COLORADO: Among other new regulations for medical and recreational marijuana sales, Colorado recently created labeling, packaging, and safety standards for marijuana-infused food. For the most part, regulators, food manufacturers, and cannabis testing labs all seem to agree that they’re a step in the right direction.
“I think this set of rules is a good start and that further updates will be necessary to ensure cannabis infused products produced in Colorado are of the highest standard,” said a representative of Dixie Elixirs and Edibles, Colorado’s leading manufacturer of marijuana-infused products.
The Marijuana Enforcement Division (MED) of Colorado’s Department of Revenue (CDOR) published the “Permanent Rules Related to the Colorado Retail Marijuana Code” on September 9, 2013.
MED created these rules to implement an amendment to the Colorado State Constitution, “Amendment 64,” which Colorado voters approved in November 2012. In addition to legalizing up to an ounce of Marijuana for personal use by persons 21 or older, Amendment 64 legalized retail sales of medical and recreational marijuana by licensed establishments.
Amendment 64 also directed CDOR to govern retail sales by creating licensure regulations, labeling requirements, health and safety regulations, advertising restrictions, and civil penalties. To create these rules, MED facilitated a special task force and collaborated with five working groups.
The Labeling, Packaging, Product Safety & Marketing Working Group gave input and guidance on food-related rules such as labeling requirements. This group included representatives from the Governor’s office, the Medical Marijuana industry, the Colorado Department of Public Health and the Environment (CDPHE), laboratories, and others. MED also held a public comment period and heard oral testimony at public hearings.
“The coordinated efforts to create the rules was so comprehensive that the public hearing actually ended early because people felt like their voices had already been heard,” said a CDOR representative.
Amendment 64 requires CDOR to begin accepting and processing applications for Retail Marijuana Establishments on October 1, 2013. MED does not expect the recently published rules to change before that time.
The U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) regulate the majority of food in the U.S. While there have been reports that the USDA has enforced its food safety standards on marijuana infused foods that would otherwise fall under its jurisdiction, FDA does not currently enforce any federal food safety standards on marijuana-infused foods. Recently, an FDA representative stated, “In light of the recent developments in Colorado and other states, FDA is considering the relationship between federal food and drug laws and current state laws relating to products containing marijuana.”
Key Rules Related to Marijuana Infused Food
These new rules governing retail sales of marijuana-infused foods essentially fall into three categories: 1) required labeling, 2) optional labeling, and 3) required labeling when a certified lab performs tests.
Things required on the label include the license numbers of the facilities where the marijuana ingredients were grown and manufactured, a complete list of nonorganic pesticides and herbicides used during cultivation, and a list of warning statements, including “This product was produced without regulatory oversight for health, safety, or efficacy.”
The optional labeling category permits, but does not require, labels that state the products’ compatibility with dietary restrictions and a nutritional fact panel.
The final category addresses potency and contamination tests. If a licensed Retail Marijuana Testing Facility tests for potency, then the product needs a label with the potency profile expressed in milligrams and the number of THC servings. Alternatively, if a licensed lab does not test for potency, then the product must have a label that states “The marijuana product contained within this package has not been tested for potency, consume with caution.”
If a Retail Marijuana Testing Facility tests for contaminates, then the product’s label must state the test results. Alternatively, if a licensed lab does not test for contaminates, then the product’s label must state that no contaminates test was performed. Contamination tests include tests for molds, mildew and filth; microbial organisms; herbicides, pesticides and fungicides; and harmful chemicals.
Unfolding Food Safety Standards in the Marijuana Infused Food Industry
CDOR confirmed that it cannot currently require contaminates or potency tests because Colorado does not have enough testing facilities to meet the potential demand. It estimated three labs currently have the testing capabilities.
But CDOR will likely require potency testing in 2014. It is working with CDPHE’s Laboratory Division to create certification standards for third party labs. As for contaminates testing and other standards, MED anticipates that it will engage in future rule-making to improve upon its regulations, and labeling and packaging requirements may be considered for these types of improvements.
Jeff Lawrence of CDPHE indicated that although his agency will aid and consult with CDOR on testing processes or requirements, CDOR has complete authority to determine whether testing should be required.
“Standards for marijuana-infused foods are the responsibility of CDOR,” Lawrence said.
When asked whether his agency thought more testing standards were necessary for consumer protection, Lawrence said he did not think it would be appropriate.
Dixie Elixirs and Edibles has a different attitude toward food safety standards in the industry.
“One of our primary goals is to protect consumers from food borne illness,” a company representative said.
Even without regulatory oversight, Dixie Elixirs uses a Hazard Analysis and Critical Control Points (HACCP) plan to establish hygiene and protocols. Additionally, it recently engaged an FDA lawyer to guide it on federal packaging and labeling standards for non-Marijuana ingredients.
Christie Lunsford, Media and Marketing Director at Dixie Elixirs, sits on American Herbal Products Association (AHPA) Cannabis Committee, which has been working to develop recommendations for nationwide regulations on best practices for manufacturing, packaging, labeling, and holding cannabis and cannabis-derived products.
Lunsford said that while Dixie Elixirs is happy to pay compliance costs, small or new retail establishments may struggle with these costs if CDOR mandates testing and further labeling standards.
Julie Dooley of Julie&Kate Baked Goods, a somewhat smaller manufacturer than Dixie Elixirs, said she absolutely supported any regulations that protected customers.
“First and foremost, we don’t want people to get sick,” she added. “They are already sick. We don’t want them to get sick from the product.”