Allison Fulton and Sarah Blitz are members of Sheppard, Mullin, Richter & Hampton's cannabis industry team and advise companies in matters relating to the development, manufacture and marketing of products regulated by the FDA.
CBD has quickly gained mainstream popularity. The market is flooded with hemp-based, CBD-infused products including gummy candies, coffee, honey, sparkling water, popcorn, cereal and cookies. And yet the U.S. Food and Drug Administration has made it clear that any food containing CBD is illegal under federal law. The FDA is under pressure from stakeholders to find a regulatory path forward for CBD-containing foods. Until then, however, it is a regulatory wild west.
The 2018 Farm Bill legalized hemp, but the status of hemp-derived CBD remains in regulatory limbo. The FDA prohibits the introduction of food or dietary supplements containing added CBD regardless of whether the CBD is hemp derived. Under the Federal Food, Drug and Cosmetic Act, a manufacturer may not introduce into commerce a food or dietary supplement containing an active ingredient that is in an FDA-approved drug or for which substantial clinical investigations have been conducted. CBD is an active ingredient in FDA-approved drugs and has been the subject of substantial clinical investigations, and therefore is not permitted in food.
In May 2019, FDA held a public hearing on how FDA should, or should not, regulate cannabis derived products. The FDA did not provide a strategy for regulating cannabis at the hearing. FDA panelists, however, did ask questions that reveal the agency’s concerns over the widespread use of CBD in the food supply, including the scientific evidence to support safe levels of CBD in various forms, restrictions on youth access and data collection efforts by consumer product companies to identify adverse events experienced by the larger consumer base.
Since 2015, FDA has issued about 25 warning letters to companies selling CBD-derived human and animal products. "Warning Letters" are administrative actions that are akin to cease and desist letters. The majority cited hemp or CBD-derived human ingestible products, such as oils, tinctures, gummies, lollipops and capsules. FDA's most recent warning letter was published in September 2019.
The FDA objected to a variety of specific claims — including anxiety, pain, arthritis and cancer — for CBD-infused products in its warning letters. Here are some of the claims that FDA objected to:
- "CBD promotes neurogenesis, or the growth and development of neurons, slowing the deterioration of cognitive functions."
- "Natural cannabinoids, such as CBD (cannabidiol), have been shown in research to have therapeutic possibilities in helping diabetes."
- "CBD was administered after onset of clinical symptoms, and in both models of arthritis the treatment effectively blocked progression of arthritis.”
- "CBD has been shown to reduce growth of aggressive human breast cancer cells in vitro, and to reduce their invasiveness."
Guideposts from the warning letters
The FDA does not plan to exercise a policy of enforcement discretion with respect to any CBD products, yet the agency has garnered criticism for not aggressively pursuing marketers of online retailers of CBD products. While the FDA has issued a handful of warning letters to companies making egregious therapeutic claims, it has not initiated an aggressive pursuit of CBD marketers.
Based on the warning letters, the following are guideposts that legal and marketing teams should consider as they advise on strategies for promoting their products.
- Avoid "over-the-line" therapeutic claims. A clear takeaway from the letters is that FDA's focus is on therapeutic claims for diseases and serious conditions. Claims that CBD can treat diseases such as arthritis, Alzheimer’s, bipolar disorder and cancer are a major red flag to FDA.
- Avoid "pain," "anxiety" and other "drug-like" claims. Like therapeutic claims, claims about treating or alleviating symptoms such as "pain," "inflammation" or "anxiety" are likely to be considered impermissible "drug-like" claims for food products.
- Claims on social media, and testimonials, are fair game. All of the warning letters include claims from the company’s website, and nearly all of the letters cite to statements on social media sites like Twitter. For example, FDA cited to customer testimonials such as: "I was pleasantly surprised to find that CBD helped my arthritis," and "I have been severely depressed . . . [so] I started taking this [CBD oil] product . . . I have gone from basically clinically depressed to feeling OK about life." Website and social media sites are easy for regulators to access remotely, and companies should be monitoring posts on their social media sites to ensure impermissible drug-like claims — whether explicit or implied — are not being posted.
Joining the CBD product trend may be lucrative, but companies should use caution and consult with qualified counsel to avoid potential pitfalls and enforcement actions.