On Wednesday, September 11, 2019, in response to a number of highly-publicized vaping-related deaths and illnesses, the Trump Administration (the Administration) announced its intention to ban most flavored e-cigarette products. While the Administration's proposal would target nicotine-containing e-cigarettes, regulated by the U.S. Food and Drug Administration (FDA or the Agency) as tobacco products, it is not yet clear that these are the products that have been causing vaping-related deaths and illnesses across the country. Although federal and state regulators continue to investigate what is behind these health-related issues, initial results suggest that many, if not all events have been caused by tetrahydrocannabinol (THC)-containing products purchased illegally (i.e., not at state-regulated cannabis dispensaries). While FDA has not yet identified the source of the illnesses, all samples tested by New York State have reportedly contained vitamin E acetate, an oil-based preparation of vitamin E.
Despite the uncertain link between nicotine-containing e-cigarettes and recent vaping injuries, FDA has, for some time now, been frank in its assessment of the impact such products are having on our nation's youth. The Administration's announcement comes on the heels of the publication of the results of the National Youth Tobacco Survey, which reveal staggeringly that over twenty-five percent of high school students are current e-cigarette users, drawn to such products because of popular fruit flavors. The Agency has called the youth vaping crisis an "epidemic."
Just two days before the announced flavor ban, on September 9, 2019, FDA issued another warning letter to JUUL Labs Inc (JUUL) for marketing unauthorized modified risk tobacco products by engaging in suspect advertising practices. Just last year, JUUL was one of 1,300 companies targeted in a robust series of enforcement actions related to the sale and marketing of e-cigarettes to minors (which we discussed in our prior post, here).
In order to implement the Administration's proposed flavor ban, the Agency plans to finalize in the coming weeks a compliance policy that will be designed to strengthen enforcement of FDA's premarket authorization requirements for e-cigarettes that are anything other than tobacco-flavored.
By way of background (see our earlier discussions here and here), on July 28, 2017, FDA announced a comprehensive plan to overhaul the Agency's tobacco regulatory efforts. Under this plan, the deadline for marketing applications for non-combusted products such as electronic nicotine delivery systems (ENDS) or e-cigarettes is August 8, 2022. However, as long as an e-cigarette product was on the market as of August 8, 2016 (i.e., the effective date of FDA's Deeming Rule), the manufacturer could continue to market its product until the marketing application deadline (and during FDA's review of its application). However, under the above-referenced flavor ban, FDA now seems poised to take enforcement action against companies marketing non-tobacco flavored e-cigarette products introduced to the market after August 8, 2016. Acting FDA Commissioner Ned Sharpless, M.D., has kept the door open for more dramatic regulatory action taken with respect to tobacco-flavored e-cigarettes, too, stating that "if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products."
Recent federal marketing scrutiny has extended to cannabidiol (CBD) products, as well. Just one day before the e-cigarette announcement, the Federal Trade Commission (FTC) issued three warning letters to unidentified companies selling CBD products and making aggressive claims that their products worked "like magic" to relieve pain, and were "clinically proven" to treat a variety of serious conditions, including cancer, Alzheimer's disease, multiple sclerosis, fibromyalgia, colitis, depression, and epilepsy. Interestingly, FDA did not join FTC in issuing these letters, as it has done in the past.
As we discussed here and here, although the Agriculture Improvement Act of 2018 (2018 Farm Bill) legalized hemp, after the bill was signed into law, FDA was quick to clarify that it remains unlawful under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. FDA and FTC issued warning letters on March 28, 2019 to three companies making unsubstantiated medical claims similar to those targeted last week by FTC. FTC's recent solo enforcement is interesting, although not necessarily an indication that FDA has lost focus on CBD products. One has to wonder: As researchers, legislators, and regulators clamor to understand what is behind recent vaping-related illnesses, will FDA and states start policing CBD vaping products more aggressively?
While stakeholders consider that question, they should also consider CBD-related language that Senate Majority Leader Mitch McConnell (R-Ky.) recently proposed for inclusion in the report to the 2019 Agriculture Appropriations bill. At the outset, it is important to remember that "report language itself is not law and therefore not binding in the same manner as [statutory] language," as the Congressional Research Service (CRS) has opined. However, as CRS notes, "agencies usually seek to comply with the directives contained" in report language. If the report language is adopted, and if FDA seeks to comply with it, it would mean that:
- Within 90 days, the Agency would need to provide Congress with a report regarding FDA's progress toward obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products; and
- Within 120 days, FDA would need to issue a policy of enforcement discretion with regard to certain products containing CBD meeting the definition of hemp, and that such policy would need to be in effect until FDA establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product.
While some hemp and CBD stakeholders have come out in support of McConnell's language, believing it will force FDA to allow marketing of CBD ingestibles (e.g., supplements, tinctures, and beverages), others are hesitant to endorse it without understanding how the Agency will carry out its response. One concern is that if within 120 days of the Agriculture Appropriations bill becoming law, FDA feels compelled to issue an enforcement discretion policy statement, it could issue a restrictive policy (e.g., permitting only low amounts of CBD, limiting product categories, etc.). One of the themes that emerged at the Agency's May 31, 2019, CBD hearing is the significant data (and time) that FDA needs to make informed policy choices in this space. As we observed, the Agency did not appear satisfied with the data-related testimony it received that day, several times asking for more information to be submitted. And, as of the close of FDA's CBD docket, the Agency received just under 5,000 comments, far less than is typical in FDA public comment proceedings.
Although CBD vaping was not a major (or even minor) focus of the May 31 hearing, one has to wonder how it might enter into the Agency's thinking as FDA continues its CBD work given recent vaping-related illnesses. To be sure, it does not seem that these illnesses have related to CBD vaping products purchased at retail, but it is not clear that the Administration's and Agency's approaches to vaping will be narrowly tailored. And given that FDA could enact a CBD enforcement discretion policy to implement a congressional directive, as discussed above, it is possible that the Agency could soon take a formal position on CBD vaping.
We are continuing to monitor these developments and will provide updates, as appropriate. 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.