Health groups back in court pressing FDA to act on menthol and e-cig PMTA applications

Menthol

Over the last year health groups have started suing the FDA in efforts to force action, particularly in the areas of menthol and evaluating e-cigarettes and other new tobacco products.

As part of a political compromise, the 2009 Family Smoking Prevention and Tobacco Control Act banned characterizing flavors (but not the flavors themselves) except menthol in cigarettes and smokeless tobacco products and directed the FDA Tobacco Products Scientific Advisory Committee to complete a study of menthol within a year. That study was completed on time and recommended banning menthol. The FDA then did its own assessment and reached the same conclusion. In 2013 health groups filed a citizen’s petition urging FDA to act on menthol. Yet, as of 2020 FDA had not started the laborious process of actually banning menthol.

As a result, on June 17, 2020, the African American Tobacco Control Leadership Council and Action on Smoking and Health sued the FDA seeking a product standard menthol in cigarettes.

In response to the litigation, on April 29, 2021, FDA finally responded to the 2013 citizen petition and announced, in a letter summarizing the overwhelming scientific evidence that banning menthol would protect public health, it would move forward toward banning menthol.

Unfortunately, the FDA did not publish the required notice in the Federal Register to start the rule making process. As a result, on July 7, 2021 AATLC and the other plaintiffs went back into court arguing that the court should order FDA to move forward with the formal rule making process.

A wide range of public health groups submitted an amicus brief supporting the plaintiffs.

Not surprisingly, the FDA submitted a FDA motion to dismiss arguing that FDA had met its legal obligation and that the court should drop the case.

The judge took a middle ground, refusing to order the FDA to immediately start the formal rule making process to ban menthol, but refused to dismiss the case. Rather, the judge hold the case in abeyance until May 2022, after the FDA expects to issue the Notice of Rulemaking. Specifically, the court ruled that

The FDA has stated that it intends to issue a notice of rulemaking by April 2022, or in approximately five months. If the FDA does not issue the Notice of Rulemaking, the Court may find that the delay is unreasonable …

Should the FDA not issue a notice of rulemaking in the year since granting Plaintiff’s citizen petition, a delay of more than one year could very well be unreasonable (particularly as that delay continues). Further, as Plaintiffs [AATCLC et al] observe, other [legal] factors could support a finding of undue delay, as the FDA has described a final rule banning menthol as “‘one of the Agency’s highest priorities.’” In short, whether the FDA issues the Notice of Rulemaking as currently planned is potentially determinative to the Court’s disposition of the pending motion to dismiss. The Court therefore finds it prudent to hold the motion in abeyance in order to give the FDA an opportunity to issue the Notice of Rulemaking on its stated schedule. Accordingly, the Court CONTINUES the hearing on Defendants’ motion to dismiss to June 2, 2022.

In other words, the court expects that FDA will have started the formal process of banning menthol as a characterizing flavor by June 2, 2022. (It is, however, important that FDA ban menthol as an ingredient not just as a characterization flavor.)

Even if FDA moves ahead on menthol in cigarettes, it will likely take years before a final rule takes effect.

And the FDA hasn’t made a squeak on menthol in e-cigarettes.

Action on pending e-cigarette Premarket Tobacco Product Applications (PMTAs)

A broad coalition of health groups led by the American Academy of Pediatrics, the Campaign for Tobacco Free Kids and others, sued the FDA because it granted a years-long delay in requiring e-cigarettes to comply with the Family Smoking Prevention and Tobacco Control Act’s provisions requiring premarket review for new tobacco products. Indeed, despite exploding youth e-cigarette use, the FDA did not even plan to require e-cigarette companies to submit marketing applications by 2022, which would trigger the review process.

The Plaintiff health groups won the case and the court ordered FDA to require that PMTA applications be filed by September 9, 2020 with the expectation that FDA would act on those applications within a year.

While the FDA did deny applications for millions of e-liquids and other products from small companies by the September 9, 2021 deadline, it did not act — and has still not acted — on any of the major brands.

FDA has only acted on one e-cigarette device from a major tobacco company, RJ Reynolds’ Vuse Solo, a minor brand. (Other Vuse models are very popular with youth.)

As a result, on November 15, 2021, the Plaintiffs filed a motion with the judge asking that he “require FDA to provide regular status reports to the Court giving FDA’s estimate of the date(s) by which it expects to complete its review of the Premarket Tobacco Product Applications (PMTAs) for all products for which PMTAs were filed by Juul, Vuse, NJOY, Blu, SMOK, Suorin, and any other brands that rank among the top 10 brands in market share, according to FDA.”

The health groups argued:

FDA’s September 9, 2021 deadline has now passed, yet the vast majority of products, as measured by market share, remain on the market with neither the required marketing order nor enforcement. While FDA announced that it has taken action on 98% of timely filed PMTAs, most of these actions simply rejected “one company’s applications for approximately 4.5 million products because required contents were missing.” FDA has not issued a single PMTA decision on any of the products with the largest market share in the market as a whole or in the youth market. This inaction is inconsistent with FDA’s previous statement that it was “ensuring first review” of the applications for “products that account for most of the current market.” As the agency recognized, prioritizing “these products has the potential to have the greatest public health impact—either positively or negatively.” FDA has offered no explanation for its failure to complete its review of these products.


Moreover, FDA does not appear to have enforced the premarket review requirements against any product still awaiting a PMTA decision, including products with the greatest market share and those most used by youth. This suggests that FDA may be continuing its unlawful, indefinite holiday despite the absence of any such statutory exemption. Indeed, on September 9, 2021, FDA Acting Commissioner Janet Woodcock explained that FDA’s “highest enforcement priorities” include “products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted.” Thus the Court’s Remedial Order memorializing FDA’s prior intentions may be inadequate to cure the harm caused by its statutory violations. [citations dropped]

FDA has until December 13 to respond, but, given its previous behavior, it will likely oppose the health groups.

What should health advocates be doing in the meantime?

It is very disappointing that the health groups continue to have to go to court to press the FDA to protect the public health. In addition, the precedent set in FDA’s seriously flawed decision to authorize Vuse Solo leads me to expect that it will become the template for approving Juul and the other major e-cigarette brands.

Among the many things wrong with the Vuse Solo decision, the FDA found that the benefits to adult smokers would overcome the risks to youth without providing quantitative estimates of the claimed benefits and offsetting risks. If the FDA’s decision making on the remaining major e-cigarette brands tries to similarly skate around this tradeoff, the health groups will likely have to go in to court again accusing the FDA of abuse of discretion and failure to protect the public health.

In addition, as I have written before, I expect that FDA will use its inaction on menthol cigarettes as a reason to allow menthol e-cigarette products, another abuse of discretion.

In any event, final action on menthol is likely years away and, as noted above, I have little confidence that FDA will take effective action on the major e-cigarette brands any time soon.

This situation reinforces the importance of continuing local and state action to prohibit the sale of all flavored tobacco products and follow the 47 countries that have prohibited the sale of e-cigarettes.

Dec 6, 2021 update: The industry publication CSP Daily News reported that at a webinar held on Dec. 2 by Minneapolis-based trade organization the National Association of Tobacco Outlets (NATO) CTP Director Mitch Zeller said that the goal is to publish the standards by April to eliminate menthol in cigarettes and all flavors in cigars. He said that e-cigs are a special case and menthol would be considered on a case-by-case basis.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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