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FDA Deems!

FDA Deems!

The proposed "deeming" of electronic cigarettes as tobacco products by the US Food and Drug Adminstration has finally emerged from the President's Office of Management and Budget and been published. Substantial equivalence aside, the proposed rules are not nearly as draconian as it had been feared they might be, however a thorough legal interpretation is needed. Related materials available online include the proposed regulation, a press release summarizing it, a statement by FDA chief Margaret Hamburg, and a page containing these links and others.

The proposal bans:
--sale to minors,
--sale in vending machines,
--free samples, and
--health claims in advertising.

It stipulates that:
--product approval is required within 2 years, with products on market in interim,
--packaging must include a health warning about the addictiveness of nicotine, and
--ingredients must be listed.

The proposed regulation does not:
--restrict flavors (pending further deliberation),
--ban internet sales to adults,
--ban advertising,
--impose a federal tax, or
--limit nicotine strength, as in the EU.

A 75-day comment period begins Friday, April 25 (tomorrow), after which the regulation will go into effect (with any alterations that are approved at that time), and manufacturers and marketers will have two years to comply. Comments should include agency name and the Docket number: FDA-2014-N-0189, and RIN 0910-AG38, and be sent to: this address. Comments sent by postal mail may be directed to an address given on page 3 of the document.

One welcome paragraph states the agency's awareness that compliance might be an onerous burden on smaller companies, and implies willingness to show some understanding: "FDA recognizes that some of the proposals in this document might impose significant costs on certain manufacturers,... including the requirement to register and list products.... FDA seeks comment and data on alternative approaches for manufacturers to satisfy these requirements that would reduce costs for manufacturers yet would still be appropriate for the protection of the public health." The agency appears eager to avoid weighting the regulations to favor large companies such as those of Big Tobacco.

Comment has been varied. At times commentators don't seem to know whether the proposed regulations are harsh or lax. CNN calls it a "crackdown", while opponent Stanton Glantz complains it is a "failure to act to reign (sic) in youth-rated marketing". Wells Fargo tobacco investments watcher Bonnie Herzog calls it "Not as bad as feared – Positive for industry". The piece on National Public Radio, by e-cig advocate Rob Stein, was even-handed, and quoted both Hamburg and FDA Tobacco Products Division head Mitchell Zeller, who trotted out the tired "Wild West" metaphor, even adding one "wild": "We call the current marketplace for e-cigarettes the Wild Wild West." CNN quoted Hamburg with the same metaphor (also using 2 iterations of "wild"). Glantz, allegedly the original perpetrator of the image, typically uses only one "wild". This is a metaphor out of control, and it's time to put a stop to it! Where is literary regulation when you need it?

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