WASHINGTON - The federal agency charged with keeping food and drugs from
harming people may soon be asked to take a consumer product that kills more than
400,000 people a year and make it safer.
A smoker lights a cigarette in a file photo. Several major
tobacco companies are set to go to a US appellate court on Tuesday to
argue about whether a $200 billion lawsuit against them by 'light'
cigarette smokers should proceed as a class action. [Reuters]
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The product is the cigarette - generally
acknowledged as anything but safe. Smoking accounts for nearly one in five
deaths in the United States.
That toll can be reduced, tobacco foes say, and they point to a bill that is
expected to pass a Senate committee Wednesday as the tool to make it happen.
The legislation would give the Food and Drug Administration the same
authority over cigarettes and other tobacco products that the regulatory agency
already has over countless other consumer products. It's not something the
agency necessarily wants, according to past comments by FDA commissioner Dr.
Andrew von Eschenbach.
The bill would let the FDA regulate the levels of tar, nicotine and other
harmful components of tobacco products. Cigarette smoke alone contains some
4,000 chemicals, more than 40 of which are known to cause cancer.
"Are we going to cut cancer in half with FDA control? No. Can we do with
cigarettes things that are important in regulating a product to minimize its
toxicity? Yes, I think we can," said Dr. David Burns of the University of
California, San Diego, scientific editor of several surgeon general reports on
tobacco.
New products would need FDA approval before they could be sold, according to
the legislation. The bill also would authorize the FDA to set national standards
for tobacco products to control how they are made, as well as force the
disclosure of their ingredients, including compounds and additives, and in what
quantities. That, supporters claim, should help expose and ultimately limit the
ways cigarettes are engineered to the detriment of the public's health.
"This bill wisely doesn't try to predict what a cigarette will look like once
FDA begins to take action. Instead, it says to scientists at FDA, 'You have the
power to require changes in tobacco products in whatever ways you believe, based
on the science, that will reduce the harmfulness of the products or the
addictiveness of the products,'" said Matthew Myers, president of the Campaign
for Tobacco-Free Kids. The group, once known as the National Center for
Tobacco-Free Kids, has long supported the bill, which has faltered in previous
Congresses.
No one among those for or against the Senate bill, mirrored by matching
legislation in the House, believes it could result in a safe cigarette. There is
consensus that there is no such thing. But some foes of the bill maintain it
could create that impression.
"It would still be a deadly product. They are not going to make it a safe
product by taking out particular smoke constituents. The problem is the public
is going to perceive the product is safe because the FDA has assumed
jurisdiction," said Dr. Michael Siegel, a Boston University School of Public
Health professor.
Advocates say the bill would, at a minimum, give the FDA the authority to go
where the scientific evidence takes it and only then make decisions based on the
science.
"There is a broad range of actions that the FDA potentially could take, some
of which we understand now and some we can only see dimly," Burns said. "To say
that there's nothing we can do is nihilistic in thinking and inconsistent with
science."
The bill also would keep tobacco companies from tinkering with their products
in ways that would make them any more dangerous, supporters add.
"The tobacco industry would not be allowed to manipulate the ingredients -
like increase nicotine or decrease nicotine or whatever they do - without
disclosing it," said M. Cass Wheeler, chief executive officer of the American
Heart Association. "The bill would put the burden of proof on industry to
demonstrate to the FDA that what they're doing would not be more harmful,"
Wheeler said.
When asked for some likely targets that regulators could tackle, Centers for
Disease Control and Prevention chemist David Ashley rattled off more than a half
dozen compounds in tobacco and smoke that worry scientists, even though it's
unclear just how beneficial removing or reducing their levels would be. They
include:
_Nitrosamines, a potent carcinogen. The burley tobacco used in American
cigarettes is especially high in nitrosamines.
_Acetaldehyde, a potential carcinogen that may make tobacco more addictive.
It's produced when sugars, added to tobacco, are burned.
_Cadmium and lead, two heavy metals that are toxic. Their levels generally
depend on the environmental conditions where the tobacco is grown.
But Ashley, an expert in the constituents of tobacco and tobacco smoke,
cautions that cigarettes are a very complex product and have traditionally
changed with time as manufacturers tinker with them.
"One problem from a scientific standpoint is the product changes so often but
the health effects are long-term. The cigarettes people are smoking today aren't
the cigarettes of 10 years ago," Ashley said. "It's hard to link a change in the
products to a particular health end point because there's nothing you can get
your hands around."
Another expert called the task of figuring out how to reduce tobacco's harm
basic "bread-and-butter stuff" for the FDA.
"This is what they do all the time: develop performance criteria for
products," said Jack Henningfield, a former tobacco researcher at the National
Institute on Drug Abuse. That in turn would act as an incentive for tobacco
companies to create products that are less harmful, he added.
As for the FDA, commissioner von Eschenbach said recently he wouldn't want
his agency put in the position where it had to determine a cigarette is safe.
Nor would it appear that the agency could approve any new cigarette, even if
it were purportedly safer, under the legislation, said Sen. Richard Burr,
R-N.C., who opposes the bill.
"It's an impossible pathway to understand at an agency tasked with a mission
that is to prove safety and efficacy," said Burr, contending such an arrangement
could keep any new reduced-harm tobacco product from coming on the market.
Philip Morris USA, maker of Marlboro, the nation's top-selling cigarette
brand, supports the bill. R.J. Reynolds Tobacco Co. and others oppose the
legislation, saying its restrictions on advertising would help cement Philip
Morris' No. 1 market position.