WASHINGTON -- Last week, a fifth lawsuit was filed against the U.S. Food and Drug Administration (FDA) over the agency’s “deeming” regulations over cigars, electronic cigarettes, hookah and pipe tobacco. As reported in a NATO News Bulletin, 11 vaping organizations and trade associations are listed as plaintiffs in the suit, marking the largest lawsuit over deeming to date.
Filed in the U.S. District Court for the District of Columbia, the suit makes numerous claims, including:
- 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.
The Winston-Salem Journal reports the Right to be Smoke-Free Coalition (representing 10 other advocacy groups) filed the suit.
“Plaintiffs are fully committed to the safety of electronic nicotine delivery systems, from manufacturing through distribution, and recognize the need for reasonable regulation at the federal level,” the coalition said in the complaint. “FDA substantially overestimates the benefits of the deeming rule and underestimates its costs.”
As such, the plaintiffs requested that the U.S. Federal District Court for the District of Columbia 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.