If you can’t measure it, you can’t manage it!
With Cannabis-Derived Products (“CDPs”) outpacing the existing science and imposing massive health concerns, in October 2021 the U.S. Food and Drug Administration (“FDA”) issued a “Cannabis-Derived Products Data Acceleration Plan” (“CDP Data Acceleration Plan” or “DAP”) to detect safety issues and accelerate research studies.
Because CDPs’ fragmented and dynamic market is comprised of hundreds of manufacturers selling products online and eludes clarity as to quality and safety, the CDP Data Acceleration Plan: (1) evaluates current data sources; (2) cultivates collaborative partnerships; (3) accelerates CDP scientific safety and toxicology research; and (4) launches CDP data acceleration initiatives.
By addressing safety, labeling, misleading claims, and adulteration concerns, DAP enables the FDA to track, authorize and regulate Cannabis-Derived Products sale and accelerates CDPs entry into the interstate commerce stream.
FDA’s Food and Drug Products’ Monitoring
Budgeted at $6.1 billion, the FDA protects and promotes public health through controlling and supervising food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, cosmetics, animal foods and feed, and veterinary products. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, et seq.(“FDA Act”).
To track safety issues and errors in the products it regulates, the FDA uses the Adverse Event Reporting System (“AERS”), CFSAN Adverse Event Reporting System (“CAERS”) and Vaccine Adverse Event Reporting System (“VAERS”), which are mostly dependent upon self-reported data.
An online database supporting the FDA’s “approved drug and therapeutic biologic products” post-marketing safety surveillance program, AERS monitors for possible health problems (i.e., adverse events) and medication errors. Because reporting is mostly voluntary, the FDA primarily receives adverse event and medication error reports directly from health care professionals (i.e., physicians, pharmacists, and nurses) (“HCP”) and consumers (i.e., patients, family members, and lawyers). Additionally, if HCPs or consumers directly report these events to the products’ manufacturers, the manufacturer is required to present an “adverse event report” to the FDA.
To monitor dietary supplements, foods, and cosmetics’ safety, the FDA’s Center for Food Safety and Applied Nutrition launched CAERS encompassing both major (e.g.,death, hospitalization) and minor (e.g.,complaints about taste or color, defective packaging) events submitted by manufacturers, HCPs, and the public.
Following vaccines’ FDA authorization, VAERS monitors safety through accepting and analyzing “post-vaccination adverse events reports” directly submitted by manufacturers and patients.
Cannabis-Derived Products and the FDA
Pursuant to the FDA Act, the FDA oversees a wide range of food, drugs and cosmetics and, following the plants’ cultivation, has enormous sway over how hemp derived products can be prepared, manufactured and sold. Like all emerging substances, CDPs challenge the FDA’s ability to execute its “track safety issues and errors” mandate and, because Marijuana-derived-products cannot be sold across states lines (and, thereby, elude federal oversight), the FDA is focusing on Hemp-derived products like Cannabidiol (“CBD”).
Generating $4.6 billion in annual revenue and spanning thousands of FDA approved and unapproved human and animal drug, food, beverage, cosmetic, and dietary supplement products, CBD is sold across diverse distribution channels not easily tracked by traditional third-party data providers or surveillance methods. Other than Epidiolex (an FDA-approved severe epilepsy treatment), the FDA deems most CBD products to be “adulterated” or “misbranded”, maintains that CBD cannot be used in a food or dietary supplement if listed as “an active ingredient in a drug product” and both regulates hemp products making medical treatment claim of therapeutic values for humans or animals (including dietary supplements) and determines what new food type may enter the U.S..
While still nascent, emerging Hemp-derived cannabinoids products (including delta-8-tetrahydrocannabinol, delta-10 tetrahydrocannabinol, cannabinol, tetrahydrocannabivarin, and cannabigerol) impose evolving public health concerns of known or potential safety problems, lack of labeling information, potentially misleading product claims, and product adulteration.
Cannabis-Derived Products Data Acceleration Plan
Seeking to advance “data-driven safety signal detection” and build advanced technological capabilities, the FDA’s DAP leverages novel data sources and analytics to identify “CDP market safety and consumer vulnerabilities”, forges state data partnerships, champions evaluative scientific research, and launches CDPs data acceleration initiatives.
First, to grasp the current CDPs data landscape and available data sets and collection methods’ capabilities, the FDA evaluates data sources/providers ranging from third-party purchase data and surveys to traceability systems and mobile apps enabling:
proactively identifying CDPs safety signals (including adverse events from online activity and content);
monitoring and evaluating a digital-first market with thousands of companies across multiple product categories and forms;
understanding CDPs usage motivations and patterns;
understanding how CDPs safety misinformation impacts consumer behavior and identifying education and outreach opportunities; and
informing scientific, healthcare and social related CDPs research.
This analysis aims to understand human/animal HCPs role in promoting/preventing CDPs consumption, determine if CDPs are replacing approved prescription and over-the-counter drug products, evaluate whether human/animal healthcare data can inform CDPs safety gaps or identify consumer vulnerabilities, and gauge HCP knowledge, practices, and needs related to improving/reporting CDP adverse events.
Second, the FDA is partnering with states to harness respective “CDP usage and adverse events insights”, developing an inter-agency scientific agenda for CDP through a National Toxicology Program pilot initiative, and collaborating with the Center for Disease Control to pursue CDP public health strategy and epidemiological intelligence.
Third, the FDA is conducting toxicology, safety, and quality initiative research including CBD’s impact on the male reproductive system, CBD’s transdermal penetration and pharmacokinetics, CBD’s impact on neurological development, risk of liver injury from CBD, characterization of chemical constituents for smoked hemp flower and vaped cannabis products, in vivoand vitrotoxicity studies, and ingredient labeling accuracy.
CDP Data Acceleration Initiatives
Testing the feasibility of using advanced analytical tools and data sources to detect safety signals associated with CDPs, DAP is also launching seven (7) “CDP data acceleration initiatives”.
Initiative One analyzes Certificates of Analysis (“COA”) to evaluate whether a CDP’s actual ingredients match what the manufacturer/seller is representing. COAs are used by product manufacturers to express both the product’s quality and that its THC levels are below the requisite threshold. To identify inconsistencies and quality issues, this initiative maps product COA data against data collected through FDA’s CBD product sampling project (which tests for cannabinoids, toxic elements, pesticides, residual solvents, and microbial pathogens). The initiative also seeks to ascertain how consumers access and use COA information, hurdles to accessing COA documents, and opportunities to improve consumers’ COA access.
Initiative Two both identifies CDP safety issues viaonline data (e.g., Reddit, consumer reviews) and improves safety signal detection through evaluating how online data can complement traditional signal detection and adverse event surveillance systems (e.g., AERS, CAERS, VAERS) and identify issues not easily captured by traditional systems.
Initiative Three deploys “real-time surveillance tools” to contemporaneously detect emerging CDPs safety signals and usage patterns, inform future surveillance capability development for emerging trends beyond CDPs and identify potential safety issues before they become mainstream, and create data sets informing regulatory science and enforcement across the unapproved CDP market.
Initiative Four fortifies FDA enforcement through analyzing CDP’s current online market and identifying automated processes and technical solutions to evaluate technical feasibility and enforcement application.
Initiative Five evaluates online misinformation’s impact on CDP quality and safety perceptions.
Despite not having been evaluated nor approved by the FDA, many purported cannabinoid- containing-products are marketed for unsubstantiated therapeutic or medical uses. This initiative develops a data-driven framework and process to understand how online safety misinformation creates consumer safety vulnerabilities and impacts consumer behavior (e.g., replacing FDA approved drugs with unproven CDPs).
Initiative Six gauges HCPs’ perception’s impact on CDP’s usage and safety. Presently, 68.9% of clinicians believe that Cannabis has medicinal uses and 26.6% have recommended it to a patient. Gillian L. Schauer, Rashid Njai, and Althea M. Grant. Clinician Beliefs and Practices Related to Cannabis. Cannabis and Cannabinoid Research. To assess HCPs impact on CDP usage and safety, this initiative leverages: (1) qualitative/quantitative data sources to understand HCP’s CDP safety perceptions, usage perceptions and current CDP patient interactions; and (2) insights to identify potential consumer safety issues, inform an overall CDP education and outreach strategy, and improve CDP adverse event reporting.
Initiative Seven determines if healthcare data can fill gaps in CDP’s safety and usage. Although consumers use CDPs for a variety of health-related concerns, it is unclear if healthcare data systems are capturing the usage and, if so, if the data can enhance regulatory science and safety signal detection. This initiative identifies specific initiatives and key research questions to test if healthcare data can inform safety signal detection and identify consumer vulnerabilities across a variety of potential health topics including chronic pain and mental health.
Reprinted with permission from the March 17, 2022 edition of The Legal Intelligencer © 2022 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited, contact 877-257-3382 or reprints@alm.com.
Copyright ©2022 by Steven M. Schain, Esquire
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