Ed. note: Please welcome Nathalie Bougenies to the pages of Above the Law. She will be writing about the legalities surrounding cannabis and hemp CBD. This post is the first in a series dedicated to the federal and state legality and regulation of hemp-derived cannabidiol, more commonly known as “hemp CBD.”
The enactment of the 2018 Agricultural Improvement Act (the “2018 Farm Bill”) and the legalization of hemp and hemp derivatives, including hemp CBD, in some states has led to a massive hemp CBD health craze in the United States. The highly coveted cannabinoid is currently infused into everything from bath bombs to dog treats, and even workout clothes (yes, workout clothes!). According to a 2019 survey conducted by Cowen, the sales of these products are expected to reach $16 billion by 2025.
Despite this strong consumer interest, the Food and Drug Administration consistently takes the position that the sale and marketing of these hemp CBD products is unlawful and that the use of hemp CBD is dangerous. That was until the newly appointed FDA Commissioner, Stephen Hahn, M.D., publicly announced on February 26 to a roomful of representatives from state Departments of Agriculture that the FDA’s current approach to hemp CBD is not sustainable:
“We’re not going to be able to say you can’t use these products. It’s a fool’s errand to even approach that[.] We have to be open to the fact that there might be some value to these products and certainly Americans think that’s the case.”
The FDA’s new stance on the regulation of the sale and marketing of hemp CBD products raises the question in the minds of many of whether the agency will cease its enforcement actions against hemp CBD companies, which to date have been limited to sending warning letters to those companies that make egregious, unfounded health claims about the therapeutic value of hemp CBD.
Although Commissioner Hahn’s statements are promising, they did not ultimately do away with the FDA’s current moral position on hemp CBD, which is one of extreme consumer caution. Indeed, in his February 26 speech, the FDA Commissioner reiterated the agency’s goal of providing consumers with sound information about the effects of these products so they can make educated decisions about their purchases.
But what exactly gets the FDA’s hackles up around Hemp CBD?
According to the FDA, hemp CBD foods and dietary supplements can neither be lawfully sold nor marketed. The FDA takes issue with these products because of the Drug Exclusion Rule. The Drug Exclusion Rule provides that an article that has been approved or investigated as a drug cannot be a dietary supplement or be added to food unless the article was marketed as a supplement or food before it was investigated. Hemp CBD has been approved as a drug ingredient in the treatment of epilepsy (i.e., Epidiolex) and the FDA does not believe that hemp CBD was marketed as a food or dietary supplement prior to that investigation. Nevertheless, the Food, Drug and Cosmetic Act (“FDCA”) gives the FDA Commissioner the authority to override the Drug Exclusion Rule by issuing “a regulation, after notice and comment, finding that the article would be lawful under [the FDCA].” As the head of the FDA, Commissioner Hahn has the ability to regulate hemp CBD, so his recent statements certainly suggest he may eventually act on that conferred power.
Despite its position on food and dietary supplements, the FDA indicated that hemp CBD can be added to topicals, which fall under the FDCA definition of “cosmetics,” so long as these products (1) do not contain marijuana, (2) are not adulterated (i.e., unsafe) or misbranded or intended to be used as drugs, and (3) if no claims are made about these products regarding diseases or bodily structure/function on their packaging, labeling, or in their marketing materials. Not making health claims on a product label or other marketing materials will significantly reduce the risk of an FDA enforcement action because any claim made about the therapeutic value of hemp CBD will lead the FDA to conclude that the product is a “drug.” And because no hemp CBD products have been approved by the FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease (other than Epidiolex), those products will be deemed unlawful by the FDA if such claims are made.
The FDA has yet to address the sale and use of hemp CBD smokables. This is likely due to the fact that the FDA has the authority to regulate the sale, manufacture, and marketing of tobacco products, but has repeatedly refused to extend its authority to products free of nicotine or tobacco. Accordingly, it seems unlikely that hemp CBD smokables devoid of tobacco would be considered “tobacco products.” Although the FDA is not likely to regulate most hemp CBD smokables like it does tobacco products, it could potentially regulate them as a drug under the FDCA if any health claims are made about the therapeutic value of the products.
Therefore, until the FDA adopts a formal legal path for the sale and marketing of hemp CBD products, industry players will need, at a minimum, to comply with those loose FDA guidelines and applicable state laws, which, as I will explain in the second portion of this series on hemp CBD, are all over the map.
Nathalie Bougenies practices in the Portland office of Harris Bricken and was named a “2019 Rising Star” by Super Lawyers Magazine, an honor bestowed on only 2.5% of eligible Oregon attorneys. Nathalie’s practice focuses on the regulatory framework of hemp-derived CBD (“hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and regulations surrounding hemp and hemp CBD products. She also advises domestic and international clients on the sale, distribution, marketing, labeling, importation and exportation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s Marketplace. Nathalie is also a regular contributor to her firm’s Canna Law Blog.
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