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The White House weakens the FDA’s Proposed Regulations of E-Cigarettes (Reuters)

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Reuters News reported on June 24, 2014 that the White House has weakened the FDA”s proposed regulations of electronic smoking devices and premium cigars.  Below are key excerpts from the June 24 Reuter’s story.
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.
 
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.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.  This means that internet sales of electronic smoking devices could remain permissible.
 
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.
 
MB 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.
 
Read OMB’s deletions to the proposed FDA regulation at http://www.regulations.gov/#!docketDetail;D=FDA-2014-N-0189 under “Supporting Documents”.