CBD OIL REGULATION: WHY IT’S NECESSARY
Across the nation, individual states are scurrying to create local legislation for the sale and use of CBD oil (Cannabidiol). Why the sudden rush to regulate, and where does the FDA stand on the packaging, promotion, and quality assurance of CBD oil?
With the passing of the Agriculture Improvement Act of 2018 also known as the U.S. Farm Bill in December of 2018, CBD oil manufacturers suddenly found themselves in an all-holds-barred business boom. The bill legalized what it designated as “industrial hemp,” or the growth and production of cannabis products containing less than 0.3% THC, the psychoactive element contained in much higher amounts in marijuana.
But while the U.S. Food and Drug Administration is still scratching its head over how to tackle the behemoth task of regulating this now-legal substance, individual states are starting to develop their own legislation about what is and isn’t allowed. However, this patchwork regulation is further complicated by the fact that CBD oil can be shipped to all fifty states, and state legislation varies widely.
Some advocates and consumers wonder, “Why regulate CBD oil at all?” It’s non-intoxicating and boasts scores of anecdotal support for a wide range of physical and emotional conditions. But with new companies exploding like popcorn, consumers and the industry as a whole can benefit greatly with regulation of this popular product.
For starters, who is responsible for determining the purity of CBD products? Currently, manufacturers are self-regulating their own product, which has the potential for twofold consequences. Ethical companies are taking the initiative to conduct intense third-party testing, and subsequently sharing their lab-verified results to ensure their products are free from contaminants and toxins, such as pesticides, fungicides, mold, heavy metals, fungi, or mycotoxins.
Since the USDA is not currently certifying any domestically grown hemp, outside lab testing is the only way to ensure CBD oil is free from these substances. Some states have created new packaging regulation that requires the CBD manufacturer to include a QR code that links to the most recent lab results. Without access to these lab results, how can consumers be certain they are following the law by consuming only CBD oil that contains less than 0.3% THC?
Dosing is another concern that could be resolved with appropriate FDA regulation. Currently, CBD oil consumers are encouraged to use trial and error to determine their ideal dosage, and some manufacturers aren’t offering specific dosing instructions on their website or the product package. How much CBD oil should you take, how often should you take it, and how much can you take in one day? Is it safe for children, teens, or those who are pregnant or nursing? These questions don’t have clear answers, and that is why CBD is being scientifically investigated by research professionals.
Additionally, potency varies from brand to brand, which makes it difficult for consumers to clearly understand how much CBD they are taking. For example, if a person takes a sublingual dosage of CBD oil in the morning, and then has a CBD-infused latte during their lunch hour, and then rubs some CBD salve into their sore neck, how much CBD have they actually consumed?
The amount of CBD oil varies widely from brand to brand and product to product, and without clarity in the packaging, there are currently numerous unknowns from the end-user perspective. Some states and municipal regulations currently prohibit the sale of foods and beverages infused with CBD oil, until the FDA comes up with uniform dosing recommendations. Research is also necessary to determine any contraindications to the use of CBD oil, such as potential adverse drug interactions, interference with other forms of treatment, or conditions that could potentially worsen.
How should the FDA go about regulating CBD oil? On May 31, 2019, the FDA called a first-of-its-kind all-day public meeting in the interest of public safety. One hundred and forty individuals spoke as representatives of a broad range of CBD-related topics including academia, health professionals, patients, public safety, growers, consumers, manufacturers, retailers, distributors, etc. The event may have raised more questions than it answered, as the FDA has yet to announce its next step in the regulation of CBD.
Essentially, there are two likely outcomes. The FDA could deem CBD oil to be lumped in with medication, which would subject CBD to the same rigorous safety testing and scientific clinical trials as prescription medication. One could argue that this door has already been opened. In June of 2018, the FDA approved Epidiolex (an oral solution of cannabidiol) for the treatment of seizures associated with two very specific and rare kinds of epilepsy. Should the FDA take this route for CBD, it could exercise its option to designate CBD as “breakthrough therapy,” which would expedite clinical research using CBD oil as its primary treatment.
Alternatively, the FDA could choose to categorize CBD oil as a dietary ingredient, which would treat CBD more like vitamins and supplements. Manufacturers and distributors would not be able to make any specific medical claims regarding treatment, and packaging may contain the customary disclaimer, “These statements have not been evaluated by the FDA.” Should this option win out, manufacturers would be responsible for quality assurance, ethical practices and production, and delivery of the promised amount of CBD in their products. Additionally, companies would not be allowed to make any outlandish claims of cure.
But what about products containing CBD, such as lotions, bath bombs, beauty products, dog treats, and salves? Should these be treated as cosmetics? The FDA has quite a lot to sort through as it proceeds with product regulation of CBD.
Some industry experts advocate for label standardization, which would certainly minimize confusion for consumers and streamline production for CBD companies. Can you imagine the challenge manufacturers must overcome to suddenly alter their packaging to suit all of the new state regulation surrounding CBD? Implementation of a national standard for CBD would streamline processes significantly while creating a safer, more seamless consumer experience.
In summary, FDA regulation of CBD oil would help consumers understand their risks and benefits; would clarify dosing, purity, and potency; would help ensure safety and efficacy; and would streamline the consumer process with clear packaging, labeling, and marketing guidelines. Regulation would also provide consequences for companies using questionable or unethical processes to mislead consumers, which would streamline the marketplace.
Crystal Guess, Senior Client Relations Associate at NuLeaf Naturals, a Denver-based CBD manufacturer, was in attendance at the FDA open forum in May. “We need labeling, we need education, and we need the ability to hold companies and individuals who make false promises responsible.” Indeed we do. The question is, how long will it take?