Requirements for Cannabis Product Labeling by U.S. State

Abstract

Introduction:

As more states allow for medical and nonregistered adult cannabis (i.e., marijuana) use, ensuring proper utilization should be a priority. Standardized labeling for foods and pharmaceutical drugs promotes consumer safety. This study investigated cannabis product labeling requirements in the United States.

Materials and Methods:

Researchers compiled the requirements for cannabis product labeling across 31 U.S. states with medical cannabis programs from state regulatory publications.

Results:

Information requirements ranged considerably by U.S. state. All states required delta-9-tetrahydrocannabinol content and manufacturer contact information, >80% of states required the batch number, health risks, production tracking, a cannabis symbol, cannabidiol content, children disclaimer, and an impairment disclaimer. There appeared to be a random pattern in requirements for other specific items. The relationships between the extent of cannabis product labeling requirements and the number of years that a state had a medical cannabis program or whether states allowed nonregistered adult use cannabis were not significant, although there was a trend for nonregistered adult use states to require more recommended label attributes.

Conclusion:

A comprehensive framework for cannabis use is needed to protect the public, maximize benefits, and minimize harms and risks. Standardization of cannabis product labeling requirements would benefit consumers and promote safer and more effective usage of cannabis products.

Introduction

As more U.S. states allow medical and nonregistered adult use of cannabis (i.e., marijuana), ensuring fully informed use with the minimization of risks and harms should be a priority. Standardized labeling for food and beverages is an integral part of consumer safety.¹ The Food and Drug Administration (FDA) provides clear guidelines on food label requirement to ensure transparency and convey critical information. Nutrition labeling of food products enhances consumer knowledge,² can effectively reduce consumer intakes of total energy and fat and increase intake of vegetables,³ and is particularly effective when consumers are provided with contextual information aiding interpretation of product characteristics.⁴ Currently, there are 31 U.S. states with labeling requirements for cannabis products. However, there is a lack of uniform labeling practices, as each state independently determines labeling requirements.

As with food product nutrition labels, uniform guidelines for the packaging and labeling of cannabis products may promote consumer awareness and consistency for those who use it. Consistent labeling facilitates educational campaigns on informed use, which may lower consumer risks and harms. Canada has standardized packaging and labeling guidelines for cannabis products through the Cannabis Act and the Cannabis Regulations.⁵ The Cannabis Regulations require usage guidelines such as delta-9-tetrahydrocannabinol (THC) content, cannabidiol (CBD) content, and health warning messages (e.g., delayed effects from edibles). Requirements also include aspects similar to marketing restrictions for tobacco products, such as plain packaging and labeling for all cannabis products, with restrictions on logos, colors, branding, and specific display formats about how product information must appear on the label (e.g., typestyle, size, and spacing).

Issues with inconsistent labeling

The lack of consistency in labeling cannabis products may endanger public health. Providing clear and specific guidelines could reduce adverse health effects such as excessive dosing. Although a comprehensive comparison is needed to assess the impact of cannabis labeling, the need for better educational efforts is demonstrated by the rise in cannabis-related poison center calls in states with legalized cannabis.⁶ This may be especially important for those using cannabis for medical purposes.

In a regulated cannabis market, consumers should easily be able to identify the cannabinoid composition and concentration of products and determine how much of the product to consume based on their desired dose or outcome.⁷ One of the challenges of labeling products is ensuring people who use the product can understand what is on the label. The comprehension of food labels is associated with literacy and numeracy; however, even individuals with strong literacy skills may have trouble reading food labels.⁸ Similarly, few consumers can understand and effectively utilize quantitative THC labeling on cannabis products.⁹ THC labels that provide “interpretive” information, such as descriptors, symbols, or references to servings, have greater efficacy.⁹ Consistency in labeling may also promote comprehension.

There are no current regulations on naming conventions of cannabis cultivar (i.e., “strain”) or standards for levels of cannabinoid content, and the same cultivar may have different cannabinoid profiles depending on the source or harvest.¹⁰ Recent articles call for the standardization of dosage or serving size (depending on whether the product is an inhalant or edible),^11,12 as several U.S. states use 5 mg of THC as a standard “serving” for cannabis edibles, whereas other states and Canada use 10 mg of THC as a standard unit for serving size or dosage and packaging regulations.¹¹ Given that definitions of THC dosage are not consistent even within the United States, it would be valuable to examine the variation in guidelines regarding cannabis product labeling related to cannabinoid content and other properties.

Others have recently identified the need for accurate and informative labeling of hemp and hemp-derived CBD products as an important public health issue.¹³ Current labels may lack accurate information and may include false health claims.¹³ This study investigated cannabis product labeling requirements in the United States to determine the extent and variation of requirements across U.S. states.

Materials and Methods

This project was reviewed by the Institutional Review Board for Health Sciences and Behavioral Sciences at the University of Michigan (HUM00165859). Researchers compiled documentation on regulations of cannabis products from state regulatory agency websites in 31 U.S. states where cannabis is legal at the state level for medical and/or nonregistered adult use purposes. States where cannabis remained illegal were excluded due to the lack of labeling requirements. Regulations were current for January 2020. Researchers developed a coding scheme to include specific types of information based on recommended best practices and a subsample of state-level cannabis regulations. Each type of information was coded as a requirement (1) or not a requirement (0) for each state. We examined the extent of cannabis product labeling requirements (total number of aspects required) by the number of years a state had a medical cannabis program and whether or not a state allowed nonregistered adult use of cannabis. We examined the prevalence of seven label attributes identified as necessary by Corroon et al.¹³ and relationships with the number of years that a state had a medical cannabis program and whether or not a state allowed nonregistered adult use.

Information requirements were determined for (1) the THC content of the entire packaged product; (2) THC amount per serving; (3) CBD content of the entire packaged product; (4) CBD content per serving of the product; (5) all label words are in the English language; (6) keywords such as “cannabis-infused” included on the label; (7) net weight of contents; (8) manufacturer (the source of the THC) contact information; (9) children disclaimer, for example, “keep out of reach of children”; (10) impairment disclaimer, for example, “may impair your ability to operate a vehicle or heavy machinery while using this product”; (11) food allergens within edible products on a nutrition panel; (12) expiration date; (13) instructions on how to use the product properly and safely; (14) universal statewide cannabis symbol; (15) verified potency statements; (16) the batch number from the manufacturer; (17) nutrition panel on edible products including all standard nutritional information; (18) color requirements for label text; (19) associated health risks; (20) production tracking label of a specific product; (21) age requirement (e.g., 21 years old); (22) transport to another state is illegal; (23) date of sale; (24) content restrictions; (25) mold testing completed; (26) cannabinoid content within the entire product sold; (27) testing facility name and contact information; and (28) storage recommendation.

Results

There was a considerable range of information requirements by the U.S. state. States had an average of 16.7 required label attributes (standard deviation [SD]=4.8), ranging from 4 to 26. All states (N=31) required information on THC content and manufacturer contact information (Table 1). Over 80% of states had requirements for a batch number (29 of 31), health risks (29 of 31), information for production tracking (29 of 31), cannabis symbol (28 of 31), CBD content (27 of 31), children disclaimer (27 of 31), and impairment disclaimer (26 of 31). There appeared to be a random pattern in requirements for other specific items (Table 2). Less than five states also had requirements for cultivar name, date of harvest, activation time range, and dosing for individually packaged units.

Table 1.

Proportion of States Requiring Label Content by Type of Information

Type of information	Proportion of states
THC content	100
Manufacturer contact	100
Batch number	94
Health risks	94
Production tracking	94
Cannabis symbol	90
CBD content	87
Children disclaimer	87
Impairment disclaimer	84
Key words	74
Expiration date	74
Net weight	68
Cannabinoid content	68
Nutrition panel	61
Potency statement	52
Testing facility	52
Storage recommendations	48
THC amount per serving	45
Food allergens	45
Date of sale	45
Usage instructions	42
Content restrictions	35
Mold testing	35
CBD amount per serving	29
Font size	23
English language	19
Illegal use out of state	16
Age requirement	10
Color requirement	3

CBD, cannabidiol; THC, delta-9-tetrahydrocannabinol.

Table 2.

Distributions of Label Content Requirements by U.S. States, Nonregistered Adult Use States in Bold

There was no relationship between the extent of cannabis product labeling requirements and the number of years that a state had a medical cannabis program, r(31)=−0.09, p=0.640, or whether or not a state allowed for the nonregistered adult use of cannabis, t(29)=0.93, p=0.362, d=0.36. States had 4.3 recommended label attributes required on average (SD=1.4, range 1–6); no state required all seven recommended attributes. There was no relationship between the number of recommended label attributes required and the number of years that a state had a medical cannabis program, r(31)=−0.01, p=0.969. The trend for states that allowed for the nonregistered adult use of cannabis to have more recommended label attributes required did not reach statistical significance, t(29)=1.28, p=0.210, d=0.49.

Discussion

Cannabis is rapidly transitioning from an illicit substance to one legally available and widely used for recreational use and treatment of a wide variety of health and medical conditions.^14,15 This study demonstrates the lack of consistency in cannabis product labeling requirements across U.S. states. Nearly half of states do not include storage recommendations, the amount of THC per serving, usage instructions, content restrictions, mold testing, or have language or font size requirements. This is especially concerning as this could possibly result in consuming too much or too little of the product.¹⁶ It is important to label all cannabis products no matter whether the intended use (medical or nonregistered adult use) or mode of use (inhalable or noninhalable). Many of those purchasing cannabis products through adult use (“recreational”) outlets are using it for therapeutic purposes.¹⁷

There was no relationship between the extent of cannabis product labeling requirements and the number of years that a state had a medical cannabis program or whether it had a nonregistered adult use program. Although states may modify labeling requirements due to experiences after a legal program is established, they did not appear to adopt the requirements established by other states. This further suggests the unique trajectory of each state and the lack of consistency in regulations across states.

Consumers may have expectations for labeling information based on other psychoactive products, such as tobacco and pharmaceuticals, and/or from dietary supplements. Greater alignment with other labeling standards may promote consumer comprehension and greater label literacy. Labels should at minimum contain the following: instructions on how to use the product properly and safely; THC and CBD content of the entire packaged product; THC and CBD amount per serving; associated health risks; impairment disclaimer, for example, “may impair your ability to operate a vehicle or heavy machinery while using this product”; child disclaimer, for example, “keep out of reach of children”; age requirement; manufacturer (the source of the THC) contact information; batch number and production tracking; potency verification information from the analytic laboratory; mold testing results; nutrition panel on edible products including all standard nutritional information and food allergens; storage recommendation; date of sale, and universal cannabis symbol. Information should be in an easily readable font type and size. The FDA and Federal Trade Commission (FTC) are likely to implement labeling standards nationwide only when cannabis is legalized at the national level. Until then, individual states will have the responsibility of creating and enforcing labeling standards.

Implications

Cannabis product labeling requirements are inconsistent across U.S. states. Standardization of cannabis product labeling requirements would benefit consumers by promoting label literacy that could lead to safer and more effective usage of cannabis products.

Conclusion

A comprehensive framework for cannabis use is needed to protect the public, maximize the benefits, and minimize the harms and risks to individuals and society. More effort is needed in standardizing labeling of cannabis and cannabis products to fully inform consumers and ensure safe and effective use.

Abbreviations Used

CBD

cannabidiol

d

Cohen's effect size; small=0.20, medium=0.50, large=0.80

FDA

Food and Drug Administration

FTC

Federal Trade Commission

r

Pearson correlation coefficient

SD

standard deviation

t

student's hypothesis test statistic

THC

delta-9-tetrahydrocannabinol

Author Disclosure Statement

No competing financial interests exist.

Funding Information

Support for this project was provided by the Undergraduate Research Opportunities Program at the University of Michigan.

Cite this article as: Kruger DJ, Korach NJ, Kruger JS (2022) Requirements for cannabis product labeling by U.S. state, Cannabis and Cannabinoid Research 7:2, 156–160, DOI: 10.1089/can.2020.0079.