FDA -- Looking at 2009 Federal Legislation &
the related 2000 U.S. Supreme
The proposed federal
legislation to give the FDA (Food and Drug
Administration) oversight over cigarettes and smokeless tobacco is also
called the Family Smoking Prevention
and Tobacco Control Act.
In 2009, the U.S. House bill, HR 1256
passed the U.S. House of Representatives.
In late April, 2009, a U.S. Senate version is expected to be introduced
While many public health groups support this legislation, a growing
number of public health groups and individuals who actually have read
the language of the legislation oppose that language for several
reasons. Here are a few of those reasons.
supports this bill,
***the FDA in its mission statement is empowered to protect the public
health regarding the safety of foods and drugs. There is no way
that tobacco products can be safe, they are addictive and lethal.
the FDA would be prohibited
from eliminating nicotine from cigarettes and smokeless tobacco, and
prohibited from banning these products, unlike their powers over other
dangerous, addictive, and lethal drugs,
the legislation would endanger
state laws on
would provide immunity for
tobacco companies from legal prosecution by establishing national
standards for cigarettes,
would give PM the market advantage
over other companies,
concentrates on filth and toxins in tobacco preparation and packaging
but would not regulate nicotine
as the poison and addictive core of the tobacco products,
would put the federal
government in partnership with the nicotine cartel,
*** would not touch any tobacco product such as cigars, cigarillos, hookah, electronic
nicotine delivery devices, and other new products currently
being test marketed by the industry.
As of April, 2009, this has passed the
House of Representatives in
the US Congress. A Senate version is expected to be introduced
You may wish to call your two
Senators in the US Congress
(1-202-224-3121 switchboard) to urge
defeat of HR 1256 and the Senate version to be introduced in late April.
Here's what a vice president of Philip Morris
said about getting such legislation passed.
This is from a document released under the court agreement on tobacco
It is from a speech given by Steve Parrish
on April 27, 2001. Parrish was a vice president of Philip Morris
and of Altria until his retirement in 2008.
want to be, and be perceived as, responsible manufacturers of products,
some of which carry serious health risks."
"Without regulation, our relationships
with governments and our critics, especially here in the United States,
will continue to deteriorate. The demonization, the acrimony and the
distrust that has been building for decades will continue. If we remain
unregulated, our critics will be able to continue to define us as a
member of a rogue industry and this will continue to affect how we are
viewed by legislators, regulators, opinion leaders and, significantly, the general public.
"Regulation will not bring us total
peace. And it will not solve all of our problems. But, together with
our other strategies of societal alignment and image enhancement,
regulation can give us an opportunity to move down the road toward
corporate normalcy, allowing us to conduct our businesses in less
volatile and contentious environments."
Letter to the
Editor, The Virginian-Pilot,
March 9, 2009, "Toothless legislation", Anne Morrow Donley, Richmond.
Family Smoking Prevention and Tobacco Control Act, which would have the
Food and Drug Administration oversee tobacco, is misleading.
While requiring nonhazardous,
nonpoisonous additives and packaging, it prohibits the FDA from
eliminating nicotine. Further, this bill would give the nicotine cartel
virtual immunity from future court cases, because it would require
national tobacco standards; the industry could argue it was only
It only addresses cigarettes and
smokeless tobacco, excluding cigars, cigarillos, hookahs and the myriad
new products being test-marketed by the industry.
This is not a bill for the FDA, but
some agency geared to regulating advertising. It is not a bill to
protect families or children, but only to protect Philip Morris.
Letter from Dr. K. H. Ginzel opposing the current 2009 legislation to
have the FDA regulate tobacco.
K.H. Ginzel, MD, Professor Emeritus of Pharmacology and Toxicology
University of Arkansas for Medical
Please vote against the current
legislation to give the FDA authority to regulate some tobacco
products. "The Family Smoking Prevention and Tobacco Control Act”, HR
1256, passed in April 2009. Additionally, the Senate bill will soon be
introduced into the 2009 Senate.
legislation would violate the mission of the FDA to protect the public
health regarding foods and drugs.
Tobacco products are lethal:
Cigarettes kill one out of two of its long-term users when used as
intended. Indeed, one must consider the insidious toxicity, and
especially the serious harm it can inflict upon the developing and
growing organism (K.H. Ginzel et al. Critical Review: Nicotine for the
Fetus, the Infant and the Adolescent? J Health Psychol 2007,12,
The current legislation does
not address all tobacco products.
products are addictive to children and adults:
The current legislation would prohibit the FDA from eliminating
former Surgeon General Koop clearly stated that the very “heart of the
issue” is “not smoking, not tobacco, but nicotine addiction”.
Nicotine addiction was the subject of the 1988 Surgeon General’s Report
which concluded that nicotine, fulfilling all criteria for drug
dependence, is the drug in tobacco products (cigarettes and other forms
of tobacco) that causes addiction, and that "...the pharmacological and
behavioral processes that determine tobacco addiction are similar to
those that determine addiction to drugs such as heroin and cocaine".
The 1994 Surgeon General’s Report on "Preventing Tobacco Use Among
Young People" confirmed that nicotine causes rapid addiction in up to
half of all children who experiment with tobacco.
In 2000, the US
Supreme Court noted that having the FDA involved in regulating tobacco
products which are lethal and addictive goes against the mission of the
Court Justice Sandra Day O'Connor's majority opinion, in the 5-4
decision, stated that the FDA has concluded that cigarettes are unsafe
federal law ''would require the FDA to remove them from the market
entirely.''... ''The inescapable conclusion is that there is no room
for tobacco products within the (federal law's) regulatory scheme,...
if they cannot be used safely for any therapeutic purpose, and yet they
cannot be banned, they simply do not fit… it strains credibility to see
how these products can be safe.''
"By no means do we
question the seriousness of the problem that the FDA has sought to
address,....the agency has amply demonstrated that tobacco use,
particularly among children and adolescents, poses perhaps the single
most significant threat to public health in the United States.''
This legislation has the unmistakable
imprint of Altria/Philip Morris, PM, the nation's and the world's
largest tobacco company, which has endorsed and actively fostered this
bill. The legislation would create national tobacco standards,
going against the FDA's mission, and these standards could be used by
tobacco companies to stifle and fight litigation brought by consumers.
The legislation would place tobacco representatives on all science
boards and reviewers of all reports.
This legislation would promote "safer"
and "lower risk" cigarettes and smokeless tobacco, ignoring PM's blunt
admission several years ago that "There is no safe cigarette." This
landmark admission had been posted on the PM website until about 2005,
but can no longer be found there. Yet, despite stating "There is no
safe cigarette," PM has not only not quit its lucrative tobacco
business, but has increased it by adding new products.
Some reputable authorities have stated
their opposition to this legislation. The American Association of Public Health
stated on their web site their opposition to this legislation, noting,
"Passing this bill would be like turning off a fire alarm without
putting out the fire ... Finally, and sadly, note that, as seen by
AAPHP, no bill at all would be better than [this bill] in its current
Andrew von Eschenbach, a cancer surgeon,
who had headed the FDA, stated in an interview with the Associated
Press, “We could find ourselves in the conundrum of having made a
decision about nicotine only to have made the public health radically
worse. And that is not the position FDA is in; we approve products that enhance health,
not destroy it”.
According to Reuters (7/31/08):
"Requiring the FDA to oversee tobacco products also 'could be perceived
by the public as an endorsement that these products are safe, resulting
in more people smoking', the White House said........The agency (FDA) would not be empowered to
ban cigarettes or require nicotine levels of zero... ".
A former Virginia State Health
Commissioner, Kim Buttery, wrote in a letter to the editor of "The
Richmond Times-Dispatch", 8/6/08:
readers should not assume that this bill is a public-health bill. It is
not. It is a support-Philip-Morris bill. Despite the support of the
AMA, American Lung Association, and others, this bill has been set up
to pull the wool over many people's eyes"......."All this bill would do
is give a perception that cigarettes and other tobacco products are
approved for sale by the FDA".
In "FDA Regulation of Tobacco —
Pitfalls and Possibilities", New England Journal of Medicine 359:
445-448, July 31, 2008, Allan M.
Brandt wrote: "Philip Morris, the dominant player among the US tobacco
companies, has endorsed the bill,
whereas the other major companies vigorously oppose it. Some, arguing
that FDA regulation would cement Philip Morris's sizable market
advantage, have dubbed the proposed legislation the 'Marlboro Monopoly
Michael Enzi, the top Republican on the health panel, vowed to
fight the measure: "We
need to fight the war on tobacco head on, not sign a peace treaty with
Philip Morris, a company that perpetuates and profits from the crisis...
They're happy with a bill that doesn't stop people from smoking. I'm
not. I want real change''.
Ruth Malone, a
registered nurse and the current editor of the magazine, "Tobacco
Control", observed, “I fear that passing this conservative, weak
regulation with great fanfare ... will ultimately protect the tobacco
industry while delaying the stronger public health measures that are
needed to address the single most deadly consumer product ever made."
I agree, the current FDA legislation
would help the tobacco industry, and not advance public health. Please
vote against this legislation. Thank you.
K.H. Ginzel, MD
2000 -- U.S. SUPREME COURT 5-4
the opinions and more at http://www.tobacco.neu.edu
EXCERPTS from The
Virginian-Pilot, March 22, 2000, FDA's control of tobacco
snuffed, Paul Clancy and Ledyard
"If they were allowed by their sheer mandate to regulate
tobacco as a drug,
they would be left with no choice but to outright ban tobacco and
it," said J.T. Davis, a Halifax County crop insurance salesman and
of Concerned Friends for Tobacco.
"I think it is a little light at the end of the tunnel,''
said David Jones,
a tobacco farmer from Bracey, Va., near South Hill.
Although the Food and Drug Administration repeatedly said it
to regulate cigarettes and not ban them, a Philip Morris spokesman said
the industry feared that anti-smoking groups would have tried to force
the government to impose such a prohibition.
That would have devastating economic effects not just on
farmers but thousands
of cigarette manufacturing plant employees in Richmond, Brendan
a spokesman for the New York-based company, said Tuesday.
Such a move would also abruptly end multibillion-dollar
industry has entered into with states over health care costs incurred
smoking, he said.
Not everyone in Virginia is happy with the Supreme Court's
likely will throw the responsibility for regulating teen-age smoking
Anne Morrow Donley, an anti-smoking advocate in Richmond,
said the court's
ruling has left the regulation of an addictive substance up to a
whose leaders are beholden to the free-spending tobacco lobby and whose
members do not appear interested in protecting the health of their
"If we're going to say that as a government we're going to
look out for
the welfare and well-being of the people, then we must say that tobacco
must be regulated as a drug,'' said Donley, who co-founded Group to
Smoking in Public, GASP, 15 years ago.
"This is agreeing with the tobacco companies that it's OK to
business as usual and sell an addictive drug that kills,'' she said of
Because of Tuesday's ruling, the state no longer will be
federal government about the violators it catches, said Suzanne
spokeswoman for the Virginia Department of Alcoholic Beverage
EXCERPTS from Reuters,
March 21, 2000, writer James Vicini, "High Court Rules FDA
Lacks Power Over Tobacco", James Vicini.
The nation's highest
court by a 5-4 vote ruled that the federal agency overstepped
its authority in 1996 when it issued
regulations for cigarettes and smokeless tobacco.
The decision was a
major victory for the tobacco industry, which has been hit with
a number of civil lawsuits seeking huge damages for smoking-related
The ruling initially
sent the stock prices of tobacco companies sharply higher on
Wall Street, although most of the gains disappeared by the
time the market closed.
The ruling sends the
battle over cigarette regulation back to Congress. Immediately
after the decision, Clinton urged congressional leaders
to get tobacco legislation approved.
Some lawmakers plan
to introduce legislation to explicitly give the FDA authority over
tobacco, although it seems unlikely the Republican-controlled
Congress will approve such a major initiative before
the November elections.
on a key election-year issue for Democrats, Vice President Al Gore
``Tobacco is one of the most addictive substances known to man
should be regulated as a drug.''
Gore, who is likely to face
Republican George W. Bush in the
race, said, ``It is time for the
Congress and George Bush to show their independence from Big
and do the right thing by passing legislation.''
Justice Sandra Day
O'Connor said in the court's majority opinion that the case involved
one of the most troubling public health problems facing the
nation -- thousands of premature deaths that occur each year from
said the FDA had ``amply demonstrated'' that tobacco
especially among children and adolescents, posed perhaps the
single most significant threat to public health in the United
matter how important, conspicuous and controversial the issue
and regardless of how likely the public is to hold the
branch politically accountable, an administrative agency's
power to regulate in the public interest must always be
in a valid grant of authority from Congress,'' she wrote.
was joined in the majority by cigarette smokers
Rehnquist, the chief justice, and Antonin Scalia, former cigar
smoker Clarence Thomas, and nonsmoker Anthony
They represent the court's most conservative members.
were justices Stephen Breyer, John Paul Stevens, Ruth Bader
Ginsburg and David Souter, all nonsmokers and the court's
most liberal members.
the unusual step of reading his dissent from the bench,
said he would have ruled that the law gives the FDA the power
to regulate tobacco.
upshot is that the court today holds that a regulatory statute aimed
at unsafe drugs and devices does not authorize regulation of
a drug (nicotine) and a device (a cigarette) that the court itself finds
unsafe,'' Breyer said.
noted that ``tobacco products kill more people in this country
year than ... AIDS, car accidents, alcohol, homicides,
drugs, suicides and fires, combined.''
EXCERPTS from Associated
Press, March 21, 2000, "Court:
FDA Can't Regulate Tobacco", Laurie Asseo.
F. Banzhaf of Action on Smoking and Health,
the government's appeal, said he was disappointed but
surprised and said the ruling ``will put tremendous pressure
Congress, especially during an election year, to ensure that nicotine
does not remain the only totally unregulated drug.''
for the four, [Justice] Breyer said the federal Food, Drug and Cosmetic
Act allows the FDA to regulate tobacco. ``Far more than
most, this particular drug and device risks the life-threatening harms
that administrative regulation seeks to rectify,'' he added.
said he did not believe the law would require a ban on cigarettes.
also said the fact that only 2.5 percent of smokers manage to
each year ``illustrates a certain reality - the reality that the
in cigarettes creates a powerful physiological addiction
from chemically induced changes in the brain.''
Updated 24 April