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FDAeditorial

From: Patrick Reynolds
Tel: (310) 880-1111
Revised December 14, 1999, 2 pm EST
This editorial has not been published.

SUPREME COURT: IF NO FDA
REGULATION, BIG TOBACCO WINS

Editorial by Patrick Reynolds, President, tobaccofree.org

In recent years, we have made tremendous strides in our fight against Big Tobacco. Important progress has come from local governments, which passed hundreds of vending machine bans, 100% citywide smoking bans, and sales-to-minors compliance checks. Unprecedented triumphs came from the Judicial branch of government, which awarded a total $246 billion in settlement of the States’ lawsuits.

There has been mixed progress in the State legislatures; only a few have passed progressive laws. California’s bans smoking 100% statewide, even from bars and nightclubs, and is by now both widely accepted and popular. Of the settlement, so far, only a paltry 3% has been allocated for youth tobacco prevention programs. Inexplicably, the States’ agreement with Big Tobacco did not require States who signed on to spend any funds on teen prevention. So far, most legislatures have allocated little or nothing.

It’s no surprise that the tobacco industry’s attorneys are now making a passionate case to the Supreme Court that Congress should regulate the cigarette industry, and not the FDA. In spite of the overall progress made by other divisions of government, Congress itself has done almost nothing to regulate Big Tobacco.

For thirty years, in fact, Congress has passed no significant bills making it harder for children to purchase cigarettes, no laws to limit cigarette advertising, and no Federal workplace smoking law. In addition, Congress has passed no truly substantial increase in the Federal tobacco tax.

Small wonder that the tobacco companies now want Congress to oversee them, and not the FDA. Big Tobacco knows well that Washington has a long and reliable history of achieving little to bring their industry to heel.

The primary reason for Congress’ stunning leniency on the tobacco companies is our system of campaign finance, and vote trading among politicians. A recent example: in order to help induce the Republican-dominated Congress to agree to many of his budget requests, Clinton abandoned his proposed 55 cent Federal cigarette tax increase, already down from $1. Campaign donations equate to raw power: in recent years Republicans have gutted every good bill regulating tobacco which has been placed before the Congress. In June ’98, Republican leaders even killed the Congressional Tobacco Bill. Republicans have also passed bills which will help protect Big Tobacco from further regulation in the future.

There are no accidents here. Big Tobacco is the second largest donor to the Republican party, after Big Insurance. In 1999, 90% of their political donations have gone to Republicans; for several years, the figure has been at about 80%. In the ’96 election, five of the top ten donors to the GOP were tobacco companies.

Despite politicians claims that political contributions have no effect over the way they vote, the reality is that no corporate executive gives away millions of company dollars without expecting something fairly substantial in return. In fact, studies show that politicians who accept donations from the tobacco companies are several times more likely to vote the way Big Tobacco wants them to.

Looking at the larger picture, other industries have also amassed excessive influence over Congress, through their huge political donations and hundreds of lobbyists. The largest corporations have acquired truly awesome power over the government. The tobacco industry is but one example of excessive corporate influence.

Perhaps those who believe that big government is too much their lives should reconsider. The truth is, we may have big business too much in our lives. While it’s true that industry is the engine which powers our economy and provides us tremendous benefits, many corporations are freely buying and selling our addresses, home numbers, e-mails, our private medical data, and our personal financial data. Even more worrisome, corporations like Big Tobacco have acquired too much clout on Capitol Hill. It’s time for some keen oversight — and especially, for campaign finance reform.

As long as Republicans remain in the majority, FDA regulation of the tobacco industry is the only way we will see meaningful regulation of tobacco at the national level. Sadly, it’s unlikely that Congress will pass campaign finance reform anytime soon. Incumbents depend heavily on their fundraising advantage to get reelected, and Republicans get twice the money Democrats get from the special interests. It’s no coincidence that every year Republicans have blocked campaign finance reform — most recently in October (1999). They won’t give up their two-to-one advantage over Democrats in special interest donations.

Among the Republicans, however, Mr. McCain has gone against his own party, and made campaign finance reform a top issue. But his fellow Republicans have annually blocked McCain’s campaign finance reform bill, for several years. This year, the Senator substantially watered his bill down to appease his party, but they still blocked it. Conclusion: even if he were President, McCain could not pass strong reform, if his party remains in the majority.

Democrats are far more likely to pass a stronger bill, if only to level the monetary playing field. Public finance of campaigns, while not perfect, would keep our politicians more honest, and would cost every American just $4.00. The Internet also offers excellent possibilities for reducing the cost of political campaigns, and for giving more candidates greater access to be seen and judged by the public in the elections of the future.

The sad fact is that campaign reform remains an elusive goal. So FDA Regulation is the single most vital and important step we can take to finally bring Big Tobacco to heel.

The Supreme Court, before it washes its hands of the matter for FDA regulation and leaves oversight of tobacco up to Congress, should remember that Washington has done almost nothing in the past. With no FDA regulation, our children will continue to pay the price.

 

Revised December 13, 1999, 1pm EST

SUPREME COURT SHOULD LET FDA
REGULATE TOBACCO, NOT CONGRESS

Editorial by Patrick Reynolds, President, tobaccofree.org

This editorial has not been published.

Why does the tobacco industry want to make sure Congress oversees them, and not the FDA? It’s simple: Congress has a long and reliable history of doing next to nothing to regulate Big Tobacco.

In spite of the recent strides made by other divisions of government against the tobacco companies, for thirty years, Congress has passed no significant bills making it harder for children to purchase cigarettes, no laws to limit cigarette advertising, and no Federal workplace smoking law. In addition, Congress has passed no substantial increase in the Federal tobacco tax.

So of course the tobacco industry’s attorneys have made a passionate case to the Supreme Court that Congress should regulate Big Tobacco, and not the FDA. The tobacco companies know that Congress has a long history of doing nothing.

The primary reason for Congress’ stunning leniency on the tobacco companies is our system of campaign finance, and vote trading among politicians. A recent example: in order to help induce the Republican-dominated Congress to agree to many of his budget requests, Clinton abandoned his proposed 55 cent Federal cigarette tax increase, already down from $1. Campaign donations equate to raw power: in recent years Republicans have gutted every good bill regulating tobacco which has been placed before the Congress. In June ’98, Republican leaders even killed the Congressional Tobacco Bill. Republicans have also passed bills which will help protect Big Tobacco from further regulation in the future.

There are no accidents here. Big Tobacco is the second largest donor to the Republican party, after Big Insurance. In 1999, 90% of their political donations have gone to Republicans; for several years, the figure has been at about 80%. In the ’96 election, five of the top ten donors to the GOP were tobacco companies.

Despite politicians’ claims that political contributions have no effect over the way they vote, the reality is that no corporate executive gives away millions of company dollars without expecting something fairly substantial in return. In fact, studies show that politicians who accept donations from the tobacco companies are several times more likely to vote the way Big Tobacco wants them to.

Looking at the larger picture, many industries have also amassed excessive influence over Congress, through huge political donations and lobbyists. Big Tobacco is but one example of excessive corporate influence on Capitol Hill. Campaign finance reform would do much to clean up the present system. Without it, FDA regulation of the tobacco industry is the only way we will soon see meaningful regulation of tobacco at the national level.

Sadly, it’s unlikely that Congress will pass campaign finance reform anytime soon. Incumbents depend heavily on their fundraising advantage to get reelected. And Republicans get twice the money Democrats get from the special interests. It’s no coincidence that every year, Republicans have blocked campaign finance reform (most recently in October, 1999.) They won’t give up their two-to-one advantage over Democrats in special interest donations. The sad fact is that campaign reform is an elusive goal.

FDA Regulation is the single most viable step we can take to finally bring Big Tobacco to heel. The Supreme Court, before it washes its hands of the matter of FDA regulation and leaves oversight of Big Tobacco up to Congress, should remember that Washington has done almost nothing in the past. With no FDA regulation, our children will continue to pay the price.


Mr. Reynolds bio at tobaccofree.org/bio
For additional facts, also see tobaccofreee.org/republicans


A Cautionary Tale from Florida

Supplementary excerpt from tobaccofree.org/univ

The tobacco industry’s influence is strong not just in Congress, but in State legislatures as well. The brazen slashing of Florida’s tobacco education campaign is a sad but excellent example of the tobacco industry’s tremendous influence with State legislators.

Spearheaded by their “Truth” ad campaign, Florida’s tobacco education program resulted the most successful effort ever in reducing youth smoking. But in early 1999, the Republican-led Florida House actually voted to kill funding for the entire program. How could this happen? Let’s go back in time.

Florida’s Tallahassee-based “Tobacco Pilot Program” was funded by that State’s early settlement with the tobacco industry. Their paid advertising and school-based tobacco education programs were largely teen-driven. Within a year, smoking had dropped 8 percent among high school students and by an unprecedented 19 percent among sixth to eighth graders. These are some of the largest decreases ever observed in the United States — at a time when teen smoking rates elsewhere in the nation were soaring.

Despite a poll by the Campaign for Tobacco Free Kids which showed that 78% of Floridians wanted the program there to continue at present levels, in early 1999, state officials fired its director, Peter Mitchell. Then Florida’s Republican-led House of Representatives abolished the program by cutting its funding to zero.

In April 1999, as the legislature approved the budget, the program was revived. But its funding was cut by about 50 percent from previous levels. And the “Truth” campaign, its signature advertising blitz aimed at teenagers, was slashed by more than half, and most of the teens were fired.

Republicans in the legislature claimed they were unconvinced by the recent studies showing the dramatic drop in teen smoking rates. However, the truth might be that the unspoken promise of future campaign donations from Big Tobacco is more important to these politicians than the health of our children.

The best solution to this is strong campaign finance reform. In recent years, however, the Republicans have consistently been able to raise twice the total money Democrats raise for the nation’s political races. Campaign finance reform would level the financial playing field, and would take away the Republicans’ 2-to-1 advantage in funding over their rivals.

So Republicans in Congress have on at least 4 occasions since 1996 filibustered to block campaign finance reform bills. Conclusion: as long as Republicans remain in the majority, we are unlikely to have a strong campaign finance reform bill passed, and business will continue as usual.

 


 

***********************************************************************
Background notes and related newstories
from the Advocacy Institute’s Tobacco Control Project (Washington DC)

************************************************************************

Bulletin of December 1, 1999

Supreme Court Showdown for FDA

Perhaps the most important 60 minutes in the history of the tobacco control movement occur today when the US Supreme Court hears oral arguments in the case of Food and Drug Administration vs. Brown & Williamson Tobacco. The Court is being asked to decide if FDA has the authority to regulate the nicotine delivery devices commonly referred to as cigarettes and smokeless tobacco.

In 1996, the FDA issued sweeping regulations governing the marketing of cigarettes and smokeless tobacco, particularly as it impacted youth, and providing comprehensive oversight of tobacco products. In April 1997, a federal judge in North Carolina upheld FDA’s authority to regulate tobacco and its methods of sale, while denying its jurisdiction over advertising. But in August 1998, a three-judge appeals panel reversed the judge’s ruling, saying that Congress did not explicitly grant such authority to FDA. Now the Supreme Court will ultimately decide whether FDA has the authority to regulate tobacco products.

The decision has global implications. If FDA is granted power to regulate the marketing, design and content of tobacco products, it will impact the industry worldwide. Among other things, a regulated industry may be more likely to successfully develop and market reduced toxicity nicotine delivery devices.

The industry’s arguments and the government responses are expected to go something like this:

Big Tobacco – Congress never meant to include tobacco when it granted FDA authority to regulate “drugs” and “devices” “intended to affect the structure or any function of the body.” The law only covers products that make specific health claims, and tobacco does not make such claims. If FDA were granted authority over tobacco, numerous other devices, including guns and thermal underwear would be subject to regulation. Since tobacco products do not meet the criteria as “safe” or “effective” drugs, an FDA mandated to regulate them would have no alternative but to ban tobacco altogether, clearly a broad policy decision which should be left to an elected legislature.

Government – Congress has never explicitly excluded tobacco from the FDA mandate. Nicotine, unlike guns and underwear, acts on the body as a drug, as that term is commonly understood. Moreover, internal industry documents show that the industry has long understood nicotine’s effect on the body and designs its products to maintain smokers’ addiction. FDA has reasonably determined that banning tobacco products would pose a greater threat to public health than allowing regulated products to remain in the market.

The Court will probably announce its decision next Spring. If it comes down in favor of FDA regulation, the industry may try to get Congress to rewrite the Food and Drug Act. FDA’s jurisdiction over tobacco advertising will simultaneously be tested in the courts. If the Court rules against FDA, the tobacco control movement will have to determine the advisability of seeking legislation specifically granting authority. The outcome of the 2000 national elections will affect that decision.


Advocacy Institute Bulletin of December 2, 1999

Supreme Court Hears Oral Arguments In FDA Case
USA TODAY Debates FDA Authority Over Tobacco Arizona

SKEPTICISM IN THE SUPREME COURT … most observers don’t think our position fared very well Wednesday during the U.S. Supreme Court oral arguments regarding Food and Drug Administration jurisdiction over tobacco products.

It is important to note that throughout history it has been rather difficult to predict Supreme Court decisions based on the justices questioning during the oral arguments. In some cases, justices try to play devil’s advocate because they are intentionally trying to illicit arguments against their prevailing view.

That being said, yesterday certainly didn’t go as well as our side would have hoped. Two of the classic “swing” votes we would likely need to cobble together a majority — Justice Sandra Day O’Connor and Justice David Souter — expressed serious concerns about the FDA’s legal authority to regulate tobacco and nicotine. Justice O’Connor focused on the idea that FDA is supposed to regulate products that make a health claim, to make sure they live up to that claim and are generally safe. She made it clear that cigarettes don’t fit her perception of that definition. Justice Souter, while seemingly sympathetic to the cause, expressed several concerns with the FDA’s interpretation of the law.

Veteran Supreme Court reporters and pro-health advocates in the courtroom were nearly unanimous in their assessment that the Court leaned Big Tobacco’s way yesterday. Glenn Schneider, community organizer for Smoke Free Maryland, was in the courtroom and offered this assessment:

“The main arguments from the justices’ point of view were:

1) Whether the company showed intent to sell tobacco as a drug (the company said it never publicly claimed that in its advertising);

2) Would the FDA be required to ban tobacco if it did have authority since cigarettes cannot be declared “safe and effective”;

3) What changed in 1994? Why did previous FDA commissioners say they did not have the authority to regulate tobacco? and

4) Did Congress intend that tobacco be covered under the Food Drug and Cosmetics Act?

It was quite packed inside and quite fascinating to watch. But overall, my gut told me it wasn’t positive.”

The Court will probably take an internal straw poll in the near future but they likely won’t release a formal decision until the Spring. We can only hope that the Justices reflect carefully on the case presented in writing and during the oral arguments and decide that FDA has legal authority to regulate the nation’s leading preventable cause of death and suffering.

***********************************************************************

Supreme Court Hears Oral Arguments In FDA Case

In considering whether the Food and Drug Administration can regulate cigarettes, several Supreme Court justices appeared skeptical of the FDA’s arguments yesterday. Solicitor General Seth Waxman asked the court to grant the FDA authority to regulate tobacco products because nicotine is a highly addictive substance, and new evidence shows that tobacco manufacturers manipulate nicotine content to keep smokers addicted. Justice Sandra Day O’Connor noted that the 1938 Food, Drug and Cosmetics Act requires the FDA to regulate products that are safe and effective. “Is it the position of the government that tobacco is safe and effective?” she asked Waxman. “If not so, it just doesn’t fit.” Other justices expressing doubts were Chief Justice William H. Rehnquist, Antonin Scalia, David H. Souter and Anthony Kennedy.

The industry argued that if the FDA was granted the authority to regulate tobacco products, it would have no choice but to ban them outright because they are not safe. An outright ban would leave millions of smokers unable to legally satisfy their addiction, and would create enormous economic and social policy problems. The industry also argued that Congress never explicitly authorized the agency to regulate tobacco products. A decision is expected sometime next spring.

Source(s):Raleigh News & Observer, (12/1/99) “FDA power over tobacco debated before justices”, JAMES ROSEN / Washington Correspondent [Full Text:
http://www.news-observer.com/daily/1999/12/01/nc00.html]
The Washington Post, (12/2/99) “Court Hears Debate In FDA-Tobacco Case”, Joan Biskupic / Washington Post Staff Writer [Full Text:
http://search.washingtonpost.com/wp-srv/WPlate/1999-12/02/231l-120299-idx.html]
Bloomberg News, (12/1/99) “Top U.S. Court Voices Doubt Over FDA Tobacco Rules (Update1)” [Full Text: http://quote.bloomberg.com/analytics/bquote.cgi?story_num=be1267c1d0b7ce92e43b6619896a62d4&view=story&version=markets.cfg] Bloomberg News, (12/1/99) “FDA’s Former Head David Kessler on Tobacco Regulation: Comment” [Full Text: http://quote.bloomberg.com/analytics/bquote.cgi?story_num=adbf99af4c36a4c98bf29576aed12051&view=story&version=markets.cfg] The Wall Street Journal Interactive Edition, (12/1/99) “Supreme Ct Seems Skeptical Of FDA’s Role Over Tobacco”, SCOTT RITTER / Dow Jones Newswires [Full Text: http://interactive.wsj.com/archive/retrieve.cgi?id=BT-CO-19991201-002991.djml]
AP, (12/1/99) “Gov’t, Tobacco Industry in Court”, Laurie Asseo / Associated Press Writer [Full Text: http://www.washingtonpost.com/wp-srv/aponline/19991201/aponline120847_000.htm] Reuters, (12/1/99) “Supreme Court seems skeptical on tobacco rules”, Joanne Kenen [Full Text: http://biz.yahoo.com/rf/991201/61.html] USA Today, (12/2/99)
“Justices question FDA’s right to regulate tobacco”, Wendy Koch / USA TODAY [Full Text: http://www.usatoday.com/usatonline/19991202/1705200s.htm] New York Times, (12/2/99) “Justices Skeptical of U.S. Claim on Cigarettes”, LINDA GREENHOUSE [Full Text: http://www.nytimes.com/library/politics/scotus/articles/120299smoke-fda.html]
Richmond Times-Dispatch, (12/2/99) “High court appears skeptical / Tobacco opponents face difficult questions”, PETER HARDIN / Times-Dispatch Washington Correspondent [Full Text: http://www.timesdispatch.com/editorials/dc/fda02.shtml]
The Wall Street Journal Interactive Edition, (12/2/99) “High-Court Justices Express Skepticism About FDA’s Jurisdiction Over Tobacco”, SCOTT RITTER and ROBERT S. GREENBERGER / Staff Reporters of THE WALL STREET JOURNAL [Full Text: http://interactive.wsj.com/archive/retrieve.cgi?id=SB944095470184238752.djm]

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USA TODAY Debates FDA Authority Over Tobacco

Two opposing opinion pieces in yesterday’s USA TODAY discussed the Food and Drug Administration’s case before the Supreme Court. In an op-ed, Tommy Payne, executive vice president/external relations for RJ Reynolds, wrote: “The FDA’s attempt to regualte cigarettes as ‘medical devices’ has never made sense in legal terms. FDA regulations remain legally flawed and make no sense in practical terms. . . . Moreover, the major issues regarding underage smoking and cigarette marketing were addressed and resolved in agreements between the states and the industry. . . . We believe the Supreme Court will affirm the Court of Appeals ruling that Congress has never given the unelected officials of the FDA authority to regulate cigarettes. That does not mean we believe the manufacturing of cigarettes should not be subjuect to additional regulation in a reasonable and practical manner as lawfully determined by Congress. If we could get past the casting of blame, we might all be suprised at what could get accomplished.”

The editors of USA TODAY, however, believe the case for FDA authority over tobacco is clear: “So why is this issue before the court? It’s a prime example of Washington’s recurring theme at the turn of the millennium: a powerful industry brings massive financial resources to bear on Congress and the courts, adds a big lie or two to fan public fears, and gets its way. The industry says it went to court only to assure that any regulation of tobacco is ‘reasonable.’ But in the industry lingo, ‘reasonable’ has generally meant anything that it can control. By going to court, it hopes to force the issue into Congress, where it has a long history of control, fed by deep-pockets lobbying, campaign contributions and political advertising. . . . If tobacco isn’t already subject to reasonable regulation in the name of public health, surely it should be.”

Source(s):USA Today, (12/1/99) “PAYNE: Let Congress regulate smoking”, Tommy Payne [Full Text: http://www.usatoday.com/usatonline/19991201/1700923s.htm] USA Today, (12/1/99) “EDITORIAL: Tobacco makes its case wielding big bucks, big lies” [Full Text: http://www.usatoday.com/usatonline/19991201/1701279s.htm]

 

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The Foundation for a Tobacco Free World merged with the Foundation for a Smokefree America in 2019. We are an anti vaping and anti smoking international group with a global outreach and mission.

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The Foundation for a Tobaccofree World is firmly on the side of the global health community, and is not associated with The Foundation for a Smoke Free World, to which Big Tobacco's Philip Morris has pledged $80 million annually.

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