[Virginia GASP]  FDA -- Looking at 2009 Federal Legislation &

                        the related 2000 U.S. Supreme Court Decision

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 (text), passed the U.S. House of Representatives. 
In late April, 2009, a U.S. Senate version is expected to be introduced in the U.S. Senate.

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.

*** Philip Morris 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 tobacco,
*** 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 soon.

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 industry papers. 
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.

"We 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.
The 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 following regulations.

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.

April, 2009 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 Sciences

Honorable Senators:

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.

This 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, 215-224. Ginzel/Critical_Review.pdf).

The current legislation does not address all tobacco products.

Tobacco products are addictive to children and adults: 
The current legislation would prohibit the FDA from eliminating nicotine. Yet, 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 FDA.
US Supreme Court Justice Sandra Day O'Connor's majority opinion, in the 5-4 decision, stated that the FDA has concluded that cigarettes are unsafe and dangerous
... 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, again 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 Physicians, AAPHP, 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 form."

Dr. 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:
"..your 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 Act'".

Senator 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.

Respectfully submitted,
K.H. Ginzel, MD

 Read 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 King.

"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 remove it," said J.T. Davis, a Halifax County crop insurance salesman and secretary 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 sought only 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 McCormick, a spokesman for the New York-based company, said Tuesday.

Such a move would also abruptly end multibillion-dollar settlements the industry has entered into with states over health care costs incurred from smoking, he said.

Not everyone in Virginia is happy with the Supreme Court's decision, which likely will throw the responsibility for regulating teen-age smoking back to Congress.

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 Congress whose leaders are beholden to the free-spending tobacco lobby and whose members do not appear interested in protecting the health of their constituents.

"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 Alleviate Smoking in Public, GASP, 15 years ago.

"This is agreeing with the tobacco companies that it's OK to continue with business as usual and sell an addictive drug that kills,'' she said of the ruling.

Because of Tuesday's ruling, the state no longer will be notifying the federal government about the violators it catches, said Suzanne Horsley, spokeswoman for the Virginia Department of Alcoholic Beverage Control. 

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  unprecedented, sweeping 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 illnesses.

 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.

Seizing on a key election-year issue for Democrats, Vice President Al Gore said, ``Tobacco is one of  the most addictive substances known to man and should be regulated as a drug.''

Gore, who is likely to face Republican George W. Bush in the presidential race, said, ``It is time for the  Republican Congress and George Bush to show their  independence from Big Tobacco 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 tobacco use.

 O'Connor said the FDA had ``amply demonstrated'' that tobacco use, especially among children and adolescents, posed perhaps the single most significant threat to public health in the United States.

 ``No matter how important, conspicuous and controversial the issue and regardless of how likely the public is to hold the executive branch politically accountable, an administrative agency's power to regulate in the public interest must always be grounded in a valid grant of authority from Congress,'' she wrote.

 O'Connor was joined in the majority by cigarette smokers  William Rehnquist, the chief justice, and Antonin Scalia, former cigar smoker Clarence Thomas, and nonsmoker Anthony  Kennedy. They represent the court's most conservative members.

 Dissenting were justices Stephen Breyer, John Paul Stevens, Ruth Bader Ginsburg and David Souter, all nonsmokers and the court's most liberal members.

 Taking the unusual step of reading his dissent from the bench,  Breyer said he would have ruled that the law gives the FDA the power to regulate tobacco.

 ``The 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.

 He noted that ``tobacco products kill more people in this country every year than ... AIDS, car accidents, alcohol, homicides,  illegal drugs, suicides and fires, combined.''

EXCERPTS from Associated Press, March 21, 2000, "Court: FDA Can't Regulate Tobacco", Laurie Asseo.

 John F. Banzhaf of Action on Smoking and Health, which supported the government's appeal, said he was disappointed but not surprised and said the ruling ``will put tremendous pressure on Congress, especially during an election year, to ensure that nicotine does not remain the only totally unregulated drug.''

 Writing 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.

 Breyer said he did not believe the law would require a ban on cigarettes.

 He also said the fact that only 2.5 percent of smokers manage to quit each year ``illustrates a certain reality - the reality that the  nicotine in cigarettes creates a powerful physiological addiction  flowing from chemically induced changes in the brain.''

[Virginia GASP]Updated 24 April 2009