“On May 31, 2019, over 100 speakers, including industry scientists, researchers, advocates, parents and health professionals, descended upon Washington to share their experiences and findings at the FDA’s first public hearing on CBD.”
The market has been flooded with cannabidiol (CBD) products over the past year, from creams, balms, and oils to beverages and baked goods. In fact, Kroger, the nation’s largest grocery retailer, just announced that they will sell CBD in nearly 1,000 stores within the next few weeks. This puts them in the company of a growing list of national retailers and big brands entering the market, including Walgreens, CVS, Coca-Cola and Mondelez International, the maker of Oreo, Chips Ahoy and Cadbury.
CBD is the non-psychoactive cannabinoid best known for its perceived medical benefits. There are two main sources of CBD, cannabis and hemp. Cannabis, the lesser known but accurate name for the marijuana plant, is not as readily available, but certainly becoming so. The major difference? CBD derived from hemp, by nature, contains 0.3% or less of tetrahydrocannabinol (THC), a compound known to induce psychotropic or euphoric effects on the user, while cannabis can contain more.
With the signing of the 2018 Farm Bill, the federal government now fully recognizes hemp as a legal agricultural product in all 50 states. The lines are still quite blurry, however, as to the legality of CBD derived from cannabis versus hemp, whether it can be shipped or consumed in certain states, and the ability to make health-related CBD claims or refer to it as a dietary supplement.
What is the Big Deal With CBD?
While there has been little research done to corroborate the health claims that producers and users make, CBD has been said to cure or ease a wide swath of ailments, including anxiety, insomnia, chronic pain, autoimmune disease, and some claim it can cure cancer and Alzheimer’s.
The difficulty remains that, due in part to strict regulations, very few studies have been done to prove these claims, and CBD remains in a very gray area. Yet patients continue to flood the Internet and publications with testimonials to this powerful plant.
Queue the FDA
On May 31, 2019, over 100 speakers, including industry scientists, researchers, advocates, parents and health professionals, descended upon Washington to share their experiences and findings at the FDA’s first public hearing on CBD. The major issue at hand was that with the passage of the 2018 Farm Bill, industrial hemp production and hemp-derived products—including CBD—were legalized, but this did not legalize CBD derived from cannabis or adding CBD of any kind to food, beverages, and dietary supplements.
This initial hearing was intended to lay the groundwork for what will most likely evolve into a lengthy process. The FDA made it very clear that they have serious reservations about CBD and its effectiveness.
Also brought to the public’s attention was the well-known fact among industry insiders that CBD products don’t necessarily contain what they say they do. A study from the JAMA Network journal recently noted that more than two-thirds of CBD products tested by researchers were mislabeled, actually containing more or less CBD than listed, or in some cases, none at all. Some even contained elevated levels of THC. Toxicologists also noted finding evidence of high levels of pesticides, toxins, bacteria and heavy metals in many of the products they tested.
So What is the Net-Net?
The FDA is acknowledging the fact that CBD and its applications have become larger than life in many respects. The industry is already deemed too big to fail, and the FDA is picking up the responsibility of regulating the space and taking steps forward to formally recognize hemp-derived CBD as a dietary supplement or food additive.
The FDA will ultimately be responsible for setting guidelines to be used for packaging and labeling and ensuring that safe levels of CBD, and more importantly THC, are being used. Compliance is key, and the agency will be tasked with enforcing good manufacturing practices ensuring that products are being produced consistently and controlled according to quality standards.
While the FDA’s regulatory process for CBD is far from over and may prove to be a laborious journey for the agency and businesses alike, the ultimate goal is to protect consumers and guarantee that the CBD products they are purchasing are safe.
This does create a lot of uncertainty for growers, business-owners and patients who depend on CBD to help ease their medical conditions. The FDA’s review is slated to continue through mid summer.