FDA is failing the 28 million adult smokers by denying and discouraging new innovative smoke-free products from coming to market.
Reforming the FDA, including through updating the agency’s user fee program, is a key component to ensuring the Agency prioritizes its resources to efficiently and transparently review smoke-free tobacco product applications and benefit public health.
Robust oversight of the Agency is also important to ensure that the Center for Tobacco Products (CTP) meets its statutory requirements as Congress intended and to authorize smoke-free products that are appropriate for the protection of the public health.
Since 2009, more than 26 million premarket tobacco product applications (PMTAs) have been submitted for FDA review, but the CTP has authorized fewer than 50 of those applications. While the CTP is required under statute to decide on a PMTA within 180 days, the process on average takes nearly three years.
We are committed to working with policymakers to reform FDA and to create a modern user fee system that incorporates oversight, accountability, and an effective regulatory process for the CTP.
Risk-based taxation is a commonsense way to tax tobacco products and supports public health objectives. We believe smoke-free nicotine products should be taxed less than cigarettes in order to help incentivize adult smokers to switch.
According to the U.S. Food and Drug Administration (FDA), tobacco products fall on a continuum of risk, with combustible cigarettes posing the greatest threat. Tax policies at the federal and state levels should reflect the continuum of risk and maximize the potential of harm reduction by providing adult smokers with access to affordable smoke-free products.
Excessive excise taxes on smoke-free nicotine products fuel a black market and decrease projected state tax revenue. Providing adult smokers smoke-free alternatives at a more affordable price incentivizes smokers to switch and reduces demand for cigarettes.
Flavor bans for smoke-free alternatives limit the availability and acceptability of these products, which play a vital role in shifting adult smokers away from cigarettes. More than 28 million American adults smoke cigarettes today and on average, nine out of 10 continue smoking each year. Adults who continue to smoke cigarettes deserve access to and information about scientifically substantiated smoke-free nicotine products, including those with flavors that adults prefer.
Without reasonable flavor options, including for e-cigarettes, nicotine pouches and heated tobacco products, adult smokers are less likely to switch and more likely to continue smoking combustible cigarettes. Policymakers should reject restrictions that undermine adults’ preferences for flavored products and support an FDA regulated market.
Responsible manufacturers and retailers play a key role in guarding against underage use of their products, and Coalition for Health, Opportunity, Innovation and Consumer Education is committed to advocating for policies that ensure smoke-free nicotine products remain out of the hands of people under the age of 21.
Underage smoking rates are at historic lows and vaping rates are the lowest in 10 years. The latest data from the Centers for Disease Control and Prevention (CDC) and the FDA’s National Youth Tobacco Survey show oral nicotine pouch and heated tobacco product use remains low.
Commonsense approaches to limit underage access, such as education, raising the legal purchase age to 21, and enhanced age-verification requirements, are working and driving this continued decline.
