The US FDA commissioner: is increasing efforts to regulate the e-cigarette product business

Blue Hole New Consumption reported, February 26 news, according to foreign power reports, the US Food and Drug Administration (FDA) is increasing its efforts to regulate the e-cigarette product business.

The agency's Tobacco Products Centre (CTP) outlines the steps it plans to take to further prevent the public health harm that e-cigarettes cause to young people.

FDA Commissioner Robert Califfe said in a Feb. 24 statement:

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

The FDA lists its pending application review process for e-cigarette products as a focus area.

"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 illegal products from the market — especially those that make e-cigarettes a hot product." Tobacco products most commonly used by young people." The statement said.

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

"Philip Morris is far ahead of its peers in risk reduction products, which the company expects to be a major part of its business by 2025." Barron's said. "They already account for almost 30% of sales, while Altria Group (MO) and British American Tobacco (BTAFF) account for about 15%."

Currently, CTP targets 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 to continue selling e-cigarette products that lack the required FDA marketing authorization." The statement said. "These companies have millions of products listed at the FDA."

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

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

Today, the U.S. Food and Drug Administration's Tobacco Products Center (CTP) outlined the steps it plans to take in response to an external evaluation, which I commissioned last year with an independent evaluation panel that worked through the Reagan-Youdel Foundation. The evaluation is an important opportunity to take a critical look at the regulatory processes and operations of tobacco programmes.

We have made tremendous progress in preventing death and disability from tobacco use, but I firmly believe that we can always benefit from studying how best to protect public health, support our employees, and respond as much as possible to external stakeholders. When I started my career in intensive care, the hospital was full of relatively young people who had died suddenly from smoking, heart attacks, strokes, and cancer. When the FDA was given the authority to regulate tobacco, the effectiveness of the public health and medical communities in reducing the loss of tobacco products increased. 

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

CTP Director Dr. Brian King, Master of Public Health, provided more details about our approach to responding to evaluation recommendations and our new program, including in that year. CTP has committed to regularly update the progress of these activities, including some of the activities mentioned here.

Application for review

In particular, in the past few years, CTP has made important progress in the review of e-cigarette product applications - authorizing a number of tobacco-flavored e-cigarette products and devices, and rejecting millions of marketing applications for non-compliant products.

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

Further simplification of the review where appropriate; 

Increase the use of the Scientific Advisory Committee on Tobacco Products to discuss broader scientific issues critical to premarket assessment and individual product applications; 

Publish current and future science policy memoranda and reviewer guidance, as appropriate;

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

To achieve these goals, we need to have the right resources to hire and retain staff with the skills needed to effectively carry out our public health responsibilities with regard to tobacco. Since the agency's fiscal year 2020 budget request, the FDA has asserted the right to charge e-cigarette companies for user fees, which do not currently pay user fees despite the significant review and decision-making workload for these products. FDA also continues to explore a variety of 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's needs.  

Compliance & 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 — particularly those that make e-cigarettes the most common tobacco products used by youth.

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

In addition, the FDA filed its first civil penalty complaint this week against four tobacco product manufacturers for manufacturing and selling new e-liquids without marketing authorization. The agency will continue to remove illegal products from the market as quickly as possible, while identifying new ways to strengthen compliance and enforcement.  

Effective immediately, FDA will begin planning for a enforcement-related summit with senior officials from HHS and DOJ, based on the recommendations of the external evaluation. The agency will also continue to work with other government agencies, such as U.S. Customs and Border Protection, the U.S. Postal Service, the Federal Trade Commission, the Bureau of Alcohol, Tobacco, Firearms, and Explosives, and our compliance and enforcement partners at the state/local/territorial/tribal level. This work will maximize compliance and enforcement activities where there are mutual interests. In addition, FDA will explore alternative ways to achieve compliance beyond judicial enforcement actions. 

The agency acknowledged that some illegal e-cigarette products continue to be sold in the United States. Many companies have challenged the agency's marketing denial orders in courts across the country. In some cases, this limits 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 institute legal proceedings for injunctions or confiscation of violators.

Instead, the agency must rely on the Department of Justice, which must assess the legal risks of taking specific enforcement actions and decide whether to devote its limited resources to prosecuting on our behalf. FDA will continue to use all 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 in the agency's approach to compliance and enforcement. By this spring, we plan to begin publishing content for all enforcement activities on a new comprehensive webpage that will include a searchable public database of all tobacco products that have FDA marketing orders to block 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 formative research that conveys to adult smokers that nicotine—while highly addictive—is delivered through products that represent continuous risk.

The state of tobacco control in the United States

When Congress entrusted the FDA with regulating tobacco products more than 13 years ago, its vision was to make tobacco-related illness and death part of America's past, not America's future, and by doing so ensure that every family lived healthier lives. 

We have made significant progress, but as we seek to regulate an evolving market, important opportunities and challenges lie ahead. The percentage of U.S. adults currently smoking in the total population declined from 20.6% in 2009 to 11.5% in 2021. Despite this progress, nearly 500,000 Americans still die each year from smoking, and continued vaping among young people is producing long-term health consequences for another generation of addiction to products with unknown ingredients. 

We have announced the deadliest form of tobacco use outside the program to prevent initiating and helping people quit smoking – 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 the development of a proposed product standard that would establish maximum nicotine content to reduce addiction to cigarettes and certain other burning tobacco products. These actions are key to achieving the cancer moonshot goal of halving cancer mortality rates over the next 25 years, an important pillar of President Biden's unity agenda.

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

FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The agency also issued marketing refusal orders for more than 1 million flavored e-cigarette products that lack enough evidence that they are beneficial to adult smokers enough to overcome the public health concerns posed by well-documented and alarming levels of e-cigarette use among teens. Such a product. While some e-cigarettes may help adult smokers quit altogether or significantly reduce their use of more harmful incendiary cigarettes, the law's public health standards balance this potential with known and significant risks in terms of teenage attraction, uptake, and use of these highly addictive products.  

Unfortunately, the tobacco industry has fought the agency for many of the science-based actions we have taken – putting profit ahead of public health. For example, although we are the only country with full regulatory authority over the industry, unlike many other countries, legal challenges have so far twice prevented us from implementing congressionally mandated warnings on cigarette packs that depict the serious health risks of smoking. And, as mentioned earlier, many decisions on the application of products are also 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 public health standards in the law, with the American public — not the tobacco industry's interests — at the forefront. We have made progress, but much remains to be done.