The Center for Tobacco Products: What It Has Done and What It Should Do Next
Since its establishment in 2009 under the Family Smoking Prevention and Tobacco Control Act, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has played a pivotal role in regulating tobacco products to protect public health. The CTP has authority over three application pathways that allow manufacturers to market their products legally in the United States:
- Substantial Equivalence (SE)—Legacy tobacco products
- Premarket Tobacco Product Applications (PMTA)—Novel tobacco products
- Modified Risk Tobacco Product Applications (MRTPA)—Tobacco products that provide evidence for claims of lower risk
The CTP also has the ability to institute age restrictions and introduce additional limitations for tobacco manufacturers in terms of product standard rules. This allowed the foundation for comprehensive tobacco regulation to be codified into law, providing a pathway for the regulation of tobacco and nicotine products. Over the past 15 years, the CTP has played a role in significantly reducing tobacco use (particularly among youth), with adult cigarette smoking dropping from 20.9 percent in 2005 to 11.5 percent in 2021. However, its approach to tobacco harm reduction (THR) has faced criticism for limiting access to safer alternatives. With cumulative expenditures exceeding $9 billion, primarily from tobacco-industry user fees, the CTP’s journey reflects both remarkable achievements and notable shortcomings.
2010-2014: As the CTP worked to build its regulatory infrastructure, their funding increased from $235 million to $534 million to cover inspection capabilities, SE reviews, and education campaigns like “The Real Cost.”
2015: The agency set a precedent for new tobacco product reviews by approving eight Swedish Match snus products via PMTA.
2016: The “Deeming Rule” extended the CTP’s authority to regulate electronic nicotine delivery systems (ENDS), cigars, and other products.
2017-2018: With budgets of $635 million and $672 million respectively, the CTP tackled rising youth e-cigarette use (27.5 percent among high schoolers) through regulations and campaigns.
2019: The Tobacco 21 law, which raised the purchase age to 21, reduced illegal sales to under-21 individuals by 12 percent in its first year.
2020: The CTP’s expanded authority had resulted in 6,800 SE, 6.5 million PMTA, and 350 Exemption Request (EX REQ) applications and the first authorized electronic MRTPA with reduced exposure claims.
2021: The CTP had processed 5,200 SE applications, issued 120+ product orders, finalized the PMTA Rule, and handled 6.5 million PMTAs with 200,000 Refuse to Accept letters (rejection due to application errors).
2022: The CTP proposed bans on menthol cigarettes and flavored cigars aimed to prevent 1.2 million new smokers.
2023: The agency focused on synthetic nicotine regulation and a proposed Tobacco Product Manufacturing Practice Rule to address manufacturing standards and oversight, with over 1,500 warning letters issued.
2024: The CTP approved four menthol ENDS products and the first non-tobacco-flavored ENDS authorizations and processed backlogged 2020 applications, issuing 45 PMTA, 120+ SE, 230 EX REQ, and 16 MRTPA orders.
Jan. 15, 2025: The agency proposed 0.70 milligrams per gram nicotine cap for cigarettes projected to prevent 33 million new smokers, aligning with SE, PMTA, and MRTPA frameworks.
Despite these accomplishments, the CTP’s THR approach has been criticized. The PMTA process, which had approved only a few products by 2021 while denying over one million applications, has been deemed inefficient, and many have accused the agency of inadvertently pushing consumers to illicit markets. Flavor bans, including the 2022 menthol proposal, restrict adult smokers’ access to what other countries consider cessation aids despite evidence that e-cigarettes are up to 95 percent less harmful than cigarettes. Today, the CTP’s youth-focused policies, which stemmed from a nearly exclusive approach to the 2017-2018 high school vaping rate, completely overlook adult needs.
The CTP has transformed tobacco regulation, with their policies and campaigns modestly reducing smoking rates. However, its ongoing focus on youth and cautious THR stance limits access to safer alternatives for adult smokers. Rebalancing youth protection with harm reduction could maximize the CTP’s impact, further curbing chronic illness related to smoking-related harm and resulting in immediate health gains for the nation.