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FDA tries again to find balance between corrective cigarette warnings statements and 1st Amendment

FDA tries again to find balance between corrective cigarette warnings statements and 1st Amendment

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The U.S. Food and Drug Administration is requesting public comment again on potential corrective warnings statements for traditional cigarettes, including providing 15 revised statements.

The FDA issued the public-comment notification Tuesday on the Federal Register website.

The goal is choosing survey participants from an internet panel of at least 1.2 million adolescents, young adults and older adults. Comments will be taken through Oct. 19. It has not indicated how individuals can participate.

“The study will collect data from various groups of consumers, including: adolescent current cigarette smokers; adolescents who are susceptible to initiation of cigarette smoking; young adult (ages 18 to 24) current cigarette smokers; and older adult current cigarette smokers,” the FDA said in its notice.

“The results will inform the agency’s development of cigarette graphic health warnings to be tested in future studies with the goal of implementing the mandatory graphic warning label statement” consistent with federal law and the First Amendment, the FDA said.

R.J. Reynolds Tobacco Co. declined to comment on the FDA initiative.

U.S. District Judge Gladys Kessler ruled in 2006 that cigarette manufacturers had concealed the dangers of smoking for decades. The U.S. Justice Department filed a civil case in 1999 under the federal Racketeer Influenced and Corrupt Organizations law, or RICO.

Part of Kessler’s ruling was a requirement that tobacco manufacturers include corrective statements on their products.

On April 25, the U.S. Court of Appeals for the District of Columbia Circuit reaffirmed that manufacturers must meet that requirement.

However, the judges also ruled that the statements cannot include the phrase “here is the truth.”

The manufacturers have argued that the “here is the truth tagline conveys the unambiguous message that defendants have previously withheld ‘the truth’ about the effects of smoking” because they would have been ordered to include the tagline.

The court wrote that “because courts do not ordinarily order companies to disseminate information absent prior wrongdoing, defendants allege that this phrase communicates that they are being compelled to speak as punishment for prior wrongdoing.”

The court said it agreed that “read together, these two phrases most naturally suggest prior misconduct by defendants.”

“Such language can only serve two purposes: either to attract attention that a correction follows, or to humiliate the advertiser … neither of which is a permissible goal under civil RICO corrective statements opinion,” the court said.

The judges suggested that “with the minor revisions mandated in this opinion, the district court can simply issue an order requiring the corrective statements remedy to go forward.”

In court filings, Reynolds, Altria Group Inc., Philip Morris USA Inc. and Lorillard Tobacco Co. have said the 2009 Tobacco Control Act eliminated any reasonable likelihood the companies would commit future violations, thus making moot the need for remedies, such as corrective statements.

Kessler ruled in November 2012 that cigarette marketing carry the statement: “A federal court has ruled that the defendant tobacco companies deliberately deceived the American public about the health effects of smoking, and has ordered those companies to make this statement.”

Kessler has ordered that statements appear on company websites, on cigarette packages, and in newspaper and television ads.

The manufacturers filed a joint appeal in January 2013. They have tried to persuade Kessler to reject the statements, calling them “forced public confessions” in legal filings.

The proposed corrective warning statements have to be viewed not only in the context of being constitutional but also whether they can be effective in deterring smoking, said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several electronic-cigarette studies.

“These are messages meant to scare people; to be fear-arousing,” Sweanor said. “But there is much good evidence that fear-producing messages not accompanied by clear, actionable steps people can take to reduce their risks are ineffective.

“The greatest impediment to the FDA effectively using such messages,” he said, “might not be courts that prevent it from happening but the failure of agencies like the CDC and FDA to give consumers accurate information on the options available to them to reduce their risks.”

That includes, Sweanor said, informing smokers that electronic cigarettes and vaporizers could be much less harmful to consumer than traditional cigarettes.

The Royal College of Physicians in London has determined that e-cigarettes could be as much as 95 percent less harmful that combustible cigarettes.

Dr. John Spangler, a professor of family and community medicine at Wake Forest Baptist Medical Center, said he believes “stronger warnings on cigarette packages are associated with increased attention to those warnings and increased thinking of harmful habits.”

“A review of studies has shown that stronger warnings increase people’s attempts to quit and decreases the prevalence of smoking,” Spangler said. “This implies that such messages are helping people quit smoking and helping others avoid starting in the first place.”

Scott Ballin, a past chairman of the Coalition on Smoking or Health, said the FDA under the Trump administration should use the public comment period “to go back to the drawing board and develop message statements that put things in perspective using the ‘continuum of risk,’ which FDA now claims is a major priority.”

“They should be testing consumer and public reaction to not only negative statements but also messaging that encourages consumers to consider science-based. lower-risk products such as snus, patches, gums and e-cigarettes,” Ballin said. 336-727-7376 @rcraverWSJ


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