The US Food and Drug Administration recently issued warning letters to four companies – Stanley Brothers Social Enterprises LLC, Greenroads Health, Natural Alchemist, and That’s Natural! Marketing and Consulting – that market edibles, oils, tinctures, capsules, and topical creams containing cannabidiol (CBD), a non-psychotropic cannabinoid found in cannabis. Although the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) cited in these letters are nothing new (FDA sent similar letters to more than a dozen CBD companies in 2015 and 2016), they should serve as a reminder to companies marketing and selling these products that the FDA is watching and, in the words of Commissioner Scott Gottlieb, will “not look the other way” when it comes to making unsubstantiated claims.
Unsupported Health Claims & Intended Use
FDA’s primary objection noted in the most recent warning letters concerned the claims being made about the CBD-infused products on the companies’ websites and social media. Under the FD&C Act, a product becomes a “drug” (and is, therefore, subject to many stringent regulatory requirements) if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
In evaluating whether a product is intended for use as a drug, among other things, FDA looks to the statements made by the company marketing the products, as well as the circumstances surrounding the product’s promotion and distribution. Not only will FDA review statements made on product labels and on companies’ websites and social media, but it will also consider customer testimonials, company press releases, and statements made on unaffiliated, but linked websites. Importantly, disclaiming drug claims on product labels or websites (e.g., stating that FDA has not evaluated the claims, or that the products are not intended to diagnose, treat, cure, or prevent any disease) does negate against statements that clearly suggest otherwise.
Examples of the objectionable claims cited by FDA in these four recent warning letters include:
- “CBD [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow.”
- “[CBD] has antipsychotic properties, which makes it very useful for treating bipolar disorder.”
- “The following are some of the many ailments CBD oil can potentially be therapeutic for: asthma, Alzheimer’s disease, arthritis, autism, bipolar disorder, and various types of cancer.”
- “ [C]annabis plant, enriched with CBD, can be used for treating diseases like rheumatoid arthritis, colitis, liver inflammation, heart disease, and diabetes.”
- “Adding CBD oil as part of your daily Alzheimer’s medicine routine has a good chance at delaying the progression of the disease…”
- “Combats tumor and cancer cells”
- “Study: Cannabinoids a Potential Treatment Option for Chemotherapy-Induced Hearing Loss”
- “Almost all studies recognize CBD’s potential in preventing both cancer spread and growth.”
- “A patient of mine uses this for Cancer and it gives lots better relief than prescription drugs!”
- “Excellent Results For My [Traumatic Brain Injury]“
Although making any unapproved drug claim can constitute a violation of the FD&C Act, claims related to serious diseases and vulnerable populations are more likely to draw the attention of FDA –and not only for CBD-infused products. In his November 1 press release, Commissioner Gottlieb emphasized that FDA does not “let companies market products that deliberately prey on sick people with baseless claims.” He also noted that these recent warning letters to CBD companies “buil[d] on the more than 90 warning letters issued in the past 10 years, including more than a dozen this year, to companies marketing hundreds of fraudulent products making cancer claims on websites, social media, and in stores.”
FD&C Act Prohibits CBD in Dietary Supplements & Foods
Also notable in these warning letters is that FDA reiterated its position that CBD may not lawfully be sold in dietary supplements, or added to food, even if no health claims are being made about the products.
The rationale for FDA’s position is that the FD&C Act defines “dietary supplement” to exclude products that contain an FDA-approved drug or a substance that has been “authorized for investigation as a new drug.” FDA has concluded that CBD falls within this latter category because of the clinical research conducted by London-based GW Pharmaceuticals plc for Epidiolex, a drug that contains CBD as the active ingredient (more on Epidiolex below). Because FDA considers CBD to be authorized for investigation as a new drug, any products containing CBD therefore fall outside the statutory definition of dietary supplement. Further, because the FD&C Act prohibits the sale of any food to which an approved or investigational drug has been added, CBD-infused edibles are also prohibited under the FD&C Act.
There is, however, a notable carve out in the FD&C Act – for substances marketed in a dietary supplement or a conventional food before the new drug investigations were authorized. Based on evidence available to FDA, the Agency has concluded that this is not the case for CBD. However, in the recent warning letters, FDA suggested that if the companies have “any evidence that has bearing on this issue,” they should submit that evidence in their responses.
The same day that FDA issued the four warning letters to CBD companies, GW Pharmaceuticals plc completed its rolling New Drug Application for Epidiolex, which is intended to treat certain rare types of seizure disorders. If approved, Epidiolex would be the first plant-derived cannabinoid drug in the US, and its approval could lead to FDA taking a more aggressive stance against unapproved CBD products.
Currently, the Drug Enforcement Administration maintains that CBD is a Schedule 1 substance under the federal Controlled Substances Act, indicating that it has no currently accepted medical use. But FDA’s approval of Epidiolex would affirm the medical use of CBD, and within 90 days of FDA approval, DEA would be required to issue rulemaking to reschedule the substance.
In the past, the FDA has declined to comment on whether it would move to take enforcement action against companies marketing CBD-infused products if an FDA-approved version becomes commercially available. Although it is certainly possible that FDA could assume a more aggressive posture if Epidiolex is approved, given the Agency’s wide-ranging public health priorities and its limited resources, it seems more likely that FDA will continue to exercise enforcement discretion in this space. However, if the Agency becomes aware of a potential safety issue or consumer harm associated with use of unapproved CBD products, FDA will be hard pressed not to take swift action to remove the products from the market.