The Food and Drug Administration (FDA) distinguishes CBD (cannabidiol) extracts from hemp-derived products that have a history of consumption, such as cold-pressed hemp seed oil. The agency has not attempted, however, to make any distinction between highly concentrated CBD isolate versus “full-spectrum” hemp extracts that contain numerous cannabinoids, including CDB, at lower concentrations. This article discusses whether the form of CBD should impact its legality as a food additive or dietary supplement under the Food, Drug and Cosmetic Act (FDCA).
To understand the issue, it is important to define some of the terminology. Isolate is CBD in its purest form and generally refers to a pure crystalline powder that typically contains more than 95% CBD. To produce CBD isolate, a manufacturer undertakes a process to isolate only the CBD molecule, stripping out all remaining plant material. Unlike CBD isolate, a full-spectrum hemp extract contains the full assortment of cannabinoids that are naturally present in the hemp plant, including THC (though at a level that should not exceed 0.3% concentration on a dry weight basis to be compliant with the requirements of the 2018 Farm Bill).
FDA's Current Position on CBD as a Food Additive or Dietary Supplement T
he FDA’s position since at least 2015 is that certain cannabinoids, including CBD, are impermissible additives that adulterate food and dietary supplements for humans and animals. Under the FDCA’s drug exclusion rule, once a substance that was never in the food supply is (1) an active ingredient of an approved drug product or (2) an active ingredient of a product in clinical trials that have been made public, a food or supplement containing that substance cannot be shipped in interstate commerce.
The FDA has cited Epidiolex® as an example of a clinical investigation regarding CBD that has been made public. Epidiolex was approved by the FDA in June 2018 for treatment of childhood seizures associated with two rare forms of epilepsy. The FDA has therefore concluded that CBD products are in fact drugs and require FDA approval under the FDCA. The new drug-approval process is exorbitantly expensive; in 2016, the Journal of Health Economics estimated the average cost per approved drug at well over $1 billion.
CBD as Food Additive
Every ingredient in a food sold in interstate commerce is a food additive and subject to FDA preapproval requirements, unless an exception applies. Prior to adding a new food additive to a conventional food, one must obtain approval through a food additive petition, which can take years to complete. The primary exception is for a substance that is generally recognized as safe (GRAS). A substance is GRAS if it is shown to be safe using scientific procedures or if it were used in food before January 1, 1958, and shown to be safe through “experience based on common use in food.” Although GRAS determination has been made in the case of hulled hemp seeds, hemp seed protein and hemp seed oil, the FDA concludes further research is needed for CBD to be determined GRAS.
CBD as Dietary Supplement
Potentially, one could market a dietary supplement containing a cannabis-based new dietary ingredient, including CBD, if there were a history of use or other evidence of safety establishing that when used according to the direction in its labeling, the ingredient reasonably will be expected to be safe. One first must submit a new dietary ingredient notification at least 75 days before introducing the supplement to market. The FDA may send a no-objection letter, but in the absence of a response from the FDA, one may legally market the dietary supplement after the 75-day notification has expired. There is substantial risk in attempting to market any dietary supplement through this route without reliable scientific evidence of safety.
Does the Form of CBD Matter?
The active ingredient in Epidiolex is CBD isolate, not full-spectrum hemp extract. An important legal distinction therefore exists between CBD isolate and full-spectrum hemp extract under the FDCA, particularly with respect to the FDA’s drug exclusion rule. This legal distinction was perhaps best explained by the well-known cannabis attorney Rod Kight in his testimony at the FDA’s public hearing in May 2019. Mr. Kight testified:
“[The drug exclusion rule] prohibits a drug from being added to food only if the substance:
- Is intended to diagnose, cure, mitigate, treat, or prevent disease through its use in the food, as shown objectively by marketing and labeling representations; and
- Is the exact same moiety [meaning the pharmacologically active substance] as the active ingredient in an approved drug and is added to the food in the same dosage range as authorized by the new drug approval. Hemp extract as a food is an exception to [the drug exclusion rule] notwithstanding that it contains CBD. This is because CBD is a naturally occurring constituent inherent in hemp, which has been marketed and used at least since the Civil War. The prohibition on marketing a drug in food applies only to a substance that is added to food and does not apply to a substance that is in food, even where the substance is identical to an approved drug. Additionally, hemp extract contains dozens of compounds and is not the same moiety as the FDA approved CBD drug.”
The question therefore becomes when a hemp-derived extract should be considered sufficiently different than CBD isolate so as to fall outside the limitations of the FDA’s drug exclusion rule. An analogy may be drawn to arguments raised in litigation against the FDA over the dietary supplement Cholestin and its active ingredient lovastatin, used for lowering cholesterol.
Lovastatin was manufactured from red yeast rice, which has been used as a folk medicine for centuries. After the pharmaceutical company Merck released its approved drug Mevacor® with the active ingredient lovastatin, the FDA concluded that Cholestin was an unapproved drug that could not be sold as a dietary supplement. The FDA argued that because Cholestin was manufactured with a higher concentration of lovastatin than found naturally in red yeast rice, it was legally distinguishable from red yeast rice and was adequately similar to the lovastatin in the approved drug Mevacor to trigger the drug exclusion rule. After years of litigation, the court sided with the FDA.
Will the FDA Distinguish CBD Isolate from Hemp Extract?
The FDA is likely to raise the same arguments that were made in the Cholestin case with respect to the drug exclusion rule’s applicability to full-spectrum hemp extract, though the agency has not yet taken any public position on this issue. Substantial pressure has nevertheless been placed on the FDA by the public and by members of Congress to provide clarity on potential pathways for various types of CBD products to be lawfully marketed.
The 2020 federal budget includes an additional $5 million earmarked for the FDA to regulate CBD, conduct enforcement activity and carry out research. In the wake of warning letters issued on November 25, 2019, that were sent to 15 CBD companies, the FDA has announced that it “plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.”
Most recently, FDA’s newly appointed commissioner, Dr. Stephen Hanh, acknowledged on February 26, 2020 that CBD products are here to stay. “People are using these products. We're not going to be able to say you can’t use these products. It’s a fool’s game to try to even approach that.” Commissioner Hahn further recognized that “We have to be open to the fact that there might be some value in these products and certainly Americans think that’s the case. But we want to get them information to help them make the right decisions.”
Notwithstanding recent positive statements by FDA officials, few experts believe that the agency will move quickly to meaningfully change its current position on CBD products. The agency likely will continue to walk a tightrope of ensuring public health and preserving the integrity of its evidence-based process, while identifying a limited legal pathway for CBD products without causing an already unmanageable industry to become completely out of control.
A potentially realistic pathway could include requirements such as a CBD concentration limit, compliance with good manufacturing processes, use of consistent terminology and label warnings for consumer safety, and strong enforcement penalties. There is no indication at this time that the FDA will differentiate its position between CBD isolate and hemp extract, however, in which case the issue may ultimately be decided in the courts.
This article was published on February 27, 2020, in Law360.