By Steven Schain

Butters, oils and fats are essential building blocks of cannabis-infused foods and beverages, the fastest growing segment of the legalized marijuana market that generated $30 billion in 2022 domestic revenue.

The world of cannabis edibles just exploded when Alaska’s Marijuana Control Board legalized “infused dairy butters, oils or fats” preparation and sale. See, 3 Alaska Admin. Code Section 306.515(5) (March 17, 2023).

Butters, oils and fats are essential building blocks of cannabis-infused foods and beverages, the fastest growing segment of the legalized marijuana market that generated $30 billion in 2022 domestic revenue.

Due to “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). Alaska’s allowance of “infused dairy butters, oils or fats” vending should clear the way for a broader array of infused-product offerings across the nation and a more consumer-driven market.

Edibles—Infused-Cannabis Foods and Beverages

The Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. Sections 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)(”No form of state activity can constitutionally thwart the regulatory power granted by the commerce clause to Congress”).

Tetrahydrocannabinol (THC) is marijuana’s 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; and “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% 2022 sales increase, cannabis infused foods and beverages, i.e., edibles, are among legalized marijuana’s 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.

Budgeted at $6.1 billion, the U.S. Food and Drug Administration (FDA) protects and promotes public health through supervising food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, cosmetics, animal foods and feed, and veterinary products. See federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, et seq.. Because the Controlled Substance Act prevents cannabis from being sold outside of each respective legalized-marijuana state and, thus, no “interstate cannabis commerce” can occur, presently state regulators like Alaska’s Marijuana Control Board, and not federal agencies like the FDA, regulate those growing, processing, selling or transporting cannabis. However, in promulgating cannabis standards and prohibitions, many states track much of the FDA’s definitions and regulations.

‘Shelf Stability’ and Permissible Marijuana-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 three aspects:

• Best-by date. Time frame during which all 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 (dairy or meats) and solely represents last date on which product should be purchased. How long the food remains safe to consume is based on the consumer’s storage method.
• Expiration date. Indicates when a food is no longer safe to consume from a spoilage standpoint or a point in time when the preservative system is no longer active and harmful microbial activity might be present.

Cannabis edibles have a shelf life similar to their noncannabis counterparts. While THC and other cannabinoids don’t “go bad” over time they lose potency resulting in most infused products labeled with a “best-by,” 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 product’s THC content remain constant throughout its shelf-life and within respective 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 by 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, in the case of beverages, stops ultraviolet light from attacking liquids.

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

Conversely, the LCB 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 (ready-to-drink tea and barbecue sauce); must be retorted or pasteurized to assure food safety; dairy products (butter, cheese, ice cream or milk); fruit or vegetable juices (except shelf-stable concentrates); oils and vegetable butters; pies containing egg (pumpkin or custard); and dried or cured meats.

Infused Dairy Butters, Oils and Fats—Edibles’ Final Frontier

Getting cannabis into the consumable food product requires “infusing” and, due to the fat-soluble compounds found in marijuana, butter, coconut oil, or olive oil form the perfect agent for infusing consumables. Stated another way, the only THC-containing-component of the consumable food product is the infused butter, coconut oil, or olive oil, which, in turn, is used to create the gummy, chocolate, brownie or othercannabis edible.

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

The problem derailing these item’s production and sale is that because most dairy butters are viewed as requiring refrigeration” they 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 kept stored at 41 degrees Fahrenheit (5°C) or lower to avoid bacterial growth. See FDA’s Evaluation and Definition of Potentially Hazardous Foods (Dec. 31, 2001). Although, according to the FDA, pasteurized butter is not always a TCS food, it does require refrigeration to keep it safe.

However, because “interstate cannabis commerce” is prohibited, state regulators, and not federal agencies like the FDA, regulate cannabis manufacture and sales and 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.

The world of cannabis edibles experienced a seismic shift when Alaska amended its regulations last month legalizing “infused dairy butters, oils or fats” preparation and sale. Beyond aligning a state’s cannabis program with the FDA’s strictures, Alaska’s infused dairy butters, oils or fats allowance 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, which, in turn, creates 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 “infused dairy butters, oils or fats” sales directly to the consumers. Regardless of how gradual the rollout may be, legalized marijuana jurisdictions are dropping barriers and increasing the scope of infused edible products.

Reprinted with permission from the April 28, 2023 edition of the Legal Intelligencer©2023 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited, contact 877-257-3382 or [email protected].