Ed. note: Please welcome Nathalie Bougenies to the pages of Above the Law. She will be blogging about the legalities surrounding marijuana and hemp CBD. This post is the first in a series devoted to the federal and state legality and regulation of hemp-derived cannabidiol, more typically referred to as “hemp CBD.”
The enactment of the 2018 Agricultural Improvement Act (the “2018 Farm Expense”) and the legalization of hemp and hemp derivatives, including hemp CBD, in some states has led to an enormous hemp CBD health trend in the United States. The highly coveted cannabinoid is presently infused into everything from bath bombs to pet treats, and even workout clothes (yes, exercise clothes!). According to a 2019 study performed by Cowen, the sales of these items are expected to reach $16 billion by 2025.
Regardless of this strong customer interest, the Food and Drug Administration consistently takes the position that the sale and marketing of these hemp CBD products is illegal which the use of hemp CBD is unsafe That was up until the newly appointed FDA Commissioner, Stephen Hahn, M.D., openly revealed 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 items. It’s a fool’s errand to even approach that[.] We need to be open to the reality that there might be some value to these products and certainly Americans believe that’s the case.”
The FDA’s new stance on the policy of the sale and marketing of hemp CBD products raises the question in the minds of many of whether the firm will stop its enforcement actions against hemp CBD business, which to date have been restricted to sending out warning letters to those business that make egregious, unproven health declares about the therapeutic worth of hemp CBD.
Although Commissioner Hahn’s declarations are promising, they did not ultimately get rid of the FDA’s present ethical position on hemp CBD, which is among extreme customer care. Certainly, in his February 26 speech, the FDA Commissioner reiterated the agency’s goal of supplying customers with sound details about the effects of these items so they can make informed choices about their purchases.
But exactly what 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. Hemp CBD has been approved as a drug component in the treatment of epilepsy ( i.e., Epidiolex) and the FDA does not think that hemp CBD was marketed as a food or dietary supplement prior to that investigation. As the head of the FDA, Commissioner Hahn has the ability to manage hemp CBD, so his current statements certainly suggest he might ultimately act on that gave power.
Despite its position on food and dietary supplements, the FDA indicated that hemp CBD can be contributed to topicals, which fall under the FDCA definition of “cosmetics,” so long as these products (1) do not consist of cannabis, (2) are not adulterated ( i.e., hazardous) or misbranded or planned to be used as drugs, and (3) if no claims are made about these items regarding diseases or physical structure/function on their packaging, labeling, or in their marketing products. Not making health claims on a product label or other marketing materials will significantly reduce the threat of an FDA enforcement action due to the fact that any claim made about the healing value of hemp CBD will lead the FDA to conclude that the product is a “drug.” And since no hemp CBD products have actually been approved by the FDA for the medical diagnosis, treatment, mitigation, treatment, or avoidance 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 usage of hemp CBD smokables The FDA is not most likely to control most hemp CBD smokables like it does tobacco products, it could possibly manage them as a drug under the FDCA if any health claims are made about the restorative worth of the products.
Therefore, until the FDA adopts an official legal path for the sale and marketing of hemp CBD products, industry players will need, at a minimum, to comply with those loose FDA standards and applicable state laws, which, as I will explain in the second part of this series on hemp CBD, are all over the map.
Nathalie Bougenies practices in the Portland workplace of Harris Bricken and was called a “2019 Rising Star” by Super Lawyers Publication, an honor bestowed on only 2.5%of eligible Oregon lawyers. Nathalie’s practice focuses on the regulatory structure of hemp-derived CBD (” hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and policies surrounding hemp and hemp CBD products. She likewise recommends domestic and worldwide clients on the sale, circulation, marketing, labeling, importation and exportation of these items. Nathalie regularly speaks on these problems and has actually made national media looks, including on NPR’s Marketplace. Nathalie is also a regular factor to her firm’s Canna Law Blog
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