(Updates overnight story with comment from OMB)
By Toni Clarke and Sharon Begley
WASHINGTON, June 25 White House changes to
proposed rules for tobacco products significantly weakened
language detailing health risks from cigars and deleted
restrictions that might have prevented online sales of
e-cigarettes, published documents show.
The White House's Office of Management and Budget (OMB),
which analyzes the potential economic consequences of proposed
regulations, deleted language in the U.S. Food and Drug
Administration's recently proposed regulations describing how
the rules would keep thousands of people from taking up cigar
smoking and have enormous public health benefits.
The OMB also weakened language detailing the FDA's concerns
about the safety of e-cigarettes, according to documents
published Tuesday in the Federal Register.
Emily Cain, a spokeswoman for OMB, said that as with any
rule, OMB's office of information and regulatory affairs
conducted an interagency review process "to ensure that the
regulations through which agencies implement policies are
efficient, well-designed to achieve their objectives, and based
upon the best available evidence."
"It is routine for agencies to make changes to their draft
rules during the course of OMB review," she added. "The goal is
to maximize the effectiveness and benefit of the rules we
An FDA spokeswoman, Jennifer Haliski, said the FDA does not
comment on changes to a proposal during the review process but
said the period for the public to comment on the proposal is
still open until Aug. 8.
"All comments will be carefully considered as the final rule
is being developed," she said in an email. "As the science base
continues to develop for these products, the agency has the
ability to take additional regulatory actions designed to
further minimize the public health burden of tobacco use in this
The FDA has authority under a 2009 law to regulate
cigarettes, smokeless tobacco and roll-your-own tobacco, but
must issue new rules before regulating e-cigarettes, cigars,
hookahs, water pipes and other tobacco products.
In April, the FDA issued a proposal which would subject the
$2 billion e-cigarette industry to federal regulation for the
first time. It would ban the sale of e-cigarettes to people
under the age of 18 and vending machine sales.
The proposal disappointed public health advocates who
criticized the agency's failure to restrict flavored products or
television advertising, which they say attracts children, and
criticized the agency for not moving to restrict online sales,
where it can be harder to verify a person's age.
In its draft, the FDA had proposed "prohibition of
non-face-to-face sales (e.g. vending machines)." That would have
opened the door to a ban on online sales. But OMB edited the
sentence so that the prohibition refers only to vending
In another significant change, OMB turned the FDA's proposal
as it relates to cigars from a two-part rule - one for
traditional tobacco products and one for products that have not
previously been regulated - into a "two-option" rule, one of
which would exempt "premium cigars."
The cigar industry, backed by some members of Congress, had
lobbied OMB heavily for such an exemption. In a December 2013
letter to FDA Commissioner Margaret Hamburg and Sylvia Mathews
Burwell, who was director of OMB at the time and is now
Secretary of Health and Human Services, 24 Republican lawmakers
asked that premium cigars be exempt.
"As you know," they wrote, "premium cigars are a niche
product with an adult consumer base, much like fine wines. The
majority of people who enjoy a cigar do so occasionally, often
in social or celebratory settings."
When the proposed rule came out in April, some public health
advocates expressed dismay.
"The part of the proposal we are deeply troubled by is the
sweetheart deal for the cigar industry," Erika Sward, assistant
vice president for national advocacy at the American Lung
OMB also deleted an FDA analysis showing that exempting
premium cigars from a proposal to require large warning labels
would save manufacturers $1 million to $3 million but incur
costs to public health of $32.6 million to $34.2 million.
The White House office also deleted an extensive section in
which the FDA calculated how many lives would be saved by
regulating cigars, as well as the value of those lives. And it
deleted a similar analysis for the improvements in health that
would come from dissuading people from smoking cigars, such as
through warning labels.
The "welfare gain" from reducing the number of cigar
smokers, FDA calculated, would be $16 million to $52 million.
Similarly, OMB modified or deleted FDA concerns about the
safety of e-cigarettes, including manufacturing quality.
It deleted FDA draft language saying it would review
electronic cigarette cartridges to respond to evidence of poor
quality control, variable nicotine content or toxic ingredients
such as diethylene glycol, a chemical that the FDA said has
caused mass poisonings in products such as the painkiller
acetaminophen and cough syrup.
Last week a panel of U.S. senators excoriated the chiefs of
two of the biggest e-cigarette companies, blu eCigs, which is
owned by tobacco giant Lorillard Inc, and privately held
NJoy, saying they were irresponsibly targeting children with
advertisements depicting cartoon characters, movie stars and
Both companies defended the advertisements, saying they
target adult smokers.
To see the edited proposal, click here under "Supporting
(Reporting by Toni Clarke in Washington and Sharon Begley in
New York; Editing by Clive McKeef)