Warning letters to CBD companies hinge on disease claims, sidestep issue of ingredient's legality

04-Mar-2015 - Last updated on 04-Mar-2015 at 19:37 GMT

Industrial hemp cultivation. Creative Commons image

Four companies marketing dietary supplement products containing cannabidiol (CBD), a non-narcotic fraction of Cannabis sativa, received warning letters recently from the Food and Drug Administration. But the letters said nothing about the status of CBD itself; rather, they concentrated on disease claims made on the products.

The interest in CBD as a dietary supplement ingredient has moved in lockstep with the national trend toward liberalizing marijuana regulations. Medical marijuana is now approved in 23 states with legislation pending in 11 others and the citizens of Washington and Colorado have voted to make small-scale recreational use of the plant legal. The plant is still a scheduled substance as far as the US Drug Enforcement Administration is concerned, but so far enforcement has been hands off at the federal level, even though vigorous enforcement still takes place in states where neither medical nor recreational marijuana is approved. There is even growing pressure to take the plant off the DEA list; Rep. Steve Cohen, D-TN, recently called on outgoing US Attorney General Eric Holder to reclassify the plant.

Cannabidiol, a non-narcotic fraction of cannabis, has been studied for a variety of health effects, from antioxidant properties to anti-seizure effects. The health effects appear to be real, increasing the interest of some supplement formulators in the ingredient, and companies have started to crowd into the space, all trying to secure that coveted first-to-market position.

Industrial hemp origin

The proponents of CBD as a dietary supplement ingredient seem to be hanging their hats on the origin of the molecule from industrial hemp. Industrial hemp is a cultivar of Cannabis sativa that has very low levels of tetrahydrocannabinol (THC), which is the narcotic fraction of the plant. Most regulatory bodies define a THC content of 0.05% as the boundary line between marijuana and hemp. And hemp is approved as a food, proponents say, so portions thereof are legal to market, or so the argument goes.

Does that argument hold regulatory water? And if CBD can escape from under the shadow of the DEA list via its industrial hemp origin, might it not still require a New Dietary Ingredient notification? On other occasions, FDA has made clear that even if it is possible to detect a molecule at low levels in a botanical that has a history of human use that does not necessarily equate to it being present in the food supply as an article of food (and therefore qualifying for Old Dietary Ingredient status) when looking at that same molecule after it has been extracted and concentrated. And what about hemp’s other applications? Proponents of hemp’s industrial and food uses are distinctly uncomfortable with the current CBD landscape and fear that pushing too hard, too fast on CBD as a dietary ingredient could cause a regulatory backlash and complicate the re-entry of the plant into mainstream agriculture in the US. None of those questions has a definitive answer.

No answer here

In the recent warning letters, it’s clear that FDA doesn’t intend to provide those answers, at least not at the moment. The letters to the CBD marketers Ultra CBD, Hemp Oil Care, purecbd.net and Twin Falls Biotech which were included in a big slate of warning letters sent by the agency on Feb. 26, all sidestepped the questions about CBD itself and focused on what the companies were claiming about what it does.

“These warning letters were based solely on disease claims,” said attorney Justin Prochnow, a shareholder in the law firm Greenberg Traurig. “They went after the low hanging fruit. These claims weren’t even implied claims; they were outright disease claims.”

For example, claims such as “Cannabidiol inhibits lung cancer cell invasion and metastasis” and “CBD has shown promise in preventing cancer from cigarette smoke, reducing heart damage from chemotherapy” are representative of the type of claims cited by FDA in the warning letters.

Reserved judgement?

The absence of a mention in the letters of the regulatory status of CBD does not mean FDA has decided to ignore the issue, Prochnow said. Marketers of these products would be well advised not to assume that FDA has come around to their way of thinking on the legality of the molecule as a dietary ingredient. But it could be an indication that the agency is not overly concerned about the safety of the ingredient. FDA has moved (relatively) swiftly to address the status of ingredients in cases it considers pose public health risks, such as DMAA.

“The absence of that discussion was certainly noticeable,” Prochnow told NutraIngredients-USA. “That could mean they are not ready to address it or they don’t believe it’s an important issue. But the fact that FDA doesn’t mention something in a warning letter doesn’t mean they are signing off on it. That being said, you would think if they were feeling strongly about it they would have addressed it.”

The slate of warning letters issued by FDA also includes letters sent to two companies marketing CBD products for pet care. The full list of warning letters can be found here.