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THE FDA’S DEEMING REGULATIONS are now in
full swing, and several deadlines have come and gone
since its implementation on August 8, 2016. Current-
ly, the tobacco industry is working hard to comply with
the imminent deadlines in connection to the FDA’s new
labeling requirements. Manufacturers/importers of ci-
gars are required to submit a rotational warning plan in
compliance with FDA regulations by May 10, 2017, and
the new labels must be implemented and in commerce
no later than May 10, 2018.
The material aspects of the new FDA warning plan
are fairly straightforward. Manufacturers and importers
of cigars must rotate six warnings:
1.
WARNING:
Cigar smoking can cause cancers of the
mouth and throat, even if you do not inhale;
2.
WARNING:
Cigar smoking can cause lung cancer
and heart disease;
3.
WARNING:
Cigars are not a safe alternative to
cigarettes;
4.
WARNING:
Tobacco smoke increases the risk of
lung cancer and heart disease, even in nonsmokers;
5.
WARNING:
Cigar use while pregnant can harm you
and your baby; or SURGEON GENERAL WARNING:
Tobacco Use Increases the Risk of Infertility, Stillbirth,
and Low Birth Weight; and
6.
WARNING:
This product contains nicotine. Nicotine
is an addictive chemical.
These rotated warnings must be permanently af-
fixed to the cigar packaging and advertisements. For
packaging, the warning must encompass no less than
30 percent of the two principal display panels of the
product’s packaging (a principal display panel being
defined by the Deeming Regulations as the panels of
the package that are most likely to be displayed, pre-
sented, shown or examined by the consumer) and no
less than 20 percent of the total display area of the
advertisement, with the caveat that the warning on
advertisements appear in the upper portion of the ad-
vertisement within the trim area of the advertisement.
The warnings have some other requirements such as
font size, capitalization and color.
The Law
on Labels
Noah Steinsapir, general counsel for Kretek
International, offers a legal look at what
the FDA’s new warning label requirements
mean for manufacturers and retailers.
For packaging,
the warning
must encompass
no less than 30
percent of the
two principal
display panels
of the product’s
packaging.
Although the rule is relatively straightforward, the
industry still remains confused in connection with two
looming issues: First, how will this warning coalesce with
California’s current Proposition 65 warning require-
ments? Second, how will the timing of selling through
products with older warnings on them work?
PROP 65 VS. FDA WARNING
For Prop 65, certain industry groups are working to de-
vise a plan. The purpose of California’s Proposition 65
is to warn the consumer and the public at large that to-
bacco products contain toxic chemicals. The new FDA
warning plan achieves California’s objective and does
so in a meaningful manner such that 30 percent of the
principal display panels of the product’s packaging will
notify the consumer of the health warnings of the tobac-
co product. In terms of size and visibility, the FDA’s rule
goes above and beyond what is required by California’s
Proposition 65. Therefore, a proposed and reasonable
outcome is that California determines that the addi-
tional Prop 65 warning is unnecessary, duplicative and
may cause customer confusion in light of the new feder-
al guidelines that require such a clear and conspicuous
warning. In either event, hopefully the State of Califor-
nia will provide clarity in connection with this issue.
PRODUCTS ALREADY IN
THE RETAIL PIPELINE
Another common concern is that the May 10, 2018
deadline for implementing the new warning scheme may
create challenges in light of the fact that product can sit
in a warehouse or on a retail shelf for extended periods
of time. This may result in the sale of product without
the adequate warning to the consumer after the May 10,
2018 deadline, which would not be the fault of the man-
ufacturer/importer or the retailer. While the answer is
not crystal clear yet, the Deeming Regulations appear to
have considered this issue and provide a safe harbor to
both the manufacturer/importer, as well as to the retailer.
The manufacturer and importer appear to be allowed to
introduce product without the current warning require-
ments into commerce up until May 10, 2018. They then
have an additional 30 days after this deadline as a safe
harbor to continue selling the last of the product.
In addition, retailers appear to be provided a safe har-
bor as long as the retailer purchased the product from a
licensed manufacturer, the packaging contains some type
of health warning, and the retailer has not altered the
packaging. Both the FDA and the industry want to pro-
vide clear and conspicuous warnings so that consenting
adults may make informed decisions. With time, the new
FDA warning plan will be further clarified
.
TB
LEGAL MATTERS
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