Question and Answer with Ann Simoneau, JD, MBA, Director of CTP’s Office of Compliance and Enforcement
Could you share a little bit of your background? How did you get into tobacco regulation?
My background is in pharmacy, law, and business administration. I have worked in compliance and enforcement at FDA for about 18 years now. Before joining CTP, I worked in the Center for Drug Evaluation and Research, the New England District Office of the Office of Regulatory Affairs, and the Center for Devices and Radiological Health. Prior to coming to FDA, I was a litigation attorney in Boston, Mass. for several years.
I came to CTP shortly after the Tobacco Control Act was enacted in 2009. Several people were asked to come on detail from other Centers of FDA to organize and stand up the new Center. There were about 15 of us. The first thing we did was review the new law and identify FDA’s new authorities, mandates, and deadlines. We worked together quickly to plan, stand up the new Center, and hire leadership and staff. I was initially the acting director of the Office of Compliance and Enforcement and became the permanent director for that office in 2011.
For people who might not know, could you summarize what the Office of Compliance and Enforcement at CTP does and why enforcement work is important to public health?
The Office of Compliance and Enforcement (OCE) is tasked with ensuring that tobacco product manufacturers, distributors, importers and retailers and their tobacco products are in compliance with the law. As new provisions of the law become effective, including any new regulations issued, we develop and implement an inspection and surveillance plan to monitor compliance. Although our goal is to gain voluntary compliance from regulated industry, OCE uses a three-prong approach to ensure compliance. First, we develop material to educate regulated industry on the regulatory requirements that apply to them. This may include detailed information and examples in webinars, guidances, or CTP webpages. We work collaboratively with other offices in CTP to develop this compliance education. For example, we work with the Office of Health Communication and Education to create webpages and with the Office of Regulations to develop guidances. Second, we conduct surveillance, inspections, and investigations to determine whether companies are complying with the law. Third, if we identify evidence of violations of the law, we initiate enforcement actions to obtain compliance. After a first violation, we typically send a warning letter to retailers and manufacturers. FDA has issued civil money penalties of increasing amounts and no-tobacco-sale orders (preventing the company from selling any tobacco products for a specific amount of time) in cases where retailers continue to violate the law.
Which accomplishment over your tenure at CTP are you most proud of?
That would be creating and building the Office of Compliance and Enforcement from just one person in 2009 to over 250 people today. I’m proud of all the work that we have accomplished, including all the inspections and important enforcement actions like the food-imitating and drug-imitating warning letters that were sent to electronic nicotine delivery systems (ENDS) manufacturers and retailers.
The tobacco product retailer inspection program is another example of an important accomplishment of OCE. The program initially started in 2010 in just 15 states. The program has expanded over the years to cover tobacco retailer inspections across the U.S., territories, and tribes. Last year we reached a milestone of conducting our one millionth tobacco retailer inspection. To date, these inspections have resulted in issuing over 93,000 warning letters, 23,000 civil money penalties, and 160 no-tobacco-sale orders.
I am proud of all the smart, dedicated, and hardworking staff in OCE. They have all contributed to the success of the office over the past 10 years.
What is the biggest challenge facing your organization today?
Since we published the final Deeming Rule in 2016, which extended FDA’s authority to regulate all tobacco products, including ENDS, the biggest challenge has been the rapid growth in the overall number of tobacco products we regulate. Initially, it was an IT challenge to have the capacity for all the manufacturers of newly regulated tobacco products to register and list their products. This represented a significant increase in data to be submitted to the agency. Today, we have IT systems and tools to better capture and manage this data.
What unique issues have e-cigarette products brought and how has your office responded to those issues?
The unique issue with e-cigarettes that is of concern is the appeal of these products to kids and the significant increase in youth use. We have worked to address this problem by conducting retailer inspection blitzes using minors who attempted to purchase different ENDS products. We also conduct online surveillance to determine whether these products are being marketed and sold to kids. These inspections and the online surveillance have resulted in FDA issuing several hundred warning letters to retailers who were found to be selling ENDS products to kids.
How does your office partner with state and local governments and tobacco control organizations?
The Tobacco Control Act directs FDA to contract with U.S. states and territories to conduct our tobacco retailer inspections, where feasible. We have commissioned state and local officials and employees to conduct these inspections under contract with FDA. A list of the organizations within each state that have contracted with us is posted on our website. The states have been an important partner with us in our joint efforts to keep tobacco products out of the hands of kids.
In your conversations with industry, what is the most common misperception or thing that industry doesn’t know?
Before we started conducting our routine biennial inspections of tobacco manufacturers, some companies initially expressed concern about FDA coming into their facilities to inspect them. Despite their initial concern, we have received feedback from industry that our inspections were a positive experience. Industry has told us that our inspections were educational for them. They have said that the inspectors were professional, prepared, asked relevant questions, and requested relevant documents to determine their compliance.
How do you see CTP evolving in the next 5 to 10 years?
CTP will continue to grow, both in the scope of work and the size of the Center. CTP will continue to do a great job in support of our important public health mission.