3 Lawsuits Filed Against FDA ‘Deeming’ Regulations

Tobacco manufacturers seek to overturn entire set of new rules

MINNEAPOLIS -- In the three weeks since the U.S. Food and Drug Administration (FDA) released the final tobacco deeming regulations to regulate all cigars, pipe tobacco, e-cigarettes, vapor products and hookah tobacco, three lawsuits have been filed seeking to either enjoin and overturn the entire set of deeming regulations or prevent the application of a specific provision to particular tobacco products.

On May 10, 2016, Nicopure Labs LLC filed a lawsuit in the United States Federal District for the District of Columbia seeking to have the court vacate and set aside the FDA deeming regulations and to issue a preliminary injunction preventing the FDA from enforcing the deeming regulations. Nicopure Labs is a manufacturer of closed- and open-system vaping devices and e-liquids with and without nicotine.

In the lawsuit, Nicopure Labs brings four claims against the FDA. They are:

  • The FDA has exceeded its statutory authority because the definition of “tobacco product” and the extension of the agency’s regulatory authority through the deeming regulations is an unreasonable interpretation of the Family Smoking Prevention and Tobacco Control Act;
  • The deeming regulations are arbitrary and capricious (i.e., a clear error in judgment and not based on relevant facts) because of the extraordinary burden on manufacturers to file Pre-Market Tobacco Applications (PMTA), the unreasonable regulation of less harmful vaping devices and e-liquids in comparison with traditional cigarettes, and the frustration of innovation and advancements in public health through vaping devices and e-liquids;
  • The deeming regulations overstate the benefits of the new regulations, fail to quantify the benefits of the new regulations, underestimate the tremendous costs to the industry and erroneously conclude that the regulations outweigh the costs; and
  • The deeming regulations violate the First Amendment (which protects free speech, including commercial speech by companies) by prohibiting manufacturers from making truthful and nonmisleading statements about vaping devices and e-liquids and engaging in the distribution of free samples.

The second lawsuit was filed by John Middleton Co. LLC seeking to set aside and enjoin the enforcement of that provision in the tobacco deeming regulations that prohibits the company from using the word “mild” in its Black & Mild trademark. In the complaint filed in United States District Court for the District of Columbia, John Middleton Co. advances a number of claims, including:

  • That the FDA’s expansion and misapplication of the ban on the use of the descriptor “mild” in labeling and advertising for cigars and pipe tobacco is arbitrary and capricious and in excess of the FDA’s authority because the agency did not take into account whether the use of the word “mild” on John Middleton products conveyed a modified-risk claim;
  • That the deeming regulations impermissibly restricts protected commercial speech (i.e., labeling and advertising) under the First Amendment of the U.S. Constitution by categorically prohibiting the word “mild” in labeling and advertising for cigars and pipe tobacco without regard to whether the word conveys a modified risk claim; and
  • That the deeming regulations constitute a taking of John Middleton Co.’s property without just compensation by prohibiting the use of the company’s Black & Mild trademark.

The third lawsuit was filed by another vapor manufacturer, Lost Art Liquids LLC, which is suing to overturn the entire set of deeming regulations. In its suit filed in the United States District Court for the District of Central California, Lost Art Liquids has several claims, including:

  • That the FDA failed to consider the effect of the deeming regulations on small-business entities;
  • The FDA’s fiscal analysis on the effect of the deeming regulations does not quantify the costs on small-business entities nor investigate or explain alternatives or exemptions for small businesses subject to the new regulations;
  • 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; and
  • That the deeming regulations violate the protection of free commercial speech afforded by the First Amendment.

Under federal district court rules, the FDA has a period of 60 days from the receipt of each lawsuit to file a formal answer or reply to the lawsuit with the U.S. District Court where the lawsuits were filed.

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