Why Is the FDA Easier on Cigarettes Than Smoking Cessation Tools? – RealClearHealth

Report on FDA Tobacco Regulation and its Implications for Sustainable Development Goal 3

Introduction: Public Health and Tobacco Harm Reduction

The regulatory actions of the U.S. Food and Drug Administration (FDA) concerning tobacco products present a significant challenge to achieving Sustainable Development Goal 3 (SDG 3), which aims to ensure good health and well-being for all. A critical analysis of the FDA’s approval process reveals a contradiction between its stated mission of reducing tobacco-related harm and its operational outcomes. This report examines the current regulatory landscape, its impact on public health, and provides recommendations for aligning U.S. policy with the objectives of SDG 3, particularly Target 3.4, which seeks to reduce premature mortality from non-communicable diseases.

Analysis of the Current Regulatory Framework and Public Health Outcomes

Discrepancy in Product Authorizations

The FDA’s approval record demonstrates a significant imbalance that undermines tobacco harm reduction strategies, a key component of advancing SDG 3. This imbalance is evident in the number and type of products authorized for market entry.

• Between 2018 and 2022, the FDA authorized 892 new combustible cigarette products.
• In its entire history, the agency has only authorized 45 products designated as “modified risk,” which include harm reduction and smoking cessation tools.

This disparity directly conflicts with efforts to reduce the 480,000 annual deaths from smoking-related illnesses in the United States, hindering progress toward SDG 3.4.

The Role of Lower-Risk Alternatives in Achieving SDG 3

Scientifically substantiated lower-risk alternatives to combustible cigarettes, such as Heated Tobacco Products (HTPs) and vaping products, represent a crucial pathway for reducing the public health burden of smoking. Evidence indicates these products can significantly contribute to the goals of SDG 3.

1. Heated Tobacco Products (HTPs): The FDA’s own review found that the aerosol from HTPs contains substantially fewer toxic chemicals than cigarette smoke. Subsequent studies confirm up to 90% lower levels of harmful and potentially harmful constituents (HPHCs) and 95% lower levels of known carcinogens. Renewing and expanding authorizations for such products is a viable strategy for harm reduction.
2. Vaping Products: Vaping delivers nicotine with fewer toxic chemicals than combustible cigarettes. Flavored vapes, in particular, have been shown to be an effective method for helping adult smokers quit, thereby reducing their risk of developing non-communicable diseases. Protecting youth is paramount, yet current data indicates that youth nicotine use is falling, suggesting that targeted regulations can be implemented without resorting to blanket flavor bans that negatively impact adult cessation efforts.

Legislative Barriers to Harm Reduction

The current regulatory framework, established by the 2009 Family Smoking Prevention and Tobacco Control Act, creates a significant barrier to the authorization of innovative, lower-risk products.

• Combustible Cigarettes: New cigarette products can be approved via a “substantial equivalence” pathway, which requires demonstrating similarity to a product on the market before February 2007. This is a lower regulatory bar, reducing cost and time to market.
• Lower-Risk Products: Newer technologies like vapes and HTPs have no pre-2007 equivalent and must undergo the full, resource-intensive Premarket Tobacco Product Application (PMTA) process.

This legislative structure inadvertently favors the approval of the most harmful tobacco products, actively working against the public health objectives enshrined in SDG 3.

Recommendations for Aligning U.S. Policy with SDG 3

Legislative and Regulatory Reform

To effectively address tobacco-related disease and mortality, and to strengthen the implementation of tobacco control as outlined in SDG Target 3.a, Congress and the FDA must reform the current system. This involves creating a more equitable and health-focused approval pathway.

• Congress should amend existing legislation to create an approval avenue for harm reduction products that is comparable to that for cigarettes, thereby leveling the regulatory playing field.
• The FDA should be mandated to prioritize a harm-reduction strategy that provides smokers with multiple, appealing, and accessible ways to transition away from combustible cigarettes.

Expanding Access to Scientifically Substantiated Harm Reduction Tools

The FDA should accelerate and expand the authorization of lower-risk products that have demonstrated a significant public health benefit.

1. Prioritize PMTA applications for products that show substantial reductions in toxic chemicals and are manufactured to consistent quality standards.
2. Renew existing authorizations for vetted reduced-risk products, such as HTPs, to ensure continuity of access for adults who have switched from smoking.
3. Recognize the critical role of flavored vapor products in adult smoking cessation and develop a regulatory approach that allows adult access while preventing youth uptake.

By implementing these changes, policymakers can create a regulatory environment that actively promotes public health, reduces premature mortality from non-communicable diseases, and makes substantial progress toward achieving the targets of Sustainable Development Goal 3.

Analysis of SDGs, Targets, and Indicators

1. Which SDGs are addressed or connected to the issues highlighted in the article?

• SDG 3: Good Health and Well-being

  The article is fundamentally centered on public health. It directly addresses the severe health consequences of tobacco use, citing that “480,000 Americans whom smoking kills each year.” The entire discussion revolves around strategies to reduce the harm caused by smoking, such as promoting lower-risk alternatives like heated tobacco products (HTPs) and vaping. The core argument is that current regulatory policies are failing to protect public health by making it harder to approve smoking cessation tools than traditional cigarettes. This aligns directly with SDG 3’s goal of ensuring healthy lives and promoting well-being for all at all ages.

2. What specific targets under those SDGs can be identified based on the article’s content?

• Target 3.4: By 2030, reduce by one-third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.

  The article’s primary focus is on reducing the number of deaths caused by smoking, which is a leading cause of non-communicable diseases (NCDs) like cancer and cardiovascular disease. The statistic of 480,000 annual deaths is a direct measure of premature mortality from NCDs. The proposed solution—expanding access to “lower-risk alternatives” to help smokers quit—is a prevention strategy aimed at mitigating the “death and disease” associated with combustible cigarettes, thereby contributing to the reduction of premature mortality.

• Target 3.a: Strengthen the implementation of the World Health Organization Framework Convention on Tobacco Control in all countries, as appropriate.

  This target is relevant as the article critically examines the implementation of national tobacco control legislation, specifically the “Family Smoking Prevention and Tobacco Control and Federal Retirement Reform Act of 2009.” It argues that the current regulatory framework, which makes it easier to approve new cigarettes than harm-reduction products, is a failure in policy implementation. The call for Congress and the FDA to “adopt a broader strategy that meets smokers where they are and provides multiple ways to quit cigarettes” is a direct appeal to strengthen and reform the national tobacco control framework to be more effective in protecting public health.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

• Annual deaths from smoking

  The article explicitly states, “480,000 Americans whom smoking kills each year.” This figure serves as a direct indicator of premature mortality from non-communicable diseases, aligning with Target 3.4. A reduction in this number would signify progress.

• Levels of harmful constituents in tobacco products

  The article mentions that studies report “roughly 90 percent lower levels of harmful and potentially harmful constituents (HPHCs) and 95 percent lower levels of known carcinogens” in HTPs compared with cigarettes. These percentages are specific, measurable indicators of harm reduction, reflecting the potential to prevent NCDs.

• Ratio of new product authorizations

  The article provides concrete numbers: “Between 2018 and 2022, the FDA authorized 892 new cigarette products” while only authorizing “45 ‘modified risk’ products” in its entire history. This ratio is used as an indicator of a flawed regulatory implementation (related to Target 3.a), suggesting that progress would involve a shift in this balance towards authorizing more harm-reduction tools.

• Youth nicotine use rates

  The article mentions that “youth nicotine use rates… are falling.” This is a direct reference to a prevalence indicator, which is used to measure the effectiveness of tobacco control policies (Target 3.a) and address concerns about the unintended consequences of new products.

4. Create a table with three columns titled ‘SDGs, Targets and Indicators” to present the findings from analyzing the article. In this table, list the Sustainable Development Goals (SDGs), their corresponding targets, and the specific indicators identified in the article.

Source: realclearhealth.com