5 Lawsuits Challenging the FDA's Tobacco ‘Deeming’ Regulations
By Melissa Vonder Haar on Jul. 08, 2016Since the U.S. Food and Drug Administration (FDA) announced its final “deeming” regulations over cigars, electronic cigarettes, pipe and hookah tobacco on May 5, numerous lawsuits have been filed challenging various aspects of the law. According to NATO, 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 suits were filed.
Here’s a look at the lawsuits that have been filed to date:
Nicopure Labs LLC (filed May 10)
The Claims:
- 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 because of the extraordinary burden on manufacturers to file premarket tobacco applications (PMTAs), 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.
- 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.
Seeking:Nicopure Labs has asked the U.S. Federal District for the District of Columbia to vacate and set aside the FDA deeming regulations and to issue a preliminary injunction preventing the FDA from enforcing the deeming regulations.
Lost Art Liquids LLC (filed May 19)
The Claims:
- 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.
- The deeming regulations violate the protection of free commercial speech afforded by the First Amendment.
Seeking:Lost Art Liquids asked the U.S. District Court for the Central District of California to overturn the entire set of deeming regulations.
John Middleton Co. LLC (filed May 26)
The Claims:
- 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.
- The deeming regulations impermissibly restricts protected commercial speech (e.g., labeling and advertising) under the First Amendment 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.
- 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.
Seeking:John Middleton asked the U.S. District Court for the District of Columbia 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.
Global Premium Cigars LLC (filed June 1)
The Claims:
- The deeming regulations violate the First Amendment of the U.S. Constitution by requiring warning labels on cigar boxes hindering the manufacturer’s ability to communicate to the public about the product and by limiting commercial speech (e.g., advertising) since new products to be introduced after Aug. 8 would first need FDA approval.
- The deeming regulations violate the Fifth Amendment of the U.S. Constitution because the federal government would be taking property (space on cigar boxes for warning labels) without justly compensating the plaintiffs.
- The deeming regulations violate the Federal Administrative Procedures Act by substantially underestimating the cost for premarket tobacco applications leading to an erroneous conclusion that the benefits of the deeming regulations outweigh the costs.
Seeking: Global Premium Cigars and its owner, Enrique Fernando Sanchez Icaza, asked the U.S. District Court for the Southern District of Florida to set aside the entire set of deeming regulations.
Right to be Smoke-Free Coalition (filed June 20)
The Claims:
- The FDA violated the Federal Administrative Procedures Act (APA) by not establishing a new grandfather or predicate date for electronic cigarettes and vapor products and not exercising the agency’s flexible enforcement authority for these new products.
- The FDA should have exercised its enforcement authority to treat vapor products differently than combustible cigarettes. By not doing so, the FDA will prevent newer and safer products from entering the marketplace.
- The ban on free samples of vapor products violates the First Amendment, which protects commercial free speech.
- The FDA does not provide any rationale in the deeming regulations for subjecting vaping equipment (including the device, batteries, software and tanks) to the deeming regulations as a component or part of a tobacco product.
- The FDA failed to comply with the Federal Regulatory Flexibility Act, which requires agencies to consider significant alternatives to the proposed regulations in order to minimize the economic impact on small business and therefore cannot claim that the benefits of the deeming regulations outweigh the costs.
Seeking: The Right to be Smoke-Free Coalition (representing 10 other advocacy groups) asked the U.S. District Court for the District of Columbia to set aside and remand or, alternatively, return the deeming regulations to the FDA to be rewritten in order to comply with the First Amendment, the Administrative Procedures Act and the Regulatory Flexibility Act.