The U.S. Vaping Association (USVA) is suing the U.S. Food and Drug Administration over its handling of premarket tobacco product applications (PMTAs) and its impact on small businesses.

The USAVA lawsuit, a trade association representing small businesses, says the FDA failed to properly consider the impact of the seemingly impossible and expensive PMTA process on small businesses.

The USVA wrote in a statement: "In the presumptive rule, the FDA said as if vaping applicants would be able to fully rely on public data, or the FDA's own 70 studies that were underway at the time. In the end, the FDA instituted a onerous PMTA rule that put a lot of people in the industry out of business. However, in fact the FDA claims that there will be no significant impact on small businesses.

The lawsuit seeks relief for businesses that are members of the USVA, including:

Declared that the PMTA final rule violated the Regulatory Flexibility Act;

Return the PMTA final rule to FDA; and

FDA is prohibited from enforcing the PMTA Final Rule against any member of the USVA and taking necessary and appropriate action to correct their violations resulting from any such actual or attempted enforcement.

The lawsuit also criticizes the FDA for prioritizing manufacturers with the largest market share, which are well-funded in handling the PMTA process. Some larger companies were also allowed to change their PMTA submissions, while smaller companies with the same issues received marketing denials for those issues.

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