On December 1, according to foreign news reports, the plaintiff in the US lawsuit to change the deadline for submission of pre-market tobacco applications (PMTA) has asked Federal Judge Green to request the FDA to regularly report on its PMTA review process in the case.

An attorney representing the plaintiff wrote a letter to US District Court Judge Paul Green on November 15 asking Green to retry the case so that the plaintiff can move to amend the judge's order. They hope that Green Law Palace will force the FDA to explain its progress in the PMTA submitted by mass market e-cigarette brands.

"Specifically." Attorney Jeffrey Dubner wrote, "The plaintiff will seek amendments and require the FDA to provide the court with periodic status reports and provide the FDA with information on its expected completion of the review of pre-market tobacco product applications. Based on FDA data, JUUL, Vuse, NJOY, Blu, SMOK, suorin and any other top 10 market share brands have submitted all PMTA products (PMTA).”

"The amendment will be in the public interest, because the FDA's periodic report will enable the court to continuously evaluate the extent to which the FDA has extended the illegal supervision period, leading to the continued prevalence of e-cigarette use by young people."

The plaintiffs suing the FDA are the American Academy of Pediatrics (AAP) and its Maryland chapter, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Tobacco Free Children's Campaign and the Truth Initiative.

On July 28, 2017, FDA Commissioner Scott Gottlib announced that the agency will postpone the PMTA deadline from 2018 to 2022. The following year, A, AP and the other plaintiffs listed above sued the agency, claiming that Gottlieb had changed the deadline and failed to pass the usual agency procedures stipulated in the Administrative Procedure Law.

In 2019, Judge Green made a ruling for the plaintiff and gave the manufacturer 10 months to submit the PMTA (the deadline was later postponed to September 8, 2020). It is expected that the FDA will make a decision on most (or at least some) applications within one year, and manufacturers who submit PMTA on time will be given one year to stay on the market without being enforced.

Five months after the submission deadline, the FDA announced that it would prioritize the use of its resources and first complete the evaluation of the most popular products. However, when the one-year review period set by the agency itself arrived, the FDA did not make any decision on the product with the largest market share. Today, nearly three months after its second year of review, the FDA ruled that the only PMTA for e-cigarette products from the mass market-either authorize or reject the absolutely unpopular Vuse Solo.

In addition to asking Judge Green to oversee the progress of the FDA's PMTA review of popular e-cigarette brands, AAP and other plaintiffs complained that the agency did not take any enforcement actions against companies that are still awaiting PMTA's decision. These companies have not been formally extended to remain in the market, nor have they been ordered to withdraw from the market.

The plaintiff’s lawyer wrote: The FDA only issued marketing orders or marketing rejection orders for products with the smallest market share, and would not decide on any mass-marketed e-cigarette products, including those that are most responsible for the popularity of youth e-cigarettes. Second, the FDA does not seem to have implemented the pre-market review requirements for any companies waiting for the PMTA's decision, which indicates that they may have extended a comprehensive extrajudicial exemption for these companies.

The U.S. Food and Drug Administration is mired in legal proceedings that challenged its cookie-cutter PMTA review process, which resulted in the vast majority of small independent e-cigarette manufacturers receiving marketing denial orders (MDOs), and it was forced to cancel some MDOs. , While others were shelved by the Federal Court, while the court reviewed the denial.

It is not clear what Judge Green can or will do, but it is certain that whatever he takes (or does not take) will make someone very unhappy.

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