Almost three years since the legalization of hemp production in the United States, the U.S. Food and Drug Administration (FDA) is still in the process of determining the regulatory framework for CBD and other hemp derivatives.
Despite the continuously growing hemp marketplace, the FDA has long maintained the position that many food and dietary supplements containing hemp and CBD are prohibited from being sold or marketed as such under the Federal Food, Drug and Cosmetic Act (FDCA). This provision is colloquially known as the “Drug Preclusion Provision.”
“...a product that contains an article that is an approved new drug or licensed biologic cannot be a dietary supplement unless the article was marketed as a dietary supplement or as a food before its approval as a new drug or licensing as a biologic. Dietary supplements also may not include articles that are authorized for investigation as a new drug or biologic (and for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public), unless the article was marketed as a dietary supplement or as a food before it was authorized for investigation.”
But how does this FDCA provision apply to CBD? In one word: Epidolex. The “article” in question is cannabidiol, which just so happens to be the active ingredient in the FDA-approved drug Epidiolex.
While an important exception rests in the language “unless the article was marketed as a dietary supplement or as a food before it was authorized for investigation,” the FDA has concluded that “this is not the case for THC or CBD.”
Despite its multi-year process of assessing potential exceptions from the Drug Preclusion and evaluating the safety and science of CBD, the FDA has not changed its prohibitive approach. However, the plain language of the Drug Preclusion, supporting case law (see Pharmanex, Inc. v. Shalala, 35 F. Supp. 2d 1341 (D. Utah 1999)), and statements made by the FDA (see page 14) have made it clear that some hemp ingredients may not constitute the same article as the CBD in Epidiolex and therefore may not be subject to the Drug Preclusion. The hemp industry is still waiting for the FDA to provide significant guidance on distinguishing lawful ingredients that do not constitute the same article as the active ingredient in Epidiolex.
Nevertheless, the FDA recently gave the industry valuable insight into their approach when it revealed its objections to two New Dietary Ingredient (NDI) notifications for full spectrum hemp products, taking the position that despite being marketed as full-spectrum hemp products, the products contain the same article as an FDA-approved drug’s active ingredient and are therefore prohibited under the Drug Preclusion. Notably, the FDA also objected to both NDIN’s on the grounds that the safety evidence submitted was inadequate to support the conclusion that the ingredients are reasonably expected to be safe under the intended use.
While the FDA unsurprisingly maintains its status quo with these rejections, there are some key takeaways.
Changes in Enforcement are Unlikely
Nothing in the rejection letters indicates a shift in the FDA’s long-standing non-enforcement approach, but rather a continuation of the dysfunctional status quo. Absent unlawful drug claims or other serious safety concerns, the FDA’s limited resources have not generally been used to enforce its current position that CBD cannot be marketed or sold as a dietary supplement or food. In the meantime, states continue to develop and enhance laws governing the production and sale of consumable hemp products and will likely continue to do so, underscoring the importance of state law compliance.
Safety Data Matters
The FDA cites inadequacy of safety data as the basis for rejecting the two NDI notifications, citing, among other things:
- That evidence for general history of use was vague;
- That adequate descriptions of cannabis compositions, serving levels, frequencies, and durations of use were not provided;
- That safety concerns related to toxicity were not adequately addressed; and
- That certain studies could not be applied to the ingredient at issue.
Charlotte’s Web, Inc. challenged this assertion with a response to the FDA, citing significant factual inaccuracies as to whether certain supplemental data was actually requested, among other things. While much of the subject data is confidential, the dialogue is a reminder that hemp and CBD companies must be diligent in ensuring that safety data is based on the specific product (at its marketed dose) and for the intended use—not general studies for hemp or CBD.
We Have More Insight into FDA’s Factors Differentiating “Full Spectrum” from “CBD”
Companies have generally relied on the Pharmanex precedent as to which factors may be considered in determining whether an article is subject to the Drug Preclusion. This includes:
- Facts relating to the date in which the product was marketed;
- How the product is manufactured and promoted; and
- Whether the product has been engineered to have levels of the subject substance similar to those found in an approved drug than to the levels found in traditional natural products.
The recent NDIN objections give us more insight into how broadly the FDA applies the factors to CBD and highlight how challenging it is to apply this precedent to a cannabis plant. We know that the FDA will consider these in determining whether an ingredient is subject to the Drug Preclusion.
For hemp, this includes whether the substance is genetically engineered and/or manufactured to produce a high amount of CBD “comparable to a drug product.” Whether this means high-CBD genetics (without further enhancement or modification) could be considered a different article than the article in Epidiolex is still unknown, and it’s quite possible the FDA doesn’t know the answer either. To assess how the FDA may categorize a hemp ingredient, it’s advisable to consider the starting genetic material, the manufacturing process, how/if the hemp ingredient is produced to enhance CBD content, and how the product is marketed.
Congress Must Act
These NDIN objections underscore that the FDA’s ineffective prohibition on CBD fails to evolve despite years of engagement on the issue. It is incumbent for Congress to act, and these objections might just incentivize congressional action. Increasing bipartisan support of HR 841 (legalizing hemp ingredients as dietary supplements), progress of S 1698 (would legalize CBD in food), and the discussion draft of Sens. Booker, Wyden, and Schumer’s Cannabis Administration Opportunity Act (would legalize CBD in dietary supplements only) make clear that Congress is also frustrated with the FDA’s inaction and sees the need to protect consumers, businesses, and farmers.
Even if certain full spectrum hemp products are arguably lawful under the FDA’s current position, the majority of CBD products on the market remain subject to the Drug Preclusion in the eyes of the FDA, an agency that maintains this prohibitive position without enforcing it. The fragmented and confusing state framework, along with the crippling effect the FDA’s inaction and uncertainty have on the market, continues to harm consumers, businesses, and the hemp industry as a whole.