Labeling legislation is a moving target in the fast-emerging cannabis-infused food and beverage industry. An absence of federal regulation amidst a patchwork of state-based labeling rules only compounds the complexity. Therefore, companies developing and producing cannabis-infused foods and beverages must have ongoing diligence in order to remain in compliance.
CALIFORNIA VARIANCE RELIEF
In September, California Governor Gavin Newsom signed into law Assembly Bill 1458, which raises the label variance threshold for cannabis-infused food and beverage products from plus or minus 10 percent to plus or minus 12 percent until January 1, 2022. This larger degree of acceptable variance should help reduce the volume of product that faces destruction due to being out of specification.
After January 1, 2022, the level of allowable variance will revert to the current industry standard of plus or minus 10 percent. The generally acceptable variance for labeled potency of plus or minus 10 percent is the same amount of variance generally allowed by the U.S. Pharmacopeia in drug monographs.
CANNABIS GOES ORGANIC
The Cannabis Certification Council, Denver, has developed standards and certification criteria to establish an Organically Grown Cannabis Certification Program for cannabis producers seeking to gain recognition in the marketplace for growing cannabis in accordance with organic production practices.
The standards differentiate three separate labeling categories for cannabis based on cultivation (“Indoor Grown,” “Greenhouse Grown,” and “Outdoor Grown”). The standards align with the requirements of USDA National Organic Program 7 CFR Part 205.
Public commenting on the Organically Grown (OG) cannabis standard was slated to close by October, followed by finalization of the standard. The Cannabis Certification Council is developing a unique seal for use on certified product labels
CANNABIS PACKAGING & LABELING RESOURCES
Packaging resource links for the top five cannabis markets in the U.S.:
- California Bureau of Cannabis Control Resources, https://cannabis.ca.gov/general-resources
- Colorado Department of Revenue, Specialized Business Group, Marijuana Enforcement, https://www.colorado.gov/pacific/enforcement/marijuanaenforcement
- Washington State Liquor and Cannabis Board, Cannabis Packaging and Labeling Resources, https://lcb.wa.gov/laws/labeling-resources
- Michigan Marijuana Regulatory Agency, https://www.michigan.gov/mra
- State of Nevada, Cannabis Compliance Board, https://ccb.nv.gov.
AN ABUNDANCE OF CAUTION
Several U.S. states with full cannabis legalization currently require warning labels on products stating, “Cannabis use while pregnant or breastfeeding may be harmful,” “Cannabis should not be used by women who are pregnant or breastfeeding,” or something similar.
California recently passed labeling legislation along these lines, adding cannabis to Proposition 65, meaning products in that state will require a label warning starting in 2021.
Michigan Governor Gretchen Whitmer similarly signed required “pregnant or breastfeeding” labeling legislation for that state.
Much of this activity stems from a 2017 American College of Obstetricians and Gynecologists report on cannabis use during pregnancy. The report focused on self-reported cannabis use and found children exposed to cannabis during pregnancy displayed reduced ability for successful visual problem solving, visual-motor coordination, and visual analysis.
Despite the advancement of these precautionary pregnancy-related label-based warning statements, the industry has argued that more analysis is required to examine the validity of this claim. The American College of Obstetricians and Gynecologists itself has noted there is insufficient data to evaluate the effects of cannabis use on infants during lactation and breastfeeding, and in the absence of such data, cannabis use is discouraged.
CERTIFICATE OF ANALYSIS
Every cannabis product should include a certificate of analysis (COA). The COA should come from a third-party analytical testing lab or an internal lab confirming the cannabis-infused food or beverage passed inspection and meets regulatory standards. The COA must include levels of all cannabinoids and terpenes.
Current protocol also dictates the COA to include testing results for the presence of heavy metals, pesticides, microbes, mycotoxins, residual solvents, and foreign materials. However, in “Cannabis Packaging and Labeling: Recommendations for Sensible and Consistent Regulations Across States and Nations,” NCIA recommends the industry remove statements of containment testing from cannabis labels. The guidance notes: “Members of the committee and survey respondents showed strong support for mandatory contaminant testing, which involves assessment of pesticide residues, harmful chemicals, residual solvents, microbials, mold, filth, toxins, and other substances that are unsafe for human consumption.” However, the guidance document further notes, “We are not aware of any other consumer product that must contain statements about contaminant testing on the product itself, much less a list of contaminants that are not present.” Therefore, NCIA suggests looking into removing this requirement from the COA.
RECOMMENDATIONS FOR SENSIBLE AND CONSISTENT PACKAGING REGULATIONS
- Use a font that is at least 1/16th of an inch in height based on the lower case letter “o”
- Use the common name of the product in boldface type, with “cannabis” included
- Name and contact information for the licensee that produced the finished product
- Net quantity of contents
- License number of the manufacturer who produced the finished product, and the product batch or lot code
- Ingredients listed by common name in descending order by weight
- List all major food allergens
- Include Nutrition Facts and Cannabis Facts (potency) in milligrams content of active THC and all other marketed cannabinoids
- Establish a universal symbol that indicates the presence of THC in a cannabis product
- Include relevant warning statements, including:
- “Keep out of reach of children and pets.”
- “This product may have intoxicating effects. Do not drive or operate heavy machinery while under the influence of cannabis.”
- “Activation times vary but might take up to two hours after this product is consumed.”
- Use child-resistant, opaque primary packaging or a child-resistant exit bag
- Prohibit cannabis product packaging that primarily appeals to minors
- Prohibit cannabis product packaging that bears a reasonable resemblance to any trademarked or characteristic packaging of any commercially available candy, snack, baked good, or beverage
For the complete list of packaging and labeling guidance, including comprehensive and detailed explanations, see “Cannabis Packaging and Labeling: Recommendations for Sensible and Consistent Regulations Across States and Nations” on the National Cannabis Industry Association website at https://thecannabisindustry.org/reports/cannabis-packaging-and-labeling-recommendations-for-sensible-and-consistent-regulations-across-states-and-nations-february-2019.
CANNABIS AND NUTRITION FACTS
A Cannabis Facts (Potency) panel on all cannabis product labels should include:
- The milligram content of active THC and all other marketed cannabinoids per manufacturer-specified unit if the product is an adult-use edible infused product, transmucosal infused product, or transdermal infused product
- The milligram content of active THC and all other marketed cannabinoids per container if the product is an adult-use topical infused product or a medical infused product
NCIA also recommends requiring that each edible cannabis-infused product label include a Nutrition Facts panel as specified by FDA in 21 CFR Part 101, extending labeling to cannabis concentrates like cannabis-infused butter that are intended for use in cooking, to align with federal nutrition labeling requirements for cooking fats.