Ruthless Insider: The Center For Tobacco Products 2.0

Ruthless Insider: The Center For Tobacco Products 2.0


Last week the White House fiscal 2021 budget
plan proposed an interesting move to take the Center for Tobacco Products or CTP out
of the FDA; Creating a new agency within the HHS to focus on tobacco regulation. Find out
more on this edition of Ruthless Insider. Hello and welcome to another edition of Ruthless
Insider. According to the budget plan, the transfer would allow the FDA commissioner
to focus on its traditional mission of ensuring the safety of the Nation’s food and medical
products supply. A new director of the HHS-based CTP would be confirmed by the senate. Many
seem to think that this transfer doesn’t stand a chance in congress, but if it is passed,
No lawmaker will want to be seen as soft on vaping. That aside, others believe that the
“CTP 2.0” has the potential to be very beneficial for the vaping industry. With new
leadership and guidance, it could be a significant boon to smokers who are trying to quit combustable
tobacco. Ideally congress could start by empowering the CTP 2.0 to establish a new regulatory
model for vaping products, which would address two major drawbacks of the current FDA pathway
for premarket approval. The first drawback being the prohibitive cost to manufacturers
of application costs, which the agency admits would drive nearly all e-cigarette products
out of the market. Secondly, the risk and benefit analysis now required for manufacturers
could use some revisions as well. As it stands, the FDA evaluates pre-approval applications
based on a standard that has two criteria. First, the agency evaluates whether the availability
of e-cigarettes makes it more or less likely that current tobacco users (mainly smokers)
will quit. Second, the agency gauges the likelihood that e-cigarettes will spur non-tobacco users
to start using e-cigarettes or any other tobacco product. These criteria are vague and tricky
to apply. As tobacco policy analyst Clive Bates asks, “How do you include the adolescent
[smokers] that benefit from vaping in the analysis? How much weight do you give to one
additional adolescent who starts vaping compared to one adult who quits smoking using vaping?”
Conceptual challenges aside, how can analysts perform a clear-eyed risk-benefit calculus
when the facts about vaping are routinely distorted by advocates and even some scientists? Do you think that a new agency would be beneficial
for the vaping industry, or would it only create more issues? Please share your thoughts
with us down below and as always don’t forget to like, share, subscribe and ring that bell
button to keep up to date with all of our Ruthless content. This has been Nick with
Ruthless Insider, and we’ll see you next time!

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