Lawsuits Proliferate Against FDA 'Deeming' Regulations

Four have been filed by companies or trade associations in the vapor segment

Thomas A. Briant, NATO Executive Director

deeming tobacco

The first lawsuit seeking to set aside some or all of the Food and Drug Administration’s (FDA) new tobacco “deeming” regulations was filed May 10 by Nicopure Labs LLC. Since then, at least seven other suits have been filed. Different segments of the tobacco industry, and even one state lawmaker, have filed the lawsuits taking either a blanket approach to vacate the entire set of deeming regulations or a more rifle-shot approach to overturn just specific rules.

Four of the lawsuits have been filed by companies or trade associations in the vapor segment.  Besides Nicopure Labs, the other three vapor-related suits were filed by Lost Art Liquids LLC, three vapor shops in Alabama and 11 vapor trade organizations.

Some of the similar claims made in these four lawsuits include the improper regulation of vapor products, which do not contain tobacco; the failure of the FDA to consider the impact of the deeming regulations on small businesses (as required by the Federal Regulatory Flexibility Act); the FDA’s fiscal analysis of the deeming regulations does not quantify the costs on small businesses nor consider alternatives to the new regulations; and the FDA overstates the benefits of the deeming regulations and grossly underestimates the costs of compliance leading to an erroneous conclusion that the benefits of the deeming regulations outweigh the costs. 

A federal court judge in the Federal District Court for the District of Columbia is consolidating the Nicopure Labs lawsuit and the suit filed by the 11 vapor trade groups because the claims are very similar. A federal court hearing on these two lawsuits has been scheduled for Oct. 19.

John Middleton Co. LLC has filed a lawsuit claiming the FDA is improperly applying the ban on product descriptor words such as “mild” when applied to the company’s Black & Mild trademark. In the complaint, John Middleton Co. advances a number of claims, including:

  • That the FDA’s misapplication of the ban on the descriptor “mild” in labeling and advertising for cigars and pipe tobacco, the prohibition exceeds the FDA’s authority because the agency did not take into account whether the use of the word “mild” in the Black & Mild trademark name conveyed a modified-risk/lower-harm claim.
  • That prohibiting the word “mild” in labeling and advertising for cigars and pipe tobacco without regard to whether the word conveys a modified-risk claim is unconstitutional.
  • That prohibiting the use of the word “mild” constitutes a taking of John Middleton Co.’s Black & Mild trademark property without just compensation.

There are two premium cigar lawsuits pending: one brought on by Global Premium Cigars LLC, which is seeking to set aside the entire set of deeming regulations, and the other by three premium cigar-related trade associations, which claims the premium cigar provisions and pipe tobacco rules should be overturned. The lawsuits focus on the FDA’s decision to apply the Feb. 15, 2007, grandfather date to cigars and pipe tobacco, an improper cost/benefit analysis related to the costs of complying with the deeming regulations vs. the benefits of the regulations, and the unjustified decision to require warning labels on 30% of the primary panels of a cigar box.

The eighth lawsuit was filed by West Virginia state legislator Larry Faircloth who claims that his use of nicotine vapor products allowed him to quit smoking and that the deeming regulations would likely cause him to return to using traditional tobacco products.

With the impact of the deeming regulations on the tobacco industry so significant, and the deeming regulations scheduled to go into effect on Aug. 8, the determination of whether all or just portions of the deeming regulations will be administered and enforced now lies with the courts.