The American e-Cigarette Association sued the FDA over PMTA’s impact on small businesses
The Electronic Cigarette Association (USVA) is suing the Food and Drug Administration over its handling of the Application for Pre-Sale Tobacco Products (PMTA) and its impact on small businesses, according to foreign news reports.
The lawsuit by USAVA, a trade association representing small businesses, alleges that the FDA failed to properly consider the impact of the seemingly impossible and expensive PMTA process on small businesses.
In the presumption rule, the FDA spoke as if the steam applicant would be able to rely sufficiently on public data, or FDA’s own 70 studies being conducted at the time, the USVA wrote in a statement. Finally, the FDA created a burdensome PMTA rule that put a lot of people in the industry out of business. In fact, however, the FDA claims there will be no significant impact on small businesses.
The lawsuit seeks relief for businesses that are members of the USVA, including:
Declared the PMTA final rule a violation of 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 from taking necessary and appropriate actions to correct their violations resulting from any such actual or attempted enforcement.
The lawsuit also criticizes the FDA for giving preference to manufacturers with the largest market shares, which are well-funded to handle the PMTA process. Some larger companies were also allowed to change their PMTA submission questions, while smaller companies with the same questions received marketing denial orders for these issues.

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