On September 2, according to foreign reports, Stephanie Roselle, an editorial writer for "Tobacco Reporter", wrote that the US Food and Drug Administration's marketing denial order for Juul may be a political decision.

The following is the full text:

Long-standing criticism of the FDA's handling of premarket tobacco product applications (PMTAs) finally caused a public outcry in June.

“The whole regulatory process is now surreal,” wrote independent public health and sustainability advocate Clive Bates on his blog The Counterfactual.

Bates was referring to the agency's June 23 Marketing Denial Order (MDO) for all Juul Labs products currently sold in the U.S., comparing it to the FDA's previous marketing authorization for 22nd Century's low-nicotine combustible cigarettes.

"No one can make a vaping product as toxic as a cigarette, but guess which one got the green light," Bates said.

In its press release, the FDA said Juul's application lacked sufficient evidence about the product's toxicological profile to justify the product's marketing as appropriate to protect public health.

In particular, some of the company's findings have raised concerns due to insufficient and conflicting data, the agency said.

According to the FDA, the issue of genotoxic and potentially harmful chemicals leached from Juul's proprietary e-liquid pods was not adequately addressed in the application, so the agency was unable to complete a full toxicological risk assessment of the product.

However, the agency acknowledged that, to date, it has received no clinical information indicating immediate harm associated with the use of Juul devices or Juul pods.

Another reason for MDO is the inability to know whether other authorized or unauthorized third-party e-liquid pods are used with Juul devices or Juul pods with non-Juul devices, the FDA wrote in a statement.

Michel Mital, acting director of the FDA's Center for Tobacco Products, said the agency's mandate is to ensure that tobacco products sold in the U.S. meet standards set by law, but the onus is on manufacturers to demonstrate that products meet those standards. .

“Like all manufacturers, Juul has the opportunity to provide evidence that its products are marketed to these standards,” she said. "However, instead of providing this evidence, the company leaves us with significant questions."

A day later, Juul Labs petitioned the U.S. Court of Appeals for the Washington, D.C. Circuit to urgently suspend the FDA's order to give a judge time to assess the merits of Juul's appeal.

In its court filing challenging the FDA's ruling, the company called the FDA's order extraordinary, discriminatory and illegal, and said it would suffer significant irreparable harm if it wasn't suspended.

Juul Labs claims the agency ignored more than 6,000 pages of data from the app that users inhaled aerosols.

The company, arguing that it has helped 2 million adult smokers quit traditional cigarettes, also said the FDA's decision was influenced by political pressure -- the company said in its filing that members of Congress sent letters and hearings to the FDA officials pressured them to make promises that Juul products would not be authorized.

Additionally, the manufacturer questioned the agency's handling of the MDO announcement, which was leaked to the media before it was officially announced.

On July 5, the FDA backed down and temporarily halted the ban on Juul Labs products, while the manufacturer appealed the agency's decision.

The agency said it has determined that the Juul app has unique scientific issues that warrant additional scrutiny.

The FDA emphasized that its suspension does not mean withdrawing the MDO. While the suspension technically does not allow Juul to continue selling its products, the FDA later made clear for the first time that it did not intend to take enforcement action against MDO-bound Juul products.

Pulling Juul products from the U.S. market would have far-reaching consequences. The company has experienced a fairytale rise from a small business to the U.S. e-cigarette market leader.

It is said to have reinvigorated the stagnant U.S. e-cigarette market and became so popular that the term Juuling has become almost synonymous with vaping.

With a sleek design and a nicotine salt-based cartridge system, Juul products are easy to use and can satisfy a smoker's previous nicotine craving for cigarettes.

At the peak of its success, Juul Labs accounted for more than 80 percent of U.S. nicotine e-cigarette sales. In 2018, it sold a 35% stake to Altria. If its products were to be withdrawn from the market, smokers and e-cigarette users looking to switch would be left with a handful of FDA-approved but apparently less popular products.

Financial services firm Morgan Stanley wrote in a letter to investors that Juul MDO will create opportunities for other low-risk products already approved by PMTA, most notably BAT, which recently replaced Juul as U.S. The leading e-cigarette manufacturer has a market share of over 33% brands.

In recent months, the FDA has authorized several vaping products for sale in the U.S. market, including Njoy and Logic.

While tobacco control activists welcomed the FDA's decision, e-cigarette advocates were alarmed, and the events following the MDO sparked a lot of speculation.

According to critics, the agency treated Juul's application very differently from those submitted by rival e-cigarette companies. As per normal process, FDA should seek answers to material questions about Juul's application through a letter of defect.

Instead, the FDA simply banned Juul's products. Also, the agency did not withdraw its MDO for Juul, as other companies have done after acknowledging potential mistakes. Additionally, the FDA holds Juul accountable for third-party or counterfeit Juul products in its MDO—a task that falls under the regulatory agency.

"It appears the FDA is looking for an excuse to reject Juul products, the best they can come up with," Bates wrote.

MDO seems designed to punish Juul for past mistakes. When the company entered the U.S. market in 2015, its early ad campaigns were heavily criticized for targeting young people.

Critics see the company as a single-shot behind the teen vaping epidemic. By the time Altria bought a stake in Juul, the e-cigarette maker was facing a slew of lawsuits. Cities, counties, school districts and states have filed roughly 2,000 lawsuits against the company, alleging that Juul knowingly allowed teens to indulge in its products, which contained high-nicotine capsules.

Although teen e-cigarette use among never-smoking teens has been declining since 2019, and teen vaping has shifted to other primarily disposable products such as the Puff Bar, Juul Labs continues to take responsibility for teen vaping in the popular imagination.

Over the past few years, the company has gone to great lengths to please anti-vaping advocates — which, according to critics, may have been wrong. Rather than challenge misinformation spread by rivals, Juul pulled its flavored pods from the market before the law required it.

While the MDO's decision surprised many, the subsequent FDA administrative stay made the story even more curious. Almost immediately questioning the decision that took the FDA two years to make is bizarre at best. Experts believe the FDA realized its arguments were weak to withstand legal challenges. The retraction leaves the agency with two options: issue a new, revised MDO or admit its mistakes, issue a full retraction, and have Juul reopen for scientific review.

In an interview with Filter, Bates said the PMTA process is vulnerable to abuse because the agency can set arbitrary standards for what it deems acceptable.

In mid-July, the American Vapor Manufacturers Association (AVMA) asked the U.S. Department of Health and Human Services Inspector General to investigate whether the FDA's MDO was motivated by political pressure.

AVMA President Amanda Wheeler wrote: Manufacturers typically meet PMTA requirements to scientifically demonstrate how their products are suitable for use in protecting public health. Despite compliance, the agency does not approve vaping products sought by adults who want to quit smoking. The Office of the Inspector General should leave the door open to hold FDA accountable for its standards.

The FDA has faced increasing public and congressional scrutiny in recent months, not only over its regulation of new nicotine products, but also over its role in infant formula shortages.

On July 19, FDA Commissioner Robert Califf announced an external review of the agency's Office of Food Safety and Tobacco Regulation.

The agency has tasked the Reagan-Udall Foundation with evaluating the resources, procedures and organization of the Office of Food and Tobacco and the Office of Regulatory Affairs (the department responsible for inspections). Whether the measure will improve Juul's odds remains to be seen. The initial evaluation of the review process is scheduled to be completed within 60 days.