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Deeming Rule Litigation

December 4, 2018

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, electronic cigarettes (or 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.  However, a number of industry lawsuits were filed to invalidate the rule.  The first of those lawsuits was Nicopure Labs v. FDA, in which the plaintiff alleged FDA does not have the ability to regulate its 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 late July of 2017, a federal district court in Washington, DC, upheld the rule in its entirety. 

Unfortunately, the government has backed away from the rule by halting certain key compliance deadlines.  In response,  ACS CAN and its public health partners sent a letter to Secretary of Health and Human Services Tom Price urging him to defend and fully implement the rule, and filed motions to become intervenors in three pending lawsuits.  The first two cases in which the organization filed are Cigar Association of America v. FDA and Cyclops Vapor 2, LLC v. FDA.  The third is Nicopure Labs, which is on appeal to the United States Court of Appeals for the District of Columbia.  ACS CAN filed an amicus brief in Nicopure providing the court with data on the importance of FDA review for modified risk claims. 

The petition to intervene in the Cigar Association case was denied, but ACS CAN and public health partners will be permitted to file an amicus brief in the case on appeal.  

Notably, public health groups have sued the FDA in order to enforce its deadline for review of new products.  Read the press statement.  The case is The American Academy of Pediatrics et al v. FDA.  The groups have 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 what the FDA Commissioner has called an “epidemic” for youth.  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 Tobacco Control Act.