It seems as though products containing cannabidiol (CBD) are everywhere – in supermarkets, health food stores, gyms, even the corner convenience store. And CBD can come in almost every product, regardless of the shape or size: oil, toothpicks, dog treats, beverages, lotions, creams, bath bombs, gummies, and coffee, to name but a few.
Businesses, however, may not know whether – or how – they can sell CBD products, and consumers may not know just what it is they are buying.
Adding to this confusion is the relative lack of information from the U.S. Food and Drug Administration (FDA). Recently, the FDA has been holding hearings to understand more about the science and safety of CBD. But the FDA still has not issued definitive guidance in the wake of the 2018 Farm Bill, which allowed for the production and marketing of many products containing CBD.
Below are a few commonly asked questions; the answers, however, are still in flux given the state of the complex regulatory frameworks at play.
What is CBD, and is it legal?
Cannabidiol is an active chemical compound commonly found in cannabis. Unlike delta-9-tetrahydrocannabinol (THC), CBD does not cause a high. Although both CBD and THC are found in some cannabis strains, the 2018 Farm Bill allowed for the production and marketing of “hemp.” Hemp, in essence, means cannabis with less than 0.3% THC concentration on a dry weight basis.
In other words, cannabis plants and derivatives (including CBD) with less than 0.3 percent THC are no longer controlled substances under federal law.
How does the FDA treat CBD now?
Currently, the FDA has approved CBD for one prescription drug product, for the treatment of a rare and severe childhood-onset epileptic syndrome. Other than that one drug, the FDA has not approved any other CBD product. And because the FDA has approved CBD for use in a drug, the use of CBD in the food supply is complicated.
The FDA has not reviewed other CBD products to determine their safety or effectiveness in treating medical conditions, proper dosages, or whether there are other potential safety concerns. Because of this, and because of the FDA’s focus on protecting the public health, the FDA has issued warning letters to companies selling CBD products that claim to prevent or treat diseases or illnesses.
Additionally, the FDA has tested some products’ chemical composition to determine whether the product contains the quantity of CBD claimed on a label. If the label is inaccurate, then not only may a business run afoul of the federal Food, Drug & Cosmetic Act, but there could also be potential violations of state law as well, even in states where recreational marijuana is legal.
Can CBD products be sold?
It depends. First, the CBD product will need to meet the definition of “hemp” from federal law. Then, the CBD product also needs to comply with other state and federal law, most notably the federal Food, Drug & Cosmetic Act. Under the FD&C Act, currently, CBD products cannot be sold as dietary supplements. Similarly, CBD products cannot currently be marketed for therapeutic or medical uses (unless approved by the FDA).
Additionally, the FDA has taken the stance that CBD may not be included in any food, whether for humans or animals, because CBD is an active ingredient in an approved drug. While there are exceptions to that rule, the FDA’s current view is that none of the exceptions applies to CBD.
Nevertheless, the FDA’s view is more forgiving with “cosmetics” (i.e., products that can be applied to the body) or topical products. Broadly speaking, CBD may be used in cosmetics so long as the product is not otherwise adulterated, misbranded, or contains a “poisonous or deleterious substance.”
What will the FDA do?
Unfortunately, FDA guidance is still to be determined. The FDA has indicated that it is committed to supporting new drugs through the new drug approval process, and this includes products containing CBD. The FDA has also said that it is looking into updating its regulations to allow for non-drug uses. Before it will revise those regulations, however, it needs additional study of the science behind CBD.
Unfortunately for businesses and consumers, definitive regulatory guidance for CBD products is still some time off in the future. In the meantime, we are left in a situation where the market appears to have jumped ahead of the regulators, and until more guidance comes, we are left with many answers still to be determined.
Contact Christopher if you are a business with questions on how your CBD product fits into the regulatory landscape or an attorney in our Cannabis Industry Group to learn more about how we can be an asset for businesses in the cannabis and hemp industries.
Filed under