By: Sogand Falahatpour, Staff Editor
It is no secret that over the past few years CBD, the mysterious lesser-known offspring of the cannabis plant, has consistently grown in popularity.[1] Whether it’s cosmetics, nasal spray, or cheeseburgers, today’s consumer is bombarded with an overwhelming array of CBD-infused products.[2]
What exactly is known about CBD so far? While CBD is an essential component of medical marijuana, it is derived directly from the hemp plant and is non-psychoactive.[3] Part of its medicinal popularity is attributed to the fact that unlike its infamous sibling THC, CBD exhibits no effects indicative of abuse or dependency potential and won’t get users “high.” [4] Additionally, over 1,200 scientific publications in the past decade have proved not only the lack of psychoactivity of CBD but a wide array of therapeutic benefits, including anxiety, depression, and PTSD.[5] This information has led to a rise in popularity and demand for CBD products, with projected retail sales worth $16 billion in the United States by 2025.[6]
Even in high doses, CBD is generally considered safe. Still, given the variation in cannabis regulations from state to state, scientists and patient activists are concerned that consumers may not be getting what they think they are. [7]Discrepancies between federal and state laws have resulted in inadequate regulation and oversight, leading to inaccurate labeling of CBD products. [8] In fact, in a study published in 2017, a mere 30% of CBD products in the marketplace were correctly labeled, negating any potential clinical response.[9] The concerns related to CBD products have less to do with the harm caused by the chemical itself but with the quality controls enforced on manufacturers, or rather the lack thereof.[10]
The confusion came to a head in 2018 when the Agriculture Improvement Act was signed into law and legalized the cultivation and sale of CBD oils at the federal level and removed hemp from the Controlled Substances Act. [11] However, the FDA classified CBD as a dietary supplement, not a medication, and therefore does not regulate the safety and purity of the ingredients at the dose listed on the label. [12] Regrettably, the absence of FDA regulations has led quality control issues regarding the unknown composition and safety of the CBD products sold. [13] CBD products obtained from uncontrolled sources may be contaminated with various harmful substances and could lead to severe health issues. [14] To precisely judge the potential therapeutic effects and the risks associated with CBD, it is essential to know the exact composition of a product.[15]
For example, last year when California legalized recreational marijuana, a series of stringent quality controls were phased in, including tests for various microbes, pesticides, and heavy metals. [16] Customers who purchase from licensed dispensaries could be confident that what they were buying was safe for consumption. [17]
These mandated quality controls are not aspirational but necessary. Traces of heavy metals like arsenic, lead, and metal is not uncommon in a wide range of agricultural products.[18] The presence of these heavy metals in exceptionally high concentrations can lead to a variety of health problems, including cancer and heart disease. [19] For CBD and other Cannabis-derived products, the heavy metal contamination varies greatly and is dependent on the plant’s origin and strain; therefore, it is imperative to evaluate where these products originate from.[20]
These regulatory changes may not be far off. Over the past year, the U.S. Food and Drug Administration (FDA) has embarked on a comprehensive evaluation of CBD products, gathering science to inform them of both the potential benefits and safety concerns.[21] The FDA said it would continue efforts to take appropriate actions against unlawful CBD products that pose a risk of harm to the public.[22] Furthermore, the agency promised that the long-awaited CBD usage-guidelines release to businesses with a focus on protecting public health and providing market clarity. [23] Given the importance of answering these questions and concerns, hopefully, the FDA will address the knowledge gaps and educate the public about the risks associated with certain CBD products.[24]
[1] Peter Grinspoon, Cannabidiol (CBD) — What We Know and What We Don’t, Harvard Health Publishing: Harvard Medical School, https://www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476(2018).
[2] Dawn MacKeen, What Are the Benefits of CBD?, N.Y. Times (Oct. 17, 2019), https://www.nytimes.com/2019/10/16/style/self-care/cbd-oil-benefits.html.
[3] Grinspoon, supra note 1.
[4] Moises Velasquez-Manoff, Can CBD Really Do That?, N.Y. Times (May 14, 2019), https://www.nytimes.com/interactive/2019/05/14/magazine/cbd-cannabis-cure.html.
[5] Benedette Cuffari, CBD Quality Control Measures, azo Life Sciences, (Feb. 14, 2020), https://www.azolifesciences.com/article/CBD-Quality-Control-Measures.aspx.
[6] MacKeen, supra note 2.
[7] Velasquez-Manoff, supra note 4.
[8]Marcel O. Bonn-Miller et al., Labeling Accuracy of Cannabidiol Extracts Sold Online, 318 Jama 1708-1709 (Nov. 7, 2017).
[9] Id.
[10] Velasquez-Manoff, supra note 4.
[11] John Hudak, The Farm Bill, Hemp Legalization and the Status of CBD: An Explainer, The Brookings institution, (Dec. 14, 2018), https://www.brookings.edu/blog/fixgov/2018/12/14/the-farm-bill-hemp-and-cbd-explainer/.
[12] Arno Hazekamp, The Trouble with CBD Oil, Med. Cannabis Cannabinoids, 65-72 (June 12, 2018).
[13] Cuffari, supra note 5.
[14] Hazekamp, supra note 12.
[15] Id.
[16] Velasquez-Manoff, supra note 4.
[17] Id.
[18] Cuffari, supra note 5.
[19] Id.
[20] See Id.
[21] Stephen M. Hahn, FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity, U.S. Food & Drug Admin., (March 5, 2020), https://www.fda.gov/news-events/press-announcements/fda-advances-work-related-cannabidiol-products-focus-protecting-public-health-providing-market.
[22] Id.
[23] See id.
[24] Id.