New FDA guidance

Change is coming. Nine years after the Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law and one year since it announced its Comprehensive Plan for Tobacco and Nicotine Regulation, the U.S. Food and Drug Administration (FDA) announced today its intent to “quickly advance” three new initiatives concerning tobacco and vapor products.
In a joint blog post, Scott Gottlieb, commissioner of the FDA, and Mitch Zeller, director of the FDA’s Center for Tobacco Products, wrote that the regulatory agency would be expediting action of flavored products, is developing an e-cigarette product standard and will explore various ways to accelerate enforcement of the marketing of vapor products to youth, as well as youth access. The three advanced notices of proposed rulemaking (ANPRM) related to flavors, youth access and premium cigars are now closed for comment.
In its post, the FDA states that flavors are at the forefront of any discussion of youth use. However, some flavored tobacco products may also play a role in helping some adults quit smoking cigarettes.
“We intend to expedite the review and analysis of the comments so that we can leverage the information into policy as quickly as possible, should the science support further action,” the authors write.
“Input on these issues will assist in the consideration of the most impactful regulatory options the FDA could pursue to achieve the greatest public health benefit. We’re proceeding in a science-based fashion, building a strong administrative record by securing more information about the potential positives and negatives of flavors in both youth initiation, and in getting adult smokers to quit or transition to potentially less harmful products.”
The FDA has also announced that the regulatory agency had begun exploring a product standard for e-cigarettes to help address existing concerns. This has been a major issue for vapor industry product manufacturers as the lack of guidance has slowed innovation. The FDA states that, as part of the standard, the agency will consider, among other things, levels of toxicants and impurities in propylene glycol, glycerin, and nicotine in e-liquids. “While the process for establishing a product standard takes time, we recognize the urgency in setting some minimum, common sense standards and will work to address this on an accelerated timeline,” the blog states.
The FDA is also looking at how it can act more efficiently when the agency becomes aware of violations affecting youth use of e-cigarettes, such as illegal product marketing. “We need to be faster and more agile when we identify new risks. We’ve also become aware of reports that some companies may be marketing new products that were introduced after the FDA’s compliance period and have not gone through premarket review,” the blog states.
“These products are being marketed both in violation of the law and outside of the FDA’s announced compliance policies. We take these reports very seriously. Companies should know that the FDA is watching, and we will take swift action wherever appropriate.”
The FDA is now evaluating new ways to strengthen its partnership with its sister agencies, including the Federal Trade Commission, and will soon announce a robust series of additional enforcement actions in the coming months, according to the blog post. “Today, we’re committing to redoubling our efforts. Too many kids are still starting to use tobacco products and getting addicted,” the blog states. “Too many adults are still struggling to quit or to switch to less harmful options. To reduce the disease and death caused by tobacco use, the FDA will do everything within our power to help all ages.”
Additionally, the FDA is pursuing additional new policies as part of its comprehensive plan for nicotine and tobacco regulation. Part of these efforts are aimed at making the pathway for developing nicotine replacement therapy (NRT) products more efficient and to promote the development of novel NRT products.
“The agency’s efforts to reevaluate and modernize its approach to the development and regulation of NRT products is aimed at opening up new pathways for the development of improved products, regulated as new drugs, that demonstrate that they are safe and effective for the purpose of helping smokers quit,” the blog states.
“Many of our new efforts, as part of our comprehensive plan, are aimed at using our existing authorities under the TCA to minimize addiction to the most harmful products, principally cigarettes, while encouraging innovation in new products that may offer adults less harmful forms of nicotine delivery.”
A key part of achieving these goals is issuing “foundational rules and guidances” to help the vapor industry better understand what is needed to submit product applications. At the same time, the agency is pursuing “new efforts to improve the transparency and efficiency” of its premarket review process.
“These important foundational steps are a key element of our efforts to advance the pre-market review of tobacco [and vapor] products. This review is one of the most important responsibilities we have. It’s how we can … determine how a product [or new products] may positively or negatively affect both non-users and current users,” the blog states. “To address these goals, we’re committing to a number of steps, some new, to respond to stakeholders and to make the regulatory process more efficient, predictable, and transparent for industry … establishing a rigorous, predictable, science-based framework for the pre-market review of tobacco products is a key element of our program.”
The steps the FDA is pursuing to better achieve these goals are proposing foundational rules, holding a public meeting on the premarket authorization process and seeking ways to make those processes more efficient. The agency will begin publishing these foundational proposed rules in the coming months.
“They will lay out a transparent, modern and science-based framework for manufacturing practices and the development of tobacco product applications that meet the legal requirements. We’re working to propose new rules to help industry on topics including Substantial Equivalence (SE), Premarket Tobacco Applications (PMTA), Modified Risk Tobacco Product Applications (MRTP), and Tobacco Product Manufacturing Practices,” the blog states.
Within the next few months, the FDA expects to hold a public meeting on the premarket application and review process. The goal of the meeting is to “solicit comments on our processes and provide a dedicated venue for specific suggestions on how to further improve them.
“If carefully developed, rulemaking and guidance efforts in this area could help ensure that our public health standards for premarket review are met while mutually benefiting both the industry and the FDA,” the blog states. “For example, an opportunity may exist to allow for faster and cheaper development of products that will benefit public health … We also plan to advance a comprehensive suite of improvements to the review process, as part of a regulatory modernization, to make our program more efficient, transparent, predictable, and efficient.”
The FDA expects to unveil these program-related reforms in advance of its upcoming public meeting, which has not yet been scheduled.
Read the blog post here.