“Let food be thy medicine and medicine be thy food.” - Attributed to Hippocrates
To begin, as with each article in this area should, CBD is a drug. Full stop. That ship sailed a while back with the recognition of clinical studies of the chemical entity for the purposes of investigating its therapeutic effects in diseased populations as a prelude to drug approval. There, once more the obvious is shown. That said, we all operate in the world where consumer products containing CBD are readily available through legitimate outlets and pharmacies, without a prescription and without any questions asked. This is not uncommon through the increasing majority of states that have individually begun to deal with all things cannabis. The products range from topically applied lotions and creams to ingestible products and even transdermal patches. However, the interface of foods and drugs (let’s just stick with gummies that include CBD) is a tricky one, even at the state level.
The purpose and intent of these products, with minimal cynicism, is to provide consumers the benefits of CBD in forms that are easily accepted and that deliver the substance in way that is useful. Food is logically the most readily identifiable of these. The challenges begin with the inclusion of what is, please re-read the first statements, a drug in a food product. There is no provision for this in the law and thus there is no specific allowance in the regulations for a food to contain a drug, or vice versa. FDA has gone out of its way on more than one occasion to discourage such activities and has gone after some very large players (i.e. Proctor & Gamble) through regulatory action. FDA’s position on this matter is historic and has not changed. The inclusion of a dietary ingredient in a drug product for the purpose of creating a combination “dietary supplement/drug” is not acceptable. From the dietary supplement side of the challenge, active components of the product are not dietary ingredients and therefore render the product something other than a dietary supplement. From the drug side, the product is a combination product that is not in line with regulatory requirements for such products. Such combinations are simply not allowed by the regulatory agency. FDA’s written position on this is that there are currently no OTC monographs that include combinations of drugs and dietary supplements as active ingredients. The position further clarifies that when drug and dietary supplement active ingredients are combined into a single dosage form, the resulting product becomes a drug in its entirety.
The next layer of challenge is in the components themselves. The inclusion of synthesized CBD would clearly be the inclusion of a drug entity. The current marketplace is populated instead with “hemp extracts” that provide specific levels of CBD. The presence of the CBD is, therefore, coincidental. This avoids the concentration steps that are performed in order to achieve the relatively higher levels CBD in the resultant extract than would be found in the botanical itself. At this point, the immediate picture that should form is that of red yeast rice. The ultimate determination as to the acceptability of dietary supplement products that contain red yeast rice is that the presentation not provide more of the active drug entity naturally found in the substance without extraction. That model is still the bellwether for what ultimately can be achieved through regulatory or legislative effort. Improving on that outcome is where the target for every regulatory effort should focus. That acceptability is the floor for what should be determined.
Apart from the matter of dietary supplement/drug combinations, there is the matter of the inclusion of these materials in conventional foods. This is where it gets very interesting. The discussion involves whether hemp extract can be considered a food in and of itself. That is the initiation point. Consider that it is not likely to be viewed as such for a variety of reasons. This leaves the routes of notification for quickest acceptability into the marketplace in a compliant fashion. That, in turn, means development and notification of a determination that a specific hemp extract is GRAS if one wishes to include it in food products (back to the gummies again) or, a New Dietary Ingredient Notification for its inclusion in dietary supplements (without drugs). As the fates would have it, there are already some GRAS self-determinations that have been notified for hemp products. These are not concentrated to any great extent for CBD but the precedent is one to apply. The pathway is open and visible for those who wish to pursue it.
The importance of pursuing this aspect of compliance rather than working within the gray areas found in individual states is increasing. State of California laws changed effective in January of this year to disallow use of CBD products in foods unless there is federal notification without objection and/or a New Dietary Ingredient notification. In Colorado, the most liberal state when it comes to the use of cannabinoids, CBD products are legally precluded from being offered in food products.
What lies ahead is what has come before. Even as products are being marketed more successfully, the regulatory parameters constrict while industry ponders its next steps. The message is simple, there are pathways forward, there is significant challenge in precedent, and yet, owing to consumer interest and demand, there appears to be notable potential to improve on the regulatory status. While this discussion does not include a raft of other small details (such as whether the hemp extracts marketed are actually “hemp” as defined), the point is that action is necessary or the opportunities to market such products will dry up entirely.
Jim Lassiter, chief operating officer, oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural products industries.