TOB Magazine

sociation’s Tony Abboud in a panel dis-

cussion about FDA’s final deeming rule

and shared their views on how manufac-

turers of newly regulated products will

respond to the announcement, what the

decision will mean for the competitive

landscape, and what the status is on efforts

to change the predicate date.

…

TheNewYorkTimes’

“RoomforDe-

bate” column

asked the question “How

will the FDA’s decision affect anti-smok-

ing efforts?” to four debaters. Kenneth E.

Warner, public health professor and for-

mer dean of the School of Public Health

at the University of Michigan, said that

the new FDA regulation “is likely to

squander an opportunity to hasten the

demise of the enormous toll of combust-

ed tobacco” because it is “hugely unbal-

anced, emphasizing the hypothetical risk

to children while ignoring the potential

harm-reduction benefits for adult smok-

ers.” Harold P. Wimmer, president and

chief executive of the American Lung

Association, said that the FDA’s new

rules represent “an important step for-

ward in protecting public health and pre-

venting a new generation of youth using

and becoming addicted to nicotine,” and

“[u]nproven claims that e-cigarettes can

help smokers quit are troubling.” Amy

L. Fairchild, professor of sociomedical

sciences at Columbia University’s Mail-

man School of Public Health, said even

if the final rule is so burdensome that

it effectively bans e-cigs, the document

also states FDA’s belief that “inhala-

tion of nicotine (i.e. nicotine without the

products of combustion) is of less risk to

the user than the inhalation of nicotine

delivered by smoke from combusted to-

bacco products,” and therefore stakehold-

ers need to use the FDA rule “as a lever

to elevate tobacco harm reduction as a

foundation of U.S. tobacco policy” and

a challenge to the abstinence-only scare

tactics approach. Delmonte Jefferson, ex-

ecutive director of the National African

American Tobacco Prevention Network,

said that the FDA rule “is a huge step in

tobacco prevention, and it will protect

underprivileged communities who dis-

proportionately suffer death and disease

due to these products,” but the agency

also needs to ban the “sale of mentholat-

ed tobacco products,” given that menthol

cigarettes are smoked by nearly 75 per-

cent of African American smokers.

…Major cigar associations are expect-

ed to gather shortly to plan out a strategy

to address the FDA’s final deeming rule

that includes premium cigars in its over-

sight. The

premium cigar industry

lob-

bied for several years for an exemption

from FDA regulations, and some indus-

try representatives, including Eric New-

man of J.C. Newman Cigar Company of

Tampa, Florida, said that they will meet

with members of Congress or take legal

action to fight the new rules.

…The bill H.R. 5054, introduced April

26 by U.S. Rep. Robert Aderholt (R-Ala.),

would make appropriations for Agricul-

ture, Rural Development, FDA, and Re-

lated Agencies programs for the fiscal year

starting October 1, 2016, and includes the

rider (originally proposed as H.R. 2058)

by U.S. Reps Cole (R-Okla.) and Bishop

(D-Ga.) to

change the February 15, 2007

predicate date

for currently unregulated

tobacco products that would be deemed

subject to FDA oversight. H.R. 5054

would also exempt “traditional large and

premium cigars” from FDA regulation

and require, no later than 12 months after

the date on which the deeming regula-

tions for e-vapor products are issued, that

a notice be issued of a proposal to estab-

lish a product standard for e-vapor prod-

uct batteries, with a final product standard

for such batteries to be published within

24 months.

It also sets marketing and sales regula-

tions for e-vapor products such as: ban-

ning ads in any publication other than

an “adult publication” (defined in the

amended rider); requiring retailer estab-

lishment sales of e-vapor products to be

in direct face-to-face exchanges without

the use of “any electronic or mechanical

device (such as a vending machine)…

that is not in an area restricted to those

over 18,” but exempts “mail-order” sales;

and requiring final regulations for the la-

beling of e-vapor products that would in-

clude the phrases “Keep Out of Reach of

Children,” “Underage Sale Prohibited,”

and an “accurate statement of nicotine

content.”Those who “own or operate an

establishment in any state engaged in the

retail sale of a vapor product” are required

to register with the Secretary of Health

and Human Services “within the later of

60 days after the date of enactment…or

30 days after first engaging in such retail

sale,” unless the establishment is already

under state regulation or is regulated un-

der Section 905 of the FD&C Act.

…The Keller and Heckman (K&H)

law firm, explaining what would have to

follow the April 19 vote on House Re-

port 114-531 by the U.S. House Appro-

priations Committee, a vote that took

TMA REPORT

BY FARRELL DELMAN

Major cigar

associations are

expected to gather

shortly to plan

out a strategy to

address the FDA’s

final deeming

rule that includes

premium cigars in

its oversight.

TOBACCO BUSINESS INTERNATIONAL

JULY/AUGUST 2016