On November 25, 2019, the U.S. Food and Drug Administration (FDA or the Agency) announced that it had issued Warning Letters to 15 companies for illegally selling products containing cannabidiol (CBD). Simultaneous with its latest round of CBD-related enforcement, the Agency also published a revised Consumer Update, in which it detailed specific safety concerns and questions about CBD products. Although FDA raised these concerns and questions before (e.g., at its May 31, 2019 CBD hearing and in a previous version of the Consumer Update), the Agency was a bit more specific in these most recent communications.
Despite widespread interest in FDA's approach to CBD products, and pressure from trade groups, members of Congress (see here and here), and consumers to establish a pathway to market consumer CBD products, the timing of the Agency's announcement is interesting, but not surprising. First, Senate Majority Leader Mitch McConnell has proposed report language to accompany the Agriculture Appropriations Bill, which would instruct FDA to, within 120 days of the underlying bill being signed into law, issue a policy of enforcement discretion with regard to certain products containing CBD. The Agency's recent actions could be FDA voicing its specific concerns about CBD in order to give the Agency cover for not implementing an industry-friendly enforcement policy (i.e., in response to the report language). If Congress gives the Agency a blank check to issue "something" within 120 days, FDA would likely take the path of least resistance (e.g., permit only low amounts of CBD per serving, prohibit companies from making claims, only permit certain product forms, etc.). Second, it is a slower-than-normal news week, given the upcoming holiday, and the Agency might have hoped that its latest efforts to crack down on a publicly-popular industry would be less conspicuous to stakeholders than normal. Third, Dr. Stephen Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center, and President Trump's nominee to serve as the next FDA commissioner, has yet to be confirmed by the U.S. Senate. Given the lack of certainty around how Dr. Hahn, if confirmed, will approach CBD, it is possible FDA pushed out this new round of enforcement and guidance ahead of Hahn joining the Agency as a way to preserve FDA's position.
Although the Agency's Consumer Update, "What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD," is not new – FDA issued it for the first time in July 2019 – this latest version contains some enhancements to FDA's previously-articulated positions. Based on what the Agency has characterized as a "lack of scientific information supporting the safety of CBD in food," FDA indicated definitively in this version, for the first time, that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. By way of background, any substance that is intentionally added to food is a food additive that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.
Moreover, the Agency again detailed the potential risks associated with using CBD products, including: liver injury; affecting the metabolism of other drugs; and sedation or drowsiness caused by use with alcohol or other depressants. FDA also reiterated potential side effects that CBD could cause, including: changes in alertness; gastrointestinal distress; and changes in mood. Finally, the Agency again noted that there are several unknowns related to CBD, including: what happens if you take CBD daily for sustained periods of time; what is the effect of CBD on the developing brain; what are the effects of CBD on the developing fetus or breastfed newborn; how does CBD interact with herbs and botanicals; and does CBD cause male reproductive toxicity in humans. Again, while FDA had previously teed up potential risks, side effects, and unknowns related to CBD, the Agency has further specified these points in the most recent iteration of the Consumer Update.
Historically, and as discussed previously (here, here, here, here, and here), the Agency has focused its CBD enforcement on marketers making aggressive therapeutic claims (e.g., for treatment of Alzheimer's disease, psychiatric disorders, and diabetes). In a potential foreshadowing of expanded enforcement, the Agency indicated in its update that, in addition to continuing to pursue such products, it will also monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants (e.g., pesticides, heavy metals, delta-9 tetrahydrocannabinol (THC)) and those marketed to vulnerable populations (e.g., the elderly, children, adolescents, pregnant, and lactating women).
FDA's latest Consumer Update does not discuss use of, or risks associated with, topical CBD products, use of which has been expressly permitted by FDA in the past (absent therapeutic claims). Accordingly, topical products without claims continue to be permissible, although it is worth monitoring this area closely. The Agency's focus instead remains on CBD added to human foods and supplements, and animal foods and feeds, which still remain, in the Agency's view, illegal to market under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
In addition to issuing its revised Consumer Update, FDA also published 15 new Warning Letters that it sent recently to online CBD retailers. These Warning Letters maintain the themes evident in earlier enforcement sweeps from 2015, 2016, 2017, and 2018, but also include new language representing FDA's determination that CBD is not presently recognized as GRAS in human or animal food.
In the most recent Warning Letters, FDA cited problematic labeling and claims observed on retailers' websites, in social media posts, and in customer testimonials. While the Agency certainly continued to target aggressive therapeutic claims aimed at vulnerable populations (such as children or the chronically ill) as it has in the past, notably, the Agency also addressed less aggressive claims, including use to manage "aches and pain," "minor pain that comes with exercise," skin irritation, inflammation, promoting a "calming effect," and improving mood. In spite of this new scrutiny, however, we have not yet seen standalone enforcement action for these traditionally lower-risk claims; each target made aggressive therapeutic claims, as well.
FDA took issue with many retailers' CBD dietary supplement labeling, noting that, simply because a product may be otherwise properly labeled as a dietary supplement, once it contains CBD, the product is no longer a permissible supplement. Among the myriad reasons why CBD firms may decide to label their ingestible products as supplements is that they are required to do so by state law (e.g., New York). Just as in the less aggressive claims context, discussed above, simply labeling a CBD product as a supplement is not currently grounds for receiving a Warning Letter. There would have to at least be an aggressive claim before FDA would issue a Warning Letter for a product being labeled as a supplement. The Agency also cited many retailers for use of health claims in the pet product context, rendering such products unapproved new animal drugs under the FD&C Act.
Ultimately, it is clear that the Agency is trying to curb the recent explosion of CBD products. These Warning Letters emphasize that no health claims, no matter how seemingly innocuous, are permissible. CBD ingestibles marketed without health claims are likely lower risk, but because of FDA's concern about marketing to vulnerable user populations, companies choosing to market in this space should be exceedingly careful, as the Agency could police such sales more aggressively in the future.
While it cannot be denied that the Agency was more specific in its safety assessments and questions in its Consumer Update and Warning Letters than it had been previously, FDA's latest concerns in the CBD context are nothing new. The Agency continues to remain focused on aggressive therapeutic claims, but has now suggested that it will monitor products for general therapeutic claims, as well, particularly when directed at vulnerable populations.
We will continue to closely monitor this space as FDA's regulatory treatment of CBD products evolves. In the meantime, if you have questions regarding an issue raised in this post, please contact the authors or the attorney at the firm with whom you are regularly in contact.