TOB Magazine

28 / 118

3.
4.
5.
May 8, 2018: deadline to submit substan-
tial equivalence reports; Aug. 10, 2018: im-
plementation of labeling requirements for
tobacco products and retailer point-of-sale
warning statement requirements for cigars
sold individually and without packaging; Nov.
8, 2018: deadline to submit premarket tobac-
co product applications; Nov. 8, 2019: dead-
line for submission of listing of harmful and
potentially harmful constituents (HPHCs).
COLE-BISHOP
AMENDMENT UPDATE:
On Feb. 16, 2017, Reps. Tom Cole (R-OK)
and Sanford Bishop (D-GA) introduced into
Congress H.R. 1136, more commonly known
as the FDA Deeming Authority Clarification
Act of 2017. The act provides for regulation
of vapor product batteries and advertisements
of vapor products, but it also amends the
deeming regulations to move the grandfather
date for all covered tobacco products from Feb.
15, 2007, to the effective date of the deeming
regulations, Aug. 10, 2016, which would pre-
vent certain vapor and tobacco products from
having to go through the premarket review
process. The act was left out of the agricultural
appropriations bill passed by Congress in May,
but there will still be an opportunity that the
bill could be revived when Congressional Fed-
eral Budget negotiations resume in October.
A LACK OF CLEAR GUIDANCE
ON THE SUBSTANTIAL
EQUIVALENCE PROCESS:
Under the Family Smoking Prevention and
Tobacco Control Act, tobacco products (cig-
arettes, roll your own [RYO] tobacco and
smokeless tobacco) that were not grandfathered
were required to go through a premarket review
process, including the filing of a substantial
equivalence report showing that any differenc-
es between a covered tobacco product and a
grandfathered predicate product did not pres-
ent “a different question of public health.”
The deeming regulations require all covered
tobacco products that are not grandfathered
to go through the same premarket review
process. Though the FDA released guidance
in 2011 on filing a substantial equivalence re-
port relating to cigarettes, RYO tobacco and
smokeless tobacco, they have not provided
any new or updated information on what is
required for substantial equivalence reports
for newly covered tobacco products, includ-
ing cigars, pipe tobacco and e-cigarettes/
vapor products. With substantial equivalence
reports for each product likely to require nu-
merous hours of work and cost hundreds of
thousands of dollars (at least) to prepare, the
FDA’s delay in issuing updated guidance of the
substantial equivalence process for these newly
deemed tobacco products puts manufacturers
at a severe handicap in trying to navigate the
premarket review process.
FDA FIELD INSPECTIONS OF
RETAILERS TARGETING MINIMUM
AGE REQUIREMENT TO SELL
DEEMED TOBACCO PRODUCTS:
Ensuring that tobacco products are sold ex-
clusively to those of legal age is one issue the
entire industry agrees on. In recent industry
presentations, the FDA has informed the in-
dustry that it has conducted thousands of field
inspections and the target appears to be retail-
ers selling to minors under the legal age for
purchasing tobacco.
As with almost every state and local law,
the deeming regulations also prohibit retailers
from selling deemed tobacco products in any
medium (including mail order as well as the
internet) to any individuals under 18 years of
age. In addition, the FDA mandates that re-
tailers physically check the photo identifica-
tion of all customers under the age of 27 who
attempt to purchase a cigar. We have also re-
cently received an influx of notifications from
our retailer partners concerning these inspec-
tions. All retailers should remember to request
the proper age verifying identification prior to
selling tobacco products. TB
[ 24 ] TOBACCO BUSINESS [ JULY / AUGUST | 17 ]
Light up your
business.
Intertabac 2017
22–24 September
DortmunD
Germany
World’s largest trade Fair
for tobacco products
and Smoking accessories
IT_2017_AZ_Besucher_TobaccoBusinessInter_127x190_E_RZ.indd 1 12.04.17 09:20
Legislative Matters Continued