From: SMOKEFREE@compuserve.com
Date: Fri, 08/08/08
The fundamental flaw of the Philip Morris/CTFK negotiated FDA legislation
is that it grandfathers in (i.e. allows future marketing of) the deadliest
tobacco products (i.e. cigarettes), while banning future market entry by
the least hazardous tobacco products (i.e. smokefree), which are far less
hazardous alternatives to cigarettes for smokers. That's how the
legislation protects Philip Morris's enormous US cigarette market at the
expense of public health. Bill Godshall
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Loophole in tobacco regulation bill
By Ricardo Alonso-Zaldivar
The Associated Press
Washington Post
Thursday, August 7, 2008; 6:30 PM
http://www.washingtonpost.com/wp-dyn/content/article/2008/08/07/AR200808070
0292.html
WASHINGTON -- A loophole in a sweeping tobacco regulation bill would give
the industry a 21-month window to introduce some new products without first
getting federal approval.
The House last month overwhelmingly passed the legislation, which for the
first time would empower federal public health authorities to regulate
tobacco. Some tobacco foes say the bill's 21-month escape clause would let
companies start marketing cigarettes and other products in the development
pipeline before the Food and Drug Administration has fully ramped up to
regulate them.
"It is an opportunity for the companies to continue to put products on the
market without a pre-market evaluation by the FDA," said Mitch Zeller, who
headed the agency's tobacco office during the Clinton administration. That
office was disbanded after the Supreme Court ruled in 2000 that the FDA did
not have the authority to regulate tobacco, a decision that provided the
motivation for the current bill.
Zeller, who said he still considers himself a strong supporter of the
legislation, nonetheless called the loophole "unfortunate" and said it
seems to be a "gift" to the tobacco companies.
The office of Sen. Edward M. Kennedy, D-Mass., a main author of the bill,
disagreed. The provision is in the bill to give the FDA some breathing room
to set up its new tobacco division, not a favor to the industry, said
Kennedy's staff.
The legislation represents a compromise among major anti-smoking groups and
some tobacco companies, including Philip Morris USA, the nation's largest..
The bill has the support of a majority of senators, but it's unclear
whether it will become law this year because the Bush administration has
threatened a veto.
The controversial clause would not apply to all new products, only to those
that are similar _ or "substantially equivalent" _ to ones that were on the
market when the bill was introduced in 2007. The provision is in Sec. 910
of the 200-page bill.
It would let tobacco companies begin selling a new product provided they
file a report with the FDA showing why the new product is similar to an
existing one. That could be done at any time in the 21 months after
enactment of the legislation. If the FDA later disagreed, it could still
yank the product off the market.
"This is a provision that recognizes the reality that as the agency staffs
up, it won't be able to do every single thing from Day 1," said Melissa
Wagoner, a spokeswoman for Kennedy.
After the 21 months, winning FDA approval for any product would get
tougher.
Once the window closes, products similar to ones already on the market
would need FDA clearance before they could be sold to consumers.
Completely new products would face a higher hurdle from the time the bill
is enacted. Companies would have to apply to the FDA before going to
market, and the agency could deny approval if it finds a product is not
"appropriate for the protection of the public health" _ a standard that may
be difficult for cigarettes to meet.
A Philip Morris spokesman said the bill's language speaks for itself and
the company would have no further comment. But Kevin Altman, a consultant
to small tobacco companies, said the 21-month window gives the industry
some security as it prepares for a new world of closer oversight.
"Here was our concern: Let's say I launch a product today (that's) a
straight-up-the-gut traditional cigarette," Altman said. "The big fear was
you go out there and the FDA comes out with regulations and says, 'Oh,
that's not a registered product. You have to take it off the market.'"
Some companies launch different versions of essentially the same cigarette
to try to expand their market, Altman said. He predicted that companies
with brands under development, or those considering new versions of current
products, would scramble to introduce them within the 21-month window.
Small cigarette companies were also able to get an expansion of the
loophole in negotiations with Congress, Altman added.
When the legislation was introduced last year, it provided that only
products similar to ones introduced by mid-2003 could be marketed without
prior approval from the FDA during the initial time window.
But the bill passed by the House expanded that to include products similar
to ones introduced by February 2007, a gain of more than three years.
Kennedy's office said changes in the effective dates of various legislative
provisions are routine in drafting major bills, and some were recommended
by former senior FDA officials.
But Zeller, the former tobacco office chief who is critical of the
loophole, commented, "They didn't ask me."
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