Tobacco control efforts in the U.S. have predominantly been a state, local, and increasingly tribal endeavor with landmark federal reports and legislation spurring or guiding local actions. When I started in tobacco control at the local level in 2006, the CDC’s Best Practices for Comprehensive Tobacco Control Programs was our roadmap. It focused our efforts on the actions we could take to get the most bang for our limited buck and remains the linchpin for bottom-up efforts.
When talks of potential tobacco regulation by the Food and Drug Administration (FDA) became more serious in early 2009, our community-level policy efforts were often met with a common tactic to elude responsibility for public health improvements: arguing that they’re not needed because the feds would soon take care of the problem. Of course, we know now—almost 10 years after the adoption of the Family Smoking Prevention and Tobacco Control Act (TCA)—that FDA tobacco regulation is slow and no substitute for local interventions. In fact, the TCA specifically acknowledges the preservation of local authority to regulate tobacco products in ways that are not preempted. While this draws jurisdictional regulatory boundaries and requires a more coordinated approach, it also recognizes that local tobacco control efforts would not, and should not, stop.
Part of a more coordinated approach is, of course, an understanding of the TCA, the tobacco regulatory authorities it granted FDA, and how FDA actions (or inaction) can impact local work. Another important part of the equation, though, is that tobacco control advocates must also strive to better understand the expansive scope of all of FDA’s authorities, which can be wielded to either detour tobacco control efforts or complement them. Why? There are a number of reasons, but at the top of my list is that FDA has begun to build its own roadmap centered on nicotine and addiction that acknowledges nicotine products deliver harm along a “continuum of risk.” This includes not only tobacco products but also FDA-approved medicinal nicotine products that have met safety and efficacy standards to help people who smoke to quit. Thus, for tobacco control advocates to effectively shape how FDA’s roadmap detours or complements the predominantly local tobacco-free path we’ve been on since before FDA tobacco regulation began, we must engage in the broader FDA-regulated products arena.
From a more practical standpoint, the FDA has been regulating a variety of other products under the Federal Food, Drug, and Cosmetic Act since 1938. With eighty years of experience in those spaces, the agency is sure to borrow from that expertise as it further develops how it will regulate tobacco products. With the announcement of FDA’s new regulatory roadmap for tobacco and nicotine in particular, the agency must determine how it will distinguish a new public health standard for tobacco products from its usual safe and effective standards for medical products. As just one example of how complex distinguishing tobacco and medical products regulation will be is one particular bump in the road thus far for one of the pathways to market for a new tobacco product: substantial equivalence (SE). The pathway resembles 510(k) clearances/premarket notification for medical devices, but it is also distinct given the different products’ attributes. This specific resemblance to the medical device regulatory framework, though, served as one of the reasons why part of FDA’s September 8, 2015 SE Guidance was struck down in court. This part of the decision demonstrates that, despite tobacco products being different from other FDA-regulated products and having a different public health standard that must be met, FDA’s implementation and enforcement of its tobacco product authorities must also seriously consider the regulatory frameworks for its other regulated products.
The FDA had not yet announced its comprehensive regulatory plan for tobacco and nicotine during the SE litigation, but its very public announcement in July 2017 and constant reference back to it since then signal loudly that the time for tobacco control advocates to engage with broader FDA regulation is now. Tobacco companies have already pivoted to what others have termed “pharmaceuticalization,” indicating that it “represents the next phase … and a new threat to public health.” Tobacco companies have also already hired firms with broad food and drug law and regulatory expertise, which affirms that they’re already thinking this way. Tobacco control advocates must catch up.
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.