Thursday, October 06, 2016

National Anti-Tobacco Groups File Feeble Lawsuit Against FDA While Continuing to Oppose Smoking Cessation via Vaping

Earlier this week, eight national anti-tobacco groups, headlined by the Campaign for Tobacco-Free Kids, filed a lawsuit against the FDA in an attempt to force the agency to re-issue a requirement for graphic warning labels on cigarette packs.

As the lawsuit explains, here are the key facts:

1. "The Tobacco Control Act became law on June 22, 2009. Section 201 required the FDA to  promulgate its final rule [regarding graphic warning labels] “not later than 24 months after the enactment” of the Act: June 22, 2011."

2. "On June 22, 2011, exactly two years after the Tobacco Control Act was enacted, the FDA promulgated a final rule designating nine graphic warning labels depicting the negative health consequences of cigarette smoking as required by Section 201 and set September 22, 2012 as the time by which such warning labels would be required."

3. "On September 2, 2011, a group of tobacco product manufacturers and sellers filed an action in the United States District Court for the District of Columbia alleging that the 2011 Rule was unconstitutional as applied because the specific required content, placement and type style of the mandated warning labels infringed their rights of free speech under the First Amendment."

4. "On February 29, 2012, the United States District Court for the District of Columbia found that the specific warning labels required by the 2011 Rule were unconstitutional and enjoined the  enforcement of the rule. On August 24, 2012, the Court of Appeals for the District of Columbia Circuit affirmed the judgment of the District Court and vacated the 2011 Rule. The Court of Appeals remanded the rule to the FDA and vacated the District Court’s permanent injunction."

5. "On March 15, 2013, Attorney General Eric Holder, in a letter to Congress, stated that, given the FDA’s plan to undertake research to support a new rule mandating graphic warning labels consistent with the Tobacco Control Act, the Solicitor General had determined not to seek Supreme Court review of the Court of Appeals’ ruling."

The lawsuit's complaint is that although "more than four years have now passed since the Court of Appeals vacated the 2011 Rule, the FDA has not even be gun rulemaking proceedings to promulgate a new graphic warnings rule as required by Section 201. No proposed rule even appears on the FDA’s Unified Regulatory Agenda for action during 2016."

The Rest of the Story

This is a very weak lawsuit. At this point, whether or not the FDA re-issues a rule regarding graphic warning labels is entirely up to the agency's discretion. The agency has already complied with the statute, which merely requires it to issue a graphic warning rule by June 22, 2011. The FDA did issue that rule, on June 22, 2011, as required. The rule was deemed unconstitutional by the D.C. District and Circuit courts and was vacated. Since the FDA issued the rule as required by the statute, it has fulfilled its obligation under the law and is not required to issue a subsequent rule. There is nothing in the statute indicating that if the initial rule is found to be unconstitutional, the agency must keep issuing additional rules until one finally passes Constitutional muster.

The key argument of the plaintiffs, which include the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, and the American Academy of Pediatrics, is that the FDA has failed to comply with Section 201. I don't find that argument compelling because the agency has in fact complied with Section 201 by issuing a rule on graphic warning labels, as required, by June 22, 2011. The FDA is not in violation of Section 201.

While the plaintiffs have every right to use advocacy strategies to urge the FDA to re-issue a graphic warning label requirement that does not conflict with the First Amendment rights of the cigarette companies, their attempt to use the law to force the agency to re-issue a graphic warning label rule is unsupported by the facts of the case.

While not directly relevant to the legal issues in the case, the plaintiffs repeatedly claim that the scientific evidence shows that graphic warning labels are effective in getting smokers to quit. However, I do not believe that is the case. The evidence supporting the use of graphic warning labels to promote smoking cessation is weak. Moreover, there is substantial evidence that graphic warning labels are ineffective. A body of psychology and neurophysiology research suggests that graphic warning labels on cigarette packages will have very little effect in deterring smoking among existing smokers.

The Circuit Court recognized as much: "FDA has not provided a shred of evidence - much less the 'substantial evidence' required by the APA - showing that the graphic warnings will 'directly advance' its interest in reducing the number of Americans who smoke. FDA makes much of the 'international consensus' surrounding the effectiveness of large graphic warnings, but offers no evidence showing that such warnings have directly caused a material decrease in smoking rates in any of the countries that now require them. ... FDA's Regulatory Impact Analysis (RIA) essentially concedes the agency lacks any evidence showing that the graphic warnings are likely to reduce smoking rates. ... The Rule thus cannot pass muster under Central Hudson."

Thus, the lawsuit's claim that the failure of the FDA to issue a new graphic warning label rule is hindering the anti-tobacco groups' ability to carry out their mission is unsupported.

The rest of the story is that what is really hindering the ability of these groups to carry out their mission is their continued refusal to promote smoking cessation if that cessation involves anything that resembles smoking, even if no tobacco is involved. Of course, I am talking about their continued attack on electronic cigarettes and vaping, despite the evidence that vaping has helped millions of smokers to quit or substantially cut down on the amount they smoke.

The obsession of the anti-tobacco groups with graphic warning labels coupled with their vigorous protection of cigarette consumption by discouraging smokers to switch to vaping suggests that something else is going on beyond a simple desire to promote smoking cessation. It appears that the desire is to promote smoking cessation only in the way that these groups prefer. Whether the advocated strategy is actually the most effective or most helpful to smokers is not important. What is important, apparently, is not that smokers quit, but that they quit in the "right way."

Quitting using e-cigarettes is not the "right way" because it involves an activity that resembles the act of smoking (even though the product is tobacco-free). Quitting by being bombarded with graphic warnings is the "right way" because smokers are being punished and chided for what is viewed as an immoral or stupid decision to smoke (even though the approach has been shown not to be very effective).

These groups also continue to urge smokers to use other ineffective methods, such as nicotine replacement therapy, because they view these as a "right way" to quit. For the 90% of smokers who fail to quit using nicotine replacement therapy, and for whom e-cigarettes might be the only viable option, these groups still discourage vaping because it is just not the "right way" to quit.

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