FDA Public Hearing on E-cigarette Manufacturing Reveals Diverse Concerns

On April 12, 2023, the FDA Center for Tobacco Products hosted a public hearing on the Proposed Requirements for Tobacco Product Manufacturing Practice, gathering comments from 18 commentators, of which 8 specifically addressed e-cigarettes. Attendees included industry representatives, public health advocates, researchers, and consumers, who shared their perspectives on the proposed regulations for e-cigarette manufacturing and marketing.

Commentators and Comments

Here are the main points raised by the 8 commentators on e-cigarettes:

1. Huiyu Shi: Expressed concern about the differences in regulatory requirements at a biochemical level, particularly drinking water level requirements between the U.S. and China. Shi is the former Medical Manager of Shenzhen Smoore Technology Co., Ltd., and the current Medical Manager of Shenzhen Concourse Technology Services Co., Ltd.
2. Jason Hodge: Shared personal experience as a dual user of combustible tobacco and e-cigarettes, claiming that nicotine vaping had no detrimental effects and accusing the FDA of announcing unfounded fears for nicotine.
3. Meredith Berkman: Supported the rule in general but emphasized the importance of childproof packaging and the need for strong enforcement against bad actors in the e-cigarette industry. Meredith Berkman is the Co-founder of Parents Against Vaping E-Cigarettes (PAVe).
4. Maham Akbar: Stressed that no tobacco products are safe and urged the FDA to address issues such as mislabeling and battery dangers in e-cigarettes. Maham Akbar is the public policy director of Truth Initiative, a non-profit research body on the tobacco industry.
5. Mark Anton: Criticized the proposed regulation for being an umbrella approach and placing a disproportionate burden on small businesses. Anton is the CEO of a small vape maker company.
6. Patrick Murphy: Suggested that the FDA should provide more clarity in the validation and verification of tobacco product manufacturing and address other areas requiring further definition and guidance. Patrick Murphy is the VP and Chief scientist of RAF service company, a subsidiary of R.J. Reynolds.
7. Pamela Granger: Expressed a desire to end all tobacco sales by 2035, highlighting concerns about e-cigarette disposal and suggesting clear disposal methods.
8. Delorse Orlando: Requested the FDA to issue rules and regulations ensuring the quality of manufacturers while accusing the agency of waiting for small tobacco-related businesses to die off.

Key takeaways

The key takeaways from the FDA public hearing on the Proposed Requirements for Tobacco Product Manufacturing Practice related to e-cigarettes revolve around the need for consistent international regulations, the safety debate surrounding nicotine vaping, and the importance of robust enforcement and childproof packaging. Additionally, there is a desire for clearer guidance from the FDA, addressing issues like mislabeling and battery dangers, while being mindful of the impact on small businesses. Finally, concerns related to waste management and striking a balance between regulation and industry survival were also highlighted.