With the recent passage of the Agriculture Improvement Act of 2018 (“2018 Farm Bill”), the hype for CBD-infused products has peaked. In 2018, estimated retail sales of CBD consumer products ranged between $600 million and $2 billion because society became aware of the wellness benefits of cannabidiol (“CBD”).[1] Celebrities became brand advocates, spas began offering CBD-infused massages, and CBD even started making its way into our pet’s food. With this societal hype setting the stage, we need to ask, under the current state of the law, can CBD even be sold for human consumption?
CBD, which provides no psychoactive effects, is proven to inhibit inflammatory and neuropathic pain, two of the most difficult types of chronic pain to treat.[2] Hemp and cannabis, colloquially known as “marijuana,” are two plants rich in CBD. In 1970, Congress categorized cannabis as a Schedule I controlled substance.[3] Hemp, unfortunately, was looped into the same classification. Hemp and cannabis are different. Cannabis and hemp originate from the same plant—Cannabis sativa L.—yet hemp, unlike cannabis, contains less than 0.3% tetrahydrocannabinol (“THC”).[4] This means a human could consume large quantities of hemp and not feel psychoactive effects (hence the problematic Schedule I classification).
In December of 2018, hemp’s history changed when President Trump signed the Farm Bill into law. The 2018 Farm Bill removed hemp from its Schedule I classification and allowed states to regulate the cultivation and commercial sale of hemp and hemp-derived products.[5] But, even with the passage of the 2018 Farm Bill, restaurants and cafés still face barriers in selling CBD-infused food and beverages.
The 2018 Farm Bill did not remove all barriers to selling hemp-derived CBD products. The United States Department of Agriculture (“USDA”) regulates hemp cultivation and processing. The Food and Drug Administration (“FDA”) obtains regulatory authority once hemp is processed into a product intended for human consumption.[6] The FDA regulates products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (“FDCA”). Under the FDCA, it is illegal to introduce any food or dietary supplement into interstate commerce where an active ingredient in an FDA-approved drug product is present.[7]
In June 2018, the FDA approved GW Pharmaceuticals’ Epidiolex, a drug containing CBD. Under federal law, it is illegal to sell food in which CBD has been added because CBD “[was] authorized for investigation as a new drug [. . .] and for which [the] investigations [have] been made public.”[8] GW Pharmaceuticuals triggered section 321(ff)(3)(B) when they filed a New Drug Application for Epidiolex and conducted clinical trials.
If CBD is an active ingredient in an FDA-approved drug, how can cafés and restaurants get into the CBD food and beverage market?
In March 2019, speaking during a hearing before the U.S. Senate, FDA Commissioner Scott Gottlieb stated the FDA is using enforcement direction when it comes to regulating products containing CBD. Commissioner Gottlieb’s comments have been interpreted to mean if a vendor is selling a CBD-infused food or beverage in compliance with state law, the FDA will not try to find them in violation of section 331(ll). While the FDA has not been very active in enforcing this position, if a vendor claims their CBD-infused food or beverage has medicinal benefits, the FDA will utilize its enforcement discretion by issuing a warning letter. [9]
Companies that receive warning letters make unsubstantiated medical claims about their CBD product. The FDA recently issued a warning letter to Curaleaf, one of the nation’s largest cannabis multi-state operators whose products can be found in CVS. Curaleaf’s website stated their CBD products can be used to treat medical conditions such as cancer, Alzheimer’s disease, chronic pain, and anxiety.
Restaurants and cafés are taking notice. Last week, the first cannabis café in the United States opened in Hollywood, California. Even though you can bring your own cannabis and consume on-site, Lowell Café will not serve infused dishes due to the current state of the laws and the FDA’s position on CBD-infused food.
The FDA is primarily concerned with companies making medical claims about their CBD dietary supplement, food, or beverage. The FDA does not want to be in the business of regulating local restaurants and cafés. But if a vendor claims their CBD-infused food cures cancer, that’s an easy way to increase their chances of being issued a warning letter. In fall of 2019, food establishments have operational wiggle room. It appears as long as the establishment does not claim their CBD-infused food or beverage cures a certain disease or helps treat a certain medical condition, the FDA will not issue a warning letter or take legal action.
*J.D. Candidate, 2020, Florida International University College of Law
[1] Iris Dorbian, CBD Market Could Pull in $16 Billion by 2025, Says Study, Forbes (Mar. 12, 2019, 8:23 AM), https://www.forbes.com/sites/irisdorbian/2019/03/12/cbd-market-could-pull-in-16-bln-by-2025-says-study/#51a875c23efd.[2] D.C. Hammell et al., Transdermal Cannabidiol Reduces Inflammation and Pain-related Behaviours in a Rat Model of Arthritis, 20 Eur. J. Pain 6, 936–48 (2016).
[3] 21 U.S.C. § 812 (2016).
[4] 7 U.S.C. § 1639o(1) (2019).
[5] Id. at § 1639p(a)(1).
[6] 21 U.S.C. § 331(ll) (2019).
[7] Id.; see also 21 U.S.C. § 321(ff)(3)(B) (2019).
[8] 21 U.S.C. § 321(ff)(3)(B).
[9] As of October 2019, the FDA has issued over a dozen warning letters to companies who sell CBD-infused products.