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 the new standards are a step in the right direction. On Sept. 9, 2013, the Marijuana Enforcement Division (MED) of Colorado’s Department of Revenue (CDOR) published the “Permanent Rules Related to the Colorado Retail Marijuana Code.”
MED created these rules to implement an amendment to the Colorado State Constitution, “Amendment 64,” which Colorado voters approved this past November. 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. Amendment 64 requires CDOR to begin accepting and processing applications for Retail Marijuana Establishments on Oct. 1, 2013. MED does not expect the recently published rules to change before that time.
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 non-organic 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 such 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 that 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 rulemaking to improve upon its regulations, and that 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, Colorado’s leading manufacturer of marijuana-infused products, has a different attitude toward food-safety standards in the industry. “One of our primary goals is to protect consumers from foodborne illness,” said a company representative. Even without regulatory oversight, Dixie Elixirs uses a Hazard Analysis and Critical Control Points (HACCP) plan to establish hygiene and protocols. Additionally, the company recently engaged a U.S. Food and Drug Administration (FDA) lawyer to provide guidance on federal packaging and labeling standards for non-marijuana ingredients.
“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 Christie Lunsford, media and marketing director at Dixie Elixirs. Lunsford sits on the 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.
She also 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 supports any regulations that protect customers. “First and foremost, we don’t want people to get sick,” she said. “They are already sick. We don’t want them to get sick from the product.”
“I want regulations,” said Genifer Murray of CannLabs, Inc., which is Colorado’s leading third-party cannabis testing lab. “We all preach the good word of cannabis and say you can’t die from cannabis. The last thing we ever want is that somebody dies from contaminated cannabis via E. coli, Salmonella, pesticides, or residual solvents.”
The U.S. Department of Agriculture (USDA) and FDA regulate the majority of food in the U.S. While there have been reports that 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. As an FDA representative recently 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.”
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