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The following statement was submitted to the U.S. Senate HELP Committee, which
is holding a hearing today on S. 625, the FDA tobacco legislation that is
supported by Philip Morris.
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Statement for the Record
 

William T. Godshall, MPH
Executive Director

Smokefree Pennsylvania

1926 Monongahela Avenue

Pittsburgh, PA 15217

412-351-5880

FAX 351-5881

bill@smokescreen.org

http://smokefree.net/bg-announce/messages

  

"The Need for FDA Regulation of Tobacco Products"
 

U.S. Senate Committee on Health, Education, Labor and Pensions
 

February 27, 2007
 

Smokefree Pennsylvania is a nonprofit organization founded in 1990 whose goals
include protecting people from the involuntary exposure to tobacco smoke
pollution, reducing tobacco marketing to youth, increasing cigarette prices,
preserving civil justice remedies for injured tobacco victims, and increasing
tobacco prevention and cessation services. 

 

Smokefree Pennsylvania strongly opposes the introduced version of S. 625, the
"Family Smoking Prevention and Tobacco Control Act" that would authorize the
U.S. Food and Drug Administration (FDA) limited regulatory jurisdiction over
tobacco products.


In sum, Smokefree Pennsylvania opposes the current text of S. 625 because it
would:

 

- mislead the public into believing FDA regulation reduces tobacco products
risks,

- protect cigarettes from market competition by less harmful smokeless tobacco
products,

- increase Philip Morris' 51% cigarette market share, as well as Marlboro's
market share,

- increase inaccurate public beliefs that smokeless products are as hazardous as
cigarettes,

- encourage FDA to set cigarette emission standards based upon inaccurate
machine tests,
- increase inaccurate public beliefs that certain cigarettes are less hazardous
than others,

- mandate counterproductive and/or ineffective warning labels on tobacco
products,

- fail to adequately inform consumers of comparable risks of different tobacco
products,

- prohibit harm reduction marketing of lower risk smokeless products to smokers,

- do very little, if anything, to reduce cigarette caused disease, disability
and death,
- allow tobacco manufacturers and others to promote cigarettes as FDA approved,
- severely limit the FDA's authority to issue effective tobacco product
regulations, and

- reduce cigarette manufacturer liability by misleading potential jury pools.

 

Reducing health risks of future tobacco products 

 

Effective regulations gradually phase out the most hazardous products, and
encourage the development of and transition to lower risk products.  Effective
product regulations also adequately inform consumers of relative and comparable
product risks.  In sharp contrast, S. 625 protects the most hazardous tobacco
product (cigarettes), the largest cigarette company (Philip Morris) and the
largest cigarette brand (Marlboro) from market competition from far less
hazardous noncombustible tobacco products by misleading consumers to incorrectly
believe that smokeless tobacco products are just as hazardous as cigarettes, and
by prohibiting truthful harm reduction marketing claims by smokeless tobacco
products that are directed towards already addicted cigarette smokers.


Cigarettes kill fifty percent of addicted smokers, and up to 63,000 American
nonsmokers annually (from secondhand smoke and fires).  In contrast, smokeless
tobacco kills about one perecent of addicted users, and ZERO nonusers.  Swedish
smokeless (snus) and other new low nitrosamine noncombustible tobacco products
pose even fewer risks.  Smokers who switch to smokeless products can sharply
reduce their disease and death risks. 

But S. 625 perpetuates the myth/fraud that noncombustible tobacco products are
just as hazardous as cigarettes by requiring larger labels on smokeless packs
and advertisements that state: "This product is not a safe alternative to
cigarettes," and by failing to inform smokers (e.g. via labels on cigarette
packs and advertisements) that smokeless tobacco products pose fewer morbidity
and mortality risks than cigarettes.  If U.S. Congress is sincere about
truthfully informing consumers about the health risks of different tobacco
products, this misleading warning MUST be removed from smokeless tobacco
products.

 

S. 625 also could be improved if FDA was encouraged to approve clean nicotine
products (e.g. skin patches, gum, lozenges, inhalers) for nicotine maintenance
instead of just for temporary use as a smoking cessation aid.  Shiffman et al
found that 36.6% of nicotine gum users consumed the product for longer than six
months, despite the product warning urging discontinued use after twelve weeks. 
 Clean nicotine products are far less hazardous than relapsing to cigarettes,
and should be approved for nicotine maintenance. 

 

Although Section 911 of S. 625 includes provisions for FDA to approve the
marketing of  "modified risk tobacco products", it is highly unlikely that any
product would be approved since any manufacturer applying for FDA approval for a
modified risk product would need to demonstrate that the product wouldn't
discourage smokers from quitting tobacco use and wouldn't result in use by non
tobacco users.  Besides, the Campaign for Tobacco Free Kids, American Cancer
Society and other proponents of S. 625 have repeatedly alleged that the
marketing of smokeless tobacco products for harm reduction discourages smokers
from quitting and encourages youth to begin using those products. 


In contrast, Section 911(g)(2) of S. 625 would allow a cigarette manufacturer to
apply for and receive FDA approval for "an explicit or implicit representation
that such tobacco product or its smoke contains or is free of a substance or
contains a reduced level of a substance, or presents a reduced exposure to a
substance in tobacco smoke."  This clause could very likely result in the FDA
approving the marketing of a "reduced exposure" cigarette even if the cigarette
is as hazardous as other cigarettes.  Even worse, the marketing of an FDA
approved "reduced exposure" cigarette is likely to confuse smokers into
believing that the product is less hazardous than other cigarettes.      

 

Cigarette machine testing methods are inaccurate, and only serve to misinform

Effective product regulations also protect consumers from health frauds. 
Although S. 625 eliminates cigarette brand descriptors "Light", "Low-Tar" and
"Mild," (which arguably is the deadliest consumer fraud of the 20th century),
consumers of these products would barely notice this change because these brands
would remain on the market in their easily recognized package designs and colors
(minus one word).  Marlboro Lights, which has the largest market share of any
cigarette, would simply become known as Marlboro Gold, while Marlboro
Ultralights would simply become known as Marlboro Ultras or Marlboro Silver. 
Meanwhile, S. 625 does nothing to warn smokers that the brands previously named
"Lights" and "Ultralights" are just as hazardous as other cigarettes.



But far more troublesome, S. 625 authorizes the FDA to establish cigarette
emission standards for various smoke constituents based upon inaccurate smoking
machine testing methods similar to the notorious FTC smoking machine tests that
were partly responsible for creating the thirty five year old consumer fraud
that duped smokers into believing that Low-Tar, Light and Ultralight cigarette
brands were less hazardous than other cigarettes.


Although a recent study by the Harvard School of Public Health concluded that
cigarette companies have increased the nicotine yields of cigarettes by about
ten percent during the past decade leading some news reports to claim that
cigarettes are now more addictive, that same study also concluded that (during
the past decade) nicotine yields of Light brands were about twenty five percent
less than those of Full Flavor brands, and that nicotine yields of Ultralight
brands were about thirty percent less than those of Light brands.  But in fact,
all cigarettes are similarly and quite adequately addictive.  The fundamental
problem with the Harvard study is that it relied upon another inaccurate smoking
machine testing method somewhat similar to the defective FTC testing method.  

 

Hammond et al recently evaluated the accuracy of the International and Canadian
cigarette machine testing methods, and concluded that neither of those machine
testing methods are accurate, and that NO machine testing method should be
relied upon for establishing government regulatory standards for cigarette smoke
emissions. 

 

Besides, cigarette smoke contains more than 50 carcinogens and 3,000 other
constituents. So even if an accurate FDA machine testing method is devised
(which doesn't appear viable), an FDA product standard that reduces or removes
one, two or a few chemicals or carcinogens from cigarette smoke would not reduce
the overall health risks of cigarettes.

 

Any FDA product standard for cigarettes almost certainly would be perceived by
smokers and the public as making cigarettes less hazardous, which could
discourage smokers from quitting and could encourage youth and ex-smokers to
begin smoking.



S. 625 also authorizes the FDA to reduce nicotine levels in cigarettes, and some
supporters of S. 625 have advocated mandatory nicotine levels reductions in
cigarettes.  Yet, there is broad scientific consensus that smokers of cigarettes
with purportedly lower nicotine yields simply puff more intensely, take more
puffs and/or smoke more cigarettes in order to obtain a similar level of
nicotine that they are accustomed to receiving, which is known as "nicotine
compensation".  As such, smokers of purportedly lower nicotine yield cigarettes
inhale greater quantities of smoke, which increases their disease risks.  

 

Thus, it would be counterproductive for public health if the FDA mandated
reductions in nicotine, because doing so could make cigarettes even more
hazardous.  If the FDA were to require any changes in nicotine content (assuming
that an accurate machine testing method could be developed), it would be better
for public health to require higher levels of nicotine in cigarettes, because
smokers would inhale less cigarette smoke.

 

Constitutional concerns about S. 625

Another concern with S. 625 is that some of its tobacco advertising restrictions
are virtually certain to be struck down by the Supreme Court for violating a
manufacturer's First Amendment right to advertise to its adult customers.  That
is precisely why in 2001 the Supreme Court (in Lorillard Tobacco Co. v. Reilly)
struck down a Massachusetts regulation that prohibited outdoor tobacco
advertisements within one thousand feet of a school or playground.   And yet, a
similar one thousand foot outdoor advertising restriction is contained in S.
625.  

 

Denying FDA authority to effectively regulate tobacco products 
 

Effective product regulations also allow regulatory agencies unfettered
authority to issue regulations that reduce use of and access to the most
hazardous products.  But S. 625 prohibits the FDA from issuing many of the most
effective regulations that could reduce cigarette usage, especially among youth,
including prohibiting the FDA from: 

- increasing the minimum age to purchase cigarettes beyond 18 years;
- eliminating cigarette sales from any type of retail outlet;
- requiring prescriptions to buy cigarettes (as FDA requires for other hazardous
drugs);
- removing nicotine from cigarettes; and
- eventually removing cigarettes from the market.

While these restrictions limiting the FDA's authority to regulate tobacco in S.
625 are not necessarily opposed by Smokefree Pennsylvania, our organization is
never-the-less concerned that their inclusion in S. 625, along with the many
truly counterproductive provisions that were previously cited, have severely
compromised this legislation. 

 

The following report compares the health risks of different tobacco products and
recommends the only viable tobacco product and policy harm reduction strategy
for smokers who are not ready or willing to quit tobacco use; providing truthful
comparable product risk information, and encouraging switching to a smokeless
tobacco product. 



http://www.harmreductionjournal.com/content/3/1/37