Pressure mounts for regulatory clarity on CBDs

By Hank Schultz contact

- Last updated on GMT

Image: © iStockPhoto / Zzvet
Image: © iStockPhoto / Zzvet

Related tags: Cbd, Hemp, Cannabis, Food and drug administration

The recent spate of FDA warning letters on the use of CBD as an ingredient in dietary supplements seems to have done little to dampen formulators’ enthusiasm for its use in new products. The situation is unprecedented in the herbal products sphere, observers say.

“The enthusiasm is incredible. I’ve never seen anything like this before,”​ Mark Blumenthal, founder of the American Botanical Council told NutraIngredients-USA. 

Regulatory questions

A number of big regulatory questions hover over the CBD space. The biggest is that as far as the federal Drug Enforcement Agency is concerned, cannabis and all its parts are still a Schedule 1 substance. All of the push on the state level for medical and in some cases fully legal recreational usage of the plant has left DEA unfazed. Unless and until the federal law is changed, the entire category will operate under a serious impediment. It has been nearly impossible, for example, for growers of industrial hemp in the US in those states where growing it is legal (Kentucky and Colorado are a couple of examples) to get reliable sources of seed, as DEA is liable to seize seed shipments.

For another thing, FDA has taken the position in several warning letters that CBD, or cannabidiol, a non narcotic cannabinoid found in Cannabis sativa​, is not a legal dietary ingredient because before it came to market as a potential legal dietary ingredient it was being investigated as a new drug by GW Pharmaceuticals, an English company. GW is developing two drugs, one to alleviate seizures in children afflicted with certain forms of childhood epilepsy and another to address nerve pain among MS sufferers. From a regulatory standpoint compounds new to the market may start life as dietary ingredients used in supplements and then later be developed into drugs. The prescription grades of fish oils are a good example. But they may not go in the other direction, in other words, an ingredient, even one from a wholly botanical source, that was first used as a drug can’t subsequently be used in a supplement. If a company comes forward with evidence showing that CBDs were on the market as legal dietary ingredients prior to GW’s Investigational New Drug filings the IND issue might be circumvented.  But to date that has not been proven to FDA’s satisfaction.

"There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, the FDA has concluded that this is not the case for CBD,"​ the agency said in a statement.

Jane Wilson, director of program development at the American Herbal Products Association, which has a cannabis committee, said that evidence might be forthcoming.

“It’s my understanding that at least one organization has submitted a documentation package to FDA,”​ Wilson said.

NDI status

FDA has also taken the position that even if the GW IND situation were not the case, a company wishing to use CBD in a supplement would have to file a New Dietary Ingredient Notification to assemble and provide safety information on the ingredient. The agency seems to have turned a deaf ear to arguments that hemp is approved as food, and so therefore anything found in hemp should be good to go. (Promoters are invariably careful to state that their CBDs are derived from industrial hemp, a cultivar of cannabis that is very low in THC, the narcotic fraction of the plant.)

“Hemp’s status as a food has mostly been based on the use of hemp seed oil and that contains very little CBD,” ​Wilson said. “I don’t know if FDA would accept the presence of those products on the market as substantial confirmation that CBD has been on the market as an ingredient.”

“Many of us have been warning the CBD people that  at the very least that if they want to go into a supplement they need to get NDI status, and even if they did because of the pre-existing IND from GW pharmaceuticals they would be pre-empted,”​ Blumenthal said.

Wilson said questions on CBD dominated the AHPA’s cannabis committee’s most recent meeting, which happened in conjunction with the Expo West trade show in Anaheim, CA.  Wilson said the main questions were what companies interested in exploring the area could do, given the unresolved regulatory uncertainties.  Wilson said a main theme focused on product quality, as this has been mentioned in recent warning letters​, where FDA went to the unusual step of testing CBD products and found that some met label claims while others did not, and some contained no CBD at all.

“We are trying not to convey a position on CBD per se but to be responsive to responsible members to the CBD industry that do want to market in that category. At the meeting is was discussed that like any dietary supplement they need to have specifications of what their product is, document how they produce it and how they control its contents,”​ Wilson said.

“In this particular case there is the issue of the patented medicines from GW Pharmaceuticals that is the complicating factor. Marketers of CBD products would need to be able to point to specific things about how their products are differentiated from those products, such as in the combination of ingredients or what part of the plant they are using,”​ she said.

What claims to use?

Another question surrounding the category concerns claims. The most-researched heath effects of CBD are in seizure suppression and pain relief, neither of which can be fitted nicely into a claim on a dietary supplement. So even if you believe passionately that the use of CBD can positively affect health, how can you legally describe that effect? One claim that has been posited by at least one hopeful marketer of a CBD-containing supplement is “promotes a healthy endocannabinoid response,”​ which at first glance might seem to be just so much mumbo-jumbo.

Not so fast, says CBD researcher Ethan Russo, MD, medical director of PHYTECS,  a company that is investigating the endocannabinoid system​. It’s a real system in the body, and is potentially affected by constituents from plants other than cannabis. Russo said it’s less well known than it should be because of some of the misinformation about cannabis as a whole.

“It’s a system within the body that acts as a homeoregulator that keeps other body system in balance. The focus of the company is not just on cannabis but on the other plant constituents that affect those systems. What we are trying to do is to broaden the target. We are more interested in that than in the particular arrow,” ​Russo said.

In some respects the endocannabinoid system hasn’t gotten as much respect as it should or as much investigation as it deserves because of some of the prejudices about cannabis,” ​he said.

Regulatory uncertainty hurts quality control

As a long time observer of the category, Russo said whatever can be done to rapidly bring CBD products into some sort of reasonable regulatory framework would work for the good of all, to make sure that consumers are buying products that are what they say they are, are safe and are effective.

“I’m a big advocate for quality control and in the black market there is no quality control. Even in a somewhat regulated market you can’t always count on those things. In Washington state where I live there is no current requirement for testing for pesticides in cannabis-based medicines. I don’t know how that got left out. It’s left to the dispensaries to decide if they are going to do the pesticide testing,”​ he said.

“Cannabidiol or herbal products containing cannabidiol are not going to disappear. But it is going to have to be figured out and there may need to be new dietary supplement rules. We need quality control and we need to create a situation in which a consumer has a reasonable expectation of the quality and consistency of the products they are buying,”​ Russo said.

Blumenthal agreed that the currently regulatory climate surrounding the use of CBD is becoming increasingly unworkable.

“The enthusiasm comes from the many demonstrated medical and/or physiological benefits of CBD. There is incredible market acceptance and there is approval in many states which has created pressure. But the problem is this almost Kafka-esque regulatory situation puts the kibosh on almost any rational discussion,”​ Blumenthal said.

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