Cannabis and cannabis products are everywhere! In fact, Fortune Business Insights reported the valuation of the global cannabis market at US $43 billion in 2022, and projected it to grow from US $57 billion in 2023 to US $444 billion by 2030.¹

When and where did this cannabis craze begin? The legalization movement we are currently experiencing began in 2012, when Colorado and Washington became the first two states to legalize the use and sale of cannabis in adult use markets. A little over a decade later, 76 percent of the country has some regulatory framework in place (Table 1).²

The "war on drugs" mentality that once surrounded cannabis and its use seems to be a thing of the past. According to New Frontier Data's "2023 Report on Cannabis Consumers," 42 percent of Americans have tried cannabis and are likely to use it again.³ The same report highlights 15 percent of Americans expressing interest in trying cannabis in the future. Not only is the American public more accepting of cannabis generally, but it is also more open to a wider array of cannabis products, including cannabis edibles and beverages.

While the vast array of cannabis products may be appealing to a growing consumer base, they present considerable challenges to state regulators that aim to responsibly shape cannabis regulation and protect public health. Each novel cannabis product that hits the marketplace introduces a new series of questions regarding product safety and efficacy. This article provides a regulatory perspective on some of the technical challenges the growing cannabis markets face, specifically focusing on product standardization, quality control testing, and consumer education and awareness amid a rapidly developing industry.

One Plant and Myriad Regulatory Frameworks

Before diving into some of the technical challenges relating to current cannabis policy, it is important to define cannabis to better understand each state or territory's regulatory authority. The National Cancer Institute defines Cannabis as the dried leaves and flowering tops of the Cannabis sativa or Cannabis indica plant.⁴ Cannabis contains active chemicals called cannabinoids that cause drug-like effects throughout the body, including the central nervous system and the immune system. The Cannabis plant contains marijuana and hemp. The differentiating factor between marijuana and hemp is the amount of delta-9 tetrahydrocannabinol (THC), a major cannabinoid attributed to the psychoactive effects of THC.

The parts of the Cannabis plant that exceed 0.3 percent delta-9 THC (by dry weight) are considered "marijuana" and are classified as a Schedule I Drug under the Controlled Substances Act (CSA).⁵ Schedule I Drugs are controlled substances that are considered to have the highest potential for abuse and are not accepted for medical use. The U.S. Marijuana's Schedule I classification prohibits federal regulation of the product, resulting in a patchwork regulatory infrastructure within each state or territory with a medical and/or adult use market. Prohibition of federal regulation is a major contributing factor in many of the ongoing product standardization and quality control challenges that state regulators are trying to overcome.

In contrast to marijuana, the parts of the Cannabis plant that do not exceed 0.3 percent delta-9 THC (by dry weight) are considered "hemp." The Agriculture Improvement Act of 2018 (i.e., the 2018 Farm Bill) was signed into law on December 20, 2018, and removed hemp from the Schedule I classification of the CSA, allowing for its production. The removal of hemp from the CSA has introduced a variety of public health concerns that will be addressed later in this article. Only a few states actively regulate hemp markets, leaving much of the hemp landscape across the country unregulated.

In summary, there is one plant (Cannabis), with two distinct parts (marijuana and hemp), requiring different state regulatory frameworks due to the prohibition of federal regulation. State-regulated cannabis products are the focal point for product standardization and quality control testing discussed below.⁶

Innovation Outpacing Regulation

The cannabis industry moves very quickly. Businesses are rapidly evolving to meet the needs of a growing consumer base, and cannabis producers are integrating cannabis into everyday food items such as beef jerky, candies, and protein shakes. The rapid pace of innovation and product development makes regulating cannabis manufacturing a challenging task for states and territories with legalized markets. The challenges generally originate from gaps or loopholes in the state laws and regulations that authorized the legalized markets. One such example specific to product specification is the absence of good manufacturing practices (GMPs) in cannabis regulations. Cannabis product types vary across the country and include modalities such as flower, vaping devices, concentrates, salves, liquids, edibles, inhalers, suppositories, etc.

Like in the food industry, a novel cannabis product coming to market will go through research and development (R&D), branding and packaging recognition, regulatory compliance, a distribution plan, as well as marketing and advertising of the product. However, unlike the food industry, there are no federal regulations that define minimum quality standards of the cannabis manufacturing and distribution process. In the absence of federal regulation, each state or territory's regulatory authority is left to identify and define minimum quality standards; however, because the regulatory process is slow, it is very challenging for regulations to keep pace with innovation and science.

Novel product form is not the only culprit when it comes to regulatory challenges. Cannabis product manufacturing introduces additional product standardization challenges with the growing trend of supplementing cannabis with additives such as flavorings and supplements. Under the Federal Food, Drug, and Cosmetic Act,⁷ a food additive must be authorized by the U.S. Food and Drug Administration (FDA) before it can be used in food on the market. Regulated cannabis industries do not have the same federal standard to uphold. Instead, regulatory authorities in states and territories are responsible for defining what can and cannot be added to cannabis products.

The lack of available cannabis research and accompanying data creates barriers to fully understanding how cannabis interacts in different matrices, the stability of each new matrix introduced, and the purity of sourced flavorings and supplements. Enforcing cannabis regulations in the marketplace is challenging for regulators because regulatory frameworks are often limited on the technical aspect of product development and manufacturing. As states attempt to draw on federal quality standards available in parallel industries, equitable comparisons are lacking due to the variety of cannabis products available. Nevertheless, the cannabis industry can learn from food and other industries as it continues to mature.

The Cost of Quality

Consumer safety is one of the paramount goals of cannabis regulatory agencies. Quality control testing is one area in which the cannabis industry can learn from the food industry. Currently, there are similarities and differences in the two industries. Product testing and packaging inspections are a regulatory requirement in both industries; however, the differences that exist are largely due to the limited quality control monitoring and lack of approved analytical methodology in the cannabis industry. While quality control in the food industry involves testing and monitoring food products throughout the production process, cannabis quality control is measured by a series of final form compliance tests. The former identifies risks relating to quality and safety, while the latter tests only prior to releasing products to consumers.

As previously noted, the cannabis industry is continuously evolving with new product formulations and cannabinoid profiles. The science and technology utilized to accurately test products for potency and purity is evolving, as well. Currently, all regulated cannabis marketplaces require some form of compliance testing; however, without federal oversight, that requirement varies from state to state.

Cannabis testing across the country has been under a high level of scrutiny in recent media, with allegations of fraudulent testing and data manipulation. Diving a little deeper into cannabis testing regulations may aid in understanding the challenges that the industry and regulators are working to resolve. The cannabis industry, unlike the food industry, initially consisted of primarily laboratory-developed testing methods for the detection and quantification of potency and purity.

State regulatory frameworks generally consisted of chemical compounds and contaminants to detect and quantify; however, they did not address all the technical aspects of cannabis testing. In the absence of federal and state guidance, it was left up to the testing laboratory to determine methodology. Cannabis testing regulations have remained static in an extremely dynamic and evolving market, largely due to certain technical aspects—now outdated—that are codified in state regulation and/or statute. The cannabis industry has evolved over the past decade, and it is critical that the regulatory frameworks evolve, as well. With help from organizations like the Cannabis Regulators Association (CANNRA), the Association of Official Agricultural Chemists (AOAC), ASTM International, and the United States Pharmacopeia (USP), state regulators can incorporate official testing methods, quality standards, and best practices into state programs that support product quality, public health, and public safety.

Consumer Awareness

While product standardization and quality control testing have focused primarily on a regulated cannabis market, consumer awareness and education need to capture both the regulated cannabis market consumer and the hemp consumer. Because market demand exists in both the cannabis and hemp marketplaces, it is critical that public health campaigns target those most at risk of the negative impacts of cannabis. In fact, a news release published by National Academies in September 2024 urged a coordinated public health approach to cannabis policy.⁸

Regulated cannabis markets have some regulatory requirements in place, such as online age gating for business websites, identification requirements in dispensaries to ensure there are no sales to minors, prohibition of medical and/or therapeutic claims on product labels, and a universal THC symbol that helps consumers correctly identify the presence of THC. Hemp products, however, are widely available online and in convenience stores across the country. These products do not fall under the state regulatory authority in many jurisdictions, so there are no rules and regulations governing sales to minors, packaging/labeling, and product content.

According to the FDA website, there is an increasing number of adverse reports received about cannabidiol (CBD, a cannabinoid found in cannabis)-containing products widely available that consumers may confuse for conventional foods and beverages.Many of these products have a product form appealing to minors, can easily be mistaken for conventional food, and may cause harm when consumed. The FDA has clearly stated it is unlawful to add CBD to foods or dietary supplements outside of the regulatory framework of state cannabis markets and has issued multiple warning letters over the years to businesses that are marketing cannabis-derived products to consumers.

Where Do We Go from Here?

Cannabis regulation is complicated; there is no "one-size-fits-all" solution to the vast array of policies or cannabinoid product profiles, for that matter. CANNRA, founded in 2021, has been a critical tool in the cannabis regulator's toolbelt. CANNRA's mission is to convene, educate, and support member states and jurisdictions responsible for regulating cannabis. Now with more than 45 participating states, the District of Columbia, two U.S. territories, and Canada and the Netherlands, state regulators can navigate cannabis regulation with a better understanding of policy approaches being implemented in other states and internationally.

Issues like product standardization, cannabis quality control testing, and consumer education and awareness are not the only policy challenges cannabis regulators face. Schauer et al. identified these policy gaps and others in the commentary, "A Research Agenda to Inform Cannabis Regulation: How Science Can Shape Policy."⁹ For future success in cannabis regulation, it is crucial to expand current policies surrounding cannabis cultivation, manufacturing, and retail sale.

References

1. Fortune Business Insights. "Cannabis Market Size, Share & COVID-19 Impact Analysis, By Type (Flowers/Buds and Concentrates), By Application (Medical, Recreational (Edibles and Topicals), and Industrial Hemp) By Component (THC-Dominant, Balanced THC & CBD, and CBD Dominant), and Regional Forecast, 2023–2030." 2024. https://www.fortunebusinessinsights.com/industry-reports/cannabis-marijuana-market-100219.
2. Johnson, J.K. and A. Colby. "Cannabis Research and Therapeutics: An International Quasi-experiment in Cannabis Policy." Clinical Therapeutics 35, no. 6 (2023): 1–6. https://www.clinicaltherapeutics.com/article/S0149-2918(23)00151-0/fulltext.
3. New Frontier Data. "Cannabis Consumers in America 2023, Part 1: An Overview of Consumers Today." https://info.newfrontierdata.com/cannabis-consumers-in-america-2023-part-1.
4. National Cancer Institute. "Cannabis (definition)." NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/cannabis.
5. U.S. Drug Enforcement Administration."Drug Scheduling." https://www.dea.gov/drug-information/drug-scheduling#:~:text=Schedule%20I%20drugs%2C%20substances%2C%20or,Schedule%20II.
6. National Safety Council. "Cannabis Regulations." https://www.nsc.org/cannabis-regulations?srsltid=AfmBOor5cU-7yA30wEU6fuPYymYS4PGgtkeISDnHJ7Sb7mgu5XaUrZIk.
7. U.S. Food and Drug Administration. "Federal Food, Drug, and Cosmetic Act (FD&C Act)." https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act.
8. National Academies of Sciences, Engineering, and Medicine. "To Protect Public Health, Federal Government Should Provide Guidance to States that Have Legalized Marijuana, Close Hemp Regulatory Loopholes, Create Public Health Campaign." September 26, 2024. https://www.nationalacademies.org/news/2024/09/to-protect-public-health-federal-government-should-provide-guidance-to-states-that-have-legalized-marijuana-close-hemp-regulatory-loopholes-create-public-health-campaign.
9. Schauer, G., et al. "A Research Agenda to Inform Cannabis Regulation: How Science Can Shape Policy." Clinical Therapeutics 45, no. 6 (2023): 506–514. https://pubmed.ncbi.nlm.nih.gov/37414500/.

Lori Dodson, M.S., M.T. (ASCP) is Senior Advisor for the Maryland Cannabis Administration and Co-Chair for the CANNRA Lab Testing and Product Safety subcommittee. She has been actively involved in developing cannabis policy, as well as helping standardize testing criteria for cannabis testing in the U.S., since 2017. Prior to her work in cannabis, Lori regulated clinical and forensic laboratories in Maryland with the Office of Health Care Quality.