FDA recently issued an advisory regarding the safety of cannabidiol (CBD), one of the compounds found in cannabis plants, alerting consumers that some companies are marketing products containing the compound in ways that the agency says violates the Federal Food, Drug and Cosmetic Act, but the market for CBD products—and especially edible CBD—is growing rapidly.
Adam Floyd, commercial operations manager for Think20 Labs, an analytical testing company for hemp and cannabis products based in Columbia, Md., notes that the testing market for cannabis edibles isn’t as evolved as CBD oil and flower testing, and he says more needs to be done to rectify this. “One of the major issues with edible testing is massive variance in sample types, e.g., gummy bears, candies, brownies, etc.,” he says. “This makes the actual testing of the products more difficult, as specific methods need to be developed for each type of edible.”
Additionally, Floyd says that concentrations of tetrahydrocannabinol (THC), another compound in cannabis plants, can vary wildly from the stated concentration on packages. “A major public health danger of this issue is people receiving inconsistent doses of THC/CBD. Edibles take longer to take effect so the danger of overconsumption can be more pronounced.”
Sara Rose Kennedy, co-founder of PuraPhy, a Las Vegas-based online publication focused on the hemp and cannabis industry, says methods of testing levels of THC in edibles is constantly evolving through the advances in technology, research, and standardization practices that have come about since the inception of state cannabis legalization, with California being the first state to legalize it in 1996.
The cannabis industry is in an unusual situation, she says. While FDA typically regulates drugs and food in the U.S. that aid in disease or impact the human body, this is not the case for THC and CBD edibles, she says. “Although there have been many advances in lab testing in the cannabis and hemp industry, there are still inconsistencies [in methods among] the different states, and even [among] labs around the country.”
Kennedy says that federal law does not consider any cannabis-infused food product legal at this point in time. However, FDA can intervene when an edible label makes a “health claim,” because it does not approve of any marijuana product. “Otherwise, [FDA has] no rules for quality assurance/control for cannabis edibles, which means they are not able to offer ‘official’ regulations for ingredients, preparation (SOP), or packaging guidelines,” Kennedy adds.
Who Is Regulating?
Currently, the laws concerning edibles are regulated on a state-by-state basis. For example, in Nevada, the state’s board of taxation monitors the production and sales of THC edibles such as gummies, while the Maryland Medical Cannabis Commission recently passed its rules for the sale of cannabis edibles in that state. Colorado, Oregon, and Washington require a universal symbol to be affixed to edibles identifying them as cannabis products, but only Colorado and Oregon require that the packaging for edibles bear a Nutrition Facts panel on the label.
Each state sets up its own guidelines and, while there is some uniformity, the gray area comes from cannabis and hemp as ingredients, as regulatory bodies are just starting to understand all the ways products can be infused with cannabis compounds.
Typically, cannabinoid methodologies will remain consistent, but the regulations for allowed concentrations of pesticides, residual solvents, and heavy metals can vary immensely. “Many edibles and cannabis products are sold in dispensaries without proper testing from laboratories and there is limited state enforcement to ensure that proper regulations are adhered to,” Floyd says. “There aren’t a lot of us, so it’s not too hard to find a lab.”
For instance, in California, there are approximately 30 licensed and operational cannabis laboratories that typically offer a turnaround time of between three and seven days from sample arrival. Yet, in Maryland, there are only five labs, which is more the norm, as most states outside of California have fewer than 10. “Investigation and thorough vetting of a laboratory testing partner is critical in ensuring success,” Floyd says. “Thorough and accurate testing of all raw and finished products will ensure that safe and properly labeled cannabis products are being produced and sold. A successful partnership with a licensed testing laboratory will guarantee safe products.”
Merril Gilbert, co-founder and CEO of San Francisco-based TraceTrust, a hemp and cannabis consulting organization, says numerous labs entered into legal cannabis testing from the food and beverage, nutraceutical, or pharmaceutical industries, without any true standard testing base, which is only adding to the confusion. “When you add in the variances in regulations by state, and no universal standard for testing ingestibles, that often produces conflicting results,” she says. “The gap in part is that most regulatory requirements focus on the plant extractions—concentrations of THC and CBD, pesticides, molds, solvents—and not on all the ingredients for the entire life cycle of a product.
There is a massive demand for testing and not enough licensed laboratories to fulfill market needs. Floyd notes that much of the method development for cannabis testing was established from academics and does not always translate to commercial testing. “Proper and consistent sample preparation are among the largest issues in the industry currently,” he says. “This can lead to huge variations in results from lab to lab. Currently, it’s up to the lab to develop methods for testing cannabis. These methods are vetted by the state prior to licensing.”
Edible Testing Issues
The cannabis market is still relatively new and the laws dictate that edibles be tested prior to packaging. Unfortunately, there’s little enforcement beyond this. The California Department of Public Health stipulated that single-serving edibles products cannot exceed 10 mg of THC, and packages of edibles cannot exceed 100 mg of THC. Other states have different requirements.
While products purchased through a legal licensed retailer have gone through rigorous testing for THC and CBD, Gilbert notes that what is not clear to the consumer is how the product will affect them. “Generally, when someone has an alcoholic drink, they have a point of reference for how they will feel,” she says. “New and returning consumers to cannabis and CBD hemp don’t have that and will share stories of unpleasant experiences. As an industry, we must unite on common terminology and know that, for many of us, this is a goal for 2020 to provide more consumer and retailer education. There isn’t enough consumer information—including on the label—that can explain when the onset and offset of the experience may happen.”
Gilbert advises clients not to choose a lab strictly by price and not to jump around among different ones. “The success and longevity of the product should be based on building a relationship with the lab,” she says. “[The lab] develops a product profile and provides points of reference over time and can often spot variances, allowing time for corrective actions.”
A Look Ahead
No one seems to have a quick, tight answer to how long it will be before cannabis testing regulations are more strictly defined. “Research is just beginning,” Gilbert says. “As an industry, we’re innovating and developing very quickly. It’s amazing.”
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