New Consumer Report, July 15 news, CNN today wrote an article about the current U.S. views and debates on the e-cigarette industry, especially the FDA-related policies that will release PMTA results before September 9. The following is the full text:

Before the new crown pandemic, e-cigarettes were a critical public health crisis in the United States, and then we stopped talking about it.

Electronic cigarettes are ubiquitous in high schools across the country, causing dozens of teenagers to become addicted to nicotine. Although industry leader JUUL Labs denies that this is its intention, the company remains a leader in the heated debate.

In recent years, JUUL, which once occupied most of the U.S. e-cigarette market share, has been involved in a large number of lawsuits and investigations about the attractiveness of its products to children. The company said it is constantly working to reset the company, will continue to combat the use of minors, and provide adult smokers with opportunities to reduce harm.

But Juul's products are just a small part of the millions of products currently on the fringe of regulation by the US Food and Drug Administration. This fall may make decisions that some experts say should have been made long ago. What happened next has been allowed to be sold on the market for many years, although the FDA has not formally approved e-cigarette products. But the critical deadline is coming.

Previously, a court decision in July 2019 stipulated that e-cigarette companies had a 10-month period to apply for public health review with the FDA. Any product that misses the application deadline in May 2020 may be withdrawn from the market by the FDA, and those products that do apply may remain on the market for up to one year during the review period.

Then there is the impact of the new crown — extending the deadline by four months to September 9, 2020. "Nine months have passed since the September 2020 deadline, and we have received thousands of submissions of millions of new tobacco products." Acting Director of the FDA, Dr. Janet Woodcock, said at the end of June. Said in congressional testimony.

At present, more than 550 companies have submitted more than 6.5 million tobacco products to the FDA, of which only a small part are related to e-cigarettes. Juul only submitted applications for five of these products.

According to Woodcock, most products in the regulatory pathway are called PMTA-or pre-sale tobacco product applications-and are evaluated in a random order, using computers to rank candidates. But in this case, because there are so many products in preparation, the FDA has opened up a separate queue for those products that account for the vast majority of the current market. An FDA spokesperson told CNN in an email that the agency is working to review the application as soon as possible. However, given the unprecedented number of applications... It is unlikely that the FDA will review all applications by September 9, 2021.

That being said, as with all unauthorized products, if the products are not authorized before September 9, 2021 and are not removed from the market at that time, they will face the risk of FDA enforcement. "

According to Matthew L. Miles, chairman of the Tobacco Free Kids Campaign, unlike some product reviews, the only data is from research trials, in which case there is a lot of real-world experience.

Myers called for greater transparency in the authorization process, and believes that FDA's actions on e-cigarettes will define FDA's views in the long term.

Prior to the announcement of these decisions, health and industry advocates were closely watching market leaders such as Juul as potential harbingers of the future.

Gregory Conley, president of the American Electronic Cigarette Association, said: The agency's views on Juul's menthol taste, nicotine content, and strict marketing controls are definitely things that other industries will pay attention to. After a long period of relative calm, things really started to heat up," said Dr. Robert Jackler, the founder of Stanford's Tobacco Advertising Impact Research.

For Juul, this is not just waiting for the FDA's decision, but also resolving a series of lawsuits against the company. First, Juul recently agreed to pay $40 million to settle a two-year lawsuit with North Carolina—the first state lawsuit accusing it of marketing to teenagers. The company stated that the settlement is consistent with its reset goal-which can be traced back to the end of 2019 after the leadership change. Under the leadership of the new CEO KC Crosthwaite, Juul has taken a series of actions, including removing seasoning products from the market and reducing its advertising and lobbying efforts.

Crosthwaite is a former executive of Altria, a tobacco company, which bought a 35% stake in Juul at the end of 2018, valued at $12.8 billion.

In an email to CNN, a spokesperson for Juul described more broadly the company's cooperation with officials to achieve its goals of keeping adult smokers away from cigarettes, eliminating cigarette use, and discouraging the use of cigarettes by minors. Reset the steam category more broadly in the United States.

In an earlier statement, Juul said that the North Carolina settlement was another step in this direction.

Jackler said that the settlement agreement will be paid within six years and may not cause a huge financial blow to a large company, but its impact may be much broader.

I think Juul chose to compromise instead of risking a jury in the heart of the tobacco country, which is very enlightening," he said.

Jackler recalled the 1990s, when Mississippi became the first state in a series of states to file a lawsuit against a large tobacco company. He described the initial settlement with Mississippi as relatively mild, but it was the first in a series of events. The most notable is the 1998 General Settlement Agreement, which granted more than $200 billion in funding to the states.

How the FDA's potential green light affects ongoing litigation is unclear. Rather, the review depends on a key question: What is the impact of the product on public health?

Ongoing debate

When deciding whether to approve certain e-cigarette products, the FDA must determine their public health value. Are smokers more likely to switch to e-cigarettes than others—especially young people—become obsessed with nicotine?

This is why the agency’s PMTA review not only focuses on the things attached to the product itself—such as ingredients, toxicology, manufacturing, packaging, and labeling—but also focuses on the net impact of individual products on public health at the population level, according to an FDA spokesperson. statement.

For e-cigarettes, this includes considering the smoking situation of young people in our country, the possible benefits of reducing the use of combustible tobacco products by adults, the potential negative health effects of dual use of e-cigarettes and combustible cigarettes, and the possibility of e-cigarettes. Cigarettes may become a gateway product for young people to use combustible cigarettes. The spokesperson added that any decision we saw this fall may not be final.

After obtaining any authorization, if the FDA determines that the product is no longer suitable for protecting public health, the agency has the right to take regulatory action, which may include the cancellation of marketing orders. "

It is estimated that smoking causes more than 480,000 deaths each year in the United States. When allowing e-cigarettes to remain on the market, former FDA Commissioner Dr. Scott Gottlieb once stated that he wanted to open the door to adults who might use these products to quit smoking.

In fact, there is some evidence that adults who smoke e-cigarettes are more likely to quit smoking. Nevertheless, some research results also face the concern of many adults becoming dual users-they will not completely quit smoking, but they may reduce smoking, at least temporarily.

Gottlieb told CNN at the end of 2018 that even considering the potential benefits to some smokers, it cannot come at the cost of making a generation of children addicted to nicotine. From 2019 to 2020, the use of e-cigarettes by young people has dropped significantly, but it is still high.

Last year, nearly 20% of high school students and nearly 5% of middle school students reported that they currently use e-cigarettes-down from 27.5% and 10.5% in 2019. Most young users also report using flavored products.

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