US Senators to back bill for FDA Regulation on Tobacco

WASHINGTON, Oct 3 - The head of the U.S. Food and Drug Administration on Wednesday raised concerns about a bill that would empower his agency to regulate cigarettes, while he said he shares its goal of reducing tobacco use.

"We have concerns that the bill could undermine the public health role of the FDA," Andrew von Eschenbach said in a written statement released at a congressional hearing.

He expressed concerns that the measure "may be extremely difficult for the FDA to implement" and whether the agency would have adequate resources for enforcement as well as "the expectations it might create."

The health subcommittee of the House of Representatives Energy and Commerce Committee held a hearing on the bill, which would require the FDA to regulate cigarettes in much the same way it regulates other products.

At the hearing, several Republican lawmakers raised questions similar to von Eschenbach's.

"We ought to take a step back and really think about it ... You can't just keep piling more and more work on the FDA without giving the agency additional resources," said Texas Republican Joe Barton.

Major tobacco companies are watching the legislation, including Altria Group Inc (MO.N: Quote, Profile, Research), Reynolds American Inc. (RAI.N: Quote, Profile, Research) and British American Tobacco Industries Plc (BATS.L: Quote, Profile, Research).

A U.S. Senate committee on Aug. 1 endorsed a similar FDA cigarette bill, with the backing of public health groups and Altria's Philip Morris, the nation's largest cigarette maker.

The Senate bill would allow the FDA to restrict tobacco advertising, prevent cigarette sales to minors, mandate stronger warning labels, bar misrepresentation of tobacco's dangers and order removal of dangerous cigarette ingredients.

Tobacco companies would fund the FDA's oversight of their industry under the Senate bill with an initial figure of $450 million in annual fees -- about 2.5 cents per pack.

Smoking is the number one preventable cause of death in the United States, leading to more than 400,000 deaths and $96 billion in health care costs each year, health groups say.

Industry analysts say Philip Morris, maker of Marlboro cigarettes, backs the measure because it would help protect the company's dominant market share.

Past congressional efforts to regulate cigarettes have failed, but advocates of the bill are hopeful this time because of Philip Morris' support and Democratic control of both the House and Senate since last November's elections.

"I am convinced that in this Congress, tobacco regulation legislation will see the light of day. We are determined it will," said New Jersey Democrat Frank Pallone, subcommittee chairman.

"Regulation of tobacco is the single most important thing we can do right now to curb the deadly toll of tobacco," said California Democrat Henry Waxman,

who chairs the House Committee on Oversight and Government .

Is Philip Morris Driving The FDA Regulation Train?

Philip Morris (PM) is a sophisticated company that runs at least ten years ahead of public health authorities in devising strategies to shape its destiny and preserve its future markets. PM knew that sooner or later push would come to shove and public pressure would make the U.S. government try to regulate its products and corporate behavior, especially after the U.S. Department of Justice found PM guilty of 50 years of conspiracy to defraud the public about the dangers of its products. True to form, in 1999 PM started an internal project called the Regulatory Strategy Project to enact Food and Drug Administration (FDA) regulations on the company's own terms. During the project, in 2000, PM generated a "Privileged and Confidential" document listing what the company would require in what it sees as "sensible" FDA regulations.

The document is heavily edited by John Holleran of Philip Morris Management's Legal Department, and states, "We [PM] support strong but sensible FDA regulation of cigarettes based on five core principles."

The first principal is that FDA "not infringe on the right of adult Americans to choose to take the risks of smoking" and that FDA be prohibited from banning cigarettes and having the power to alter cigarettes to make smoking unpalatable to smokers. This principal would both preserve a market for cigarettes and assure that cigarettes remain available.

The second requirement is that FDA regulate cigarette design and manufacturing processes "to assure that no additives increase the inherent risks of smoking" and that cigarette ingredients be "fully disclosed to FDA in a framework that protects trade secrets." The simultaneous requirements of full disclosure and maintaining trade secrets seem contradictory, since "full disclosure" means the absence of secrets.

The third principle says that "The long-range goal of FDA regulation should be to reduce the risks of smoking by encouraging industry innovations," and that "FDA should set standards that allow products to be certified as 'reduced risk' and marketed as 'reduced risk.' " This measure would appear to have a goal of transferring liability for tobacco products onto the FDA.

The 4th principle PM requires that FDA "assure continuous, updated disclosures to smokers as science evolves so that people continue to be fully informed of the risks of smoking." As it is written, this measure presumes that smokers are already fully informed about the risks of smoking, and places the burden of public health education about tobacco products onto FDA and takes it off the manufacturers.

Two alternatives are listed for the fifth requirement, which nominally claims to address youth smoking:

"5. (Alternative 1) In the area of youth smoking prevention, FDA should set policies that acknowledge the significant changes created by the MSA (Master Settlement Agreement) and, like the MSA, recognize the legitimacy of marketing communications to adult smokers..."

The first alternative further says that, "Marketing to adults...should not be regulated by the FDA." Instead of addressing youth smoking as the introduction suggests, this principle appears to be aimed at protecting marketing to adults.

The second version of principle #5 says, "FDA should NOT be given a specific regulatory responsibility regarding how cigarettes are marketed and sold. Through the [Master Settlement Agreement], states have a strong legal framework for preventing tobacco marketing to youth. The FDA's mission is and should be scientific in nature -- focusing on the products and its risks." The document threatens to embark on a Constitutional legal challenge if FDA makes any effort to regulate tobacco marketing. The second version of principle #5 also says, somewhat haughtily, "There is no need for the FDA to use its scarce resources on youth smoking prevention. That is best left to others."

This paper represents the starting point for laying out the elements of what PM wants in its preferred FDA regulation. Taken as a whole, the document indicates that PM's goals in pressing for FDA regulation are:

1) To assure a future market for cigarettes,

2) To preserve the company's ability to make cigarettes that appeal to their market,

3) To safeguard the ability to market cigarettes without restrictions,

4) To keep FDA from engaging in smoking prevention efforts, particularly among youth,

6) To prevent FDA from obtaining any authority to restrict the marketing and promotion of cigarettes,

7) To give FDA the responsibility of fully informing the public about the dangers of tobacco use, rather than the manufacturers,

8) To transfer legal liability for the safety of tobacco products onto the FDA, while allowing cigarette companies the continue to design and market cigarettes as they see fit.

Of course, all the principles PM laid out in this document serve to protect the cigarette business rather than public health. While the major health groups and Philip Morris currently are the only groups that are privy to the text of the recently-introduced Kennedy/Waxman bill to regulate tobacco, it would be prudent when the bill becomes available to see how many of PM's Core Principles are in it. If they are, the bill will benefit Philip Morris, and be detrimental to effective future regulation of tobacco.

WASHINGTON (Reuters) - The Senate overwhelmingly approved a landmark tobacco deal on Thursday to give the Food and Drug Administration long-sought power to regulate cigarettes and give $12 billion in aid to tobacco farmers.

Though hailed as a breakthrough by public health groups, the measure faces an uncertain future because it was approved as part of a massive corporate tax bill that must still be reconciled with the House of Representative's version. Those talks are expected to be long and complex.

The lopsided 78-15 vote will strengthen the Senate position in those negotiations, and many lawmakers who want greater public health jurisdiction over tobacco were more optimistic than they had been since 1998, when a tobacco bill linked to multibillion-dollar state lawsuits against tobacco companies collapsed.

"This represents a fundamental change and a fundamental step forward," said Matt Myers of the Campaign for Tobacco-Free Kids.

While the House and Senate have had extensive hearings and probes of Big Tobacco, Myers noted this would be the first time either chamber had passed meaningful regulation of the companies' advertising, marketing, ingredients and safety claims.

The FDA itself tried to assert its authority over tobacco in the 1990s, but the battle went to the Supreme Court, which ruled in 2000 that the FDA did not have jurisdiction under existing law. This legislation would change the law and grant the agency that explicit power.

Under the proposal, the tobacco industry would finance a $12-billion buyout of Depression-era crop quotas, an arcane price support system that no longer serves farmers' economic interests in an increasingly global market.

Mitch McConnell, who represents the tobacco-growing state of Kentucky and is the number two Republican leader in the Senate, agreed the components of the bill had to be linked if either was to pass.

"It's not a shotgun wedding, it's a marriage of convenience," said McConnell, lead author of the buyout legislation.

"Yes it's a marriage of convenience, but I believe it's a good marriage," agreed Ohio Republican Mike DeWine, a co-author with Massachusetts Democrat Edward Kennedy of the FDA bill.

"This is the most important step we can take for public health short of curing cancer itself," Kennedy said.

The proposal would give the FDA expanded powers to require more forceful health warnings on cigarette packs, regulate advertising, more aggressively combat underage sales and regulate ingredients to make cigarettes less harmful. It could not ban cigarettes or completely eliminate nicotine.

The major cigarette companies are divided over the measure. The Altria Group, the parent company of Philip Morris, has endorsed it, but R.J. Reynolds Tobacco Co on Thursday repeated its "vigorous opposition."

A rival House version of the tobacco measure attached to the corporate tax bill would cost taxpayers -- not the industry -- $9.6 billion, and is not linked to FDA regulation.

Smoking is the top preventable cause of death in the United States, leading to 400,000 deaths a year. Ninety percent of smokers get hooked as children or teen-agers, according to public health groups.

TED AND HENRY CAMEL

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