By: Cori Agnoni
Although the scope of the Food and Drug Administration (“FDA”) is quite broad, its primary goal is to protect public health via regulation and provide related science-based information to the public.[i] The Agricultural Improvement Act of 2018 (“2018 Farm Bill”) removed hemp with a Delta-9 THC concentration not exceeding 0.3% from the list of scheduled substances.[ii] This included any derivatives, extracts, and cannabinoids from Delta-9 THC (a cannabinoid responsible for psychoactive effects) not exceeding 0.3%.[iii] Aspects of the bill remain incredibly vague to lay readers.[iv] However, this decision led to hemp companies synthetically altering the percentage of Delta-8 THC to create a legal high with attractive alleged benefits and creating advertisements difficult to resist by people of all ages.[v] On May 4, 2022, the FDA issued warning letters to five hemp companies about selling unapproved Delta-8 THC products. The FDA must reconsider its approach and adopt a stricter and more direct stance on this increasingly popular form of THC.[vi]
In the warning letters, the FDA addressed three major areas of concern: the number of adverse event reports regarding Delta-8 THC, the misleading marketing of Delta-8 products in ways that appeal to children, and concerns regarding potential contamination during manufacturing.[vii] This first round of warnings serves as a clear sign to the industry that crack downs on Delta-8 could arise in the future and that hemp companies should correct these issues if they hope to continue expanding their products with as little federal guidance as possible.[viii]
If Delta-8 THC is legal, it must be safe, right? Wrong. Sellers of Delta-8 must be as transparent as possible to prevent accidental and unwanted adverse effects from this complex and under-researched product.[ix] Some companies provide labels on their products, but they are often inaccurate because companies purposely omit the total THC percentage and include only the Delta-9 THC percentage, which is a strong underestimation of the psychoactive potential of the products.[x] Others are simply labelling their units as “hemp,” which erroneously leads people to believe there are “non-psychoactive” effects upon consumption.[xi]
Companies ought to be receptive to the FDA’s understandable concern that aesthetic marketing causes the products to fall into the hands of children and naïve adult users.[xii] Records show that over 660 emergency calls spanning from December 2020 to July 2021 reported children being hospitalized while experiencing lethargy, slurred speech, erratic heart rates, and other symptoms attributable to overconsumption of Delta-8 THC.[xiii]
Separate from the aforementioned calls, several national poison control centers were alerted of over 2,000 Delta-8 exposures between January 1, 2021, and February 28, 2022.[xiv] Of these 2,362 cases, 41% of people were younger than age 18.[xv] Also, 40% of cases involved unintentional exposure to the Delta-8 cannabinoid.[xvi] Of these unintentional exposure cases, 82% are attributed to children.[xvii]
Because the amount of THC that naturally occurs in Delta-8 is next to nothing, companies enhance other cannabinoids with chemicals to convert them [xviii] When synthesizing for commercial purposes, manufacturers may use chemicals that are potentially unsafe and appear in household cleaners, which was noted as a clear point of concern for the FDA in the warning letters[xix] Further, synthesized Delta-8 products [xx] Quality control severely lacks in this sector of the industry, which results in little to no understanding of [xxi]how exactly these products are made. [xxii] poses serious risks for consumers.[xxiii]
Currently there are no requirements around labeling or product safety for Delta-8 products.[xxiv] To comply with the FDA’s purpose, a rule must be adopted that requires labels to accurately indicate possible side effects and to suggest an appropriate age requirement for use. Further, cleanliness guidelines should be implemented prohibiting the use of household chemicals during the synthesizing process.
Ultimately, consumers need to conduct extensive research and consult a medical professional prior to consumption of Delta-8 products.[xxv] However, companies must also expect to adopt an increased level of transparency and honesty if they wish to continue the trend toward national legalization of Delta-8 THC products. Clarity now prevents a repeat of this future confusion when another cannabis product escapes capture under the law.[xxvi]
[i] Food and Drug Administration, USA.gov, https://www.usa.gov/federal-agencies/food-and-drug-administration [https://perma.cc/2L3H-99MR].
[ii] Jennifer Fisher, Brett Schuman & Kelsey Middleton, Lingering Questions After 9th Circ.’s Delta-8 TM Ruling, Law360 (June 16, 2022, 3:16 PM), https://www.law360.com/articles/1502626/lingering-questions-after-9th-circ-s-delta-8-tm-ruling [https://perma.cc/YKF4-FYZF].
[iii] Id.
[iv] Tony Lange, Delta-8 THC Has ‘Serious Health Risks’ Warns Two Federal Agencies, Cannabis Bus. Times (Sept. 14, 2021), https://www.cannabisbusinesstimes.com/article/fda-cdc-issue-warnings-n-delta8-thc/ [https;//perma.cc/NX8U-FBGC].
[v] Barak Cohen, Andrew Kline & Tommy Tobin, What FDA Warning Letters Signal About Delta-8 Enforcement, Law360 (May 18, 2022, 2:32 PM), https://www.law360.com/articles/1494352/what-fda-warning-letters-signal-about-delta-8-enforcement [https://perma.cc/39XV-Q2HC].
[vi] Id.
[vii] FDA Issues Warning Letter to Companies Illegally Selling CBD and Delta-8 THC Products, Food and Drug Admin. (May 4, 2022), https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-companies-illegally-selling-cbd-and-delta-8-thc-products [https://perma.cc/5VLA-RBMF].
[viii] Chris Roberts, The Feds Are Coming For Delta-8 THC, Forbes (Sept. 17, 2021, 3:59 PM), https://www.forbes.com/sites/chrisroberts/2021/09/17/the-feds-are-coming-for-delta-8-thc/?sh=345823ea6d27 [https://perma.cc/N4BB-UH8Z].
[ix] Lange, supra note iii.
[x] Id.
[xi] Id.
[xii] Jennifer Karmarkar, FDA issues strong warning on cannabis products containing delta-8 THC, UCLA Health (May 6, 2022), https://connect.uclahealth.org/2022/05/06/fda-issues-strong-warning-on-cannabis-products-containing-delta-8-thc/ [https://perma.cc/E345-6M2C].
[xiii] Roberts, supra note vii.
[xiv] 5 Things to Know about Delta-8 Tetrahydrocannabinol- Delta-8 THC, Food and Drug Admin. (May 4, 2022), https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc [https://perma.cc/C9SC-CLLN].
[xv] Id.
[xvi] Id.
[xvii] Id.
[xviii] 5 Things to Know, supra note xiii.
[xix] Roberts, supra note vii.
[xx] Id.
[xxi] Karmarkar, supra note xi.
[xxiii] Roberts, supra note vii.
[xxiv] Roberts, supra note vii.
[xxv] Karmarkar, supra note xi.
[xxvi] Roberts, supra note vii.