CBD craze is out of hand
Cannabidiol — better known as CBD — is everywhere, from small specialty shops to large national retail chains. It can be found in foods, supplements, drugs, oils, creams, pet foods and more, and sellers purport that the compound treats everything from cancer to depression. Analysts predict the market could surpass $20 billion by 2024.
But many of the compound’s expansive benefits are fanciful. In fact, the sale of much of the product is illegal under current law. The Food and Drug Administration must act to make sure commercial interests don’t strip away any legitimate value the compound might have.
Most CBD is derived from hemp, the commodity that was legalized in the 2018 farm bill. But the law still prohibits putting the chemical in food or pet food, and the FDA has issued repeated warnings and actions on the blooming CBD industry. There’s only one legally available purified form of CBD: the drug Epidiolex, approved by the FDA in 2018 to treat seizure disorders.
There is a route for CBD to be legally sold in other forms, including as a food ingredient, and CBD offers potential benefits. But that legal path should be based on a clear and efficient regulatory process and sound science.
CBD has risks: It can cause damage to the liver at high doses, and it may have a cumulative effect. If you eat CBD in your breakfast, lunch and dinner, you could get a toxic dose. Currently marketed products might also have undeclared ingredients and impurities, including the psychoactive compound found in marijuana, THC.
Any path to allow CBD to be added to food products needs to preserve the incentive to study the compound in rigorous, clinical trials to prove its therapeutic potential as a medicine. It’s not appropriate or legal to make such claims otherwise.
The conflict in grappling with these illegal products stems from the misperception that the 2018 farm bill fully “legalized” CBD. When Congress passed the bill, it established a category of cannabis from hemp defined by extremely low concentrations of THC. But in doing so, Congress explicitly preserved the FDA’s authority to regulate CBD-containing products to make sure they’re safe and that their claims are valid.
Under current law, CBD is permitted in food or dietary supplements only if the FDA issues a regulation allowing its use. This is a multiyear process subject to notice and comment, requiring a substantial amount of scientific data for the FDA to dig through.
Given the pressure on the FDA to create a more immediate path for CBD products, this route might take too long. The FDA can fulfill its public health obligations and meet the political demand for these goods by approving the sale of some CBD products immediately, while effecting a framework for their safe and proper regulation.
The FDA could put the onus on manufacturers to bring forward petitions to demonstrate that CBD can be safely added to products such as food. These submissions can take the form of new dietary ingredient notifications or food additive petitions, which would include toxicity studies to evaluate the safety of CBD. These are the same standards any new food ingredients are held to. Congress can help by passing language saying that the FDA doesn’t need to issue a broad regulation on CBD and can instead rely on petitions filed by individual, prospective producers.
In the meantime, the FDA could exercise enforcement discretion to allow CBD to be marketed in food so long as the products meet certain conditions. This could mean good manufacturing requirements, showing dosage traceability, sticking to safe levels for the purity and potency, and demonstrating that CBD is being added to food products only in very low concentrations that are unlikely to pose health risks.
In setting policy, the FDA could make clear that any CBD products that remain on the market — subject to a limited period of enforcement discretion— may not make any claims to treat disease. Other claims — for example, that it might help with relaxation — require evidence. This pathway should also be unique for CBD. Otherwise, there’s a risk it becomes a possible back door for food and supplement makers seeking to add other drugs to foods.