By Jamie Corroon, ND, MPH(1,2), Douglas MacKay, ND(3), William Dolphin, MA(4,5)
1 The Center for Medical Cannabis Education, Del Mar, CA
2 Helfgott Research Institute, National University of Natural Medicine (NUNM)
3 CV Sciences, Inc.
4 Americans for Safe Access, Washington, D.C.
5 University of Redlands, Redlands
Due to federal prohibition in the United States, consumable products derived from Cannabis sativa L (cannabis or marijuana) are largely unbound by Food and Drug Administration (FDA) labeling regulations for food, dietary supplements, and drugs, with the exception of a single FDA-approved medication, Epidiolex. Instead, cannabis products are regulated independently, and often differently, by 47 states, and the District of Columbia, Puerto Rico, and Guam for medical use, and eleven states and the District of Columbia and the Mariana Islands for adult-recreational use, with more states and territories likely to follow.1
Current state requirements for labeling of licensed cannabis products are inconsistent and may contribute to consumer confusion, given that information about products freely crosses jurisdictional boundaries and consumers may travel between states.
Accurate, informative, and consistent labeling of cannabis products is an important public health issue. Missing or inaccurate labeling of the amount of cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and the lack of risk communication through consistent and recognizable warning statements may result in harm and/or lack of efficacy. Widespread mislabeling of cannabis products has been documented by independent researchers.2
Warnings and risk communications
The adoption of a universal symbol on labels of products capable of causing harm, and/or intoxication and impairment, is a fundamental component of risk communication; many states currently require such a symbol for products containing THC. Based on demonstrated effectiveness on labels of tobacco products, pictorial warnings would likely result in higher impact and effectiveness.3
A risk-based approach should not simply be linked to the mere presence of a potentially intoxicating, or harmful, phytocannabinoid, however. Trace amounts of THC are allowed in hemp-derived CBD products without a required risk communication. Nor is a risk communication required on the label of some federally regulated products that contain trace amounts of alcohol. For example, kombucha products (i.e., fermented tea beverages) containing 0.5% or less alcohol by volume are not deemed alcohol beverages and not subject to Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations which require a Government Warning communicating the risk of birth defects.4
Any risk communication should include science-based exemptions for trace amounts of harmful or intoxicating constituents.
Health-related label claims
Health-related claims on labels of food, dietary supplements and drugs, both over-the-counter (OTC) and prescription, are regulated by FDA. In the absence of federal regulation, individual states are responsible for protecting consumers from false or misleading health claims on labels of cannabis products. State-by-state disparities in this domain could jeopardize consumer safety and informed decision-making.
A basic understanding of the current FDA framework for label claims may be a useful starting point for state regulators and industry stakeholders. FDA guidelines describe four categories of allowable health-related claims on labels of food, dietary supplements, and drugs. These include: 1) Nutrient Content claims; 2) Structure/Function claims; 3) Health claims; and 4) Disease claims. Each category of claims requires a certain level of evidence in accordance with FDA regulations for substantiation of the claim.
FDA Nutrient Content claims
Nutrient Content claims simply characterize the level of a nutrient in a food or food substance (a food, food component, or dietary ingredient), using terms such as free, high, and low (e.g., “Low-calorie,” “high-fiber,” “fat-free”). Claims that use these terms are only allowed for nutrients with established Daily Values (i.e., Reference Daily Intakes or Dietary Reference Value). Nutrient Content claims can also compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and light (e.g., “reduced-sodium,” “more fiber,” or “light” to reduced fat).5
Harmonizing the use of terms such as free, high, and low for cannabis products may be helpful for promoting informed decision-making (e.g., “THC Free,”, “Low in THC”).
Industry stakeholders would benefit from engaging in an open process to reach consensus on harmonized constituent thresholds, as well as terminology for characterizing the composition of these products. Ultimately, appropriate terminology and thresholds should be negotiated with federal agencies and adopted by industry before being used in marketing.
FDA Structure/Function claims
Structure/Function claims describe the role of a food or dietary ingredient in terms of its effect on the normal structure or function of the human body (e.g., "Calcium builds strong bones," "Fiber maintains bowel regularity"). Structure/Function claims for conventional foods are limited to physical attributes such as taste, aroma, or nutritive value (e.g., “Beef provides iron to support hemoglobin levels”). For dietary supplements, Structure/Function claims may include non-nutritive support (e.g., “Supports memory and focus”), general well-being, and claims related to nutrient deficiencies (e.g., “Vitamin C prevents scurvy”).
Claims related to a product’s effect on normal function may help set expectations for consumers of cannabis products. Cannabis product Structure/Function-type claims should avoid referring to a specific disease state (e.g., insomnia, anorexia, etc.), but use appropriate terminology that describes the anticipated effect for most users (e.g., “Promotes a restful sleep,” or “May stimulate appetite”). For example, since pain can be a disease symptom, a claim that a product “relieves pain” would a Drug claim (See below). A Structure/Function claim would be that a product may be used “for occasional aches and pains due to over-activity”.
As the largest legal medical and recreational cannabis market in the world, California’s regulatory approach may set precedent for national and global policy development.3 California allows for “characteristic anticipated effects” claims, which resemble Structure/Function claims. According to the California Department of Public Health, (CDPH) a “characteristic anticipated effect” is “any physiological effect that is common to or expected from the particular cannabis strain, but excludes any claim of health benefits.”6
Such attempts at creating a more predictable experience for consumers serve an important public health need. To the extent that this particular approach is based on identifying chemical composition, it is hindered by the widespread variability in both the quantity and spectrum of phytochemicals within individual cultivars (i.e., “strains”) of cannabis.7 It seems unlikely that a consistent “characteristic effect” beyond broad categories such as “sedative” or “appetite stimulating” could be patterned given the variability within individual cultivars.
Additionally, for this reason, labels that contain terms such as “Sativa,” “Indica,” or “Hybrid,” which are often used to characterize the anticipated effects of certain cultivars, are unlikely to have any practical meaning when attempting to communicate possible effects to consumers.
FDA Health claims & Drug claims
Health claims and Qualified Health claims (Health claims) describe the relationship between a food, or dietary ingredient, and reduced risk of a disease or health-related condition (e.g., "Adequate calcium throughout life may reduce the risk of osteoporosis"). When a product bears a label claim that states or implies the product is useful in diagnosing, curing, mitigating, treating, or preventing a disease, that claim is considered a Drug claim and designates that product as a drug according to the FDA.8
Drug claims for prescription and OTC drugs are roughly analogous to Health claims for non-drugs but allow for statements beyond risk reduction (i.e., diagnosing, curing, mitigating, treating, or preventing). These claims are product-specific and subject to the rigorous FDA pre-market approval process, which results in clearly established indications and contraindications for use in specific disease populations.8
Despite demonstrated therapeutic utility for some medical conditions,9 state-regulated cannabis products are not FDA-approved drugs. As such, the labels should include the FDA statement, “This product is not intended to diagnose, treat, cure or prevent any disease". FDA regulations prohibit any product that has not received pre-market approval as a drug from making a Drug claim on its label. The two primary cannabinoids in cannabis, THC and CBD, are both available as FDA-approved medications.
Synthetic THC (i.e., Dronabinol / Marinol, AbbVie, Inc. / Syndros, Insys Therapeutics, Inc.) is currently deemed by FDA a safe and effective treatment for anorexia and cachexia in individuals with Acquired Immune Deficiency Syndrome (AIDS) and for refractory nausea and vomiting in cancer patients receiving chemotherapy. Dronabinol is a Schedule III controlled substance that can be marketed with Drug claims. Naturally occurring THC extracted from marijuana, even though it is chemically identical to the active ingredient in Dronabinol, is a Schedule I controlled substance that cannot be marketed because FDA-approved Drug claims are linked only to the finished commercial product, not the ingredient(s).
A similar dynamic exists for CBD. Naturally occurring CBD extracted from marijuana and formulated as the oral-mucosal spray Epidiolex (i.e., Cannabidiol, Greenwich Biosciences, Inc.) is currently deemed by FDA as a safe and effective treatment for two rare, severe forms of epilepsy.
Epidiolex is a Schedule V controlled substance that can be marketed with Drug claims. Naturally occurring CBD extracted from marijuana that is not manufactured and marketed as Epidiolex is a Schedule I controlled substance that cannot be marketed with Drug claims.
Naturally occurring CBD extracted from hemp produced in a state-regulated program approved by the U.S. Department of Agriculture is no longer a controlled substance per the Agriculture Improvement Act of 2018 (2018 Farm Bill), but FDA regulations prohibit any Drug claims from being made about hemp-derived CBD products.
As the medical and adult-recreational use of cannabis products continues to expand in the United States, consumer safety and informed decision-making are shared goals for public health, healthcare, and industry stakeholders. Decades-long federal prohibition of cannabis has not only delayed scientific advancements in the field but has also created a regulatory vacuum which would normally be filled by public health agencies, including FDA, Federal Trade Commission, and the United States Department of Agriculture. The lack of applicable federal regulations has led to a state-by-state patchwork of heterogeneous labeling rules which may be becoming increasingly difficult for consumers, public health, healthcare, and industry stakeholders to navigate.
Labeling of cannabis products is an important public health issue. Effective state-level regulations requiring informative, accurate, and visible labeling of contents, purported effects, benefits, and risks will minimize unintended, unwitting or overconsumption by children and adults, and can help consumers achieve safe, effective outcomes.
Elements of current FDA regulations for labeling of food, dietary supplements, and drugs can serve as a framework for a cannabis industry-led initiative directed at harmonizing label requirements across states. An industry standard for labeling, based on accepted practices for other products, can help guide policymakers as they grapple with rule-making for labeling cannabis products. Consistency in product labeling will protect public health through standardized communications about product attributes and potential risks and reduce the burden on manufacturers operating in multiple states of having to comply with disparate state regulations.
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