CBD, formally known as cannabidiol, rapidly entered mainstream commerce in recent years due to changes in the legal status of hemp. Not long ago, CBD was only found in farmers’ markets and the occasional boutique shop, but today major carriers such as CVS Health, Kroger and GNC stock CBD products on their shelves. In addition to its expansion into larger stores, the number of new CBD products has also increased. Some of the more traditional products include vaporizers, foods and drinks, and lotions. Other, more creative examples now include candles, deodorants, eyedrops and beer, to name a few.
However, many companies have misinterpreted the changes in hemp’s legal status and CBD’s presence on the shelves of major carriers as a “green light” to the unrestricted sale of CBD in any form. In their rush to compete, many companies are violating existing laws.
Before I share an overview of the current legal status of CBD, it is important to understand what CBD is.
What is CBD?
At its most basic level, CBD is characterized as a cannabinoid – a chemical compound that interacts with the brain’s cannabinoid receptors.[1] It is commonly sourced from the cannabis (marijuana) and hemp plants [2] through various extraction methods. However, it does not produce the mind-altering effects typically associated with the ingestion of cannabis, which are the result of a separate and distinct cannabinoid, tetrahydrocannabinol (THC). For this reason, the typical public concerns associated with cannabis have not been as prominent for CBD, allowing it to gain traction with the pro- and anti-cannabis public.
The History of CBD and Hemp Legislation
The emergence of CBD into the mainstream is a new development in the law. Until recently, the Controlled Substances Act (the CSA) of the 1970s broadly prohibited “all parts of the plant Cannabis sativa L.,” which expressly includes “every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or its resin.”[3] CBD fell under this definition, as it is a “derivative” of the cannabis plant. It is important to note that the CSA made no distinction between hemp and cannabis.
It was the Agricultural Act of 2014, also known as the “2014 Farm Bill” (the 2014 Bill) that began paving the way for CBD through its limited sanctioning of the cultivation of hemp, which it defined as cannabis with a THC concentration of not more than 0.3% on a dry weight basis.[4] The 2014 Bill created a legal framework whereby states could cultivate hemp for research purposes without first obtaining a permit from the DEA.[5] Though the 2014 Bill was a step towards hemp legalization, it did not provide for any commercial uses and license holders were limited to higher education institutions and state departments.[6]
While the 2014 Bill opened the door, the true catalyst for the widespread use of CBD is the Agricultural Improvement Act of 2018, also known as the “2018 Farm Bill” (the 2018 Bill). The 2018 Bill removed hemp (as defined in the 2014 Bill) from the CSA’s definition of cannabis. As a result, hemp-derived CBD (Hemp-CBD) was also removed from the CSA’s prohibitions.[7] Though this change in the law took Hemp-CBD out of the CSA’s control, it did not remove CBD from all compliance requirements.[8][9]
Specifically, the 2018 Bill preserved the Food and Drug Administration’s (“FDA”) authority to regulate products containing Hemp-CBD under the Food, Drug & Cosmetic Act (FDCA).[10] Under the FDCA, Hemp-CBD, depending on its form and how it is marketed, falls within one of four categories: “drug,” “food,” “dietary supplement” or “cosmetic.” [11] Due to the burdensome requirements of marketing CBD as a drug, Hemp-CBD companies instead attempt to market their products as dietary supplements or infuse them in food, drinks or cosmetic products.
The FDA has defined “dietary supplement” as:
“a product intended to supplement the diet that contains one or more of the following dietary ingredients: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (a) through (e).”[12]
The definition explicitly excludes:
“an article that is approved as a new drug…which was not before such approval…or authorization…marketed as a dietary supplement or as a food.”[13]
GW Pharmaceuticals Faces FDA with New CBD Drug
In 2018 the biopharmaceutical company GW Pharmaceuticals received FDA approval for Epidiolex®,[14] a purified form of CBD used to treat seizures in people living with Dravet Syndrome and Lennox-Gastaut Syndrome. Since Epidiolex is considered a new drug, as the term is used in the above exception, the cornerstone issue is whether CBD was marketed as a dietary supplement prior to Epidiolex receiving authorization for testing in 2013. The FDA’s nonbinding guidance defined “marketing” to mean:
“selling or offering the dietary ingredient for sale (1) as or in a dietary supplement,(2) in bulk as a dietary ingredient for use in dietary supplements, or (3) as an ingredient in a blend or formulation of dietary ingredients for use in dietary supplements.”[15]
Based upon this definition, it would appear CBD was “marketed” prior to GW Pharmaceutical receiving its 2013 FDA authorization to investigate Epidiolex, since CBD was being sold on shelves of farmers’ markets and boutique shops well before that year.[16] However, the guidance goes on to require such marketing to be lawful marketing, stating, “if a dietary supplement…is sold before the manufacturer or distributor submits a required new drug ingredient notification or less than 75 days after the notification is submitted, the sale of the product is not evidence that the dietary supplement was lawfully marketed.”[17]
The FDA has publicly concluded in a nonbinding statement that CBD was not marketed as a dietary supplement before authorization for the Epidiolex investigations.[18] For this reason, under the FDCA and current FDA interpretations, CBD cannot be marketed as a dietary supplement.
CBD in Food, Drink and Cosmetics
The same analysis used for dietary supplements applies to CBD infused food and drink (for humans and pets).[19] The FDA’s current nonbinding position is that the sale of CBD infused food and drink is prohibited in commerce.[20] In line with its position on CBD in dietary supplements and food and drink, the FDA has issued many warning letters over the past years to CBD manufacturers, including 22 in 2019, a significant increase as compared to past years.[21]
In contrast, cosmetic products, as defined in 21 U.S.C. § 321 (i), are not subject to premarket approval and no current prohibition or restriction exists for cosmetic products that include CBD, so long as the product adheres to the FDA’s branding requirements.[22]
Whether a CBD company is selling its product in violation of the FDCA depends in large part upon the type of product being sold. The major brands mentioned at the beginning of this article have appeared to limit their products to topicals, which one can assume was strategically done to remain within the more lenient cosmetics category. However, smaller Hemp-CBD companies still offer CBD products as dietary supplements and infused food or drink in ongoing noncompliance, an issue that continues to go unresolved.
Alex Karam
[1] Cannabidiol is a Negative Allosteric Modulator of the Cannabinoid CB1 Receptor, British Journal ofPharmacology (2015),https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/bph.13250; TheEndocannabinoid System: A General View and Latest Additions, British Journal ofPharmacology (2004),https://bpspubs.onlinelibrary.wiley.com/doi/epdf/10.1038/sj.bjp.0705666; TheEndocannabinoid System: Physiology and Pharmacology, Alcohol and Alcoholism,Volume 40, Issue 1 (2004), https://doi.org/10.1093/alcalc/agh110.
[2] Cannabis, marijuana, and marihuana are all terms for the same plant. Cannabis, being the correct botanical word, will be the term used throughout this Article. It should be noted that the Controlled Substances Act refers to the slang term “Marihuana” when referring to cannabis, a variation of an alternative slang spelling “marijuana.” See 21U.S.C. 802(16)(B)(i). To complicate the terminology further, the difference between hemp and cannabis is purely a legal distinction. Hemp is defined as a cannabis plant with less than 0.3% THC. 7 U.S.C. 1639(o).
[3] 21 U.S.C. 802(16)(B)(i).
[4] Agricultural Act of 2014, H.R.2642 at Sec. 7606, 113th Congress (2014).
[5] Id.
[6] Id.
[7] 21 U.S.C. 802(16)(B)(i) & 7U.S.C. 1639(o).
[8] It should be noted that CBD derived from cannabis (marijuana) remains prohibited under the CSA.
[9] Arizona enacted hemp bill SB1098 on May 14, 2018 (“AZ Bill”), which removed hemp from Arizona’s drug prohibitions. However, the AZ Bill specifically excludes from its definition of “hemp products” “any product made to be ingested except food made from sterile hempseed or hemp seed oil.” A.R.S. §§ 3-311(5) & 13-3405(I). To the extent CBD falls within this exclusion it is beyond the scope and protections of the AZ Bill.
[10] Agricultural Act of 2018, H.R.2642 at Sec. 297(D)(c), 113th Congress (2014).
[11] 21 U.S.C. § 321 (f), (g), (i),& (ff).
[12] Id.
[13] Id. [Emphasis added]
[14] See https://www.drugs.com/history/epidiolex.html.
[15] “Dietary Supplements: New DietaryIngredient Notifications and Related Issues: Guidance for Industry,” FDA, p. 17,August 2016.
[16] See https://www.drugs.com/history/epidiolex.html.
[17] See footnote 14 supra.
[18] “FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD),”https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#farmbill.
[19] See 21 U.S.C. § 331(ll)(Prohibits the introduction into interstate commerce any food (including animal food or fee) to which has been added a substance which is an active ingredient in an approved drug, unless the drug was marketed in food before the drug was approved or substantial clinical investigations involving the drug were instituted).
[20] See footnote 18 supra.
[21] See “Warning Letters andTest Results for Cannabidiol-Related Products,” https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products.
[22] See footnote 17 supra.
