Source: Mikhail Reshetnikov
According to a report from Vaped360, the US Court of Appeals has rejected Gripum's application for review of the FDA's Marketing Denial Order (MDO) to the Illinois-based e-liquid manufacturer.
In September 2020, Gripum submitted pre-market tobacco product applications (PMTA) for approximately 200 bottled electronic liquid products with non-tobacco flavors. The company received a marketing denial order (MDO) in September 2021. In October 2021, Gripum submitted a review application and was granted a pause on FDA enforcement in November 2021. On April 20, the company had a verbal argument in court.
Gripum believes that the FDA and Congress' release of the MDO is unfair because there are no "definable standards" in place to determine if the company's products are "suitable for protecting public health." The company claims that after the application deadline passed, the organization changed the evidence standards required for a successful PMTA, and did not conduct personalized PMTA reviews as required by the Tobacco Control Act.
The Seventh Circuit Court of Appeals has rejected all of Gripum's arguments, finding that the FDA's approach to the application was both reasonable and consistent with the Tobacco Control Act.
The failure of Gripum followed after six e-cigarette companies successfully challenged the MDO. On August 23rd, the US Eleventh Circuit Court of Appeals approved the petition for rehearing submitted by Bidi Vapor, Diamond Vapor and four other companies, questioning the FDA's denial of their e-cigarette applications.
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