The FDA and CBD have shared a complex relationship since the re-legalization of industrial hemp. Current FDA CDB regulations are insufficient to regulate hemp-derived CBD practically or to satisfy their duties as stipulated by Congress. A recent FDA hearing on CBD, however, shows that the FDA is aware of and intends to correct these discrepancies, but no one is yet sure what form the new regulatory framework will take. Let’s take a look at the near-term aftermath of the recent hearing, what led up to it, and where CBD and the FDA may be headed.
Pre-CBD FDA Regulations: A Brief History Of Hemp
For thousands of years, hemp has been used by humans as a source of fiber, oil, and wellness benefits. From ancient civilizations to the new world, hemp’s history has run alongside the development of human civilization. It was so important to the new United States of America, in fact, that many founding fathers grew hemp on their agricultural holdings and it was considered an important cash crop of vital strategic importance. All patriotic Americans were encouraged to grow hemp to provide trade goods to help pay the extensive revolutionary war debts owed the French government, to create rope and sails for our nascent navy, and uniforms for the new federal army.
Before the FDA, the first regulations affecting CBD were actually hemp regulations. Due to its variety of commercial and industrial uses, hemp threatened the monopolies that reigned over commerce in the early 20th century. Through a coordinated effort by some of America’s leading business families and Randolph Hearst’s publishing empire, industrial hemp was successfully smeared as being no different from marijuana. Marijuana itself was being targeted by a racist attack (the first of many) meant to portray it as the drug of minorities, capable of loosening morals and turning users into savages. The Marijuana Tax Act of 1937 levied heavy taxes on any commercial cannabis enterprise, effectively destroying the hemp industry until World War II.
While World War II saw a brief resurgence in hemp as America sought to replace other commercial materials needed for the war efforts, soon after the war ended, vilification returned. In 1969, the Marijuana Tax Act was overturned by the Supreme Court, but victory would be short-lived, as the Controlled Substances Act of 1970 listed all cannabis plants as a schedule 1 controlled substance, effectively banning all cannabis as having no value to health or wellness while being highly addictive.
CBD and the FDA began their relationship in earnest as attention turned toward the medicinal use of cannabis as an aging America sought more natural remedies for a variety of ailments not fully addressed by modern medicine. As the organization in charge of ensuring America’s food and medications, the FDA has been at the center of efforts to approve cannabis and its active compounds for medical and wellness use, despite the fallacies a Schedule 1 listing implied. That means the FDA has played a role since the 1970s in America’s federal small legal medical marijuana program as well as medical trials related to THC and CBD.
The Re-Legalization Of Hemp
Bowing to increasing public pressure, the 2014 Farm Bill included provisions to allow states to set up pilot programs to explore the commercialization of hemp. It defined industrial hemp as cannabis Sativa plants with a THC concentration of 0.3% or less. While these pilot programs varied in nature, they began the reintroduction of hemp-derived products, particularly CBD, and the FDA was expected to be front and center in monitoring these programs and advising on policy.
With the passage of the 2018 Farm Bill, the pilot program stipulation was eliminated in favor of full federal recognition of industrial hemp as a separate plant, no longer scheduled with its illicit sister. The USDA was tasked with managing the nation’s agricultural interests in hemp production, while the FDA would create CBD regulations and enforce them by establishing a regulatory framework. This would formalize the relationship between the FDA and CBD producers, processors, and suppliers, ensuring that Americans would have access to safe, regulated CBD products.
After The 2018 Farm Bill
This most recent farm bill was passed and signed into law on December 2018, changing the landscape for hemp-derived CBD overnight, although there’s been confusion over just what those changes were. States have struggled to pass their own laws protecting CBD-using-citizens from prosecution by aggressive DAs based on outdated state laws meant to mirror the former federal cannabis restrictions. Federal agencies have struggled to keep up with the new reality of legal cannabis, both within those bodies tasked with its regulation and other departments; the TSA and FAA, for example, have found themselves dealing with a new class of cargo and figuring out what it meant for people to travel with CBD oil. Meanwhile, without additional guidance from the FDA and CBD demand increasing among consumers, the market has continued to explode with new products from new manufacturers with questionable experiences and practices.
This is not to say the FDA has been entirely absent. On the contrary, they have been aggressive with warning letters and policy statements that address narrowly defined CBD issues not based on FDA CBD regulations, but administrative guidelines. Based on the policy that no active ingredient in a drug can be used as a food additive without an FDA exception, they issued a statement banning CBD’s use in commercial food and beverages, prompting the New York City Department of Health to issue a ban on its inclusion in menu items, a popular trend in upscale restaurants and bistros. Companies have received warnings about making specific health claims without approval.
The FDA’s July CBD Hearing
It was welcome news when it was announced that July would see a new hearing by the FDA and CBD would be the topic of discussion. While some were concerned that this would be the first step to government overreach–not unfounded considering the treatment of other natural substances considered problematic by some (Kratom, for example)–most industry professionals were hopeful this would be the first step toward a safer, more consistent industry for the consumer.
Largely, the results of the hearing were positive. Based on statements made and questions asked, the FDA seems determined to make a thoughtful, well-reasoned, science-based approach to managing the hemp-derivative market. Questions were asked about the scope of the market currently, and the opinions of major manufacturers, advocates, and public health officials on issues that they feel need to be addressed to foster the protection of consumers and responsible market growth. It was made clear early on that while we shouldn’t expect a permanent resolution, the FDA and CBD leaders were interested in finding common ground.
To further that goal, a new commission to evaluate major questions about CBD was established under the direction of Amy Abernethy, M.D., Ph.D. With a mandate to report on progress for the coming legislative framework by fall, they’ll be addressing recommended safe dosage levels, looking at potential health concerns uncovered during the medical trials of Epidiolex for long-time user of a high-quantity of CBD, FDA CBD regulations related to processing and production guidelines and standards, and how CBD affects people with special health conditions, such as children, the elderly, and those with existing conditions or medication programs that may react to CBD.
There will also need to be a discussion about existing issues, such as the potential for an exception made allowing the use of low dosage CBD in commercial food, labeling practices, and what kind of certifications, if any, will be needed to ensure consumers have adequate confidence in the CBD products they’re buying. It is a herculean task, and while the initial report may be released in the fall, actionable results may lag further behind still. That’s why it’s so important for consumers and reputable manufacturers to unite now to help create a better marketplace for CBD and show the FDA a way forward.
Make The Choice For Better CBD Now
As industry leaders, Core CBD is proud to hold ourselves to a higher standard for the CBD we offer our customers. That’s why we ensure we have an uncontaminated supply of naturally grown industrial hemp from the fertile lands of the Pacific Northwest and Kentucky. Our pharmaceutical-grade processing facility gives us a clean-room environment where our CBD specialist process raw plant material in multi-million dollar machines that are purpose-built to deliver an ultra-pure CBD oil. Then it’s formulated into products containing the finest ingredients on the market before being sent to third-party labs for independent testing. By choosing our products, you’re helping show the FDA CBD and high standards can coexist.
You can be sure that we’re watching the FDA’s deliberations and developments in federal, state, and local regulation closely, and we’ll keep you informed on the issues affecting your CBD access. If you have any questions, call and talk to one of our CBD experts. Order your premium CBD products online from Core CBD today.