FDA recently updated its Q&A on marijuana. In an earlier version of the Q&A, FDA flatly stated that CBD could not be used as a dietary supplement. The updated Q&A, which was released earlier this month, extends that prohibition to foods sold into interstate commerce.
CBD, or cannabidiol, is one of the nonnarcotic fractions of the Cannabis sativa plant. The molecule has been studied for health properties including pain relief and as an antispasmodic. A big regulatory hurdle for the molecule in dietary supplement applications has been the classification by the Drug Enforcement Administration of marijuana as a Schedule 1 prohibited substance. The DEA has taken the stance that the entire plant, and all its derivatives, share this stricture. From the Federal point of view, the only ‘legal’ marijuana—and that for research only—is grown by the National Center for Natural Products Research at the University of Mississippi.
CBD from industrial hemp
Undeterred, marketers of CBD products have sought to focus attention on the derivation of CBD from ‘industrial’ strains of hemp; i.e. those that contain very low levels of THC, or tetrahydrocannabinol, the narcotic fraction of the plant. Hemp has many approved uses, they reason, including as a food. So taking a fraction of a food for use in a supplement is OK, right? They also argue that hemp’s long history of use would qualify CBD as an Old Dietary Ingredient, not subject to the need for a New Dietary Ingredient Notification.
But the DEA status of the plant is not the only problem for the use of CBDs in supplements, nor, from the point of view FDA, the biggest one, as it turns out. FDA’s current thinking hinges on the fact that CBD has been the subject of two Investigational New Drug filings, both by English company GW Pharmaceuticals. Substances that start life, so to speak, as dietary supplement and food ingredients can subsequently make their way into the pharmaceutical realm. The pharmaceutical grades of omega-3 fish oils are an example. But the process doesn’t work in reverse; you can’t start investigating a substance as a drug and then later decide to market it as a dietary ingredient.
“What FDA did was to update their guidance the emphasize that the same exemption of the use of CBD in a supplement because of an IND filing also applies to its use in foods,” attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, told NutraIngredients-USA.
In the paragraph in question, FDA has this to say: “It is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”
GW’s INDs
The IND filing process is a public one, and GW Pharmaceuticals has filed applications for two drugs: Sativex, meant for spasticity in multiple sclerosis and Epidiolex, intended to treat some intractable forms of epilepsy in children. Sativex is on the market as a drug in 15 countries, according to GW Pharma, and Epidiolex has been granted orphan drug status by FDA for Dravet and Lennox-Gastaut syndromes. Dravet syndrome is a a rare genetic epileptic encephalopathy; Lennox-Gastaut is a type of epilepsy with multiple different types of seizures, particularly tonic (stiffening) and atonic (drop) seizures.
If CBD were marketed as a food prior to the filing several years ago of GW’s IND applications, FDA said its conclusion might be different. But to date, the agency says it has not received any evidence that would cause it to change its mind.
The use of the term ‘interstate’ in the new paragraph on food is interesting because it focuses on the still confusing nature of marijuana legality and legislation. Voters have approved the recreational use of Cannabis sativa has been approved in Colorado, Washington and Oregon, and dozens of others have medical marijuana laws on the books. Presumably FDA, like DEA, has little appetite at the moment for trying to enforce federal laws and administrative policies within the borders of those states whose laws contradict those statutes and policies.
Desultory enforcement
And even for products that are sold in other states, perhaps those with only medical marijuana statutes, FDA seems less than eager to swear in a CBD posse. In another question in the Q&A, FDA has this to say about whether it intends to go after supplements and foods containing CBDs: “When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.”
In cases where there seems to be a clear and present danger, such as in the case of DMAA when two deaths were associated with the ingredient, the agency has moved swiftly against suspect ingredients. Thus far, FDA has used a light touch on CBDs, and has merely offered its (admittedly unvarnished) opinion, indicating that it considers the public safety threat to be low. Over the past 18 months FDA has sent warning letters to 12 companies marketing CBD products, but those were motivated mostly by illegal disease claims that were being made on the products. As far as can be determined, to date no warning letter has been sent to a company solely on the basis that it is marketing a CBD-containing product. So it seems as if marketers of CBD-containing products still have a very narrow but diminishing field of maneuver; if they steer clear of making disease claims then they might avoid getting a warning letter and might be able to continue to sell their products. But there’s no guarantee of that, and so the dense regulatory thicket that still surrounds the ingredient must if possible be cleared away before CBD can fulfill the promise that so many marketing firms have seen in it.