FDA Seeks to Reduce Nicotine in Cigarettes to Nonaddictive Levels--4th Update

By Jennifer Maloney Features Dow Jones Newswires

U.S. health officials said Friday they are considering new standards that would require tobacco companies to reduce nicotine in cigarettes to nonaddictive levels, as part of a sweeping review of industry regulations.

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Shares of major tobacco companies tumbled on the move by the Food and Drug Administration. Marlboro maker Altria Group Inc. was down more than 9% midafternoon, while British American Tobacco PLC, maker of Camel cigarettes, was down 5%.

The agency said it was adopting a harm-reduction strategy that seeks to balance regulation of existing products and encourage development of "new products that may be less dangerous than cigarettes." Among the issues it will examine is the role of menthol and other flavors in tobacco products.

The FDA will consider an exemption for premium cigars, and will allow more time for makers of reduced-risk products to submit product applications under the agency's recently implemented rules, FDA Commissioner Scott Gottlieb said in a press conference.

Mr. Gottlieb said the agency would look at regulation to "render cigarettes minimally addictive."

"Cigarettes will likely remain incredibly toxic," he said. "We may be able to reach a day when the most harmful products will no longer be capable of addicting our kids."

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Philip Morris International, which doesn't sell cigarettes in the U.S., didn't immediately respond to a request for comment.

A spokesman for Imperial Brands said, "We note the FDA's announcement relating to its strategic direction but until the eventual development of specific proposals, it's too early to understand the practical implications."

Mr. Gottlieb said the FDA's new approach would consider "a continuum of risk for nicotine delivery," from combustible products such as cigarettes to nicotine-replacement therapies such as nicotine patches and gums. Cigarette smoke, he said, not nicotine, is what causes cancer, heart disease and lung disease.

"The problem is not just nicotine, the problem is the delivery mechanism, " Mr. Gottlieb said. Cigarettes kill 480,000 people in the U.S. each year, according to the Centers for Disease Control and Prevention.

British American Tobacco's U.S. subsidiary, Reynolds American Inc., said it was encouraged by Mr. Gottlieb's comments on the relative risks of different tobacco products.

"These principles have long been the core of our efforts in transforming the tobacco industry, as evidenced by our existing leadership in the snus [tobacco pouches] and vapor categories," a Reynolds spokesman said. "We are well prepared and look forward to participating in a thorough process to develop a comprehensive plan for tobacco and nicotine regulation."

Altria, which supported the 2009 legislation that gave the FDA authority to reduce nicotine levels in cigarettes, called the announcement "a meaningful step forward" in developing a harm-reduction policy.

"It's important to understand that any proposed rule such as a nicotine product standard must be based on science and evidence, must not lead to unintended consequences and must be technically achievable," an Altria spokesman said. "We intend to be fully engaged throughout this process."

Some tobacco analysts were skeptical. Citigroup analyst Adam Spielman said he didn't believe the FDA will be able to lower nicotine to nonaddictive levels because defining that level will be difficult, it would be hard to make cigarettes with a very low level of nicotine and there would be huge political opposition.

"We don't believe the proposal to reduce nicotine in cigarettes dramatically is practical," said Mr. Spielman, adding that Friday's tobacco stock drops are unjustified.

E-cigarettes and vaping devices that were on the market in August 2016 won't be subject to review until 2021 or 2022, depending on the type of product. The agency also will consider the potential impact of a black market for cigarettes.

Some antismoking advocates and public health officials been urging the FDA and CDC to provide the public with information on the relative risks of tobacco products. Until now, U.S. health officials have stuck with an abstinence-only message to the public.

The FDA's shift comes as the agency considers whether to approve new marketing claims for new heat-not-burn devices, smokeless tobacco and other products. In April, Reynolds American, which was recently acquired by BAT, submitted applications to market six styles of Camel Snus tobacco pouches as being less harmful than cigarettes. Philip Morris also has an application pending for a new device that heats tobacco instead of burning it.

Saabira Chaudhuri contributed to this article

Write to Jennifer Maloney at jennifer.maloney@wsj.com

Corrections & Amplifications

This article was corrected at 4:16 p.m. ET because the original version misstated the Food and Drug Administration's name as the Federal Drug Administration in the second paragraph.

Shares of major tobacco companies tumbled on the move by the Food and Drug Administration. "FDA Seeks to Reduce Nicotine in Cigarettes to Nonaddictive Levels" at 3:13 p.m ET and earlier versions of the article, misstated the agency's name as the Federal Drug Administration in the second paragraph. (July 28)

U.S. health officials said Friday they are considering new standards that would require tobacco companies to reduce nicotine in cigarettes to nonaddictive levels, as part of a sweeping review of industry regulations.

Shares of major tobacco companies tumbled on the move by the Food and Drug Administration. Marlboro maker Altria Group Inc. was down more than 9% midafternoon, while British American Tobacco PLC, maker of Camel cigarettes, was down 5%.

The agency said it was adopting a harm-reduction strategy that seeks to balance regulation of existing products and encourage development of "new products that may be less dangerous than cigarettes." Among the issues it will examine is the role of menthol and other flavors in tobacco products.

The FDA will consider an exemption for premium cigars, and will allow more time for makers of reduced-risk products to submit product applications under the agency's recently implemented rules, FDA Commissioner Scott Gottlieb said in a press conference.

Mr. Gottlieb said the agency would look at regulation to "render cigarettes minimally addictive."

"Cigarettes will likely remain incredibly toxic," he said. "We may be able to reach a day when the most harmful products will no longer be capable of addicting our kids."

Philip Morris International, which doesn't sell cigarettes in the U.S., didn't immediately respond to a request for comment.

A spokesman for Imperial Brands said, "We note the FDA's announcement relating to its strategic direction but until the eventual development of specific proposals, it's too early to understand the practical implications."

Mr. Gottlieb said the FDA's new approach would consider "a continuum of risk for nicotine delivery," from combustible products such as cigarettes to nicotine-replacement therapies such as nicotine patches and gums. Cigarette smoke, he said, not nicotine, is what causes cancer, heart disease and lung disease.

"The problem is not just nicotine, the problem is the delivery mechanism, " Mr. Gottlieb said. Cigarettes kill 480,000 people in the U.S. each year, according to the Centers for Disease Control and Prevention.

British American Tobacco's U.S. subsidiary, Reynolds American Inc., said it was encouraged by Mr. Gottlieb's comments on the relative risks of different tobacco products.

"These principles have long been the core of our efforts in transforming the tobacco industry, as evidenced by our existing leadership in the snus [tobacco pouches] and vapor categories," a Reynolds spokesman said. "We are well prepared and look forward to participating in a thorough process to develop a comprehensive plan for tobacco and nicotine regulation."

Altria, which supported the 2009 legislation that gave the FDA authority to reduce nicotine levels in cigarettes, called the announcement "a meaningful step forward" in developing a harm-reduction policy.

"It's important to understand that any proposed rule such as a nicotine product standard must be based on science and evidence, must not lead to unintended consequences and must be technically achievable," an Altria spokesman said. "We intend to be fully engaged throughout this process."

Some tobacco analysts were skeptical. Citigroup analyst Adam Spielman said he didn't believe the FDA will be able to lower nicotine to nonaddictive levels because defining that level will be difficult, it would be hard to make cigarettes with a very low level of nicotine and there would be huge political opposition.

"We don't believe the proposal to reduce nicotine in cigarettes dramatically is practical," said Mr. Spielman, adding that Friday's tobacco stock drops are unjustified.

E-cigarettes and vaping devices that were on the market in August 2016 won't be subject to review until 2021 or 2022, depending on the type of product. The agency also will consider the potential impact of a black market for cigarettes.

Some antismoking advocates and public health officials been urging the FDA and CDC to provide the public with information on the relative risks of tobacco products. Until now, U.S. health officials have stuck with an abstinence-only message to the public.

The FDA's shift comes as the agency considers whether to approve new marketing claims for new heat-not-burn devices, smokeless tobacco and other products. In April, Reynolds American, which was recently acquired by BAT, submitted applications to market six styles of Camel Snus tobacco pouches as being less harmful than cigarettes. Philip Morris also has an application pending for a new device that heats tobacco instead of burning it.

Saabira Chaudhuri contributed to this article

Write to Jennifer Maloney at jennifer.maloney@wsj.com

(END) Dow Jones Newswires

July 28, 2017 16:31 ET (20:31 GMT)