TOB Magazine

TOBACCO BUSINESS INTERNATIONAL

SEPTEMBER/OCTOBER 2016

ket, Prof. Michael Siegel said that Altria

is “trying to save at least some vitality

in the e-cigarette and vaping market by

urging FDA to weaken the burdensome

requirements so that many more manu-

facturers have an opportunity to stay

on the market.” Altria and RAI are the

only companies with the resources to

develop the required PMTAs, but they

are in strong support of the Cole-Bish-

op Amendment to grandfather existing

products to create a “robust market for

harm-reduction products” and prevent a

“Big Tobacco oligopoly,” Siegel said.

…The

Cigar Association of America

(CAA),

International Premium Cigar

and Pipe Retailers Association

(IP-

CPR), and the

Cigar Rights of America

(CRA) have filed suit in U.S. District

Court for the District of Columbia

against the FDA’s deeming rule. The

complaint alleges that it “violates numer-

ous federal statutes as well as the federal

rulemaking process” and asks for a de-

claratory injunction to “vacate, set aside

and enjoin the enforcement of the final

rule.” The plaintiffs said that the lawsuit

challenges the FDA’s 1) “improper appli-

cation of the February 15, 2007 grand-

father date to cigars and pipe tobacco”;

2) “impermissible assessment” of user

fees and the allocation of the fees only to

cigars and pipe tobacco, not other newly

deemed products; 3) “failure to perform

an adequate cost-benefit analysis,” per

the Regulatory Flexibility Act, to ac-

count for the deeming rule’s effect on

small businesses; 4) “unjustified decision”

to require health warning labels to cover

30 percent of the two principal display

areas of cigar packages; 5) “unlawful des-

ignation” of tobacconists as “manufactur-

ers,” rather than “retailers,” if they blend

finished pipe tobacco or create cigar

samplers; and 6) “incorrect decision” to

regulate pipes as “components” or “parts”

instead of “accessories.”

…Three

vape shops in Alabama

—

Operation Vapor in Daleville, Tiger

Vapor in Opelika, and Cyclops Vapor

2 in Montgomery—also filed a lawsuit

against FDA. Their suit claims that the

agency’s deeming rule for e-vapor prod-

ucts will “annihilate” the vaping industry

rather than regulate it. Unlike the other

pending suits against the deeming rule,

Alabama’s is the only one that demands

a jury trial.

…Representing many e-vapor associa-

tions, including the

Right to be Smoke-

Free Coalition, Not Blowing Smoke,

AEMSA, SFATA, CASAA, AVA,

EVCA, SEVIA

and various state vaping

associations, Washington, D.C.-based

law firm Keller and Heckman announced

June 21 that it filed an eight-point com-

plaint in the U.S. District Court for the

District of Columbia that challenges the

CTP’s deeming rule and the Tobacco

Control Act on various constitutional

and administrative grounds.

…Judge Amy Berman Jackson of the

U.S. District Court for the District of

Columbia ordered that the aforemen-

tioned legal challenge to the FDA’s new

deeming rule filed by a

coalition of 10

e-vapor associations

be consolidated

with another lawsuit brought by Tampa,

Florida-based

Nicopure Labs

. Judge

Jackson scheduled a hearing for Octo-

ber 19. Nicopure Labs filed a motion for

summary judgment in the same court to

request that the court affirm that “the

deeming rule is unlawful and should be

set aside.”

…Prof. Michael Siegel said that FDA

either 1) grossly underestimated the

number of regulated products on the

market

as its deeming rule estimates

only 750 pre-market tobacco applica-

tions (PMTAs) to be submitted per year,

or 2) assumed that hundreds of small

companies would go out of business and

therefore not file PMTAs, given that

Nicopure Labs alone, which has sued

the FDA, reports having 2,400 stock

keeping units (SKUs). It would cost the

company $720 million to file PMTAs

even using FDA’s conservative estimate

of $300,000 per application. Nicopure

Labs estimates the actual cost to be $3-5

million per PMTA.

…E-liquid company SQN is intro-

ducing three lines of new e-liquids called

“NKTR,” “NKTR Sour” and “Melt,”

which use

synthetic, lab-made tobac-

co-free nicotine

manufactured by Next

Generation Labs, a company co-founded

Altria is “trying to save at least some

vitality in the e-cigarette and vaping

market by urging FDA to weaken the

burdensome requirements so that many

more manufacturers have an opportunity

to stay on the market.”

TMA REPORT

BY FARRELL DELMAN