CTP should finalize the proposed rules prohibiting menthol in cigarettes and prohibiting characterizing flavors in cigars, and the rules should include menthol analogs with cooling agents that mimic menthol

We submitted this comment to the FDA on August 25, 2023. The Regulations.gov tracking number is llr-b5fn-akbs. A PDF copy is available for download here.

CTP should finalize the proposed rules prohibiting menthol in cigarettes and prohibiting characterizing flavors in cigars, and the rules should include menthol analogs with cooling agents that mimic menthol

Docket No. FDA–2023–N–2873

Developing FDA’s Center for Tobacco Products’ Strategic Plan

Lauren Kass Lempert, JD, MPH; Pamela M. Ling, MD, MPH;
Stanton A. Glantz, PhD; Benjamin W. Chaffee, DDS, MPH, PhD; Sabrina Islam, PhD;
Jennifer Fung, PhD; Stuart Gansky, PhD; Wendy Max, PhD; Suzaynn F. Schick, PhD;
Minji Kim, PhD*; Bonnie Halpern-Felsher, PhD; Sabrina Islam, PhD;
Vira Pravosud, PhD; Hai-Yen Sung, PhD; Janet Wojcicki, PhD, MPH; Karla Llanes, PhD

UCSF TCORS

*University of South Carolina

August 25, 2023

FDA announced[1] a Public Meeting and Listening Session and an opportunity to submit written public comments to obtain feedback on five proposed strategic goals it is using to develop a strategic plan for FDA’s Center for Tobacco Products’ (CTP) comprehensive Strategic Plan. CTP proposed four cross-cutting themes – (1) health equity; (2) science; (3) transparency; and (4) stakeholder engagement – in proposing the following five goals:

1. Develop, advance, and communicate comprehensive and impactful tobacco regulations and guidance;
2. Ensure timely, clear, and consistent product application review to protect public health;
3. Ensure compliance of regulated industry and tobacco products utilizing all available tools, including robust enforcement actions;
4. Improve public health by enhancing knowledge and understanding of CTP tobacco product regulation and the risks associated with tobacco product use; and
5. Advance operational excellence.

This comment addresses the first goal and urges CTP to finalize the rules it proposed in April 2022 that would set product standards prohibiting menthol in cigarettes and flavors in cigars. It emphasizes how these proposed product standards will advance health equity and are based on valid scientific evidence. CTP promised it would finalize these rules by December 2023 and it should meet its self-imposed deadline.

1. CTP should finalize the proposed rules prohibiting menthol in cigarettes and prohibiting characterizing flavors in cigars

• In April 2022, FDA announced[2] proposed product standards to prohibit menthol as a characterizing flavor in cigarettes[3] and to prohibit all characterizing flavors in cigars.[4]
• As FDA stated in the preamble to the proposed menthol rule, the proposed product standard would reduce the appeal of cigarettes, particularly to youth and young adults, and thereby decrease the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking.
• Importantly, the proposed standard would reduce tobacco-related health disparities and advance health equity. As we discussed in a public comment UCSF and colleagues submitted to the proposed menthol standard docket in June 2022, menthol has caused disproportionate health impacts to the African American community compared with the total toll in the US and the proposed standard would substantially decrease these harms and inequities.[5]
• In addition, the proposed tobacco product standard would improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.[6]^{, [7], [8], [9], [10], [11], [12]}
• UCSF submitted eight public comments in June 2022 supporting the proposed standards prohibiting menthol in cigarettes[13] and five comments supporting the proposed standard prohibiting characterizing flavors in cigars,[14] which we incorporate by reference.
• FDA announced in January 2023 that it is currently drafting the final rules and is “committed to completing the rulemaking process in 2023.”[15]
• FDA should meet its self-imposed deadline of December 2023 to finalize these rules. It has had plenty of time (nearly 16 months as of August 2023 since FDA requested public comment on the proposed rule) to do this.
• As FDA stated, additional delays “would only increase the numbers of youth and young adults who experiment with menthol cigarettes and become regular smokers, delay cessation by current smokers, and exacerbate tobacco-related health disparities.”[16]
• As we stated in our June 1, 2022 public comment,[17] every month delay in implementing the proposed menthol standard would result in an additional 29,403 new cigarette smokers.

2. CTP should finalize its pending menthol rules in ways that include menthol analogs, including WS-3 and similar cooling agents that mimic menthol in tobacco products.

• It is well understood that the perception of taste relies not only on the gustatory sense (chemoreceptors on the tongue) and the olfactory sense (sensory receptors in the nose,) but also on a third sensory system, the somatosensory system (also called the “chemesthetic” or “trigeminal sensation”), which is an integral contributor to taste and the flavor perception. All three systems – the gustatory, olfactory, and somatosensory systems – work together to create the perception of flavor or taste.[18]^{, [19], [20], [21], [22], [23]}
• Synthetic cooling agents such as WS-3 are found in several products that are being marketed to evade existing and proposed state and federal flavor and menthol prohibitions.[24] While they impart minty or cooling sensations similar to menthol, they are odorless.[25]
• For example, RJ Reynolds’ website[26] provides lists of the ingredients contained in their products by specific brand families and brand styles. WS-3 is listed under the name, “n-Ethyl-p-Menthane-3-Carboxamide” and is found in the following brand varieties: Newport Non-menthol Green, Newport Non-menthol green 100, Newport EXP Mix, Newport EXP Mix 100, Newport EXP Max, Newport EXP Max 100, and Camel Crisp Non-menthol Green. All of these varieties are marketed in California where there is a statewide prohibition on selling tobacco products with “characterizing flavors,” which is defined as a “distinguishable taste or aroma, or both, other than the taste or aroma of tobacco.”[27]
• FDA’s final rules should clarify that the prohibitions are intended to include products such as the RJ Reynolds varieties listed above that include menthol analogs such as WS-3 and similar cooling agents that impart a cooling sensation, and that the rules are not limited only to products that impart a distinct minty or menthol taste or aroma.
• FDA’s proposed product standards already include the foundation for such action. The proposed rule (21 CFR 1162.5) would establish a tobacco product standard prohibiting the use of menthol as a characterizing flavor in cigarettes. Although it does not explicitly define the term, “characterizing flavor,” FDA stated that “among the factors that FDA believes are relevant in determining whether a cigarette has a characterizing flavor [is] … the multisensory experience (i.e., taste, aroma, and cooling or burning sensations in the mouth and throat) of a flavor during use of a tobacco product, including its components or parts…”[28] The proposed rule (21 CFR 1166.5) that would prohibit characterizing flavors in cigars adopts the identical language as the proposed menthol standard in cigarettes and states that FDA would consider a “cooling sensation” in the mouth and throat to be a relevant factor in determining whether a cigar has a characterizing flavor.[29]
• FDA’s approach that would consider a cooling sensation in the mouth or throat as relevant to a determination that a tobacco product has a characterizing flavor is scientifically valid as explained above.
• In our previously submitted public comments, incorporated by reference, we urged FDA to prohibit menthol analogs as flavor additives, compounds, constituents, and/or ingredients in cigarettes[30] and cigars[31] because the cooling sensation they provide can increase the products’ appeal.
• FDA has all the scientific evidence necessary, which is already in the public docket, to meet its self-imposed deadline of December 2023 to finalize these rules.

Conclusion:

Finalizing the proposed product standards for menthol in cigarettes and flavors in cigars is a specific action CTP could take in the next four months that would have tremendous impact in significantly reducing tobacco-related death and disease.

These actions would:

• • markedly reduce the appeal of cigarettes and cigars, especially to adolescents, young adults, and other priority populations;
  • substantially reduce tobacco-related health disparities and advance health equity; and
  • minimize the likelihood that tobacco manufacturers will evade regulations designed to protect the public health.