecticut senator held a news conference asking the FDA to design and implement proper safety regulations for CBD, the ingredient found in the hemp plant.
Blumenthal warned that untested products can be potentially dangerous. “The FDA’s failure to finalize and implement a regulatory framework for CBD, including labeling, quality, marketing, and sale of CBD-containing products, is putting consumers at risk and inhibiting the industry.”
“This is one of the days we are in absolute agreement with Blumenthal,” explains Steve Mister, President & CEO of the Council for Responsible Nutrition (CRN). “We think that FDA absolutely needs to do something and do it quickly. By not exercising the enforcement authority it already has, it is leaving consumers unprotected.”
“What you have right now is an FDA that’s paralyzed.” -Steve Mister
Recognizing CBD products as foods, beverages or dietary supplements would allow the FDA to impose regulatory framework around the processing, manufacturing and marketing of hemp-derived CBD products not intended for use as drugs. It would also permit the agency to enforce existing regulations regarding registration of manufacturing facilities; observance of good manufacturing practice regulations; supply chain security; compliance with food additives and new dietary ingredient provisions for food and dietary supplements; and post-market surveillance of serious adverse events, according to CRN.
But as CPG Strategist Joshua Schall points out, “The FDA is in a Catch-22 situation. It wants to provide guidance to the CBD market, but under the current regulatory framework it cannot because of having approved CBD in a pharmaceutical. The FDA has two options: lengthy process of creating an alternative framework to approve CBD for food/beverage additives and supplements or they need those same Congress members to help speed that up with Congressional action (not press conferences).”
Mister says there are tons of hemp-derived CBD products marketed as dietary supplements, which does gives FDA jurisdiction over those products. “So you have products on the market that contain CBD, marketed as dietary supplements, and they certainly don’t measure up. They don’t have the level of CBD that they say they do, some of them have THC in them as well, they have other residues and contaminants in there that shouldn’t be, sometimes they don’t even have CBD in them. Their facilities are not registered with FDA and they’re not following GMPs.”
As a result, a flurry of lawsuits alleging that products contain “significantly lower levels of CBD than advertised” have emerged. As reported in Food Navigator-USA, the latest complaint, filed against Potnetwork Holdings, Inc., Diamond CBD, Inc., and First Capital Venture Co. on September 27, alleges the defendants' DiamondCBD products contain "a significantly lower amount of CBD than represented." Other complaints make similar claims, alleging products like hemp bombs, honey tinctures and gummies contain just a fraction of the CBD they claim, or in some cases, no CBD whatsoever.
“When you decide to market as a supplement, you have to play by those rules. So FDA needs to develop a system of framework, on how they’re going to regulate CBD and they need to do it quickly before someone gets hurt.” Mister added, “Even while they are trying to figure out how they are going to evaluate CBD, they should already be holding these products to all of the other requirements that a supplement is held to. And that doesn’t require FDA to make a final decision on CBD, because they can do all of these things merely because a product calls themselves a supplement. It makes it subject to FDA’s jurisdiction.”
Mister went on to say that the FDA is putting the cart before the horse by seeking safety studies before putting framework in place. “You can’t solve the safety issue until you have data on safety. And you’re not going to get data on companies until they know there is a marketplace out there for them. So if I’m a supplement company, am I willing to invest a million dollars on a safety study if I don’t know the FDA will let me market the product when I’m done?”
“Economically, socially, health wise this industry is potentially enormously important, but it needs the regulations that will enable both consumers and growers and manufacturers to have a path forward and rules of the road,” said Blumenthal.
Mister says he knows which direction the agency needs to head: “FDA needs to create the pathway, which is using its discretion, and say ‘we’re going to allow CBD in the marketspace.’ Once they create that pathway, then the firms will be more than happy to line up with safety data and show them their product is safe. What you have right now is an FDA that’s paralyzed.”