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before August 8, 2016 will be able to
stay on store shelves for the two-year pe-
riod manufacturers have to file an FDA
approval application, after which it will
be up to FDA whether the products can
continue to be sold. Products not on the
market by the August 8, 2016 deadline
will not be able to enter the market until
they have been approved by FDA. How-
ever, all of those facts could still change
depending on the success of a number
of efforts under way by industry asso-
ciations, noted Schaevitz, who explained
that IPCPR has teamed up with partner
associations Cigar Rights of America
(CRA) and Cigar Association of Amer-
ica (CAA) on a lawsuit challenging the
predicate date and the decision to use the
same substantial equivalence process for
cigars and pipe tobacco.
The suit asks for a declaratory injunc-
tion to “vacate, set aside and enjoin the
enforcement of the final rule” because it
violates numerous federal statutes as well
as the federal rulemaking process. “There
are nine separate counts, including chal-
lenging the predicate date that forces the
cigar industry to look back nine years
to find grandfathered products,” he ex-
plained. “Cigarettes and smokeless prod-
ucts [were regulated] in 2009, so [they]
only had to look back two years.”
In addition to the predicate date, the
industry is fighting on other fronts.
“FDA has taken the view that any
change to a cigar blend or pipe tobac-
co makes it a new product,” explained
Dave Clissold of Hyman Phelps, who
said that FDA might ultimately make
allowances for some natural variations
in cigars from year to year. “We argued
to FDA very strongly years ago that ci-
gars are completely different siblings in
that there are natural variations due to
weather conditions and availability of
tobacco. FDA accepted that argument
and said natural variations will not nec-
essarily be [considered] a new product.
Exactly what constitutes a natural varia-
tion is one of the things we will have to
work out with FDA.”
The lawsuit also challenges the health
warning requirements in the new rule,
EVENT HIGHLIGHT
74
TOBACCO BUSINESS INTERNATIONAL
SEPTEMBER/OCTOBER 2016