According to pro-cannabis groups, a new law in Minnesota that allows low levels of THC in food and beverages reflects a growing cannabis market and is a step toward legalizing adult-use cannabis in that state.
The law became official July 1 and allows adults to possess and consume hemp-based edibles that contain up to five milligrams of THC per serving, with a maximum of 50 milligrams per package.
While the Minnesota law is an outlier in allowing THC-infused food and drinks without legal adult use, sales of gummies and other edibles there and in states with legal cannabis are booming.
Likewise, the cannabidiol (CBD) market for edibles continues strong growth across the U.S., even though foods containing CBD are not legal at the federal level. This ImEPIK blog will look at the uncertain regulatory status of CBD edibles and the need for manufacturers to establish food safety programs despite the unknown future of regulations.
CBD-Infused Edibles Market Growth
Data Bridge Market Research (DBMR) released an in-depth analysis of the global CBD edibles market in 2021, charting substantial growth over the previous eight years. The firm cited strong macroeconomic conditions and healthy demand, but noted that the economic slowdown and COVID-19 pandemic could slow momentum.
DBMR calculated that the CBD food and beverage market will reach $5.16 billion (U.S. dollars) by 2027, growing at a compound annual growth rate of 24.3%
Those numbers make it easy to see why companies supplying the cannabis market would want certainty in the marketplace, including information on how the FDA or another agency will regulate the industry.
FDA as Cannabis Regulator – Reasons for Concern?
Steven Gendel, an independent food safety consultant, recently wrote an article for the Cannabis Industry Journal that looked at possible barriers to the FDA acting as a regulator for CBD edibles. Gendel worked at the FDA for 24 years in positions ranging from food safety risk assessor to biotechnology program manager.
According to the article, the 2018 Farm Bill, which created the CBD market by allowing hemp products, tasks the FDA with overseeing hemp-derived infused edibles. That puts CBD products on the New Dietary Ingredient pathway for dietary supplements, “and either the food additive petition process or the Generally Recognized as Safe (GRAS) pathway for foods before it can be used as an ingredient in a food.”
The issue, Gendel writes, is that with all three options, the FDA must judge the ingredient’s safety, requiring “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” In that regard, the FDA has been clear that it doesn’t believe available scientific data shows that CBD meets required safety standards, according to the article.
Gendel outlines those data gaps and concludes that it’s unlikely the FDA will give regulatory approval for CBD in edibles for at least several years, leaving the products in legal limbo. In light of the uncertainty, he says companies making CBD-infused foods and beverages can respond in three ways:
- In the short-term, develop manufacturing processes that ensure products are consistent in CBD levels, working with the analytical community to support validated testing methods;
- In the medium-term, manufacturer’s business risk management plans should consider that new data could lead food safety authorities to conclude CBD doesn’t meet current regulatory standards; and
- In the longer term, makers of CBD edibles and other industry stakeholders could advocate for legislative changes. The best outcome is that all cannabis-derived products are regulated by an agency outside the food safety system.
That’s how Canada handles the issue, and it’s similar to how the U.S. regulates alcohol, Gendel writes.
Regardless of the outcome, he said, it’s critical that these foods and beverages be made under a system that prevents food-borne hazards.
ImEPIK’s Courses: Three Levels of Edibles and Food Safety Training
ImEPIK’s courses help makers of edibles and establish food safety programs to prevent food-borne hazards and enable them to build custom food safety plans that identify and mitigate hazards throughout their facilities.
The cannabis-focused training is available in three levels:
- Level 1: GMPs & the Pyramid of Edible Safety
- Level II: The Edible Safety Plan
- Level III: Preventive Controls Qualified Individuals Online
Contact ImEPIK to learn more about online training for cannabis-infused products.