March 11, 2024
The Honorable Joesph R. Biden
President of the United States of America
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20500
Dear Mr. President:
We are writing to urge the Food and Drug Administration (FDA) to expedite consideration of
long-pending applications for smoke-free tobacco products that could improve public health by
providing adult smokers access to less harmful options.
In recent weeks there have been calls on the FDA to ban certain nicotine-containing products due
to the potential of underage use. There is no debate: youth should not have access to nicotine-
containing products, nor should youth be subject to marketing or advertising of these products on
social media. Congress has taken several steps to help address these challenges, including
raising the legal age to purchase tobacco and nicotine-containing products to 21 years of age and
bringing synthetic nicotine products under the purview of FDA and its mission to protect and
promote the public health.
According to data from the Centers for Disease Control and Prevention, in the past only 1 in 10
adult smokers quit smoking. These consumers deserve to have alternative, less harmful products
available to make informed choices of their own or may make it easier to quit. We cannot allow
scare tactics and misinformation to keep 30 million adult smokers in the U.S. from making
informed decisions and providing them with information about and access to alternative products
that present less risk than continued smoking.
Rather than banning products that have proven effective in converting smokers or reducing
cigarette consumption, the FDA must utilize the regulatory approval framework provided by
Congress fifteen years ago. Since the Family Smoking Prevention and Tobacco Control Act of
2009 was signed into law by President Obama, the FDA has received over 26 million
applications to market innovative smoke-free products. However, the FDA has authorized fewer
than 50 product applications (of which less than 10 are commercially available products) and
many other applications have been waiting over three years for official review. Meanwhile,
during this same period, FDA has authorized thousands of combustible cigarette product
applications, as measured by CTP’s own performance metrics.
Not only has the FDA’s inaction continued to deprive American smokers with greater choice, but
it has also contributed to the proliferation of illicit nicotine-containing products coming into the
U.S. from markets like China, many of which are intentionally designed to appeal to youth.
This is a matter of public health. According to an ever-increasing amount of scientific research,
smoke-free products hold enormous potential for current smokers to quit by switching to these
less harmful products. We must continue to work together to prevent underage use of these
alternative products, and we urge your administration to encourage the FDA to review smoke-
free product applications more effectively and efficiently and to make those determinations on
sound science.
Sincerely,
Richard Hudson Brett Guthrie
H. Morgan Griffith Guy Reschenthaler
Kevin Hern Troy Balderson
Dusty Johnson Dan Crenshaw
Bob Good Claudia Tenney
Nick Langworthy Kelly Armstrong
Kat Cammack August Pfluger
Troy Nehls Brian Mast
Randy Weber Mariannette Miller-Meeks
Earl. L. “Buddy” Carter Michael Waltz
Jenniffer González-Colón Larry Bucshon
Chuck Fleischmann Ralph Norman
Diana Harshbarger Russell Fry
James Comer Don Bacon
Scott DesJarlais, M.D. Nancy Mace
John Carter Neal P. Dunn, M.D.
Mike Bost Wesley Hunt
C. Scott Franklin Ann Wagner
Virginia Foxx Max Miller
Ronny L. Jackson Hal Rogers
Andy Barr Nicole Malliotakis
John Duarte Andrew Garbarino
Dan Bishop James Moylan
Gus M. Bilirakis Ben Cline
Roger Williams Greg Pence
Chuck Edwards Marc Molinaro
Juan Ciscomani David G. Valadao
Jack Bergman Andy Ogles
Bill Huizenga Pat Fallon
David Joyce Dan Meuser
Cc: The Honorable Robert M. Califf, M.D.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
