Smokefree/Public Health Physicians

[KDMickey]

So we're not completely alone in this. I received the following in my inbox earlier today:

Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
smokefree@compuserve.com
PH 412-351-5880 FAX 412-351-5881

April 1, 2009

The Honorable
U.S. House of Representatives
Washington, D.C. 20515

RE: tobacco Regulatory Legislation (HR 1256 & HR 1261)

Dear Representative

Smokefree Pennsylvania urges you to oppose Rep. Waxman's FDA tobacco bill
(HR 1256) and to also oppose Rep. Buyer's substitute tobacco bill (HR 1261)
because both bills contain outrageous clauses that protect future cigarette
markets at the expense of public health.

We oppose Rep. Waxman's legislation, a deal negotiated by Philip Morris and
the Campaign for Tobacco Free Kids in 2004, because it protects the most
hazardous tobacco product (cigarettes) from market competition by the least
hazardous (smokefree) tobacco products, as it:
- bans all new and recently introduced smokefree products, while keeping
cigarettes on the market,
- deceives consumers to believe that smokefree tobacco products are just as
hazardous as cigarettes,
- prohibits industry from telling smokers that smokefree products are less
hazardous than cigarettes.

Sound product regulations truthfully inform consumers (and the public)
about risks of different products, and encourage industry to make lower
risk products. Cigarettes are 100 times deadlier than smokefree tobacco
products, but 85% of smokers incorrectly believe that smokefree tobacco
products are just as hazardous as cigarettes. By switching to smokefree
tobacco/nicotine products, smokers reduce their health risks by nearly as
much as by quitting all tobacco/nicotine, and millions have already done
so. Public health agencies have an ethical duty to inform smokers that
smokefree tobacco/nicotine products are less hazardous alternatives to
cigarettes, and smokers have a human right to this important information.
I coauthored a report "Tobacco harm reduction: an alternative cessation
strategy for addicted smokers" at
Harm Reduction Journal | Full text | Tobacco harm reduction: an alternative cessation strategy for inveterate smokers

While Smokefree Pennsylvania supports the harm reduction provisions in Rep.
Buyer's substitute (HR 1261), we oppose the bill since it contains clauses
that would increase cigarette sales to minors.

Since 1990, Smokefree Pennsylvania has advocated policies to protect people
from tobacco smoke pollution, increase cigarette taxes, reduce tobacco
marketing to youth, preserve civil justice remedies for tobacco victims,
expand smoking cessation services, and inform smokers that smokefree
tobacco/nicotine products are less hazardous alternatives to cigarettes.
Thank you for your consideration, and feel free to contact me anytime.

Sincerely,


William T. Godshall, MPH
Executive Director

And...

Philip Morriss Support Casts Shadow Over a Bill to Limit Tobacco

By Duff Wilson
New York Times
March 31, 2009
http://www.nytimes.com/2009/04/01/business/01tobacco.html?_r=2

Here comes the tobacco regulation that Philip Morris can live with.

On Wednesday, the House is expected to pass a bill that would give the Food
and Drug Administration authority to regulate the tobacco industry for the
first time, including the power to block or approve new products.

The Senate, which passed a similar measure in 2004, is expected to take it
up later this year, with support from President Obama.

Passage, if it comes, may be politically impossible without the negotiated
support of Philip Morris, whose Marlboro brand helps make it the American
tobacco industrys biggest player.

The companys central role, in fact, is a reason that some antismoking
activists worry that the bill is a deal with the devil. Philip Morriss
support is also why other major tobacco companies - none of which back the
legislation - see a cunning ploy by Marlboros maker to seal the companys
dominant position.

Senator Richard M. Burr, a Republican from North Carolina, home to Philip
Morriss rival R. J. Reynolds, has threatened a filibuster.

Competitors say that the F.D.A. is unlikely to approve many new tobacco
products. That, they say, combined with the legislations broader
restrictions on tobacco advertising and marketing, would lock in Philip
Morriss market dominance.

"It would make it harder to let consumers know there are options available
to them," said Maura Payne, a spokeswoman for R. J. Reynolds, a part of
Reynolds American and the second-largest tobacco seller and maker of Camel
cigarettes.

In addition, even as Philip Morris has spent years lobbying for the
legislation, it has also poured hundreds of millions of dollars into a
research center in Richmond, Va., to develop new tobacco products it hopes
can pass federal muster - in particular, smokeless products that can be
chewed or sucked or inhaled and do not involve burning tobacco. Few other
tobacco companies have the resources to place such bets on the regulatory
future.

Philip Morriss motives notwithstanding, the legislation has broad support
from nearly 1,000 advocacy groups, including the Campaign for Tobacco-Free
Kids, which led the negotiations with the company, as well as the American
Heart Association, the American Lung Association and the American Cancer
Society.

Representative Henry A. Waxman, Democrat of California who, along with
Senator Edward M. Kennedy, Democrat of Massachusetts, has long pushed for
the legislation, says it will result in meaningful tobacco regulation. The
law would curtail many of the harmful ingredients in cigarettes, he said,
and ensure that tobacco is not advertised for children or sold to them.

"Philip Morris is supporting it for their own reasons," said Mr. Waxman, a
sponsor of the bill, called the Family Smoking Prevention and Tobacco
Control Act. "This is a good bill and a strong bill," he said. "I dont
think weve made any concessions that wed want to change."

For its part Altria, the parent company of Philip Morris USA, says it hopes
that F.D.A. regulation would create a more predictable climate than
state-by-state regulations and the product liability lawsuits that have
challenged the tobacco industry.

On Tuesday, for example, the Supreme Court upheld a decade-old $79.5
million award to an Oregon smokers widow, nearly all in punitive damages,
for what the Oregon Supreme Court had termed "extraordinarily
reprehensible" conduct by Philip Morris in a "a massive, continuous,
near-half-century scheme" of hiding the risks of products that killed many
people.

While the tobacco bill expressly allows such lawsuits to continue, legal
experts expect tobacco lawyers to argue that the new F.D.A. oversight
confers federal authorization on their products.

"We recognize that we create a product that is harmful and causes serious
disease," said David M. Sylvia, an Altria spokesman. "For the betterment of
even our business, it is best to have a set of regulations in place to
provide stability and predictability."

What the legislation actually means for the future of smoking in America is
hard to predict. The rigor of tobacco regulation would depend on how
aggressively the new powers were wielded by the F.D.A., which would need to
set up a new Center for Tobacco Products, whose operations would be
financed by up to $712 million a year in industry fees, assessed on the
basis of companies market share.

So far, F.D.A. officials decline to discuss how this may work, because
President Obama has nominated Dr. Margaret A. Hamburg, a former New York
City health commissioner, who still requires Senate confirmation.

The Waxman legislation is facing opposition from people who say its
criteria for approving new "reduced harm" products - the bills term - will
make it too difficult to approve and sell new tobacco products marketed as
giving smokers safer alternatives to current cigarettes.

Competing legislation has been introduced in the House by Steve Buyer,
Republican of Indiana, and Mike McIntyre, Democrat of North Carolina, and
in the Senate by Mr. Burr of North Carolina and his Democratic colleague
from that state, Kay Hagan.

Their bills would vest authority in the Department of Health and Human
Services, rather than the F.D.A., and emphasize disclosure of ingredients,
rather than banning ingredients or barring new products.

Mr. Waxmans bill, empowering the F.D.A., prevailed in the House commerce
committee March 4 on a vote of 39 to 13. It is thought to have more than
enough votes to pass the House, although the Senate version could meet more
resistance.

While leading nonprofit groups have lined up behind Mr. Waxman and Mr.
Kennedy, the prime sponsor in the Senate, a smaller number of antismoking
activists argue the hazards of trusting anything supported by Philip
Morris.

"The way you beat the tobacco companies is the old-fashioned way: you beat
them," said Stanton A. Glantz, the founder and director of the Center for
Tobacco Control Research and Education at the University of California, San
Francisco, and a professor of cardiology there. "Going into partnership
with them or cutting deals with them, theres not single case anytime
anywhere in the world where thats worked."

Mr. Glantz cited, for example, a provision in the Waxman bill that would
allow tobacco industry representatives to sit on a new F.D.A. scientific
advisory committee. Though the two would be nonvoting members, he said they
could still exert influence.

Mr. Glantz argues that Congress should get tougher on the tobacco industry,
now that it is more Democratic than it was last year and there is no longer
the likelihood of a presidential veto.

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, rejected
Mr. Glantzs charge that he had caved in to Philip Morris.

"It is easier for Stan Glantz to make accusations about a so-called deal,"
Mr. Myers wrote in an e-mail message, "than to acknowledge that this is Mr.
Waxman and Mr. Kennedys bill - because it is not credible to argue that the
two strongest public health leaders in Congress who are fierce opponents of
the tobacco industry are backing weak legislation."

Mr. Sylvia, the Altria spokesman, said the company had been seeking F.D.A.
regulation of tobacco since 2001, shortly after the Supreme Court rejected
an F.D.A. effort to assert legal authority over nicotine as a drug. The
court, in a 5-4 decision, said F.D.A. lacked Congressional authority.

"We support tough but reasonable federal regulation, Mr. Sylvia said. And
specifically, we support the legislation that was introduced by Mr. Waxman
and his committee."

I recommend bringing the articles to your reps' attention.

Cheers,
-Mickey

 

[CarsonCity314]

Reading through the current draft of HR 1256, it looks to me like e-cigarettes would fall under Section 918, as "drug products used to treat tobacco dependence," rather than a "tobacco product" under any of the other sections. I believe "smokeless tobacco" in this case refers to chewing tobacco and snuff - products fundamentally comprised of tobacco.

The FDA has exercised the authority to regulate non-tobacco nicotine products for years (including patches, lozenges, lollipops, and nicotine-infused water) and it seems likely that e-cigarettes would be more easily classified with these products than with tobacco. and I doubt that e-cigarettes (or e-juice) could cleverly evade classification as either. I'll admit that the definition of "tobacco product" under section 101 is vague enough that I can conceive of an interpretation that would make e-juice a tobacco product.

Overall, however, if e-juice is considered a tobacco replacement drug under this bill's definition, it might not be the worst thing in the world. The bill would have the FDA conduct continued studies to pursue reduced tobacco consumption - and approval of OTC non-tobacco nicotine products could very well serve this goal.

The hurdles associated with FDA regulation (such as finding someone willing to sponsor the battery of clinical testing required even for an ANDA) will still be significant, but IMO better than the current threat of a full NDA requirement by the FDA.