May Nelson became the director of the Office of Regulations at FDA’s Center for Tobacco Products (CTP) in January 2021, when Beverly Chernaik retired after holding the position since 2009. Learn more about May’s leadership at CTP and her contributions to improve the public health through tobacco regulation.
Can you share a little bit of your background? How did you get into tobacco regulation?
My undergraduate degree was in biology, and after college I worked in a cytogenetic testing lab doing amniocentesis and other prenatal testing. I knew I wanted to work on health issues, but I got bored working in a lab; it was kind of like cooking the same recipe every day. So, I transitioned to a maternal and child health policy center and eventually applied to law school. I did one of my law school summer internships at the San Francisco office of the HHS General Counsel’s office.
After law school, I knew I wanted to work for the federal government and applied to several federal agencies. I ended up at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). In January 2000, I started my FDA career as a Regulatory Counsel at CFSAN working on issues like bioterrorism, infant formula, dietary supplements, and more.
In 2009, shortly after the Tobacco Control Act (TCA) was signed, FDA needed to stand up a whole new Center (CTP). Since FDA had to move quickly to meet our mandate and statutory deadlines to implement parts of the new statute, FDA initially staffed the new center by recruiting experienced staff from other FDA centers to fill temporary positions. CFSAN was asked to loan one Regulatory Counsel; I got lucky and was asked if I wanted to come to CTP. I started at CTP in July 2009, and I never went back. I became the deputy of CTP’s Office of Regulations (OR) in 2011. I was the deputy until January 2021, when Beverly Chernaik retired and I became the director.
You recently assumed this role and your predecessor had been here since CTP was established. What have you learned from Bev Chernaik and what advice did she leave when she retired?
What I really learned from Bev was her leadership style: she focused on treating her employees with respect and having a lot of confidence in their abilities. She gave her staff opportunities to shine in high-level meetings and to give high-profile presentations. I really try to carry that on and let our staff show what they can do. I support their professional growth and give them all the opportunities that are available to them.
What are some of the tobacco regulations you’ve worked on at CTP that could have the greatest public health impact?
When the TCA was passed, we had jurisdiction over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. In accordance with the TCA, we issued a rule, commonly known as the “deeming” rule, that expanded our tobacco authorities to all products that meet the definition of a tobacco product, including cigars, hookah tobacco and e-cigarettes. One of my first projects at CTP was working on the cigar aspect of this, but the scope of the rule expanded and the “deeming” rule became one of CTP’s most important rules, especially considering the way the e-cigarette market was expanding in the U.S. We issued the proposed “deeming” rule in 2014 and then the final “deeming” rule in 2016, and I’d definitely say it was the most significant rule that I helped write for CTP.
For people who might not be familiar, could you walk us through the process of rulemaking, including the steps and the people involved?
FDA publishes proposed rules and then final rules. Sometimes there are steps we take before starting the proposed rule. Generally, we include a rule in the Unified Agenda about a year to 18 months before it is issued.
That’s so the public knows what’s on the horizon for CTP and what we’re working on.
Sometimes we might also publish an advance notice of proposed rulemaking (ANPRM) before a proposed rule. Let’s say FDA was thinking about a particular issue or concern, but we didn’t feel we had clarity on the right regulatory path forward. One way to solicit information and feedback from the public and regulated industry is to put out an ANPRM. We can talk about a problem or an issue that we’re trying to address, and then we can ask various questions in the ANPRM about data that the public may have. Or we could ask specific questions to industry to help shape a possible future regulation.
All of those steps happen even before starting on a proposed rule?
Yes. To get a proposed rule going, we assemble work group members from CTP program offices, FDA’s Office of Chief Counsel, and the economics team. We have work group meetings to determine what is actually going to be in the rule. Typically, then there is a clearance period for the rule, first at FDA, then at HHS, followed by review at the Office of Management and Budget (OMB).
How do you incorporate public comments on the proposed rule and what value does that feedback bring?
The comment process really is there to invite and solicit comments from the public so that they can give their input on what the rule should look like. Anyone can comment, not just industry and firms that are affected, but also individual consumers who may care about that issue.
The proposed rule has a comment period, usually a minimum of 60 days. We may get anywhere from a handful of comments all the way up to the 135,000 comments we received on the “deeming” rule and sometimes more.
And you directly use the feedback to develop the final rule?
Yes. We issue rules using the “notice and comment rulemaking” process. The Administrative Procedure Act (APA) requires us to consider all the relevant comments in a proposed rule and respond to those comments in the final rule. And once the final rule is drafted, we go through the entire clearance process again. Once the final rule gets to OMB, a synopsis is uploaded into reginfo.gov, where the public can see the general topic of each rule under OMB review.
How does FDA ensure that our regulations are based in science?
Our rulemaking is governed by the Administrative Procedure Act, which requires us to give proper consideration to the facts and data that we have before us. Our regulations reflect the science―we consider all high-quality data and studies, no matter what policy outcomes they might support. The comment period allows the public, industry, and the research community to submit data to inform our regulations. Our CTP subject-matter experts help us determine which peer-reviewed studies and other data are of the highest quality, most relevant, and should be used in the development of the rule.
In addition to rules, CTP publishes guidance documents. Could you describe the difference?
A rule holds the force of law and it’s binding on industry once it’s finalized and in effect. CTP could take enforcement action against a firm for not complying with a rule. On the other hand, a guidance is not binding. A guidance is an interpretation of either something in the Federal Food, Drug, and Cosmetic Act or something in our regulations. A guidance may talk about FDA’s interpretation of a rule. It’s just describing one way that industry can comply with a requirement. If there’s another way that industry would like to act to get to the same place at the end, that’s fine, too. CTP publishes draft and final guidance.
How has the Office of Regulations’ work changed during this time of COVID-19?
On a practical level it hasn’t changed all that much. We still have the same goals and work to accomplish, it’s just that people are working from home. It has been more challenging to acclimate new staff to the office during COVID-19. But we’ve been fortunate to be able to work from home.
What foundational rules are you working on right now and why are they important?
We have been working on several foundational rules. Two of those rules, the premarket tobacco product application (PMTA) rule and the substantial equivalence (SE) rule were both at the Office of the Federal Register on display in January 2021, waiting to be published. But they didn’t quite make it. When the administration changed, those documents had to be pulled back to CTP and they haven’t been published yet, but we are working on a way to do that.
Foundational rules, like the SE and PMTA rules, are really important in a number of ways. When a statute such as the TCA is passed, usually the language is very broad, and sometimes there aren’t a lot of details in the statute itself. In our case, we have been able to implement product review for over a decade based on the statute alone, and over time we have developed certain practices and expectations for how to do that effectively and efficiently. Up to this point, we have shared our thinking with stakeholders through guidance documents, public meetings and redacted product decisions―all of those have helped to inform manufacturers as they sought and received marketing decisions. Now, though, we are issuing SE and PMTA rules to give regulated industry even more clarity on what we expect in their applications. That increases transparency so firms know more about what we’re looking for in their applications. And when we get higher quality applications, we become more efficient in our review of those applications. We can get to the review more quickly because the submission already has everything that we need. The foundational rules really increase efficiency and transparency.
What are product standards and why are they important for public health?
The authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave us. Product standards allow FDA to take specific actions that limit the toxicity, addictiveness and appeal of tobacco products. In April 2021, FDA committed to advance two tobacco product standards – one to ban menthol in cigarettes and another to ban flavors, including menthol, in cigars.
In the last 55 years, the United States has made great progress in reducing the number of smokers across the country; however, that progress has not been experienced by everyone equally. For far too long, certain populations, including African Americans, have been targeted and disproportionally impacted by tobacco use. These product standards, when final and in effect, will reduce cigarette and cigar initiation and use, reduce health disparities, and promote health equity by addressing a significant and disparate source of harm. Taken together, these policies will help save lives and improve the public health of our country as we confront the leading cause of preventable disease and death. So, product standards can be a very powerful tool to help tobacco users quit and prevent people from ever initiating on tobacco products.
How do you see CTP evolving in the next 5 to 10 years?
I hope within the next 5 or 10 years we will see all of our foundational rules in effect. There are still a couple that we haven’t published yet, such as the modified risk tobacco products rule and the tobacco products manufacturing practices rule that are important. And I hope that we issue other product standards because that’s one of the strongest tools we have to really make an impact on public health.
Which accomplishment over your tenure at CTP are you most proud of?
I’m really proud of our staff. The Office of Regulations is the smallest office at CTP, but we’ve been able to produce very high-quality documents with the help of the program offices. We’re a tight-knit group, and we all get along really well. I’m so proud of the folks that we have in our office and I just appreciate all of them.