Deeming Rule Litigation
ACS CAN and other public health advocates celebrated a huge victory in the war against electronic cigarettes (e-cigarettes) and cigars on May 16 of this year 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 groups filed suggested remedies with the court, proposing that manufacturers be required to file new product applications in no more than 120 days, and that FDA submit regular reports to the court on its progress.
By way of background, the Family Smoking Prevention and Tobacco Control Act (TCA) – signed into law by President Obama in 2009 - granted the U.S. Food and Drug Administration (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 this 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. The groups also filed a summary judgment motion to try and get an expedited ruling on the merits of the case.
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 request.
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. The government initially defended the rule, and ACS CAN along with other public health groups filed an amicus brief outlining the importance of the agency’s role in doing so. In July of 2017, a federal district court in Washington, DC, upheld the rule in its entirety. That case is now on appeal to the D.C. Circuit.
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.