Public health advocates have been trying to discourage cigarette use since the 1960's. The bitter legal and political battles were just the beginning of the battle that could determine the fate of smoking.
Twin government proposals would limit nicotine levels and ban flavoured cigarettes in the U.S., as part of an aggressive attack on cigarettes. Vaping, also known as electronic cigarettes, can provide smokers with a nicotine fix without the harmful effects of tobacco.
The measures are the source of a clash expected to play out over the coming months and years. The steps aim to save millions of lives and reduce the billions of dollars spent on smoking related diseases.
Big Tobacco supports the transition.
Billy Gifford, chief executive of Altria, one of the world's biggest cigarette conglomerates and the parent company of Philip Morris USA, told Wall Street analysts and investors in October that there was an "unprecedented opportunity" to move beyond smoking. A company vision was offered in the opening slide of his presentation.
Major cigarette companies, like R.J. Reynolds, acknowledge that cigarettes are dangerous and addictive, and they are trumpeting their investments in electronic cigarettes and other less harmful alternatives to cigarettes. The companies have submitted letters protesting the proposed ban in traditional cigarettes, and they have signaled they will resist any efforts to lower nicotine levels.
Big Tobacco is not just duking it out at the federal level. In California, the industry has spent $22 million to support a November ballot proposition that would overturn a 2020 law banning the sale of flavoured tobacco. The law won't take effect until after the referendum.
The tobacco industry funded group that succeeded in getting the referendum on the ballot argued that the flavor ban benefits the wealthy and special interests while costing jobs and cutting funding for education and health care.
In his October call with investors, Mr. Gifford said that science doesn't support the flavor ban.
R.J. Reynolds, which is owned by British American Tobacco and is the second largest cigarette company in the United States, has said it embraces less harm but still believes in its business model.
Reynolds supports F.D.A.'s goal of reducing tobacco-related disease. It said that menthol smokers would switch to nonmenthol cigarettes or riskier options. Beyond its filing, the company declined further comment.
The legal and political might of Big Tobacco has waned as the smoking population in the United States has fallen to 13 percent from 21 percent in 2005, far from a peak of 45 percent of adults in 1954. 74 percent of Americans favored requiring tobacco companies to lower nicotine levels in cigarettes to make them less addictive, according to a Gallup survey. The majority of people favored banning cigarettes with flavors that areHOT. There is a proposal that would allow the sale of menthol e-cigarettes.
The industry still makes billions of dollars, and it hopes to use its remaining power to stop the proposals at the regulatory level or in court.
The most significant period of proposed regulations by the F.D.A. has taken place this spring and summer. Sarah Milov is an associate professor of history at the University of Virginia. It's all about where they make their money. They will fight the nicotine and menthol rules in order to show their commitment to cigarettes.
The tobacco industry has allies in the fight against the ban. The National Association of Convenience Stores and the New York City Newsstand Operators Association have stakes in the outcome.
The Tax Foundation said federal and state governments could lose billions of dollars in tax revenues in the first year of the ban. The American Civil Liberties Union is against the ban.
The proposed ban has divided Black leaders across the country due to the fact that companies heavily marketed cigarettes to Black smokers, who prefer them at a higher rate than whites do. Some welcomed the proposal as a way to lower cancer and heart disease, but others worried that it would lead to unwarranted police interactions with black Americans. Big Tobacco retained some of the Black political leaders who were against the ban to sew doubt and fear into the minds of the people who were against the ban.
The F.D.A.'s authority to regulate tobacco products has been challenged many times. Industry critics say that the goal of the companies is to maintain their share of the cigarette market. One-third of the $65 billion in sales in the US were from menthol.
Eric Lindblom is a senior scholar at the O'Neill Institute for National and Global Health Law at Georgetown University and a former adviser to the F.D.A. They would stop opposing efforts to regulate and tax smoking tobacco products if they were serious about quitting.
The price of traditional cigarettes have gone up. The number of packs of cigarettes sold in the US fell by 27 percent over the course of a year, according to a study published this year. The price of a pack of tobacco increased by 29.5% during that time.
Inflation is a part of the equation. In the first nine months of this year, the company reported a 9 percent decline in sales volumes, with executives saying that customers were buying single packs of cigarettes instead of cartons.
The company share price has fallen.
The threat of new regulation seemed far into the future but most investors knew it was coming. Nicotine regulation is a long, long way away, I think.
Even as the industry resists at every turn, the battle over nicotine limits extended the government's efforts to chip away at smoking. This moment is not the same. Many public health officials have embraced a strategy of harm reduction, which is not just to curb the cigarette market but to accept and even advocate for an alternative with e-cigarettes.
For a long time, public health officials were hesitant about allowing the use of e-cigarettes because they worried that they would encourage young people to use nicotine products.
Major companies argued that there were no appealing options to help smokers quit without an alternative or other product.
The former director of the F.D.A.'s Center for Tobacco Products said that he wasn't sure if the companies would accept a smokeless future. He said how they respond to the new proposals will be a test of their honesty.
The tobacco companies have been called a day of reckoning. They have to decide.
He acknowledged that the tobacco companies were in a difficult position and had to answer to shareholders who still depended on cigarette sales and profits.
He said that they have a fiduciary duty. He said that regulation might force the companies to adapt.
Tobacco companies are against curbs on sales. The industry has been trying to stop the federal government from requiring larger, graphic warnings on cigarette packages. Big Tobacco companies have continued to recruit former F.D.A. employees, most recently with Philip Morris International hiring Matt Holman, who was the chief of the science office in the center for tobacco products.
The tobacco industry will go to court if the F.D.A. goes ahead with a ban on menthols, according to a former associate commissioner at the agency. Rules put in place with the F.D.A. will end up in court again if they ignore valid scientific objections.
The Cigar Association of America recently won a case against the F.D.A. The judge in Washington, D.C. said the F.D.A. had acted irrationally and ignored evidence. The case isn't finished.
In another blow to the F.D.A., the U.S. Court of Appeals for the 11th Circuit set aside marketing denial orders for six e-cigarette companies.
He hopes a compromise can be reached. He wanted to know if it was possible to reduce nicotine in a way that would allow the sale of menthol cigarettes.
Now that the F.D.A. has the authority to regulate e-cigarettes, all of them have had to apply to stay on the market. According to a letter published in August, the F.D.A. is looking at applications for 350 products. The agency has allowed the sale of about two dozen products.
Tobacco companies are competing for a piece of the market. Several Vuse products were approved by the F.D.A. The agency hasn't ruled on the sale of Vuse Alto, the company's biggest seller to date, which accounted for 95 percent of its e-cigarettes sales last year. Vuse Alto has gained in popularity due to its small, sleek design, longer battery life and the fact that it wasn't mired in the same teenage use controversy as Juul.
The relationship with Juul Labs seemed to be the main focus of Altria's strategy. A 35 percent stake in the company was paid for by Altria. The company's products had been severely restricted by public pressure to pull flavors off the market out of concerns for their appeal to teens. The F.D.A. granted an additional review to the application for certain tobacco and menthol products.
By the end of September, the company had taken a $12 billion loss on the product. Some analysts think that Altria could acquire another e-cig company if it ends its noncompete agreement with Juul. It was reported in October that Juul might seek protection from the law.
Nicotine pouch, a product that is placed between the cheek and jaw, is a product that Altria has stakes in.
There are tobacco sticks that are heat-not-burn. The sale of the U.S. rights to sell IQOS to Philip Morris International was announced in October.
Japan Tobacco and Altria formed a new joint venture to develop a heat-not-burn stick for the US market.
Mr. Growe asked when a new Ploom product might be available on the call. He wanted to know if there was a reasonable time frame for launching a product in the U.S.
Mr. Gifford said that he thought you were getting ahead of yourself.
Mr. Gifford said that the underlying question was "Why are you taking so long?" We want to be disciplined.
Mr. Gifford said that the company wanted to create an alternative to the cigarette, but not in a hurry. It needs to be done in a thoughtful manner.
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