By Stacy L. Ehrlich and Justine E. Lenehan
It has been a tough week for cannabidiol (CBD) products.
In a December 22 post, we discussed the Federal Trade Commission’s first legal action taken against marketers of deceptively marketed CBD products. Later that day, the Food and Drug Administration (FDA) issued its latest round of warning letters to companies marketing unapproved CBD products that claim to treat medical conditions.
FDA continues to take a risk-based enforcement strategy with respect to CBD products. The products that were the subject of the most recent warning letters were particularly troubling from a public health perspective not only because of their impermissible health claims, but also due to their routes of administration, including nasal (e.g., nasal sprays), ophthalmic (e.g., eye drops), and inhalation (e.g., inhalers and vapor products).[1]
Many of the CBD products cited by FDA in this latest group of five warning letters were marketed with claims that rendered the products unapproved new drugs, such as:
- “May reduce acne. CBD has anti-inflammatory properties that may have a beneficial effect on acne.”
- “Applications of CBD as an anti-inflammatory, anti-bacterial, neuroprotective and vasodilator compound are well researched and documented”
- “Pain . . . Several studies have shown a significant decrease in joint pain and chronic pain for users of CBD”
- “VISION+CBD Eye DROPS . . . Also assists in combating ocular degeneration or inflammatory conditions such as (but not limited to) #glaucoma, #cataracts, #floaters, and diabetic #retinopathy. #HempCBD #CBDeyeDrops #EyeHealth”
- “Cannabidiol in Anxiety and Sleep: . . . Cannabidiol may hold benefits for anxiety-related disorders”
The warning letters point out that the cited products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body of humans or animals. The letters then observe that because the products are not generally recognized as safe and effective for their intended uses, they are “new drugs” under section 201(p) of the FFDCA. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior FDA approval unless they are over-the-counter (OTC) drugs lawfully marketed under section 505G of the FFDCA (which is not the case for these products). In its press release announcing the warning letters,[2] FDA further points out that it is unknown whether the cited products “are effective for the uses claimed in labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products[,] whether they have dangerous side effects or other safety concerns . . . or what the manufacturing conditions of, or contaminant levels in these products may be.”
Notably, not all of the claims cited by FDA as indicative of a drug intended use reference CBD specifically. For example, FDA called out the following statements on the “Why Honey + CBD?” section of Bee Delightful’s website:[3]
- “It contains antibacterial and antifungal properties. Did you know that raw honey naturally contains the antiseptic hydrogen peroxide? While it can kill unwanted bacteria and fungus, the effectiveness depends on the type of honey.”
- “Phytonutrients, containing . . . antibacterial and antifungal properties . . . can also help protect us. The phytonutrients in raw honey have also shown to have . . . anticancer benefits.”
Thus, while any unauthorized drug claims present risk of FDA enforcement, the mere presence of CBD in a product may elicit even greater scrutiny from the FDA.
In other cases, marketers added CBD to various conventional food products (e.g., lollipops, gummies, chocolate, etc.).[4] In order for an ingredient to be included in a conventional food product, it must either be approved as a food additive or “generally recognized as safe” (GRAS). However, as FDA indicated, there is no food additive regulation authorizing the use of CBD and the Agency is not aware of any basis to conclude that CBD is GRAS. Consequently, FDA deemed the ingredient an unsafe food additive, rendering the products adulterated. Further, FDA alleged that it is a “prohibited act” to introduce CBD-containing foods into interstate commerce under section 301(ll) of the FFDCA.
FDA also asserted that a variety of products intended for animals – eye drops, cookie treats, tinctures, and pet shampoo – were unapproved new animal drugs.[5]
The allegations in these warning letters are similar to those that FDA has made in prior warning letters since at least 2017. FDA continues to be active in its monitoring and enforcement related to the growing CBD market, particularly where the products could present a meaningful risk of harm to the public. Nevertheless, in its press release announcing these warning letters, FDA purports to also be focused on “exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety.”[6] It remains to be seen whether this week’s actions by the FTC and FDA against CBD products will make a dent in this rapidly proliferating marketplace – and it also remains to be seen whether enforcement practices might change under the incoming Biden Administration.
[1] Press Release, FDA Warns Companies Illegally Selling CBD Products (Dec. 22, 2020).
[2] Press Release, FDA Warns Companies Illegally Selling CBD Products (Dec. 22, 2020).
[3] Warning Letter to Bee Delightful (December 22, 2020).
[4] See Warning Letter to Bee Delightful (December 22, 2020); Warning Letter to NextL3vel Services Group, LLC dba This Stuff Is Good For You (December 22, 2020); Warning Letter to Wellness BioSciences Rx (December 22, 2020).
[5] See Warning Letter to G & L Wellness, LLC (December 22, 2020); Warning Letter to NextL3vel Services Group, LLC dba This Stuff Is Good For You (December 22, 2020).
[6] Press Release, FDA Warns Companies Illegally Selling CBD Products (Dec. 22, 2020).