Deeming Rule Litigation

May 11, 2020

The Fourth Circuit Court of Appeals delivered a resounding victory to public health on May 4, 2020 when it ruled to dismiss the case of American Academy of Pediatrics et al v. FDA, thwarting tobacco industry attempts to keep the case alive and delay meaningful regulation.

ACS CAN, along with other public health groups, filed a lawsuit against the agency in 2018 alleging the U.S. Food and Drug Administration (FDA) shirked its statutory obligations by delaying a critical provision of the Family Smoking Prevention and Tobacco Control Act. That provision requires e-cigarette and cigar manufacturers to submit new product applications to the agency; however, the FDA issued guidance in 2017 delaying the deadline indefinitely. A trial court ruled in ACS CAN’s favor last year, setting May 12, 2020 as the deadline by which FDA must comply with the provision. At that point, FDA withdrew its opposition and agreed to the deadline, so public health groups and the agency asked for the case to be dismissed by the appeals court. The tobacco industry attempted to keep the case alive in an effort to have the 2017 guidance stay in place, but failed when the Fourth Circuit ruled against it. Unfortunately, the FDA and the trial court granted an extension for the new product applications until September 9 of this year due to the COVID-19 crisis.

At trial, ACS CAN and other public health advocates celebrated a huge victory in the war against electronic cigarettes (e-cigarettes) and cigars in May when a federal judge ruled that the U.S. Food and Drug Administration (FDA) had shirked its duty to regulate e-cigarettes and cigars. In deciding for public health groups, U.S. District Judge Paul W. Grimm found that the FDA had exceeded its legal authority and the FDA’s delay had played a role in the skyrocketing youth use of e-cigarettes. Judge Grimm ruled that the FDA’s delay gave “manufacturers responsible for the public harm a holiday from meeting the obligations of the law.”

“Instead of addressing public health concerns associated with tobacco use by minors and others, the August 2017 Guidance [which delayed the product review requirement] exacerbates the situation by stating, in essence, that manufacturers can continue to advertise and sell products that are addictive and that target a youth market … at a time when minors’ use of tobacco products like e-cigarettes is at an epidemic level and rising,” Judge Grimm wrote.

Public health plaintiffs also lauded the trial court’s decision setting May 12, 2020 as the date by which FDA must require new product applications from manufacturers

By way of background, the Family Smoking Prevention and Tobacco Control Act (TCA) – signed into law by President Obama in 2009 - granted the FDA authority to regulate the manufacture, marketing, and sale of tobacco products. Prior to the law, tobacco products were largely unregulated outside of required warning labels and limited restrictions on advertising.

In May of 2016, the FDA released its final rule deeming all tobacco products, including cigars, e-cigarettes, and hookah, as being under its authority granted by Congress in the TCA.  Prior to that date, only cigarettes, roll-your-own-tobacco, and smokeless tobacco were subject to regulation under the TCA.  Additionally, the rule applies three specific provisions to the newly deemed tobacco products for the protection of public health.   More detail on the deeming rule can be found here.

Under the final rule, the FDA brought all categories of tobacco products, including certain dissolveables, gels, hookah tobacco, e-cigarettes, cigars, pipe tobacco, and all future tobacco products under its authority. The final rule took effect in August 2016.
Unfortunately, the government backed away from the rule by halting key compliance deadlines, allowing the incidence of children vaping to grow to what even the FDA terms “epidemic” proportions.  Public health groups including ACS CAN sued the FDA in March of 2018 in order to enforce its deadline for review of new products.  The case is American Academy of Pediatrics et al v. FDA.  

In November of 2018, FDA announced important steps it intends to take to curb use of e-cigarettes by children.  It filed notice of the announcement with the court hearing our case in an effort to demonstrate that it is addressing the crisis.  The public health groups responded by providing the court with legal background on why the lawsuit is still necessary to ensure the agency is fulfilling its obligation under the TCA.  
After the court ruled in our favor, manufacturers of cigars and e-cigarettes attempted to intervene in the lawsuit, meaning they would become parties in the case.  The judge denied their requests.

In addition to our case against FDA, a number of industry lawsuits were filed against the agency to invalidate the deeming rule when it was adopted in 2016.  The first of those lawsuits was Nicopure Labs v. FDA, in which the plaintiff alleged FDA does not have the ability to regulate its vaping products.  ACS CAN along with other public health groups filed an amicus brief outlining the importance of the agency’s role in regulating the products.  A federal district court in Washington, DC, upheld the rule in its entirety in 2017.  Our organizations also filed as amicus on appeal.  And in another victory for public health, the US Court of Appeals for the DC Circuit also upheld all aspects of the rule in December of 2019.  The panel recognized the unique danger of tobacco products, saying, “There is no amount of tobacco use that is health-protective for any individual.”

Two other deeming rule cases in which the ACS CAN has filed as amicus (or “friend of the court”)  are Cigar Association of America v. FDA and Cyclops Vapor 2, LLC v. FDA.