From the nation’s food supply to prescription medicines, products consumed by Americans must adhere to rigorous testing, manufacturing, labeling, and marketing standards. These standards are overseen by various federal regulatory agencies, including, but not limited to the U.S. Food and Drug Administration (FDA), the US Department of Agriculture (USDA), and the Federal Trade Commission (FTC). But many companies manufacturing and distributing products containing cannabis, including foods, cosmetics, beverages and various other tinctures and gummies, are doing so without adhering to the quality testing and rigorous oversight demanded of these institutions. This situation may be a result of a myriad of issues ranging from federal regulations that lag behind consumer demand to restrictions on conducting randomized, placebo-controlled clinical research of Schedule I substances for specific medical conditions.1
Regardless of the reasons why, many consumers don’t know that CBD purchased at a retail store or cannabis products obtained with a medical certification card from a dispensary are not regulated like pharmaceutical medicines. In fact, a recent study conducted by the Consumer Brands Association found that 92% of surveyed Americans assume or do not know if CBD products are federally regulated.2 The FDA addressed this issue in a March statement noting, “we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’” The agency clearly noted that there is still much unknown about the potential risks and side effects of sustained and cumulative CBD use as well as interaction with other medicines.3
But even with continued education, consumers are still buying products that have not been studied in randomized, placebo-controlled clinical studies to evaluate safety, effectiveness, or potential risks. In fact, a survey by the Digital Citizens Alliance showed that 46% of consumers are using a CBD product to replace a prescription medication.4 Consumers are taking these products for a variety of conditions, the most common being pain management or stress and anxiety reduction.4,2 And the boom continues, with CBD sales estimated to reach $20 billion in 2024.5
According to former FDA Commissioner Scott Gottleib, “CBD hype has outpaced science.” While the regulatory and retail environment surrounding cannabis is rapidly changing, this shift has not been accompanied by robust scientific research regarding the health effects, both positive and negative.
For pharmaceutical products, the federal oversight of everything from molecule to marketing is a stringent and calculated process to gain regulatory approval and assess product safety. Current good manufacturing practices for pharmaceutical products standardize every aspect of the production process from raw materials, production premises and equipment to staff training and personal hygiene. On average, developing a new medicine takes more than 10 years and more than $2.6 billion to research and develop.6 An approved medicine must undergo extensive preclinical trials, safety studies, randomized and controlled clinical trials and some require post-approval studies to achieve and maintain FDA approval for specific therapeutic uses. These studies answer important questions about the appropriate dosage, adverse reactions, drug interactions, contraindications, precautions and warnings, and abuse potential. Furthermore, if a batch of the medicine or an ingredient in the supply chain is tainted, there is a system in place to notify the FDA, healthcare providers, patients, and the general public to protect public health.
That doesn’t happen with cannabis. Contaminated, adulterated, unregulated and unsafe cannabis products continue to be sold every day, with consumers generally unaware that in some states no one is regulating the process from growth to purchase. According to the FDA’s most recent statement, given how quickly the market has evolved, it is critical for healthcare providers, policymakers and industry to work together to produce quality data that contribute to filling the knowledge gaps related to cannabis-based products’ safety and quality.3
According to the National Institutes of Health, the historic political climate surrounding cannabis has limited cannabis research by “restricting procurement for academic purposes.”7 The American Academy of Family Physicians (AAFP) has also acknowledged this challenge, noting that the current process and procedures present a serious burden and dissuade scientists from pursuing cannabis-related research. Consequently, there is a lack of empirical evidence regarding numerous health-related issues, including potential therapeutic benefits of cannabis, public health impact, health economics, and the short- and longer-term health effects of cannabis.8
While some companies invest in the established FDA approval route, many companies strategically sponsor and publicize the results of less-robust studies targeting lay audiences, in lieu of undertaking the necessary and expensive, large-scale clinical trials required for FDA approval. These companies are attempting to take a “free pass” by providing their products to academic institutions, with the intention that the studies will be funded by NIH or published in peer-reviewed journals. Those companies then attempt to use the limited data from such studies to promote products for medical use to patients, health care professionals, policymakers, and other stakeholders.9 But such tactics appear to be a deliberate attempt to mislead consumers by equating observational or correlational data with evidence from rigorous drug trials. According to a recent study published in the American Journal of Public Health in February, by doing this, “the Big Marijuana era may mislead consumers into making ill-informed health decisions and undermines the regulatory process that incentivizes and vets robust medical research.”10
But Americans don’t want to be fooled and they certainly don’t want to be put at risk. A recent survey conducted by the National Consumers League (NCL) demonstrates that consumers who use CBD want the assurance that the products are regulated by some governing body. In November 2019, the NCL polled 1,600 American voters across party lines, states and ages, finding that 87% of current CBD users supported federal regulation of the products they are buying. As Sally Greenberg, Executive Director of the NCL noted in a press release announcing the outcomes, the findings demonstrate “a clear and present public health issue.”11
Now is the time for the federal government to act across agencies and party lines in partnership with industry and consumer advocates to establish standards for cannabis-based product development, testing, labeling and marketing to protect public safety and ultimately benefit Americans. There is untapped potential in the cannabis plant if the right incentives are put in place and enforced to support high-quality clinical research, review and approval by FDA. That is when cannabis will clearly distinguish itself as medicine vs a mass-market consumer product.
1Mull, Amanda; “America Loves Its Unregulated Wellness Chemicals,” The Atlantic. January 1, 2020. Available at https://www.theatlantic.com/health/archive/2020/01/why-cbd-took-over-america/604327/. Accessed February 11, 2020.
2Consumer Brands Association, “The Urgent Need for CBD Clarity,” Page 1. Available at https://consumerbrandsassociation.org/research/. Accessed February 11, 2020.
3U.S. Food & Drug Administration. “FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity.” Issued March 9, 2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-advances-work-related-cannabidiol-products-focus-protecting-public-health-providing-market
4“CBD Confusion – How Consumers Can Be Misleading and Why the Market Needs Adult Supervision Now” Digital Citizens Alliance, March 2020 . Available at: https://www.digitalcitizensalliance.org/clientuploads/directory/Reports/DCA_CBD_Confusion_Report.pdf. Accessed March 20, 2020.
5BDS Analytics, “U.S. CBD Market Anticipated to Reach $20 Billion in Sales by 2024,” published May 19, 2019. Available at http://bdsanalytics.com/u-s-cbd-market-anticipated-to-reach-20-billion-in-sales-by-2024/. Accessed February 11, 2020.
6Sullivan, Thomas. “A Tough Road: Cost To Develop One New Drug Is $2.6 Billion; Approval Rate for Drugs Entering Clinical Development is Less Than 12%.” Coverage of Tufts Center for the Study of Drug Development (CSDD) research. Updated March 21, 2019. Available at https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html. Accessed March 23, 2020.
7Bridgeman, Mary Barna, PharmD, BCPS, BCGP et al, “Medicinal Cannabis: History, Pharmacology, And Implications for the Acute Care Setting,” P&T 2017 Mar; 42(3): 180–188, Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5312634/. Accessed February 11, 2020.
8American Association of Family Physicians, “Marijuana and Cannabinoids: Health, Research and Regulatory Considerations (Position Paper)” July 2019. Available at: https://www.aafp.org/about/policies/all/marijuana-cannabinoids.html
9Caputi TL “Medical marijuana, not miracle marijuana: some well-publicized studies about medical marijuana do not pass a reality check.” Addiction. 2019 Jun;114(6):1128-1129.
10Caputi TL “The Medical Marijuana Industry and the Use of “Research as Marketing.” AJPH. 2020 Feb: 110(2):174-175.
11National Consumer League press release, “Consumer groups call for FDA oversight of rapidly growing CBD market,” November 19, 2019. Available at https://www.nclnet.org/safe_cbd. Accessed February 11, 2020.