Is CBD a drug, a dietary supplement, or food (or all/none)? Can it be marketed under any of these labels?
Recently, the FDA clarified one aspect of this puzzle: CBD products should not be marketed as drugs unless they went through a rigorous regulatory scrutiny.
This month, the FDA – together with the FTC – issued warning letters to three CBD manufacturers making unsubstantiated medical claims about their products’ ability to treat various conditions. For example, some of the claims included such statements as:
“CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
“For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
“Cannabidiol May be Effective for Treating Substance Use Disorders.”
CBD may be used to avoid or reduce withdrawal symptoms.”
Note that none of the manufacturers used concrete statements, such as “CBD cures/helps /relieves, etc.” They were simply stating that there is a possibility that CBD may relieve the symptoms or improve a condition or is a treatment option. Even in this form, such statements constitute health claims. The FDA must pre-approve all health claims, and requires that they be supported by evidence from scientific studies.
If you are thinking: how about the Farm Bill that was recently signed? Know that it has not changed the way how the FDA looks at health-claims on non-approved (by the FDA) products.
Agriculture Improvement Act of 2018 (the Farm Bill) established a new category of cannabis classified as “hemp” – defined as cannabis with extremely low (no more than 0.3%) concentrations of the THC. The Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law.
Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. The FDA – however – is struggling with hemp classification and marketing requirements. It will hold a public hearing on May 31 to discuss CBD health claims and whether they are justified and explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. If you are in the CBD business, this is your opportunity to be heard.
On multiple occasions, the FDA stressed that it now treats CBD products as any other FDA-regulated product. Therefore, the FDA requires a CBD product that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce.
The FDA also announced that it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements. This is because CBD and THC are active ingredients in FDA-approved drug products (e.g. Epidiolex) and were the subject of substantial clinical investigations before they were marketed as food. In such situations, with certain exceptions that are not applicable here, the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use.
There is no clear definition – however – of “unauthorized claims” that would put CBD companies at risk of enforcement actions. The FDA hopes the stakeholders submit additional scientific and researched evidence of the CBD’s potential at its May 31st hearing. Meanwhile, if you are a producer or manufacturer – do not make any health-related claims on your products. The only claim which you can currently make is “claims of well-being” (e.g. statements that a product can “make you feel better”). Such claims do not require FDA’s pre-approval.