RICHMOND, Va. -- The U.S. Food & Drug Administration is studying the ingredients used in cigarettes and other tobacco products. In June, tobacco companies must tell the FDA their formulas for the first time, just as drug makers have for decades, reported the Associated Press. Manufacturers also will have to turn over any studies they have done on the effects of the ingredients.
On June 22, 2009, President Barack Obama signed the Family Smoking Prevention & Tobacco Control Act into law. It granted the FDA new authority to regulate the manufacture, marketing and distribution [image-nocss] of tobacco products to protect the public health generally and to reduce tobacco use by minors. Among its many provisions, the act added section 904 to the Federal Food, Drug & Cosmetic Act establishing requirements for tobacco product ingredient submissions.
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The new information will help the FDA determine which ingredients might also make tobacco more harmful or addictive, said the report. It will also use the data to develop standards for tobacco products and could ban some ingredients or combinations.
"Tobacco products today are really the only human-consumed product that we don't know what's in them," Lawrence R. Deyton, the director of the FDA's new Center for Tobacco Products, told AP.
While the FDA must keep much of the data confidential under trade-secret laws, it will publish a list of harmful and potentially harmful ingredients by June 2011. Under the law, it must be listed by quantity in each brand.
Some tobacco companies have voluntarily listed product ingredients online in recent years, but never with the specificity they must give the FDA, Matt Myers, president of the Campaign for Tobacco-Free Kids, told the news agency.
For example, Altria Group Inc., based in Richmond and the parent company of the nation's largest tobacco maker, Philip Morris USA, has posted general ingredients on its website since at least 1999.
Cigarette makers say their products include contain tobacco, water, sugar and flavorings, along with chemicals like diammonium phosphate, a chemical used to improve burn rate and taste, and ammonium hydroxide, used to improve the taste. Scientific studies suggest those chemicals also could make the body more easily absorb nicotine, the active and addictive component of tobacco.
About 46 million people, or 20.6% of U.S. adults, smoke cigarettes, according to the Centers for Disease Control & Prevention (CDC), down from about 24% 10 years ago, , according to AP. Tax increases, health concerns, smoking bans and social stigma continue to cut into the number of cigarettes sold, which were estimated to be down about 12.6% in the third quarter compared with the same period last year.
Cigarettes and their smoke contain more than 4,000 chemicals, the report said. Among them are more than 60 known carcinogens, according to the American Cancer Society. But scientists say they can't yet tell all they will learn from the new data because so little is known about how the chemicals combine to affect people.
The real test is whether the FDA acts on the information it receives, David Sweanor, a Canadian law professor and tobacco expert, told AP. Canadian authorities are collecting similar data, but they have not taken much action based on it, which is critical, he said. The European Union also has similar submission requirements.
Myers warned that a list of ingredients or an unexplained product label is "just as likely to mislead as it is to inform" if consumers don't know about the relative effects of ingredients.
Altria has supported what it is has called "tough but fair regulation."
But its chief rivalsNo. 2 Reynolds American Inc., parent company of R.J. Reynolds, and No. 3 Lorillard, both based in North Carolinaopposed the law. They said it would lock in Altria's share of the market because its size gives it more resources to comply with regulations and future limits on marketing under the law. Altria's brands include Marlboro, which held a 41.9% share of the U.S. cigarette market in the third quarter, according to AP, citing Information Resources Inc. (IRI).
Tobacco industry lawyers met with Solicitor General Elena Kagan in an effort to avoid the government's last-ditch attempt to extract billions from the tobacco companies, AP also reported.
Four cigarette makers that control nearly 90% of U.S. retail cigarette sales have until February 19 to persuade the government not to go to the Supreme Court and ask the justices to step into a landmark 10-year-old racketeering lawsuit.
In 2006, a judge ruled that the industry concealed the dangers of smoking for decades. Despite that finding, lower courts have said the government is not entitled to collect $280 billion in past profits or $14 billion for a national campaign to curb smoking.
As part of any effort to convince the government that it should skip a trip to the Supreme Court, the tobacco companies may have to drop plans to ask the justices to overturn the ruling that the industry engaged in racketeering, AP said.
On behalf of the industry, attorneys Michael Carvin and Miguel Estrada made their pitch against seeking Supreme Court review in a mid-December meeting at the Justice Department with Kagan, according to two Washington attorneys outside the government who are familiar with the meeting in her office. In the meeting, Carvin and Estrada left the impression the industry might be willing to end plans to seek a high court appeal of its own, if the Justice Department would do the same, said the attorneys, who spoke with AP on condition of anonymity so that they could discuss the private meeting with Kagan.
The discussion with Estrada and Carvin resulted in an internal department meeting a few days later. At this meeting, department lawyers discussed the possibility of seeking billions of dollars from the industry as part of a possible negotiated settlement of the suit, according to one of the private attorneys who learned about this second meeting from participants.
The department, the industry or both could request that the Supreme Court take the case, while at the same time asking that the case be delayed while the two sides try to work out a deal.
If the companies also agreed not to seek an appeal, they would be accepting the findings of U.S. District Judge Gladys Kessler that they engaged in a scheme to defraud the public by falsely denying the adverse health effects of smoking, concealing evidence nicotine is addictive and lying about their manipulation of nicotine in cigarettes to create addiction. Last May, a federal appeals court upheld the findings. The companies then pledged to appeal to the Supreme Court.
Kessler ordered the companies to make corrective statements about the adverse health effects of smoking, the addictiveness of smoking and nicotine, the companies' manipulation of cigarette design and composition to ensure optimum nicotine delivery and the adverse health effects of exposure to secondhand smoke. These statements must appear on company websites, cigarette packages and newspaper and TV ads.
If Kessler's findings stand, they will set a precedent that other plaintiffs can use for future suits against the tobacco companies.
"The trial court's findings are devastating to the tobacco industry," said Myers of the Campaign for Tobacco-Free Kids, one of the public health groups allowed by Kessler to join the case in 2005 on the side of the Justice Department. "We have urged the department to go to the Supreme Court to significantly strengthen the remedies, particularly with regard to funding smoking cessation and public education."
Charles Miller, a Justice Department spokesperson, declined comment, as did Carvin.
Tobacco company defendants in the lawsuit are Philip Morris USA Inc. and its parent company, Altria Group Inc.; R.J. Reynolds Tobacco Co.; British American Tobacco Investments Ltd.; and Lorillard Tobacco Co. Philip Morris, R.J. Reynolds and Lorillard account for nearly 90 percent of U.S. retail cigarette sales. A former U.S. subsidiary of British American Tobacco, Brown & Williamson Tobacco Corp., merged with Reynolds in 2004.
The way the federal suit has played out contrasts sharply with state action against the tobacco industry, the report said. The companies have agreed to pay $246 billion over 25 years to settle suits states brought to recover their costs of treating smoking-related illnesses in the Medicaid program, which serves the poor and disabled.
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