VTA’s Recommendations to the Reagan-Udall Foundation
Published on December 19, 2022
VTA PMTA Recommendations
- FDA must implement safeguards at the Center for Tobacco Products (CTP) to ensure that the scientific review process is insulated from external pressures and that CTP scientists are allowed to unapologetically follow the science.
- Immediately rescind the July 9, 2021 and August 17, 2021 process memos which resulted in the en masse denial of flavored ENDS products, restore the holistic review process and the primacy of the appropriateness for the protection of public health balancing test.
- Build the off-ramp from smoking by accelerating the authorization of ENDS products and using the full scope of CTP’s post-marketing order authority to monitor and control for youth concerns.
- Clearly articulate CTP’s use of enforcement discretion to work companies through the PMTA process, particularly for non-tobacco nicotine (i.e., synthetic nicotine) applications.
- Communicate with companies to seek additional information or corrections and avoid rejections based on administrative or technical failings and the needless litigation that follows.
- Establish defined testing methods for END products which create transparency and certainty.
- Eliminate redundant and unnecessary testing to streamline the PMTA process.
- Develop and publish a PMTA proposed regulation with a finite checklist of required information that is required for PMTA review.
- Equally fund research for identifying how ENDS products can be solutions for smoking, rather than simply identifying problems with ENDS products and youth.
VTA Regulations and Guidance Recommendations
- CTP should implement a Comprehensive Plan on tobacco and nicotine that includes a clear acknowledgment of the FDA’s commitment to:
- the continuum of risk related to tobacco products and a recognition that ENDS and modern oral nicotine products sit at the lower end of the risk continuum,
- promoting innovation of those products at the lower end of the risk continuum, particularly ENDS and modern oral nicotine products,
- promoting innovation in nicotine, particularly synthetic nicotine,
- a pure scientific review process,
- funding science to evaluate the benefits of ENDS and modern oral nicotine products,
- working with companies to facilitate the application review process,
- aggressively educating adult smokers on the benefits of trying ENDS products if they are otherwise unwilling or unable to quit smoking using other methods,
- using its enforcement discretion to allow products under review to remain on the market pending authorization reviews, and
- a streamlined process which will ensure prompt review of product applications.
- CTP should engage industry and other stakeholders in the guidance and regulation processes by:
- Converting its listening sessions to engagement sessions so that CTP personnel are encouraged to communicate, ask questions and engage with stakeholders during meetings;
- Reinstituting its public stakeholder workshops which bring together all stakeholders to provide input on key regulatory policies and strategies; and
- Establishing an additional technical advisory committee dedicated to newly deemed alternative nicotine products to have a more focused strategy for less harmful nicotine products
- CTP should issue proposed regulation or guidance on product standards that:
- Explicitly allows widely accepted statistical design methods of research, aggregate testing, and extrapolation for ENDS product stability testing, and
- Permits manufacturers to market safety and/or quality enhancements with 60-Day notice to FDA.
VTA Enforcement Recommendations
- CTP must use its full authority to ramp up interdiction of illicit products at the ports.
- CTP needs to streamline and reprioritize its enforcement efforts, rather than focusing so much on generally ineffective retail level enforcement.
- CTP should publish list of NTN products currently under PMTA review to facilitate industry and FDA enforcement efforts.
- CTP should restructure its enforcement efforts, through a guidance document, to achieve the following altered enforcement priorities:
- Stopping the flow all disposables into the U.S. market for which no PMTA has been filed by interdicting products at the ports;
- Enforcing against other ENDS products for which no PMTA has been filed, first prioritizing tobacco-derived products which make up the bulk of the market and then NTN products (since the latter are only a fraction of the market);
- Enforcing against counterfeit and illicit products which grossly violate marketing standards, trademark laws, or otherwise have marketing campaigns directed at youth; and
- Enforcing against products for which CTP has issued marketing denial orders (MDOs) after a full scientific review consistent with requirements of the Tobacco Control Act, except of course, those subject to an FDA administrative stay or a court-ordered stay of enforcement.
VTA Public Education & Communication Recommendations
- CTP must loudly and repeatedly correct the public record that nicotine does not cause cancer and that ENDS products, in the words of CTP Director King “have markedly less risk than a combustible cigarette”;
- CTP must commit equal resources to conducting an aggressive public education campaign, targeted to the adult consuming public, on the dangers of smoking and the lower risks of ENDS and modern oral nicotine products, explaining the continuum of risk, and encouraging adult smokers who have been unable or unwilling to quit to try e-cigarettes; and
- CTP must end the misleading youth education campaigns that are designed to scare youth (and adults) with false statements regarding the risks of e-cigarettes.