NEWS
Why February 15 2007 is proving to
be a very controversial date indeed
One of the most
controversial parts
of the new FDA vaping
regulations is the socalled ‘predicate date’
or grandfather date for
tobacco products.
This date is really important because it
means if manufacturers can show that
their products were on the market on that
date then they don’t have to go through
the costly and time consuming process
of submitting a premarket toba cco
application (PMTA) to the FDA.
Now for the bad news…the date is
February 15, 2007 and that is why it is
so controversial because the vaping
industry back then was tiny compared to
what it is today.
This means that the vast majority of
vaping products and e-liquids were not
around back then so the potential pool of
exempt products is tiny.
Vaping advocacy groups are working
hard to encourage the FDA to change
the date so that far more products are
exempt from the requirements of having
to make a PMTA submission.
Choosing a date which is so far back
is bad enough but the FDA is making
things even harder for manufacturers by
imposing a really narrow interpretation of
the actual grandfather date itself.
20 VAPOUROUND MAGAZINE USA
The relevant part of the legislation on the
matter defines a new tobacco product as:
“Any tobacco product (including those
products in test markets) that was not
commercially marketed in the United
States as of February 15, 2007.”
So you might think that products which
were on sale before that date would be
automatically grandfathered in, but this
is not necessarily the case.
The FDA says: “We interpret the
phrase “as of” February 15, 2007, as
meaning that the tobacco product was
commercially marketed (other than
exclusively in test markets) in the United
States on February 15, 2007.
”
the wide variety of
vapor products that
adult smokers have
come to rely on to live
smoke-free will be
swept off the market.
“If your tobacco product had been
commercially marketed in the United
States before February 15, 2007, but
was not commercially marketed on that
date, it is not a grandfathered product
and may not be commercially marketed
unless you comply with the premarket
requirements of section 910 of the FD&C
Act and obtain a marketing order.”
The Consumer Advocates for Smoke-
free Alternatives Association (CASAA)
wants the date changed to August 8,
2016 (the effective date of the deeming
regulations) and says: “This change
would allow for all vapor products
currently on the market to remain on
the market without being subject to the
burdensome and prohibitive pre-market
FDA approval application process.
“If Congress does not act to change the
predicate date established by the TCA,
the wide variety of vapor products that
adult smokers have come to rely on to
live smoke-free will be swept off
the market.”
The Smoke Free Alternatives Trade
Association (SFATA) said by using a date
so far back the regulations would
“essentially be banning 99% of all vapor
products on the market.”
The date is critically important because
of the time and cost involved in
complying with the new regulations
which is far from a matter of filling out a
simple form and paying a
token fee.
The FDA estimates that filing a PMTA will
take over 1,700 hours per product and
the cost of doing so has been estimated
at around $1 million or more.
Gregory Conley, president of the
American Vaping Association. “In all
reality, the true cost of a PMTA is likely to
exceed several million dollars.”