Vaping organizations and trade associations have filed numerous claims against the FDA’s new tobacco deeming regulations.
After the recent release of the final tobacco deeming regulations from the U.S. Food and Drug Administration (FDA), a great deal of controversy has arisen among vaping organizations and trade associations.
In fact, according to a report from NATO, over the past week, eleven vaping organizations/trade associations filed a lawsuit against the new FDA deeming regulations.
According to the report from NATO, the lawsuit has numerous claims including the following:
- The FDA violated the Federal Administrative Procedures Act by not establishing a new grandfather or predicate date for e-vapor products and not exercising the agency’s flexible enforcement authority for vapor products.
- The FDA should have exercised its enforcement authority to treat vapor products differently than combustible cigarettes, and not doing so prevents newer and safer products from entering the marketplace.
- The ban on free samples of vapor products violates the First Amendment of the U.S. Constitution which protects commercial free speech.
- The FDA does not provide any rationale in the deeming regulations to subject the vaping apparatus, 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.
NATO reported that the plaintiffs are requesting that the U.S. Federal District Court for the District of Columbia set aside and remand or return the deeming regulations to the FDA for proper corrective action and compliance with the First Amendment, the Administrative Procedures Act and the Regulatory Flexibility Act.