By: Kenneth McQueen, Jr.

The Food and Drug Administration (FDA) regulates drugs, cosmetics, foods, and dietary supplements.[i] At the moment, though, it does not regulate tetrahydrocannabinol (THC) or cannabidiol (CBD); compounds of marijuana.[ii] Due to the lack of FDA regulation of these two cannabis compounds, public health is becoming an extreme concern.[iii]

Unregulated cannabis products that contain tobacco or nicotine (hybrid products) have the potential to become a public health issue due to being highly addictive among consumers.[iv] At the moment, the agency’s website states that it is illegal to sell food that contains CBD or THC in interstate commerce.[v] Because the FDA prohibits mixing THC and CBD with food, many companies that currently mix would likely be in violation of this rule if the FDA regulates THC and CBD.[vi] As a result, these companies would likely have to stop selling ingestible products infused with THC/CBD.[vii] However, the FDA’s food-mixing enforcement policy would not prohibit “cannabis in its natural form” from being sold to individuals.[viii] Hence, consumers could buy cannabis products and mix them into foods and drinks themselves.[ix] Regulation by the FDA could eliminate many high-selling edible and drinking products from companies that are already manufacturing those products.[x] Hence, the FDA should make it clear that it will enforce against any state that mixes tobacco or nicotine with cannabis for the sake of public health.[xi]

Companies in legalized jurisdictions are marketing their products however they please right now while exaggerating claims about what their products can do, causing public health to be in danger.[xii]. In states where marijuana is legal, there have been spikes in hospital visits due to people consuming various cannabis products, not realizing they are ingesting more than the appropriate amount of THC.[xiii] When companies make claims about their products that aim to cure or treat any illnesses, the FDA expects scientific data to support the claims.[xiv] However, companies have made claims that guarantee certain benefits without scientific evidence to prove it.[xv] “Nutra Pure LLC, PotNetwork Holdings, and Advanced Spine and Pain, LLC,” falsely alleged back in 2019 that their respective CBD products treated diseases such as “‘cancer, Alzheimer’s…, fibromyalgia, and neuropsychiatric disorders.’”[xvi] These cannabis companies have exaggerated what their products can do so they would be classified as “drugs” under the FDA.[xvii] Since no scientific evidence backed the claims proffered by these companies, the FDA issued warning letters which put the companies on notice and urged them to fix their labeling.[xviii]

Issuing warning letters is an effective enforcement power of the FDA as well as issuing injunctions and reviewing proposed labeling—but monitoring all U.S. cannabis businesses to determine which ones exaggerate their claims is tedious.[xix] Instead, the FDA needs to be more focused on reviewing labeling and packaging of cannabis products claiming to be drugs before they hit the market.[xx] This idea would be a non-strenuous way to curb the negative consequences of unregulated marijuana sales and marketing and would prevent any Federal Food, Drug and Cosmetic Act (FDCA) violating cannabis products from hitting legalized markets that exaggerate their capabilities.[xxi] The FDA could also assist with accurate labeling of these products to prevent poison and contamination and false advertising.[xxii] With these strategies, the FDA could likely see a decrease in exaggerated claims and hospital visits because it would review products beforehand because although states can regulate products that are marketed and sold, their respective methods are not as effective as the FDA’s methods.[xxiii]

Although FDA regulation produces significant social benefits, we must consider the adverse effects on prices, wages, innovation, and job opportunities.[xxiv] In addition, some believe FDA regulation could cause higher cannabis prices for consumers—which, in turn, would cause consumers to avoid shopping in dispensaries.[xxv] These concerns present a challenge for the FDA: how can it be mindful of potential negative consequences while creating new regulations?[xxvi] The first answer is the continuation of the FDA’s statutory “‘benefit-cost analysis’.”[xxvii] The FDA could use its discretion when evaluating the cost and benefits of a regulation.[xxviii] However, if a statute laid out specific requirements, the FDA would have to follow the requirements.[xxix] Second, the FDA should find a way to test its regulations before it implements them.[xxx] Certain markets can be volatile, including the cannabis markets as it is one of those markets where we do not know what to expect once legalized.[xxxi]

Furthermore, if the FDA implements regulations too fast and the market changes, certain regulations could become obsolete.[xxxii] In such a case, the FDA could find itself in a situation where it has to create more regulations to correct the now harmful regulations.[xxxiii] If the FDA is mindful of the negative social harms beforehand, it can likely alter the provisions of the regulations to avoid the negative social impacts.[xxxiv]

With this, FDA regulation of THC and CBD would heavily impact existing markets.[xxxv] However, it should be the FDA’s responsibility to hold companies accountable for how they market and sell their cannabis products. False advertising will continue misleading many consumers if the FDA does not exercise its enforcement powers, causing public health to be at risk.[xxxvi] If the FDA regulates cannabis products using its enforcement powers, there will be safety advantages.[xxxvii] However, to truly protect public health, the FDA must consider the social harms that could result from focusing too closely on safety advantages.[xxxviii]

[i] What does FDA Regulate?, U.S. Food & Drug Admin., https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate (last updated Jan. 18, 2022) [https://perma.cc/9Y9J-FYMG].

[ii] Heather Hatcher & Mark Vaders, Seed to Sale: The Buzz on Understanding the FDA Regulatory Landscape for Cannabis, Nat’l. L. Rev. (Oct. 21, 2021) https://www.natlawreview.com/article/seed-to-sale-buzz-understanding-fda-regulatory-landscape-cannabis [https://perma.cc/ER8W-AXFB].

[iii] Id.; Eric N. Lindblom, How FDA Could Use Its Existing Authorities to Make State Legalization of Cannabis More Safe, 74 Food and Drug L. J. 191, 205 (2019).

[iv] Lindblom, supra note iii at 205.

[v] Id. at 207.

[vi] See Id.

[vii] See Marisa Maleck, Selling CBD-Products May be Riskier than you Think, JD SUPRA (Aug. 26, 2021), https://www.jdsupra.com/legalnews/selling-cbd-infused-products-might-be-7784095/ [https://perma.cc/YH9H-FC9W].

[viii] Lindblom, supra note iii at 208.

[ix] Id.

[x] Id.

[xi] Id at 205.

[xii] Id.; Id. at 197.

[xiii] Id. at 204

[xiv] Questions and Answers on Health Claims in Food Labeling, U.S. Food & Drug Admin., https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling (last updated Dec. 13, 2017) https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling [https://perma.cc/Z5ZX-KXKQ].

[xv] FTC Joins FDA in Sending Warning Letters to Companies Advertising and Selling Products Containing Cannabidiol (CBD) Claiming to Treat Alzheimer’s, Cancer, and Other Diseases, Fed. Trade Commission (Apr. 2, 2019), https://www.ftc.gov/news-events/press-releases/2019/04/ftc-joins-fda-sending-warning-letters-companies-advertising [https://perma.cc/ZK63-FGJE].

[xvi] Id.

[xvii] Id.; Elizabeth Oestreich, CBD Enforcement – Who is Keeping, Food and Drug L. Inst., https://www.fdli.org/2020/01/cbd-enforcement-who-is-keeping-watch/ (last viewed Mar. 12, 2022) [https://perma.cc/M9FZ-W7S4].

[xviii]Oestreich, supra note xxvii.; Alice Mead, Legal and Regulatory Issues Governing Cannabis and Cannabis-derived Products in the United States, frontiers (June 14, 2019), https://www.frontiersin.org/articles/10.3389/fpls.2019.00697/full [https://perma.cc/9AZV-ZK2E].; About Warning and Close-out Letters, U.S. Food & Drug Admin., https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/about-warning-and-close-out-letters [https://perma.cc/3NXP-88BM].

[xix] The History of the FDA’s Enforcement Work, U.S. Food & Drug Admin., https://www.fda.gov/about-fda/fda-history/history-fdas-enforcement-work#:~:text=The%201906%20Pure%20Food%20and,warning%20letters%2C%20and%20administrative%20procedures [https://perma.cc/TGA2-CET3].; Ryan Schonfeld, Duty of Care in the Cannabis Industry, Security Info Watch (Feb. 24, 2022), https://www.securityinfowatch.com/cannabis-security/article/21258037/duty-of-care-in-the-cannabis-industry [https://perma.cc/B9TD-V76N].

[xx] FTC Joins FDA in Sending Warning Letters to Companies Advertising and Selling Products Containing Cannabidiol (CBD) Claiming to Treat Alzheimer’s, Cancer, and Other Diseases, supra note xxv.

[xxi] Lindblom, supra note iii, at 194.

[xxii] Id. at 191, 204.

[xxiii] Id.

[xxiv]Douglas C. Throckmorton, The Public Health Role of Drug Regulation in the US, U.S. Food & Drug Admin., https://www.fda.gov/files/about%20fda/published/The-Public-Health-Role-of-Drug-Regulation-in-the-US.pdf (last viewed Mar. 12, 2022) [https://perma.cc/M4K4-HS9Q].; Howard Beales, et al., Government Regulation: The Good, The Bad, & The Ugly, Reg. Transparency Project (June 12, 2017), https://regproject.org/paper/government-regulation-the-good-the-bad-the-ugly/ [https://perma.cc/ZZJ5-VR93].

[xxv] See Charlie Minanato, Price Increases in the World of FDA Regulation, HALFWHEEL (Sept. 23, 2016), https://halfwheel.com/price-increases-in-the-world-of-fda-regulation/130618/ [https://perma.cc/V9WZ-WGSC].; Is it Cheaper to buy Weed on the Street or at a Dispensary?, PRICEONOMICS https://priceonomics.com/the-most-expensive-and-cheapest-cities-to-buy/ (last viewed Mar. 12, 2021) [https://perma.cc/9VGT-X4TF].

[xxvi] Id.

[xxvii] Beales, supra note xxiv.; Throckmorton, supra note xxiv.

[xxviii] See Id.

[xxix] See generally Beales, supra note xxiv.

[xxx] Id.

[xxxi] Matthew Johnston, Cannabis Stocks’ Volatility Spike Tied to ETF’s Mega Trades, Investopedia, https://www.investopedia.com/cannabis-stocks-volatility-spike-tied-to-etf-s-mega-trades-4767649 (last updated Aug. 15, 2019) [https://perma.cc/RZ6E-C6ZG].; See Matthew Johnston, Biggest Challenges for the Cannabis Industry in 2022, Investopedia, https://www.investopedia.com/biggest-challenges-for-the-cannabis-industry-in-2019-4583874 (last updated Dec. 21, 2021) [https://perma.cc/NDS2-9LXK].

[xxxii] See generally Beales, supra note xxiv.

[xxxiii] See generally Id.

[xxxiv] Beales, supra note xxiv.; Throckmorton, supra note xxiv.

[xxxv] See Lindblom, supra note iii at 208.

[xxxvi] Lindblom, supra note iii at 194, 208.

[xxxvii] Id.

[xxxviii] Id.; Beales, supra note xxiv.