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
"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 complete."
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
"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 country."
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 machines.
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
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
"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
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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 Association.
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
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 other celebrities.
Both companies defended the advertisements, saying they target adult
To see the edited proposal, click here under "Supporting Documents"
(Reporting by Toni Clarke in Washington and Sharon Begley in New
York; Editing by Clive McKeef)
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