TOB Magazine

TMA REPORT

ON THE FDA…

…The

redline version of the FDA’s

final deeming regulations

, reflecting all

changes that the White House’s Office

of Management and Budget (OMB)

made after receiving it in October 2015,

shows that the OMB deleted FDA’s lan-

guage that would have removed newly

deemed flavored tobacco products from

the market until they obtained FDA

authorization. OMB also deleted FDA’s

rationale for the policy on flavored

products, which noted “a dramatic rise

in youth and young adult use of typi-

cally flavored tobacco products, like e-

cigarettes and water pipe tobacco, and

continued youth and young adult use of

cigars.”Dr. Edward Anselm, a senior fel-

low with the R Street Institute, said that

the White House showed “a degree of

insight into an important public health

problem” by deleting references to flavor

in the FDA regulations.

…Tampa, Florida-based

Nicopure

Labs

filed a lawsuit in the U.S. District

Court for the District of Columbia on

May 10 claiming that FDA’s final deem-

ing regulations violate the First Amend-

ment “by prohibiting manufacturers, in-

cluding Nicopure, from making truthful

and nonmisleading statements regarding

vaping devices, e-liquids, and related

products.” Nicopure General Counsel

and Chief Compliance Officer Patricia

Kovacevic said, “[t]he government’s role

is not to regulate for the sake of regula-

tion; regulation must be based on sound

science and robust procedure, and it must

accomplish certain public health goals.”

…

Forbes

contributor and

Reason

magazine’s senior editor Jacob Sul-

lum said that Nicopure Labs’ lawsuit

against

FDA’s deeming rule

highlights

the “censorship of potentially lifesaving

information about e-cigarettes,” since

even the companies that survive the

“shakeout” caused by the new regulations

would not be allowed to inform consum-

ers that vaping is a less hazardous alter-

native to smoking combustible products

unless they first obtain prior FDA ap-

proval to market their e-vapor product

as a “modified-risk tobacco product.” If a

company truthfully describes its e-vapor

product as “smokeless” or “smoke-free,”

FDA could still render them “adulterat-

ed,” though FDA said it will evaluate the

use of those descriptors “on a case-by-

case basis.” Companies are also banned

from providing a straightforward chemi-

cal comparison of the aerosol from an e-

vapor product and the smoke produced

by a combustible cigarette, meaning that

“FDA is actively suppressing truthful in-

formation that would encourage people

to make healthier choices,” Sullum said.

…Los Angeles-based e-vapor com-

pany

Lost Art Liquids

filed a lawsuit in

the U.S. District Court for the Central

District of California challenging FDA’s

“purported authority to deem and regulate

e-liquids and other vapor products as ‘to-

bacco products’ under the Tobacco Con-

trol Act.”The lawsuit also accuses FDA of

violating the Regulatory Flexibility Act,

the First and Fifth Amendments, and

the Administrative Procedures Act. CEO

Brian Worthy said, “FDA continues to

confuse and conflate vapor products with

tobacco and chooses to ignore years of

well-established research that shows the

relative safety of the products compared

to combustible cigarettes.”

…

Altria Group

filed a civil complaint

with the U.S. District Court for the

District of Columbia protesting FDA’s

deeming regulations, which, among

other measures, prohibits the sale and

distribution of tobacco products with

modified-risk descriptors such as “light,”

“low” and “mild,” unless authorized by

the agency. Altria alleges that this mea-

sure violates the First Amendment that

protects trademarks and brand names as

well as the Fifth Amendment that deals

with privacy and property rights. Altria

also argued that the use of the word

“mild” in its Black & Mild cigar brand,

manufactured by its subsidiary John

Middleton Company, describes “taste

and body” and does not convey anything

about health, risk or safety.

…In what is the

fourth legal chal-

lenge to FDA’s deeming regulations

Miami, Florida-based Global Premi-

um Cigars filed a lawsuit June 1 in the

U.S. District Court in Miami, argu-

ing, among other things, that the rules

violate the First and Fifth Amendment

rights of the company and its owner

Enrique Sánchez. The company, which

owns the 1502 Cigars brand, urged the

court to vacate the deeming rules and is-

sue a preliminary injunction to prevent

FDA from taking any action pending

resolution of the case on the merits.

…An outflow of comments followed

FDA’s Final Rule, “Deeming Tobacco

Products To Be Subject to the Federal

Food, Drug, and Cosmetic Act,” that

BREAKING NEWS FROM THE TMA

The following are excerpts from harm reduction,

tobacco regulation and other tobacco-related news.

BY FARRELL DELMAN

Farrell Delman,

President, TMA

TOBACCO BUSINESS INTERNATIONAL

JULY/AUGUST 2016