The Well News on January 25 published my
commentary on the FDA’s recent regulatory blunder of approving a cigarette
that provides all of the smoke but almost none of the nicotine of a traditional
cigarette.
Upon its publication, I received a
number of critical emails suggesting that I had failed to properly research the
issue. In fact, those critics failed to
do their due diligence on me. To help
them, here is another analysis I published on the subject – back in 1995.
A group of tobacco
reformers, led by the Food and Drug Administration Commissioner, has a new
regulatory strategy: reduce the amount of nicotine in cigarettes. The theory is
that the nicotine concentration of cigarettes will be too low to allow nicotine
addiction to be established in new smokers. In the meantime the strategy is
intended to serve as a (mandatory) national withdrawal program for the nation’s
current smokers.
The FDA
commissioner has collaborators in this regulatory quest at the highest levels
of academia and government. Two well known experts on nicotine addiction, Dr.
Neal Benowitz from the University of California at San Francisco and Dr. Jack
Henningfield from the National Institute on Drug Abuse, wrote an editorial in
the New England Journal of Medicine essentially endorsing the fadeout
plan. Although they admitted that “a threshold for nicotine addiction is a
theoretical concept ...,” these researchers still postulated a safe
concentration of nicotine in cigarettes that would prevent addiction in new
smokers. To reach this level, the FDA would have to order a reduction in
nicotine content from about eight milligrams per cigarette to about one-half of
a milligram, representing a 94 percent reduction.
Although the
fadeout idea has not been tested with regard to prevention, the plan has been
studied for many years as a smoking cessation option. It is basically a
drawn-out variation of a strategy called nicotine fading, in which the smoker’s
exposure to nicotine is gradually reduced to very low levels. The concept was
first introduced in 1979, and numerous trials, usually combining nicotine
fading with other behavioral modifications, were conducted throughout the
1980’s.
In a recent review
of 21 different quit-smoking strategies, nicotine fading came in with an
unsurprising success rate — about 25 percent. Dr. Michael C. Fiore, director of
the Center for Tobacco Research and Intervention at the University of
Wisconsin, questioned the effectiveness of this strategy in helping current
smokers quit. Of course if the FDA has its way, this program will not be
optional. In other words, a large percentage of current smokers may not find
this forced nicotine withdrawal a pleasant experience. What will they do?
As they did with
low tar low nicotine cigarettes and those with filters, smokers will initially
respond to the nicotine phase-out plan by smoking more often and more
intensely. Benowitz and Henningfield acknowledged this problem in their
editorial. They responded by saying that these smokers’ “short-term (ten-year)
risk may be offset by the long-term benefit of a greater likelihood that they
will quit smoking (as cigarettes become less satisfying) and by the enormous
benefit of preventing nicotine addiction in future generations.” In other words, they are sorry if your risks
increase for ten years because you can't quit, but maybe you'll quit anyway and
besides, maybe your children won't get hooked.
Another drawback to
the fadeout plan is its potential to spawn another huge illicit drug problem. The
FDA commissioner commented that “even if we don’t ban cigarettes, we could
create a black market by removing the nicotine too quickly.” He seems to
believe that the problem is avoidable simply by reducing the nicotine slowly.
He is undaunted: “We need to withdraw it at just the right pace, letting the
addiction fade as we reduce the nicotine.”
There are other
fundamental problems with the strategy. For example, setting a threshold level
of nicotine exposure below which it is not addictive is an extremely
speculative tactic. This would imply that there may be a “safe” level of
consumption for all addictions including alcohol, cocaine, and heroin. A caffeine comparison serves us well here.
Utilizing the same rationale concerning effect on body function (addictive
potential) and intent (ability to manipulate levels), the FDA has ruled that
caffeine is a food additive at concentrations up to 0.02 percent. This amounts
to 72 milligrams of caffeine in a twelve-ounce soda. The FDA designates
over-the-counter products containing caffeine (up to 200 milligrams per dose)
as stimulants. Consistency is not a strong feature of the FDA’s caffeine policy,
because a twelve-ounce serving of coffee can have as much as 400 milligrams of
caffeine.
The important
lesson from the caffeine analysis is that the FDA can draw on a precedent for
every aspect of the nicotine fading strategy. The plan seems to be bolstered by
an elegant scientific rationale, and it superficially appears to be a new and
creative approach to the problem of nicotine addiction. However, that's where
the real problem lies. Because antitobacco groups have passed judgement on
nicotine addiction, they have focused all of their energy on eradicating
tobacco. The nicotine fade is simply a thinly veiled disguise for tobacco
prohibition.
That was my view, published 27 years ago in my clearly
timeless book,
For
Smokers Only: How Smokeless Tobacco Can Save Your Life. Dr. David Kessler
was FDA Commissioner at the time.
At the FDA, despite dramatic advances in tobacco science,
virtually nothing has changed.
