TOB Magazine

regulations may be struck down in court or

modified by legislative action to make com-

pliance more feasible.All together,there have

been eight lawsuits challenging the deeming

regulations thus far and more are expected

to be filed in the coming months. There’s

also a bill before Congress that contains an

amendment seeking to change the predicate

date—or the date by which a product had

to be on the market in order to be exempt

from the new tobacco product application

processes set forth by FDA.The bill’s Cole-

Bishop Amendment would change that date

from February 15, 2007 to August 8, 2016.

“This bill will still need approval by the

full House, the full Senate, and then be

signed by the president…so we are not sure

if it will get enacted or not,” says Briant.

More Regulation on the Horizon?

While many hold out hope for the tide

to turn, there is also fear that the require-

ments already in force are just the begin-

ning of a tidal wave of regulatory actions.

“FDA claims that the deeming regulations

are what they call ‘enabling regulations’—

that is, they enable the agency to issue more

regulations on tobacco products in the fu-

ture,” says Briant. “One possible addition is

extending a self-service display ban on all

newly deemed products so that pipe tobac-

co, e-cigarettes and hookah products could

not be displayed in self-service displays.”

However, lawsuits may well play a part

in what happens in the months to come.

“Several lawsuits claim that FDA exceed-

ed its authority by extending its regula-

tion to e-cigarettes and vapor products,”

says Briant. “They argue that it is not

reasonable to apply regulations that gov-

ern cigarettes to e-cigarettes and/or vapor

products because cigarettes are combus-

tible and e-cigarettes have no combus-

tion. They also claim [that] FDA failed

to adequately quantify the benefits of the

regulations and that the agency underes-

timates the cost of the regulations to [the]

industry, so FDA cannot now claim that

the benefits outweigh the costs, which is a

requirement under federal law.”

As the legal battles wage and the indus-

try trundles toward compliance deadlines,

retailers are waiting for the dust to settle

and a new normal to emerge. It may be a

long wait.

TBI

As an industry that has

repeatedly weathered regula-

tory changes, the tobacco

industry is better equipped

than most to survive this

current challenge. From filing

lawsuits to debuting new

technologies, companies are

showing grit and determina-

tion in the face of adversity.

Here’s a look at how some

have responded.

E-liquid company

SQN

is introducing three lines of

new e-liquids called “NKTR,”

“NKTR Sour” and “Melt” that

use

synthetic, lab-made

tobacco-free nicotine

manu-

factured by Next Generation

Labs, a company co-founded

by Ron Tully, consultant to Na-

tional Tobacco and the Vapor

Technology Association. “The

synthetic nicotine has the

same molecular formula as

the ‘natural’ nicotine derived

from tobacco plants, but may

potentially skirt FDA regula-

tions that took effect August

8,” noted a recent report

by the TMA. “The Tobacco

Control Act defines tobacco

products as ‘any product

made or derived from tobacco

that is intended for human

consumption, including any

component, part, or acces-

sory of a tobacco product.’”

FDA has said that the status

of products incorporating syn-

thetic nicotine will be evalu-

ated on a case-by-case basis.

Other companies report-

edly using synthetic nicotine

include

Coastline, CRFT Labs

and

KVASS

Miami, Florida-based

Global Premium Cigars

which owns the 1502 Cigars

brand, filed a

lawsuit

June 1

in the U.S. District Court in

Miami arguing, among other

things, that the rules violate

its First and Fifth Amendment

rights and the rights of its

owner, Enrique Sánchez. The

company urged the court to

vacate the deeming rule and

issue a preliminary injunction

to prevent FDA from taking

any action pending resolution

of the case on the merits.

Back in March,

R.J.

Reynolds

debuted several

next-generation products for it

Vuse line, including the

Vuse

FOB, Vuse Port

and

Vuse Pro

a move many speculated the

company made in anticipa-

tion of regulations that would

preclude further innovation

in the category and push

existing products made by

smaller companies out of the

market. RJR, however, simply

positioned the introductions

as the next step for its vapor

business.

“Adult tobacco consum-

ers are looking for a vapor

experience that delivers the

performance and satisfaction

of a tank, with the simplicity

of a cig-alike,” promised Brice

O’Brien, executive vice presi-

dent, consumer marketing for

R.J. Reynolds Tobacco Com-

pany. "And that’s what the next

generation of Vuse will deliver.”

RJR, of course, is one of the

few manufacturers with deep

enough pockets to undergo the

FDA application process.

Will Innovation be the Answer?

TOBACCO BUSINESS INTERNATIONAL

SEPTEMBER/OCTOBER 2016