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More than a year ago, the FDA unveiled a comprehensive policy to reduce deaths and illnesses caused by smoking. Smoking remains the leading cause of preventable death in America, killing nearly half a million people a year. If we do not succeed in reducing the rate of tobacco addiction more quickly, we will continue to see this unnecessary death and illness. The FDA's new legal authorities to regulate tobacco – as part of the Tobacco Control Act – have allowed us to change this trajectory.
We have seen an opening to push a generation change in the lethal course caused by tobacco. And we grabbed it.
Our global tobacco control plan against smoking has been based on a principle of central animation. What primarily causes death and illness through the use of tobacco, it is not the nicotine in these products. It is the burning of tobacco on fire to release this drug for inhalation.
Although nicotine addiction encourages people to smoke, it is primarily combustion, which releases thousands of harmful constituents to dangerous levels, killing people.
This is both the biggest challenge to reducing cigarette dependence – and also an opportunity that is a central building block for our actions.
E-cigarettes may be an important opportunity for adult smokers to dispense with fuel tobacco products and nicotine delivery products that do not necessarily pose the same risks. So we started a new regulatory process to regulate nicotine levels in fuel cigarettes to make them less or less addictive. This process is on track.
And at the same time, we are developing a pathway to properly regulate non-combustible forms of nicotine, such as electronic cigarettes, which could be an alternative for adults who still want access to satisfactory levels of nicotine without all the risks. associated with the ignition of tobacco on fire.
We saw an important opportunity. We have seen a chance to take advantage of the potential benefits of a new and noncombustible technology to allow more adults to consume nicotine from sources that could pose far fewer problems than smoking cigarettes. . We continue to believe in this central concept.
But let me clarify that nicotine is not a benign substance. This is especially true with regard to children and the effects of nicotine on a developing brain. That's why we need a rigorous regulatory process that places these new products in an appropriate set of regulatory barriers.
We need a regulatory process that requires product applications to show that marketing the product is appropriate for the protection of the health of the entire population. And we need a regulatory process that keeps these same electronic cigarette products out of the reach of young people.
This is our current policy framework to fulfill a central premise of our public health mandate.
We must ensure that we properly evaluate the net public health impact of products such as e-cigarettes prior to obtaining the FDA's marketing authorization and that these products fulfill their regulatory responsibilities. Such products may still pose health risks, possibly including the release of some chemicals at higher levels than conventional cigarettes, and these potential risks require further investigation.
But since nicotine electronic delivery products had only recently been subject to FDA regulation, few basic rules and guidance documents defining and clarifying the pre-market approval process for these products had been issued. established months ago. Thus, to create this regulatory framework on how to properly evaluate electronic nicotine delivery products, we are committed to developing guidelines and regulations, including product standards, that will set the rules of the road. And we are making significant progress in achieving these procedural goals.
If we succeed in our overall plan, the impact on public health can overshadow everything we are able to accomplish in a reasonable amount of time. This can hinder the introduction of any new medical technology. The analysis shows that our plan has the potential to reduce smoking rates from currently 15% to 1.4%. This can prevent more than 33 million people – including children – from becoming smokers; avoiding a large part of the deaths and illnesses caused by cigarettes. Despite our progress and these parameters, we are at a very difficult turning point in the execution of this plan.
This is because we have not foreseen the magnitude of what has become one of our biggest challenges. We have not anticipated what I consider to be an epidemic of electronic cigarette consumption among teenagers. Today, we can see that this epidemic of addiction appeared when we announced our plan last summer. The setback and the data we have now reveal these trends. And the impact is clearly evident to the FDA.
Unfortunately, I have good reason to believe that it has reached a proportion of epidemic growth.
I use the word epidemic with great care. Electronic cigarettes have become an almost ubiquitous – and dangerous – trend among teenagers. The worrying and accelerated use trajectory we see in young people and the path to addiction must stop. It's just not tolerable. I'll be clear The FDA will not allow a generation of young people to become nicotine addicted to allow adults to have unlimited access to these same products.
This fundamental commitment is why the FDA launched its youth smoking prevention plan earlier this year.
The plan included a series of measures to stop the use of tobacco products by young people, particularly the increasing use of electronic cigarettes. Our youth smoking prevention plan focuses on three key strategies. First, prevent youth access to tobacco products. Second, limit the marketing of youth tobacco products. And finally, educate adolescents about the dangers of using tobacco products.
Recognizing that our most immediate tool for dealing with youth use is law enforcement, this is the cornerstone of our approach. And we continue to deploy this tool, with increasing vigor, to directly address this challenge.
We have taken a series of compliance measures over the past year. In partnership with the Federal Trade Commission, we have targeted mislabelled or mislabelled e-liquids that look like child-friendly foods, such as juice boxes, candies and cookies. Since then, manufacturers, distributors and retailers warned by the FDA have stopped selling products bearing the labeling and advertising complained of. And, today, the FDA has issued 12 warning letters to other companies that continue to advertise and sell non-compliant products. This includes several companies also cited by the FDA for illegally selling the products to children.
We have also significantly strengthened our enforcement against retailers who illegally sell electronic cigarettes to children.
This spring, we focused our efforts on JUUL sales, issuing 56 warning letters and six civil monetary penalties to retailers. And today, we announce that we are taking further important enforcement and compliance measures.
We announce the largest ever coordinated initiative against illicit sales in the history of the FDA. This is the most important crackdown in the agency's history. It targets retail and online sales of electronic cigarettes to minors.
We sent more than 1,100 warning letters to stores for the illegal sale of electronic cigarettes to minors. In addition, we issued 131 pecuniary penalties against stores that continued to violate restrictions on sales to minors.
But we must do more to stem what I consider to be an epidemic of electronic cigarette use among adolescents, and deeply disturbing trends that show no sign of slowing down. As a result, we will review the compliance policy we announced last summer to extend application compliance periods for certain deemed products, including e-cigarettes released on August 8, 2016. Under the current policy, the date Compliance for the filing of applications for such products has been extended until August 8, 2022.
We exercised this discretion for finished products because, in the regulatory framework on tobacco and nicotine that we developed, which includes doors – and for businesses to prepare quality applications for new products like cigarettes e. This is where electronic cigarettes and other non-combustible products come in. Before implementing the requirements of the application, we wanted to make sure that there was a clear and viable way to get the # 1 39; FDA authorization to market alternative products for adult smokers who still wanted access to nicotine.
However, given the accelerating use of youth, we are actively examining the applicability of the pre-market review provision, although it is clear that these products are now widely used. by the young people.
One factor we are looking at closely is the availability of characteristic flavors. We know that flavors play an important role in the appeal of young people. And given current trends, we could take steps to limit the marketing and sale of flavored products. We are now actively evaluating how we implement such a policy.
I spent a lot of time figuring out whether we could have made different choices last summer to reduce or avoid the epidemic of youth use, which I believe is before us. As guardians of public health, this is an important question we must ask ourselves when we are looking at what to do at this difficult juncture.
For example, what happens if we have not extended the compliance dates for e-cig applications in the marketplace when the rule of presumption came into effect? In fact, most of these requests would not have been submitted until last month. And the e-cigs would have remained on the market for at least another year while we were reviewing them. So the products would still be on the market and we might have had the disturbing trends in 2018.
When we implemented this comprehensive plan, we also knew that we did not have all the regulations and guidelines we needed to more clearly define the application path for these non-fuel solutions. Although the law requires manufacturers to demonstrate by scientific evidence that public health standards are being met, we have also realized that many manufacturers are new to regulation. And many new products were already on the market. Given the circumstances, we felt it was important to have clear, transparent and predictable rules of conduct for the industry. For these reasons, we wanted to give the e-cig industry the time to come into compliance, while drafting guidelines and regulations to better define and explain how new products would meet these requirements. It was a good governance exercise that was put in place to take into account the continued availability of innovations that we believe have potential value.
But our public health mandate to prevent substance abuse among young people has forced us to revisit this element of our overall plan.
The legal standard governing the pre-market review of a new tobacco product by the FDA is to determine whether the product would be appropriate for the protection of public health. We need to determine if these products encourage children to nicotine. It's so simple. And we are taking aggressive action today to fix it.
This can create barriers for some adults who also like e-cigs. These are the difficult compromises we face. But the risk of young people is paramount.
It is now clear to me that by closing the children's access ramp, we will have to reduce the exit ramp for adults who want to leave fuel tobacco and electronic cigarettes.
It's not our only choice.
I have warned the electronic cigarette industry for over a year that they need to do a lot more to stop the trends of young people. In my opinion, they treated these issues as a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products. And the risks mounted.
Well, I'm here to tell them that this prerequisite is over. The FDA is closely monitoring trends in youth use. And if, as one might expect, the preliminary data in our possession, which will be finalized and published in the months to come, confirm our current observations that the use of e-cigs by young people is increasing very strongly; we will quickly change course.
Meanwhile, the FDA is announcing a series of more and more actions to aggressively tackle youth use trends.
It begins with the steps we are taking today, with the announcement of the largest coordinated effort in tobacco control in the history of the FDA.
In addition, as I noted, we are seriously reviewing our compliance dates for submitting product applications when it is evident that they are widely used by young people. We are particularly focused on flavored electronic cigarettes. And we are seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.
Today, we sent letters to five manufacturers of electronic cigarettes whose products were sold to children during the blitz and who, collectively, represent more than 97% of the current e-cigarette market – JUUL, Vuse , MarkTen, blu e-cigs. and logic. These marks will be the starting point of our attention in the protection of children.
They are now informed by the FDA of how their products are being used by young people at disturbing rates.
Given the scale of the problem, we are asking manufacturers of these brands and products to return within 60 days to the FDA with strong plans to convincingly resolve the widespread use of their products by minors. review the exercise of the FDA's discretion in terms of performance for products currently on the market.
Let me be clear. This may require these brands to review their sales and marketing practices, including online sales. stop distributing their products to retailers selling to children; and remove some or all of their flavored e-cig products from the market until they obtain pre-market approval and otherwise meet the applicable requirements.
In the meantime, we will review their marketing and sales practices, including field inspections. The FDA will continue to work to find out why so many kids are using and abusing these products.
And we will not stop there.
We are also reviewing the discretion we currently apply to other e-cigs currently on the market without authorization. Today's letters focus on the top five manufacturers of e-cigs, including those whose products were purchased by children during our blitz. But policy reviews apply to the entire category.
By doing this, we consider how different products are used by children. The greatest use by youth seems to be that of cartridge-based electronic cigarettes, not open-tank vaping products. We are therefore studying strategic options that could allow us to adjust the measures we take to take into account the different ways of using products between children and adults. We focus on products that are misused by minors.
We will also permanently strengthen our enforcement actions through a sustained campaign of monitoring, penalizing and preventing sales of cig to minors in convenience stores and other retail locations. Clearly, there is a need for the federal government to strictly enforce the restrictions on youth access.
We will continue to hold retailers to account by vigorously enforcing the law with the help of our government partners. E-cigs manufacturers should follow. They must also make sure that their online sales are not part of the problem.
Although today's action includes warning letters for online sales, as a continuation of our retail campaign, we are looking closely at the manufacturer's own online stores and distribution practices. We will examine whether websites are used to buy straw for the purpose of redistributing it to minors. If young adults go online and buy 100 units of a product for sale to teens, this activity should be easy to identify for a product manufacturer, and the FDA will consider what steps we can take in these circumstances.
Let's be clear: everything is on the table. This includes the resources of our tools of civil and criminal repression.
If companies do not know or do not want to know that straw purchases are taking place, we will now help them identify them. If illegal activities are discovered, the FDA has both civil and criminal remedies.
We are also investigating whether manufacturers of certain e-cig products can be applied to market new products without pre-market approval that were introduced after the FDA compliance date.
And next week, we're also announcing a national campaign to warn teens about the dangers of nicotine and the use of e-cigarettes. This public campaign will bring these public health messages to online sites that teenagers have access to, and even in the bathrooms of high schools.
I challenge e-cigs manufacturers to take equally bold steps to reform their own practices. There was some historical advertising I saw, particularly on social media, which makes me wonder how some of these companies have made sure that kids do not use their products.
As I indicated above, we will also take steps beyond compliance and enforcement. We plan to update our recommendations describing the pre-market application process for tobacco products, as well as the evidence that we expect to see manufacturers file these applications. We think there is no excuse for manufacturers not filing an application with the FDA because the agency did not tell them what they were supposed to do. If a manufacturer wants direct and specific advice on a specific product application, call us. Request a meeting Our door is open. And our policy is to grant pre-submission meetings to help manufacturers understand our expectations.
The staff of our Tobacco Products Center is also working on a comprehensive policy roadmap to address these trends, while staying true to the goals of our global plan announced last summer and the public health goals that drive it. our work every day. They will provide me with a strengthened approach, building on our Youth Smoking Prevention Plan, to deal with the increasing use of e-cigs by minors. I will communicate the additional decisions we make together as an agency in a timely manner.
The steps I am announcing today are the first elements of these new efforts to which we are immediately committed. I believe there is an epidemic of youth use. We have good reason to draw this conclusion from the trends and data we have seen, some of which are still preliminary and will be finalized in the coming months and presented publicly. But our actions today are firmly rooted in what we have learned. Do not be mistaken about the risks.
At the FDA, we still believe that new innovations that do not use combustion, such as electronic cigarettes, offer adults an important opportunity to get out of fuel tobacco. I still believe in this opportunity. I still believe in the concept of modified risk products. I continue to believe that tobacco products are subject to a continuum of risk and that there are opportunities to move adult smokers on this scale. The management of the FDA Tobacco Center still firmly believes in this concept.
And we are all committed to helping reduce the overall risk burden for our country.
We are committed to reducing risk.
We are committed to saving lives. And we are committed to changing the trajectory of death and tobacco disease.
We started tackling these trends from the start with the global tobacco policy that we announced last summer. We intensified these efforts with the announcement of our youth smoking prevention plan last spring. And today, we are taking a new turn in our efforts as youth trends get worse. We will look at this growing dependence of young people. We must succeed. But we are not the only party to this problem.
The industry must take up this challenge. The companies that sell the brands that have generated the most illegal sales during our enforcement campaign have 60 days to respond with aggressive plans or face regulatory consequences.
They say they have changed since the days of Joe Camel. But look what's happening right now, on our watch and on their watch. They must demonstrate that they are truly committed to keeping these new products out of the reach of children and that they must find a way to reverse this trend.
I believe in the power of American ingenuity to solve many problems, including this one. I am deeply troubled by the trends I have seen. I am troubled by a nicotine epidemic among teenagers. So, we are at a crossroads today. This is an area where the opportunities offered by new innovations will be responsibly grasped at this time, or even lost forever.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of drugs, vaccines and other biological products for human and human use. The agency is also responsible for the security of our country's food supply, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
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