The agency's Center for Tobacco Products (CTP) outlined steps it plans to take to further prevent the public health harm vaping causes to young people.

FDA Commissioner Robert Califf said in a statement on February 24:

As we enter this era of declining combustible tobacco use and constant innovation in the vaping industry, social concerns are not subtle. The pace of our ability to keep pace with these changes will depend on the immediate, short-term, and long-term actions the Center is taking that we believe will enable the agency to more successfully implement our regulation of tobacco products.

The FDA identified its pending application review process for vaping products as an area of focus.

"As the agency continues to make progress in reviewing new and pending applications for new products such as e-cigarettes, the FDA will take additional action to remove illicit products from the market -- especially those that made e-cigarettes popular. products. Tobacco products most commonly used by young people,” the statement said.

Marlboro maker Philip Morris (PM) is a growing player in the e-cigarette market.

"Philip Morris is well ahead of its peers in reducing risk products, which the company expects to become a major part of its business by 2025," Barron's said. "They already account for nearly 30% of sales, compared to around 15% for Altria (MO) and British American Tobacco (BTAFF)."

Currently, the CTP is targeting e-cigarette companies whose products lack the required FDA marketing authorization.

"Between January 2021 and February 17, 2023, the FDA has issued more than 550 warning letters to companies requiring them to continue selling vaping products that lack the required FDA marketing authorization," the statement said. "These companies have millions of products on the FDA."

"After receiving warning letters, most of these companies have complied and removed their products from the market. However, if companies fail to do so, FDA can take further enforcement action."

The following is the full statement of FDA Commissioner Robert M. Califf:

Today, FDA's Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external review, an independent review panel I commissioned last year that worked through the Reagan-Udall Foundation. Evaluations are important opportunities to take a critical look at a tobacco program's regulatory processes and operations.

We have made great strides in preventing death and disability from tobacco use, but I firmly believe that we can always benefit from researching how we can most effectively and aggressively protect public health, support our people and respond wherever possible to external stakeholders. When I started my ICU career, the hospital was full of relatively young people dying of sudden smoking deaths, heart attacks, strokes and cancers from smoking. The effectiveness of the public health and medical communities in reducing the loss of tobacco products is enhanced when FDA is granted the authority to regulate tobacco.

As we enter this era of declining combustible tobacco use and constant innovation in the vaping industry, social concerns are not subtle. Our ability to keep up with these changes will depend on the immediate, short-term, and long-term actions the Center is taking that we believe will enable the agency to more successfully implement our regulation of tobacco products.

CTP Director Dr. Brian King, MPH, provided more details on our approach to responding to evaluation recommendations and our new plans, including during that year. CTP has committed to regular updates on the progress of these activities, including some mentioned here.

application review

Especially in the past few years, CTP has made important progress in the review of e-cigarette product applications - authorized a variety of tobacco-flavored e-cigarette products and devices, and rejected millions of marketing applications for products that did not meet the requirements.

Given the evolving tobacco market, it is imperative that we optimize the application review framework to ensure that any product sold meets the law's public health and regulatory standards. This work will include:

Further streamlining the review where appropriate;

Increase the use of tobacco product scientific advisory committees to discuss broader scientific issues critical to premarket evaluation and application of individual products;

Publish current and future science policy memorandums and reviewer guidelines as appropriate;

Work internally and through engagement with external stakeholders to better communicate scientific issues and practices to support efficiency, effectiveness and transparency. These important efforts will be supported by a new director of the CTP Office of Science, who will take up his post in late March.

To achieve these goals, we need to have the resources in place to hire and retain staff with the skills necessary to effectively carry out our public health responsibilities with regard to tobacco. Since the agency's fiscal year 2020 budget request, the FDA has argued for the authority to charge e-cigarette companies user fees that they currently do not pay despite the enormous review and decision-making workload for these products. FDA also continues to explore ways, including working with the U.S. Department of Health and Human Services and the Office of Personnel Management, to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals who meet CTP needs.

Compliance and Enforcement

As the agency continues to make progress in reviewing new and pending applications for new products such as e-cigarettes, the FDA will take additional action to remove illicit products from the market — especially those that have led to e-cigarettes becoming the most common product Tobacco product use among adolescents.

Between January 2021 and February 17, 2023, the FDA has sent more than 550 warning letters to companies to continue selling vaping products that lack the required FDA marketing authorization. These companies have millions of products listed by the FDA. Most of these companies have complied and withdrawn their products from the market after receiving warning letters. However, if the company fails to do so, the FDA can take further enforcement action. For example, the FDA recently worked with the Department of Justice (DOJ) to file its first permanent injunction complaint against six e-cigarette manufacturers.

Additionally, the FDA this week filed its first civil penalty complaint against four tobacco product makers for making and selling new e-liquids without marketing authorization. The agency will continue to remove illegal products from the marketplace as quickly as possible while identifying new ways to enhance compliance and enforcement.

Effective immediately, based on the recommendations of the external review, FDA will begin planning an enforcement-related summit with senior officials from HHS and DOJ. The agency will also continue to work with other government agencies such as U.S. Customs and Border Protection, U.S. Postal Service, Federal Trade Commission, Bureau of Alcohol, Tobacco, Firearms and Explosives, and our compliance and enforcement partners state/local/ Regional/tribal level. This work will maximize compliance and enforcement activities where there is mutual interest. In addition, FDA will explore alternative methods of achieving compliance outside of judicial enforcement actions.

The agency acknowledged that some illicit vaping products continue to be sold in the United States. A number of companies have challenged the agency's marketing denial order in courts across the country. In some cases, this has limited our ability to remove these products from the market while legal cases are pending. It is also important for the public to understand that the agency does not have the authority to independently pursue legal action seeking injunctions or forfeitures against violators.

Instead, the agency must rely on the Department of Justice, which must assess the legal risks of taking a particular enforcement action and decide whether to devote its limited resources to prosecuting on our behalf. The FDA will continue to use all the tools at our disposal to hold companies accountable; however, the agency cannot be everywhere.

transparency and communication

As part of the Center's work, the agency plans to strengthen and increase its public communications to increase transparency about the agency's approach to compliance and enforcement. By this spring, we plan to begin posting the content of all enforcement activities on a new comprehensive web page that will include a searchable public database of all tobacco products that have an FDA marketing order to stop the sale of illicit products. In addition, the center plans to host more public meetings and workshops and provide more information on the application review process.

The center will also explore new ways to solicit and consider public input on its public education campaigns, including input from formative research that communicating nicotine — while highly addictive — to adult smokers is achieved through products that represent a continuum of risks delivered.

The State of Tobacco Regulation in the United States

When Congress mandated the FDA to regulate tobacco products more than 13 years ago, its vision was to make tobacco-related disease and death part of America's past, not America's future, and by doing so ensure healthier lives for every family .

We have made significant progress, but significant opportunities and challenges lie ahead as we seek to regulate an evolving marketplace. The percentage of U.S. adults who currently smoke will decline from 20.6 percent in 2009 to 11.5 percent in 2021. Despite this progress, nearly 500,000 Americans die each year from smoking, and continued youth vaping is creating another generation of addicted to products of unknown composition with long-term health consequences.

We have announced plans to prevent initiation and help people quit smoking outside the deadliest form of tobacco use - combustible tobacco products. The agency is working to finalize product standards to ban menthol in cigarettes and describe flavors, including menthol, in cigars. We also announced plans for potential future regulatory action, including a proposed product standard that would establish maximum nicotine levels to reduce the addictive properties of cigarettes and certain other combusted tobacco products. These actions are key to achieving the cancer moonshot goal of halving cancer deaths over the next 25 years, a key pillar of President Biden's unity agenda.

In addition, we continue to make significant progress towards science-based reviews of more novel tobacco products, such as e-cigarettes.

The FDA has authorized 23 tobacco-flavored vaping products and devices. The agency also issued marketing refusal orders for more than 1 million flavored e-cigarette products that lacked sufficient evidence of their benefit to adult smokers to overcome the well-documented and alarming use of e-cigarettes by teens. Public health problems posed by levels of tobacco smoke. Such a product. While some e-cigarettes may help adult smokers quit completely or significantly reduce their use of more harmful combustible cigarettes, legal public health criteria balance this potential with what is known about youth attraction, uptake, and use and significant risks in these highly addictive products.

Unfortunately, the tobacco industry has fought this agency over many of the science-based actions we take — putting profits over public health. For example, although we are the only country with comprehensive regulatory powers for the industry, unlike many other countries, legal challenges have twice so far prevented us from implementing congressional-mandated warnings on cigarette packages that paint a picture of the serious health effects of smoking. harm. And, as mentioned earlier, many decisions about product applications are also being challenged in court, which, among other things, requires significant resources to defend.

FDA will continue our important work to improve public health. We must be able to meaningfully implement transformational regulations and make decisions based on the public health criteria in the law, with the American public — not the interests of the tobacco industry — at the forefront. We have made progress, but there is still much work to be done.

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