WVA Sues FDA for PMTA Impact on Small Business

Credit: Sergin

The United States Vaping Association (USVA) is suing the U.S. Food and Drug Administration for its handling of the premarket tobacco product application (PMTA) and its impact on small businesses.

The USAVA, a trade association that represents the small businesses, suit alleges that the FDA failed to properly consider the impact the “seemingly impossible and expensive” PMTA process would have on small businesses.

“In the deeming rule, the FDA spoke as if vapor applicants would be able to substantially rely on public data, or on 70 studies the FDA itself was conducting at that time,” the USVA wrote in a statement. “In the end, the FDA wrote an impossibly burdensome PMTA rule that is putting a lot of people in this industry out of business. Yet, in fact the FDA claimed that there would be no significant impact on small businesses.”

The lawsuit asks for relief for the businesses that are members of the USVA that includes:

  • Declare the PMTA Final Rule in violation of the Regulatory Flexibility Act; 
  • Remand the PMTA Final Rule to the FDA; and 
  • Enjoin the FDA from enforcing the PMTA Final Rule against any members of the USVA, and to take such actions as are necessary and proper to remedy their violations deriving from any such actual or attempted enforcement.

The suit also criticizes the FDA prioritizing manufacturers with the greatest market share, companies that were more well funded to tackle the PMTA process. Some of the larger companies also were allowed to make changes to issues with their PMTA submissions where smaller companies with the same issues received marketing denial orders for those issues.