Legal status of CBD poses challenges for product developers, ingredient suppliers
The CBD conundrum
With its potential for helping with symptoms related to epilepsy, anxiety, pain and other conditions, demand is rapidly growing for food and beverage products made with cannabidiol (CBD). The Brightfield Group has projected that the CBD market will hit a value of $5.7 billion this year and is on a pace to approach $22 billion by 2022. And the recent passage of the Farm Bill and its approval of growing industrial hemp will significantly accelerate supply-chain resource for CBD.
In the wake of this flurry of business activity surrounding CBD, ingredient manufacturers advise that selecting the correct supplier and format is key to creating the best products.
Just like with any food-grade agricultural ingredient, manufacturers need to know where and how the cannabis got its start to get a full picture of its quality, says David Lafond, Ph.D., managing director of global innovation for Radient Technologies, Edmonton, Alberta. “You want to understand growing conditions, how the plants are harvested, how the material is stored before you get it. If there’s any damage or mistreatment of the plant, then it’s not going to get better when you do the extractions.”
Lafond notes that Radient Technologies works with Aurora Cannabis, a Canadian cultivator that grows cannabis in greenhouses to control the environment, and ultimately, the amount of CBD in each plant. “By growing it indoors, they can really control the conditions and optimize them for the best plant grow.”
Sourcing is only part of the equation, however. R&D professionals creating legal cannabis edibles and beverages should seek out ingredient suppliers that make compliance and transparency top priorities.
“Developers should look to work with a reliable and compliant supplier,” says Jake Black, chief science officer, Treehouse Hemp, Denver. “This means the supplier is transparent about their hemp sourcing.”
Black notes that farms need to be registered with their state and meet the state’s regulations. Growers should also be willing to provide safety data sheets and certificates of analysis, which typically include cannabinoid potency testing, residual solvent testing, pesticide testing, heavy metal testing and microbial testing.
CBD Selection and Use
Once the quality of the industrial hemp or cannabis is assured, developers must determine which format would work best for their intended application.
CBD is available in two main forms: isolates and full-spectrum mixtures. Isolates are singular, pure cannabinoids, while full-spectrum mixtures contain multiple cannabinoids and other biomolecules from the cannabis plant, such as sugars, fatty acids, proteins and terpenes, or aroma-producing compounds.
Lafond notes some product developers may seek out full-spectrum ingredients with the goal of offering a more-holistic experience. “There is a belief that there is a synergistic effect with all those other cannabinoids, terpenes and fatty acids to help enhance or provide better nutritional value than just CBD alone.”
While both varieties are available in powdered and oil formats, determining which to use depends on the application. Black recommends using powder for baked goods such as cookies and brownies, since a powder will easily mix into other powdered ingredients. Oils can also work in baked goods, but evenly distributing the CBD oil within the product matrix, such as during the dough stage, could be more difficult than achieving standardized distribution during the powder stage.
An oil would function best in chocolate products, Lafond notes, since, as a naturally lipophilic material, it can be incorporated into the product’s fat system.
For gummies, Black notes that oils or powders, including water-soluble forms, would work well.
Beverages require water-soluble CBD—even though the cannabinoid doesn’t naturally dissolve in water. It needs other additives to serve as emulsifiers in order to reach a hydrophilic state. Lafond pointed to SõRSE, a patent-pending technology from Seattle-based Tarukino that encapsulates cannabinoids, allowing them to easily disperse in a beverage.
“The challenge in all of these,” Lafond notes, “is getting the right dosage so you get the physiological effect people are interested in.”
Common dosages fall between 10 and 50 milligrams of CBD per serving, but in the U.S., calling the CBD content in a product a “dose” could put U.S. manufacturers in a precarious legal space, Black says.
In June 2018, the FDA approved the CBD drug Epidiolex for treatment of certain epilepsy disorders. And while the 2018 Farm Bill defined and legalized industrial hemp, a source of CBD, incorporating the cannabinoid into foods and beverages is, at this stage, illegal at the federal level. State regulations around CBD vary, so it’s best to consult with state regulators to determine the current status.
However, the FDA may soon loosen its reins. Earlier this year, the agency accepted public comment on safety concerns associated with cannabis-derived compounds including CBD, with a public hearing scheduled for May 31. FDA has also noted that it is also organizing a high-level internal agency working group to explore potential pathways for conventional foods that contain CBD to be lawfully marketed.
In the meantime, Black said some suppliers label products with the words “hemp extract” and “serving size” instead of “CBD” and “dose” to avoid stepping into murky territory.
Nonetheless, the FDA acknowledges the potential therapeutic opportunities for CBD and other cannabis-derived compounds beyond treating epilepsy, noting that more clinical research is needed. “The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective and quality products to market, including scientifically based research concerning the medicinal uses of cannabis,” notes the agency on its Q&A page dedicated to cannabis products (see “FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers” at www.fda.gov).
While available research on the benefits of CBD is limited, but there have been some reported benefits related to anxiety, sleep and pain. “Unfortunately, most of the treatment claims are just anecdotal,” Black said. “That is not to say that CBD doesn’t help those ailments, it just has not been scientifically and medically validated.”
Johns Hopkins University has been researching the effects and potential benefits of cannabis and recently completed a study on the connection between cannabis use and brain cell inflammation. In another study, Johns Hopkins and Temple University researchers found a reduction of pain and an increase in productivity by residents older than 51 who used cannabis (“The Effect of Medical Marijuana Laws on Health and Labor Supply,” Journal of Policy Analysis and Management, Spring 2019). Johns Hopkins researchers are also planning a study on the potential of using CBD to help people quit smoking.
UCLA is also dedicating resources to the study of cannabis and health. UCLA Health launched its Cannabis Research Initiative in 2018, seeking to advance scientific understanding of the biological and neurological impacts of cannabis and hemp.
As scientific knowledge of CBD and cannabis broadens, and state and federal governments grapple with how to regulate it, use of CBD in food and beverage products will expand, Lafond said. “I think change is going to happen. I think it’s going to eventually be approved across the U.S., and when that happens, it’s only going to get more popular and more available. It’s just going to grow.”