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Perspective: Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products

By Brian King, Director of the FDA’s Center for Tobacco Products
August 3, 2022

When I became the Director of the Center for Tobacco Products (CTP) in July, I joined a team of dedicated professionals that work tirelessly to make tobacco-related disease and death part of America’s past, not America’s future. In the 13 years since the landmark Tobacco Control Act was signed into law, CTP has done significant work to effectively regulate a complex and rapidly changing tobacco product landscape. With the full support of Commissioner Califf, I look forward to building on the strong foundation set by Mitch Zeller, who served as CTP’s Director for more than nine years.  

In March, Congress passed an important new federal law clarifying FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. The law, which went into effect in April, closed a loophole that several companies were using to try to evade regulation. Now manufacturers of tobacco products containing non-tobacco nicotine are held to the same public health standards, including premarket review, that we’ve worked so hard to implement for other tobacco products. This is a critical addition to our regulatory authorities because nicotine, regardless of its source, is extremely addictive, especially when used by youth.  

I’m thankful that our authority is now clear, and I will not stand by as illegal products with the potential to cause a new generation of youth to become addicted to nicotine, proliferate in the marketplace. With that commitment made clear, I am fully dedicated to implementing and enforcing this new law, building upon the important progress CTP has already made since its passage. 

I want to make it unequivocally clear that we have been working diligently to process non-tobacco nicotine product premarket applications and prepare them for the review process – day in and day out – since we were granted the authority to do so by Congress. A substantial number of applications were submitted by May 14 – nearly one million from more than 200 separate companies – with some several thousand pages long. Preparing these applications for review takes several steps and submissions varied widely in their organization, size, and completeness of data, which impacts the time it takes to process the information. 
Despite the intricacy and time-consuming nature of these important steps, we are making significant progress in processing and reviewing these applications. In the past three weeks alone, FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products in applications that do not meet the criteria for acceptance. Applications are required to provide important information needed for processing and reviewing. Without the required information, applications cannot proceed past the acceptance phase of the review process. The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization. 

Of those applications submitted by May 14, we have also accepted over 350 applications, with the vast majority being for e-cigarette or e-liquid products. This acceptance is not a determination about the products’ authorization status. Accepted applications then enter further review, which ensures certain criteria are met for applications to proceed forward for further evaluation. For example, required criteria could include information on product formulation, product testing and analysis, and evaluation of the health risks of the product both at the individual and population levels. After this further review, applications that meet the necessary criteria will enter substantive review, including consideration of the impact to the population as a whole, such as risks to youth and potential benefits to adult smokers. The substantive review phase includes evaluation of the scientific information and data in an application, which often results in follow-up questions and conversations with companies, including in situations where elements of an application raise questions needing clarification. It is only after the substantive phase that a company may be granted a marketing order. If no marketing order is granted, it remains illegal to market the product. To date, no non-tobacco nicotine product has received a marketing granted order. 

But our work does not end there. While our application review is ongoing, we remain vigilant in overseeing the market and continue to prioritize the use of our compliance and enforcement resources to curb the unlawful marketing of tobacco products, including non-tobacco-nicotine products. After July 13, 2022, a non-tobacco nicotine product can only be legally marketed in the United States if it has received premarket authorization from FDA. This means that it is illegal for a retailer or distributor to sell or distribute a non-tobacco nicotine product that is not subject to a marketing granted order (MGO) from FDA. Without this MGO, a product is in violation of the law and its manufacturer, retailer, or distributor may be subject to FDA enforcement. 

We have been closely monitoring retailer, manufacturer, importer, and distributor compliance with the law. Similar to the application review steps, our compliance and enforcement work is a multi-step process that cannot happen overnight; it takes time to ensure that any enforcement taken is supported by the available evidence with respect to the legal standards. Typically, when companies are found to be illegally marketing FDA-regulated products, including tobacco products, we first issue warning letters to promote compliance. We then follow up to ensure the violations addressed in the warning letter are corrected. Many companies comply after receiving a warning letter. If firms continue to violate the law, we can pursue further actions, such as civil money penalties, seizures, and injunctions.  

As further demonstration of our commitment in this area, on Aug. 1, FDA issued 17 new warning letters to manufacturers for marketing their products without the required premarket authorization. These manufacturers failed to submit applications for their non-tobacco nicotine products. On July 28, the agency also issued 102 warning letters to retailers for illegally selling non-tobacco nicotine products to underage purchasers. FDA requests that firms that receive warning letters respond to the agency within a specified time period, typically 15 working days, and provide an explanation of the steps they will take to address any violations and their plan for maintaining compliance with the law. Failure to address any violations will lead to further action, as appropriate. 

I remain committed to providing regular updates about our premarket review progress, as well as compliance and enforcement actions related to non-tobacco nicotine products. Our goal is clear communication and transparency, and toward that end, we intend to include information about non-tobacco nicotine products in our regular metrics reporting in the future. To keep stakeholders and the general public informed, we also launched a non-tobacco nicotine product webpage that includes information about how synthetic nicotine is made and our regulation of non-tobacco nicotine products. 

We are at an unprecedented time in the history of tobacco product regulation, which comes with both opportunities and challenges. It is critical that we seize upon these opportunities and work to mitigate the challenges through the regulatory authorities afforded to us, which now include non-tobacco nicotine products. Toward that end, CTP will continue to use the best available evidence to make marketing authorization decisions and to enforce regulations that reduce the public health burden of tobacco products at the population level.

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