RJ Reynolds
Smokeless Cigarettes- - Urgent Warning on Public Health Hazard.
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- LETTER
- Site
- Tga Database
- Copied
- Dockets Management Branch
- Request
- 1rfp52
- Minnesota
- 1rfp69
- Minnesota
- Recipient
- Reagan, R.W.
- Date Loaded
- 27 Feb 1998
- Named Person
- Natl Institute, O.F. Drug Abuse
- Fda
- Ama
- Acs
- American Heart
- Alza
- Surgeon General
- Hhs
- Fda
- Box
- Rjrc1639
- Author
- Zaffaroni, A.
- Alza
- Characteristic
- Marginalia
- UCSF Legacy ID
- vjy34d00
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aiza
SMORELESS CIGARETTES--URGENT WARNING ON PUBLIC HEALTH HAZARD
September 14, 1988
Ronald Wilson Reagan
The President
The White Kouse
Washington, DC 20500
Dear Mr. President:
co
It is my understanding that the FDA_._is...xe.vie.rrLlug...the ."smokeless
cigarette" to see if it is classifiable as a drug, and that the
AMA, the American Cancer Society, and the American Heart Associa-
tion have petitioned for a review of its safety. From the per-
spective of long experience in the field of drug delivery techno-
logy, IagouJdlike to warn of an imminent danger of this product.
It has the potent_lal,' if misused, for disastrously worsening
addiction to cocaine, heroin, and other hard drugs in the United
States.
A:. Chairman of ALZA Corporation, which I founded to improve the
administration of therapeutic drugs, I believe I can comment
knowledgeably on both the technology and risks of this product.
Unquestionably the smokeless cigarette is an extremely sophisti-
cated drug delivery system that could be useful in administering
a limited number of therapeutic agents. It is probably the most
effective system devised to date for getting drugs to the brain
via inhalation. Unfortunately, as a consumer product, it could
be quickly and simply converted to an unprecedently powerful
means of administering drugs of abuse.
My immediate concern centers on crack cocaine. The technology of
the smokeless cigarette could make that drug far more potent and
make its public use totally concealable. All that would be re-
quired would be soaking the smokeless cigarette in a cocaine
solution, drying it, and then smoking it.
The key technology element of this cigarette is its carbon end--a
highly refined unit that provides a smokeless, odorless burn. As
the user draws air through this heated end, the heated air pas-
sing through the cigarette creates a steam distillation of the
drug present, which is then inhaled as a finely dispersed aerosol
mist. Since neither the tobacco or drug are burned, the entire
amount of drug is available to be absorbed from the aerosol mist
onto the large surface area of the lungs, whence it is carried
ALZA CORPORATION, 950 PAGE MILL ROAD, P.O. BOX 10950, PALO ALTO, CA 943034902 (415) 4"5000 TELEX
345528

.,
via the-bloodstrear nto the brain. In contra__, present methods
of cocaine inhalation burn up much of the drug before it ever
reaches the user's lungs.
. The smokeless cigarette, if misused for crack, clearly would
eliminate most of the hindrances to smoking it--the elaborate
pipes and procedures required and the tell-tale odor, which is
even more pungent than marijuana. Unquestionably such a develop-
ment could greatly expand the use of crack cocaine. Crack
users would be indistinguishable from persons using ordinary
smokeless cigarettes. People could be exposed or even become
addicted to crack by being offered (unawares) a "smokeless ciga-
rette" that had been soaked in cocaine.
Of all the addictive drugs in our society, crack has had the
greatest impact. Because it is cheap, it has hit the most sus-
ceptible members .of our society, the young and the poor. More-
over, it has become increasingly addictive and dangerous as it
has been used intranasally, then injectably, and then smoked.
The last thing we need is to create another means of crack admi-
nistration that could be even more efficient than current methods
and much simpler to use. For this reason, I am addressing this
urgent message about the smokeless cigarette to yourself and
other key officials concerned with the public health, including
the Surgeon General, the Secretary of the Department of Health
and Human Services, and the Director of the National Institute of
Drug Abuse.
Sincerely,
...
Alejandro Zaffaroni
Founder and Co-chairman
ALZA Corporation
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