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was released May 5 and goes into ef-
fect on August 8, 2016:
•
Prof. Michael Siegel of Boston Uni-
versity’s School of Public Health
said
that companies “have a right to vol-
untarily disclose their ingredients” and
“not disclosing that [their] products do
not contain tobacco and do not produce
smoke…would be misleading.” Sie-
gel also noted that Nicopure has made
a valid point that FDA has interpreted
the term “tobacco products” so broadly
that it included not only e-liquids, which
contain nicotine, but also batteries, wicks,
electronic displays, and glass vials, which
do not contain nicotine and are not de-
rived from tobacco or any constituent of
tobacco, Siegel said.
•
Jonathan Adler, law professor and
director of the Center for Business
Law and Regulation at Case Western
University School of Law
, said that
the FDA rule might help protect public
health insofar as it subjects “actual to-
bacco products” like cigars to the same
regulations as cigarettes, but deeming
e-cigs and other electronic nicotine de-
livery systems to be tobacco products
and subjecting them to extensive regu-
latory requirements is likely to do more
harm to public health than help it. The
Electronic Nicotine Delivery System
(ENDS) market will shrink as a conse-
quence of the requirement for FDA ap-
proval of all deemed tobacco products,
while “Big Tobacco will be in a better
position to dominate what’s left,” there-
by replacing a “vibrant competitive mar-
ket” with a cartel, Adler said. He also
questioned whether the FDA ban on the
sale of ENDS to minors would actu-
ally help public health, citing studies by
Yale and Cornell researchers that found
a correlation between restrictions on e-
cig sales to youth and an
increase
in teen
smoking rates.
•
Dr. Konstantinos Farsalinos of the
Onassis Cardiac Surgery Center
said
that many people may think that FDA
and its scientists “created a totally inap-
propriate regulation” because of their ig-
norance about how ENDS are used, but
Farsalinos believes that FDA research-
ers are “very clever and very well aware
of the e-cigarette reality,” yet agency of-
ficials were legally obliged to create the
deeming rule. “This is the cost for clas-
sifying e-cigarettes as tobacco products,”
Farsalinos said.
•
JeffStier,aseniorfellowattheNational
Center for Public Policy Research
, said
that while FDA “wasn’t wrong to regu-
late e-cigarettes,” the agency was wrong
to “effectively ban, by its own estimate, up
to 98.5 percent of the e-cigarettes on the
market today” when responsible regula-
tion would have been to institute battery
standards, a ban on underage sales, and
marketing restrictions.
•
Ray Story, founder and CEO of the
Tobacco Vapor Electronic Cigarette
Association (TVECA)
, said that the
FDA rule is “a complete disaster” that
“essentially bans the product across the
land” and sends vapers back to cigarettes.
•
Julie Woessner, executive direc-
tor for the Consumer Advocates for
Smoke-Free Alternatives Association
(CASAA)
, said that the FDA rule elimi-
nates “choice and diversity in the mar-
ketplace” and “is an appalling breach of
public trust by FDA.”
•
Cynthia Cabrera, president and ex-
ecutive director of the Smoke-Free Al-
ternatives Trade Association (SFATA),
said that the rule “pulls the rug out from
the 9 million smokers who have switched
to vaping, putting them in jeopardy of re-
turning back to smoking.”
…U.S. Sen. Ron Johnson (R-Wis.),
chair of the Senate Homeland Security
and Governmental Affairs Committee,
sent two
letters to FDA Commissioner
Robert Califf expressing his concerns
about the agency’s recent e-vapor regu-
lations. In the first, Johnson pointed out
that the new regulations “could result in
negative unintended health consequenc-
es,” and asked if it will revise the rules if
there is sufficient data showing that e-
vapor products are a safer alternative to
conventional cigarettes. In the second,
Johnson asked for Califf’s “assistance
in understanding the consequences that
this new regulation may have on small
businesses and the public’s health.” He
also urged FDA to be “transparent and
accountable in its regulatory actions.”
…FDA unveiled an
updated online
tool
to make it easier for consumers to
report problems with e-vapor, hookah,
cigarettes, cigars and smokeless tobacco
products. The agency said users can re-
port burns or other injuries, allergic reac-
tions, poisoning and problems with the
quality of the product, alongside other
issues, using the tool.
…FDA’s May 25 Q&A session on
deeming regulations answered
questions
from retailers
, many of them pertain-
ing to e-liquid sales, with much of the
answers referring back to the statutory
definition of a retailer, a manufacturer or
a tobacco product and its components or
parts. On questions concerning nicotine-
free e-liquids, FDA said that the deem
Farsalinos
believes that FDA
researchers are
“very clever and
very well aware
of the e-cigarette
reality,” yet agency
officials were legally
obliged to create the
deeming rule.
TMA REPORT
BY FARRELL DELMAN
22
TOBACCO BUSINESS INTERNATIONAL
JULY/AUGUST 2016