By Geoffrey Taylor, MA
As hemp farmers, industry investors and CBD consumers celebrated National CBD Day on August 8. Those with a stake in the ever-growing industrial hemp industry are awaiting further clarity on how the US Food and Drug Administration, or FDA, will proceed on further regulation of cannabidiol, or CBD, the non-psychoactive cannabinoid found in higher concentrations in cannabis hemp crops.
In mid-July 2020, the FDA submitted the “Cannabidiol Enforcement Policy: Draft Guidance for Industry” to the White House Office of Management and Budget, showing the agency does plan to seek enforcement on CBD, but not revealing exactly how or what enforcement will look like to the farmers, processors, extractors and retailers in the rapidly growing CBD industry.
The agency seeks to create enforcement policy on the use of CBD in food, beverages, cosmetics, and dietary supplements.
FDA Commissioner Stephen Hahn stated “any enforcement policy would need to further the goals of protecting the public and providing more clarity to the industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.”
Over the last several years, CBD has exploded into the mainstream, being found everywhere from gas stations to high end cocktails, to true plant medicines intended to treat conditions such as seizures.
In addition to the submission of the CBD enforcement policy document, the FDA also released guidance for researchers studying cannabis for the purposes of developing therapeutic pharmaceutical drugs. Unlike it’s psychoactive cannabinoid counterpart THC, CBD is available in nearly all US states in various forms.
However, the FDA issued a statement in 2018 stating that though CBD was no longer a controlled substance under the 2018 Farm Bill, it was still not legal to infuse into food and beverage products despite innumerable companies across the country doing just that. With increasing numbers of federal enforcement cases against those who create, sell and market CBD products, the anxiety across the hemp sector is building.
“I use a lot of CBD in lotions and rubs to help with the arthritis in my hands,” said 84-year-old retired nurse and Bakersfield resident Kay Dodgin, “It’s the only thing that really helps to take the pain away, even temporarily.”
“We’ve heard a lot of our customers tell us that our CBD beverages help them in many ways from calming effects to relief of pain, chemotherapy symptoms and other benefits,” said a Kern County producer of hemp CBD-infused beverages, who wishes to remain anonymous. “Even though this is anecdotal, it still speaks to how people find relief from CBD in their everyday lives, whether it’s our products or another product that they find valuable to their overall health and wellness. Treating CBD as a dietary supplement is important to making it accessible to the public.”
Many in the industry hope to see CBD treated as a dietary supplement rather than a drug, allowing it to be infused into food and beverage, meeting certain production quality control standards and adhering to strict truth-in-labeling policies. Some can find peace in a statement from FDA Commissioner Stephen Hahn to the National Association of State Departments of Agriculture noting that “we’re not going to be able to say you can’t use these products. It’s a fool’s errand to even approach that.”
One problematic area the FDA has addressed is the use of claims that CBD and hemp-derived products can be used as a cure for COVID-19, which is patently false. The FDA has indicated they seek to enforce heavily on products, companies and producers who use false or unsubstantiated claims of how CBD can treat or cure specific ailments without appropriate evidence to do so.
“Bad actors take advantage of the lack of regulation. It’s not about it being a medicine, these actors release products that may not even be effective,” said Carli Hazard, owner of Quartz Trading Company, a Bakersfield based producer of CBD personal care and nutraceutical products since 2016. “We built this foundation for cannabis over years of advocacy and doing the right thing. We deserve the right to continue to formulate medicinal products and provide people with natural alternatives.”
Though the timeline for acceptance and implementation of the FDA Enforcement Guidelines following review by the OMB is unclear, the hemp industry eagerly awaits greater clarity and guidance on what lies ahead for the rapidly expanding hemp and CBD marketplaces.
From growers to processors, extractors to consumer goods manufacturers, more clarity means greater legitimacy to an industry desperately seeking to weed out the bad actors and snake oil salesmen and create industry-wide quality control mechanisms that promote consumer safety and wide accessibility to the public.
