The world of cannabis edibles just exploded when Alaska’s Marijuana Control Board legalized “infused dairy butters, oils, or fats” preparation and sale in March. 3 Alaska Admin. Code §306.515(5).

Butters, oils and fats are cannabis-infused food products’ essential building blocks, and are the fastest-growing segment of the legalized cannabis market, which generated $30 billion in 2022 domestic revenue. Globally, cannabis edibles had $20.5 billion in 2022 sales, reports market research organization Facts and Factors, which it predicts to reach $197.75 billion of worldwide sales by 2030.

Due shelf stability and bacterial or toxigenic growth concerns, most jurisdictions prohibit commercial sale of “potentially hazardous cannabis-infused foods” (including those requiring refrigeration and pasteurization). However, Alaska’s allowance of vending infused dairy butters, oils and fats clears the way for a broader array of infused-product offerings nationally and a more consumer-driven market.

A legal overview of edibles

The Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. §§ 801, Et. Seq (1970) (Controlled Substance Act) currently lists marijuana next to heroin as a Schedule I controlled substance having "a high potential for abuse" and for which there's "no currently accepted medical use in treatment" and "a lack of accepted safety for use" "under medical supervision." 21 U.S.C. §812(b)(1). The Controlled Substance Act prohibits Marijuana's cultivation, distribution, dispensation and possession and, pursuant to the U.S. Constitution's Supremacy Clause, state laws conflicting with federal law are generally preempted and void. U.S. Const., Art. VI, cl. 2; Wickard v. Filburn, 317 U.S. 111, 124 (1942)(”[N]o form of state activity can constitutionally thwart the regulatory power granted by the commerce clause to Congress”).

Tetrahydrocannabinol (THC) is cannabis’ psychotropic-effect producing component, and whether deemed “medical” (purchasable only with state-issued card to treat resident’s statutorily defined “covered medical condition”) or adult use (purchasable by anyone over 21 from any state with a valid identification), cannabis takes four forms: 

• “Flower” that is smoked
• Oils ingested by vaporizing
• Concentrates only consumable after being heated to a high temperature 
• Infused products ranging from eye drops to edibles  

With few exceptions, medical and adult-use cannabis items are identical and only delineated by their purchasers: medical card “patients” or “adult use” consumers.

Experiencing a 10% sales increase in 2022, cannabis-infused foods and beverages, i.e., “edibles,” are among legalized cannabis’ fastest-growing sectors and may be sold in 19 states: Alaska, Arizona, California, Colorado, Connecticut, Illinois, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana,  New Mexico, New Jersey, New York, Nevada, Oregon, Rhode Island, Vermont and Washington.

Because the Controlled Substance Act prevents cannabis from being sold outside of each respective legalized-cannabis state, and thus no “interstate cannabis commerce” can occur, presently state regulators like Alaska’s Marijuana Control Board, and not federal agencies like the U.S. Food and Drug Administration (FDA), regulate those growing, processing, selling or transporting cannabis.  

Shelf stability and permissible cannabis-infused edibles

Both a direct measure of product safety and the time period for which an item is at its sensory best, shelf stability tracks how a product's physical, chemical and microbial stability may alter over the item’s shelf life.  

Shelf life is comprised of: 

• Best-by date: Timeframe during which ingredients and product attributes are at their best, including sensory characteristics, color-fastness and flavor intensity. Ingestible food products, including cannabis edibles, can be safely consumed well beyond their best-by date.
• Sell-by date: Used for foods requiring special storage (ex., dairy or meats) and solely represents last date on which product should be purchased. How long the food remains safe to consume hinges upon the consumer's storage method.
• Expiration date: Indicates when a food is unsafe to consume from a spoilage standpoint or when the preservative system is no longer active and harmful microbial activity might occur.

Cannabis edibles’ shelf life mirrors their non-cannabis counterparts, and while THC and other cannabinoids don’t “go bad,” potency diminishes over time, resulting in most infused products labeled with a “best-by” date, rather than an “expiration” date.  

The three components of cannabis-infused products shelf-life stability are:

• Microbial stability: Is product safe to eat for its full shelf life?
• Chemical stability: Does the product’s THC content remain constant throughout its shelf life and within a respective state’s cannabis program’s defined variance range?
• Physical stability: Do the flavor, texture or other sensory attributes change over time?

All three aspects can be controlled and predicted through a clear grasp of the product’s formulation, production process and packaging. For example, packaging provides a barrier to the surrounding environment, keeping contents sanitary and microbe-free, prevents oxidization, and with beverages, stops ultraviolet light from attacking liquids.  

 According to Washington State’s Liquor and Cannabis Board (WLCB), permissible “marijuana infused edibles” are defined as “low hazard foods” not supporting “bacterial or toxigenic growth,” such as non-refrigerated baked goods (ex., cookies, brownies, fruit pies and tarts); chocolates, candies and sugar- or syrup-based confections (ex., molded chocolates, fruit rolls, roasted coated nuts, and nonbaked bars or granola products); flavored, carbonated and lemonade-style beverages; dry mixes (ex., coffee granules, leaf tea, soup mixes, beverage mixes, and seasonings); jams, jellies, roasted nut butters, honey and syrups; and vinegars. Wash. Admin. Code 246-215-01115(88) (2013).

Conversely, the WLCB prohibits commercial sale of “potentially hazardous” cannabis-infused foods, including those which must be temperature controlled (frozen, refrigerated, or hot-holding); require acidification to assure food safety (ex., ready-to-drink tea and barbecue sauce); must be retorted or pasteurized to assure food safety; dairy products (ex., butter, cheese, ice cream, or milk); fruit or vegetable juices (except shelf-stable concentrates); oils and vegetable butters; pies containing egg (ex., pumpkin or custard); and dried or cured meats. Id.

Infused dairy butters, oils and fats – edibles’ final frontier

Getting cannabis into consumable food products requires infusing, and due to the fat-soluble compounds found in cannabis, butter, coconut oil or olive oil form the perfect infusing agent. Thus, consumable food products’ only THC-containing component is the infused butter, coconut oil or olive oil, which, in turn, is used to create the gummy, chocolate, brownie or other cannabis edible.  

A primary ingredient in many infused recipes, cannabis-infused butter (“cannabutter”) is technically an extraction method whereby cannabinoids, terpenes and flavonoids are extracted from the cannabis plant and infused into the butter fats. The resulting cannabutter is substituted for butter in a product’s recipe. While many cannabis-infused edibles are presently for sale, most edible-allowing jurisdictions prohibit the direct preparation or sale of infused dairy butters, oils, or fats.

The problem derailing these items’ production and sale is that because most dairy butters are viewed as requiring refrigeration, these products are not deemed to be shelf stable. Specifically, the FDA categorizes all “dairy” as a “Time/temperature Control for Safety food” (TCS) which is dangerous to eat if not stored at 41° degrees Fahrenheit or lower to avoid bacterial growth. FDA’s Evaluation and Definition of Potentially Hazardous Foods (December 31, 2001).  Although, according to the FDA, pasteurized butter is not always a TCS food, it does require refrigeration to keep it safe. Id.

However, because interstate cannabis commerce is prohibited, state regulators, and not federal agencies like the FDA, regulate cannabis manufacture and sales. Washington State’s LCB prohibits commercial sale of “potentially hazardous” cannabis-infused foods, including those which must be retorted or pasteurized to assure food safety, dairy products and oils and vegetable butters. WAC 246-215-01115(88).

The world of cannabis edibles experienced a seismic shift when Alaska amended its regulations legalizing “infused dairy butters, oils, or fats” preparation and sale. 3 Alaska Admin. Code § 306.515(5). Beyond aligning a state’s cannabis program with the FDA’s strictures, Alaska’s allowance of infused dairy butters, oils, or fats clears the way for an entirely new line of infused-product creation and sales like butter, cheeses, ice cream, pies, and milk and cream based-items.Further, by allowing a greater array of infused product offerings, this development increases the parties across the supply chain empowered to create cannabis-infused consumables, thereby creating a broader and more consumer-driven edible market.

Unfortunately, as it limits these “stand-alone edible products for sale” to “another marijuana product manufacturing facility,” Alaska’s revised regulation is only a partial victory, as it does not presently permit sales of infused dairy butters, oils or fats directly to consumers.  

Regardless of how gradual the rollout may be, legalized cannabis jurisdictions are dropping barriers and increasing the scope of infused edible products' availability.