October 6th, 2023
We appreciate the opportunity to comment on the FDA’s proposed guidance regarding tobacco product manufacturing practice requirements: “Requirements for Tobacco Product Manufacturing Practice.”
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
Overall, NCHR supports FDA’s proposed rule for regulating tobacco manufacturing practices. Prior evidence suggests that the absence of agency established tobacco regulations may expose consumers to unnecessary hazards, addictive products, and risks associated with tobacco products.1 While this proposal will not make tobacco products safe, it will help to limit health risks that are not normally associated with the use of tobacco products. Tobacco consumers will still remain at higher risk for cancer, stroke, heart and vascular disease, and chronic obstructive lung disease compared to non-tobacco users. Thus, NCHR urges the FDA to make it clear that this rule will not make tobacco products safe or protect consumer health, but rather is intended to reduce the risks. We also strongly urge the FDA to put more emphasis on implementing explicit policies that protect the public health as much as possible, rather than emphasizing the agency’s willingness to be flexible in how companies implement this rule.
NCHR agrees with the FDA’s proposed requirement that each manufacturer maintain a master manufacturing record (MMR) so that the FDA is able to hold manufacturers accountable and is able to track whether the tobacco products conform to packaging and labeling specifications. Further, as part of the MMR, it is imperative to require tobacco manufacturers to make products that consistently and accurately reflect the nicotine concentration printed on the label. This is essential for e-liquids and e-cigarettes, as they have been shown to range from having anywhere from 35% less nicotine to 52% more nicotine than is printed on the label.2 Moreover, younger e-cigarette users frequently misinterpret the concentration and strength of nicotine in e-cigarettes and many are uncertain about whether some e-cigarettes even contain nicotine.3 When the amount of nicotine consumed is unclear, it has the potential to increase the chances of consumers becoming addicted. Therefore, in addition to requiring manufacturers to accurately and clearly specify the nicotine concentration contained in the product, we also recommend that the FDA require clear, user-friendly labeling to help consumers better understand and calculate their nicotine consumption.
We also strongly agree with the FDA’s proposed regulations to restrict flavor additives, reduce hazardous contamination, and impose maximum nicotine levels in order to mitigate unnecessary health risks. These standards are essential for everyone, but may be especially likely to decrease tobacco initiation among younger consumers, as well as reduce the duration of use and risk of tobacco addiction. E-cigarettes have been shown to contain hazardous contaminated substances such as volatile organic compounds, metals, glass, and plastics and so we support FDA’s proposal for a Quality Management System (QMS), to help reduce contamination, hasten recalls, and prompt regulatory action for contaminated or misbranded tobacco products.
While NCHR agrees with the FDA’s proposed approaches for measuring and imposing tobacco standards, we find the enforcement mechanisms and corrective actions against manufacturers who violate these proposed regulations to be inadequate. The incentive for compliance is low, the FDA’s responses to noncompliance have not been sufficiently rigorous, and prior corrective actions have not been commensurate with the gravity that violations pose to the public. For example, the civil monetary penalties that have been previously issued for past e-cigarette violations are relatively rare and not sufficient to improve compliance. As of August of this year, the FDA had sought injunctions against only six companies and filed monetary penalty complaints against only 21 companies for illegally selling e-cigarettes, which pales in comparison to the scope of the problem.4 Thousands of unauthorized and illegal e-cigarettes remain on the market, posing a major threat to public health. NCHR recommends that the FDA enforce more violations and implement more stringent and aggressive enforcement strategies for each violation. For example, when there are multiple violations, rather than charging manufacturers with a single violation in one proceeding, which results in a maximum fine of $19,192, we urge that the manufacturer be charged for each violation, since the FDA has the authority to charge a manufacturer with multiple violations up to $1.2 million in a single proceeding.5 Incentives for compliance would be much greater if the statutory maximum is issued for each violation of the Family Smoking Prevention and Tobacco Control Act. Charging manufacturers with a single violation is not having the desired impact; stiff monetary penalties are needed to increase compliance among manufacturers that repeatedly market flavored e-cigarette products, produce tobacco products with hazardous foreign material, or are non-adherent to regulatory and label requirements.
We are very concerned that in each of the injunctions filed by the FDA, there was a delay of over a year between the time the FDA sent a warning letter to the companies in violation and the commencement of injunction proceeding. Throughout this period, these companies continued to profit from the sale and distribution of illegal products, including menthol flavored cigarettes and all types of flavored e-liquids that are especially attractive to children and teenagers. This substantial delay between the FDA’s identification of violations and initiation of injunction proceedings has clear adverse effects on public health, making it especially likely that children and adolescents will try these products and become addicted to them. We strongly recommend that the FDA streamline the process, more quickly imposing corrective actions in order to reduce harm to individuals and to public health.
In conclusion, we appreciate the opportunity to comment on the proposed rule to regulate tobacco manufacturing practices. We strongly recommend requiring manufacturers to accurately reflect the nicotine concentration contained in the product on the label using clear, plain language in large font. Further, we support the proposed regulations to restrict flavor additives as required by law, reduce hazardous contamination, and impose maximum nicotine levels. Even more important, the FDA should exercise its full authority when imposing monetary penalties for violations to improve incentives for manufacturer compliance. Although tobacco products are inherently unsafe, these proposed regulations, if properly enforced, will be more effective at reducing health risks related to tobacco consumption.
- Lange, T et al. “Regulating Tobacco Product Advertising and Promotions in the Retail Environment: A Roadmap for States and Localities.” Journal of Law and Medical Ethics. 2015.
- Raymond et al. “The Nicotine Content of a Sample of E-cigarette Liquid Manufactured in the United States.” Journal of Addiction Medicine. 2018.
- Morean et al. “Adolescents’ awareness of the nicotine strength and e-cigarette status of JUUL e-cigarettes. Drug and Alcohol Dependency. 2019.
- FDA, Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products. August 10, 2023.
- Zuckerman Spaeder. “Effective Use of Civil Monetary Penalties to Control Illegal Marketing of E-Cigarette Products. 2023. Link: Federal Register :: Requirements for Tobacco Product Manufacturing Practice