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20

TOBACCO BUSINESS INTERNATIONAL

SEPTEMBER/OCTOBER 2015

TMA REPORT

By FARRELL DELMAN

…Some were expecting to see a

final

rule from the FDA Center for Tobacco

Products

on currently unregulated

tobacco products by the end of June.

Instead, the CTP issued an Advance

Notice of Proposed Rulemaking

(ANPRM) on July 1 addressing nicotine

itself,more specifically “nicotine exposure

warnings and child-resistant packaging

for liquid nicotine, nicotine containing

e-liquid(s), and other tobacco products”

defined to at least include “dissolvables,

lotions, gels and drinks.” CTP seeks

further comments, data, research, etc.

as an evidence base to take regulatory

actions regarding nicotine exposure per

se, something CTP says is not addressed

in its April 24, 2014 NPRM with respect

to unregulated products.

…Commenting on the ANPRM,

American Vaping Association (AVA)

President Gregory Conley

said that the

agency is “jumping the gun by moving on

this issue before the deeming regulation

has been finalized.” He added that

while the AVA supports child-resistant

packaging, which is already in use by the

vast majority of e-liquid manufacturers,

the group is concerned about the labeling

proposal, as poorly designed warnings

could mislead adult smokers about the

relative risks of vaping versus smoking.

Conley is also concerned that FDA is

“inquiring about placing color warnings

on vapor products when they haven’t

even fulfilled their duty to Congress

to require graphic warnings on deadly

combustible cigarettes.”

…FDA’s CTP and the National

Academy of Medicine (formerly

the Institute of Medicine) named

the five

2015-16 FDA Tobacco

Regulatory Science Fellows

, who will

be assigned to an office within CTP,

lead specific projects related to tobacco

product regulation, participate in the

“development of science-based public

health strategies,”and receive mentorship

from senior CTP staff.They are Amanda

Berger, a postdoctoral research fellow

at Oak Ridge Institute for Science and

Education in Maryland; Shari Feirman,

project director for regulatory science and

policy at Legacy’s Schroeder Institute for

Tobacco Research and Policy Studies in

Washington, D.C.; Jose Medina Torres,

health communications specialist at the

D.C.-based marketing firm Penngood;

Alexandra Merceron, visiting professor

at Georgetown University’s department

of public relations and corporate

communications; and Kimberly Snyder,

program and policy analyst at The

Nemours Foundation of Wilmington,

Delaware.

…FDA said that it continues to review

tobacco product marketing applications

and issued last month 125

Substantially

Equivalent (SE) orders

, eight Not-SE

orders, and one Refuse-to-Accept letter

for SE, while companies withdrew 190

SE reports from the review process.

The

U.S.

Food

and

Drug

Administration announced that it is

reopening the public comment period,

for 30 days until August 31, 2015,

on modified-risk tobacco product

applications (MRTPAs) submitted by

Swedish Match North America

for 10

tobacco products.

…CTP issued a warning letter to

Luis Neves Ferreira of

Puros Premium

Cigars,

saying that the cigarette

tobacco/RYO tobacco products sold on

his company’s websites cigars-habanos.

com,

cigarshabanos.eu

and

puros.pt

are

misbranded. Golden Virginia

“premium

On the fda…

Farrell Delman,

President, TMA

Breaking News From the TMA

The following are excerpts from harm reduction,

tobacco regulation and other tobacco-related news.