TOB Magazine July/August 2013

22

TOBACCO BUSINESS

JULY/AUGUST 2013

years” as they

de-normalize smoking

by

reducing consumption of conventional

cigarettes. This statement reiterated

Wells Fargo analysts Bonnie Herzog and

Jessica Gerberi’s projection that e-cig

consumption could surpass cigarette

smoking in the next decade.

…Commenting on the FDA’s plan to

issue deeming regulations for currently

unregulated tobacco products, University

of Louisville Prof. Brad Rodu said given

that the agency has “shown no interest in

tobacco harm reduction,” its regulatory

framework for electronic cigarettes might

mirror that for cigarettes and traditional

smokeless tobacco products, which

could include “onerous advertising and

marketing restrictions that would cripple

efforts to increase awareness and trial of

e-cigs by smokers,” adding that e-cigs

are also likely to be burdened with heavy

federal and state excise taxes that will

eliminate any economic advantage they

have over traditional cigarettes.

…In a May 19 op-ed in the

Raleigh

News & Observer

, Scott Ballin, a health

policyconsultant, andDr.Michael Hufford,

the chief medical officer for e-Nicotine

Technology, a Chapel Hill, North Carolina-

based company developing an electronic

nicotine delivery device, said that if the

FDA, which is preparing to issue

deeming

regulations for electronic cigarettes,

“embraces harm reduction and enacts

balanced regulations that encourage the

efficient development of safer forms of

nicotine delivery, then it can both protect

public health and enable free market

forces, driven by innovation, to help

permanently extinguish the combustible

cigarette and, with it, a man-made public

health disaster without parallel.”

…Mitch Zeller, director of FDA Center

for Tobacco Products, spoke at the

TMA Annual Meeting

on May 16. In his

presentation titled “The CTP: A New

Beginning,” he said a top priority for the

agency is to strengthen communications

between all parties involved, throughboth

formal and informal meetings, and that

“our job is to regulate the manufacture,

sale, and marketing of regulated tobacco

products effectively, efficiently and fairly.”

Zeller again listed CTP’s three immediate

priorities of substantial equivalence (SE)

applications, menthol, and deeming

regulation for currently unregulated

tobacco products, and said the agency

is “close” to a decision on initial SE

reports and expressed its intent to clear

the current backlog on applications. On

menthol, Zeller said the FDA is “close

to announcing our actions on those

issue as well,” but declined to reveal

further details. Beyond CTP’s immediate

priorities, Zeller added that the agency’s

“ongoing” priorities include its regulatory

science and research program and

investment in the Population Assessment

of Tobacco and Health (PATH) Study,

which will examine population-based

patterns of initiation and consumption.

CTP’s “long-term” strategy covers

product standards (as a potential tool

to reduce exposure to harmful tobacco

constituents) and modified risk tobacco

products (CTP is aware of their potential at

the individual level, but the agency needs

to know the net population level effect),

he said. Throughout his presentation,

Zeller spoke about maintaining an open

communication between the industry

and the FDA, noting that CTP should also

stand for “Consistent, Transparent and

Predictable,” which he said are principles

the agency is committed to uphold.

Morgan Stanley analysts said Zeller’s

presentation at the TMA meeting had

“little new substantive disclosure,” but

his remarks suggested that the agency

may be “marginally closer” to giving

feedback on SE applications, while he

also highlighted the commitment to

transparency, though Morgan Stanley

also noted that “this may have been

influenced by the venue/audience.” (For

TOB Magazine July/August 2013 - page 8

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