Tobacco regulation priorities shared with the FDA
June 10, 2022
With a new Director of the Center for Tobacco Products set to take the
position on July 3, the American College of Chest Physicians (CHEST)
extended a letter to the Commissioner of the US Food and Drug
Administration, Robert Califf, MD, to share key priorities for tobacco
and vaping regulation from the perspective of CHEST member expert
clinicians treating patients affected by tobacco use across pulmonary,
critical care, and sleep settings.
CHEST priorities include:
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Improving transparency and accountability with the
scientific community and public, including developing
standardized safety and efficacy metrics by which emerging
products, particularly in the vaping space, can be
evaluated.
-
Strengthening compliance monitoring and enforcement and
adding synthetic nicotine products into the existing
regulatory framework.
-
Speeding the implementation of Center for Tobacco Products
(CTP) policy initiatives, including finalizing and
implementing the rules related to the prohibition of
menthol as a characterizing flavor in cigarettes and
cigars.
“The matter of tobacco and vaping regulation is very pertinent to the
CHEST organization,” says David Schulman, MD, MPH, President of the
American College of Chest Physicians. “Our members see firsthand the
devastating effects of these products on the health of our patients.
The best way to protect public health is through better and more
transparent regulation, especially concerning the products that are
targeted to young adults. With Brian King, PhD, MPH, coming on board as
the new Director for CTP, it is the perfect time for CHEST to re-engage
in shaping the change our patients need.”
Read the full letter below.
To: Robert Califf, MD Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
cc: Brian King, PhD, MPH
Director of the Center for Tobacco Products
On behalf of the American College of Chest Physicians (CHEST), we would
like to congratulate you on your confirmation. We appreciate your prior
FDA experience and perspective as a cardiologist and researcher. We are
in a critical time in the space of tobacco control, including vaping
and heated tobacco products, which collectively continue to impact the
health of children and adults.
CHEST represents over 19,000 members who provide clinical respiratory,
critical care, and sleep medicine care to patients in the United States
and throughout the world. Our mission is to champion the prevention,
diagnosis, and treatment of chest diseases. CHEST has been at the
forefront in many of the landmark advances in tobacco control over the
years, including membership in the ENACT coalition during the
negotiations leading to the Attorney General’s Master Settlement
agreement with the tobacco industry, public recognition of the
carcinogenicity of tobacco, and the banning of smoking from commercial
air travel, among other initiatives. Every fellow of the American
College of Chest Physicians (FCCP) takes a pledge to engage their
patients in smoking cessation activities and education--the only
society that requires such an oath.
As you welcome Dr. Brian King as Director of the Center for Tobacco
Products (CTP), we urge you both to consider three overarching
priority areas:
-
Improve transparency and accountability with the scientific
community and the public;
-
Strengthen compliance monitoring and enforcement across the
country; and
-
Implement CTP policy initiatives as quickly as is possible
in the tightly regulated environment in which CTP
functions.
Below, we propose additional detail on our recommendations.
Priority 1. Improve transparency and accountability with the
scientific community and public
Specifically, CHEST recommends:
-
The use of independent toxicological evaluation to confirm
aerosol toxicants to override the existing self-report
mechanism;
-
The public release of product primary application data for
independent analysis by the scientific community;
-
The development of a harms scale that would enable the
consumer public to compare the risk of tobacco products
against each other;
-
The FDA post, for public understanding, the list of
products that the FDA has declined to authorize;
-
The development of more webinars presenting various
research or analyses from within the CTP; and
Priority 2: Strengthen compliance monitoring and enforcement.
Specifically, CHEST recommends:
-
The FDA to immediately include synthetic nicotine products
in the existing regulatory framework;
-
The development of a categorization schema to determine
which products cross the threshold into medication
delivery; and
-
Timely and punitive action against non-compliant
merchants/producers.
Priority 3: Speed the implementation of CTP policy initiatives
Specifically, CHEST recommends:
-
The FDA expedite premarket review of e-cigarettes,
including completing public health review and issuing
marketing denial orders for all nontobacco-flavored
products, including menthol;
-
The FDA prioritize enforcement against e-cigarette products
that continue to be sold without marketing authorization
for those that are flavored, have the highest market share,
and/or have the highest prevalence of youth usage; and
-
The public disclosure of all products that receive
marketing denial orders.
Once again, on behalf of the 19,000+ clinicians represented by
CHEST who care for patients affected by tobacco use, we
congratulate you on assuming this role. We recognize the breadth
and gravity of your charge.
We welcome the opportunity to serve as a resource to you and your staff
in exploring how these priorities can be achieved. We would like to
request that an introductory meeting be arranged in the coming quarter.
David Schulman, MD, MPH, FCCP
President, CHEST
Frank Leone, MD, FCCP
Chair, Tobacco & Vaping Work Group