A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes
Abstract
:1. Introduction
2. Principles to Guide Policy Makers
2.1. Tobacco Harm Reduction
2.2. Risk Continuum: Nicotine Concentration, Toxicants and Other Health Risks
2.3. Population Health Matters: Gateway to Smoking or Out of Smoking?
2.4. Emerging Regulatory Challenges: Consumer Perspectives, Restrictions and Flavors
3. Recommendations: Proposal for a Risk Assessment Matrix
4. Conclusions
Acknowledgments
Author Contributions
Conflicts of Interest
References
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FDA Deeming Regulation | EU Tobacco Product Directive (TPD) | |
---|---|---|
Effective as of: | 8 August 2016 | 20 May 2016 |
General Statement | Regulations stated in general terms without specification to manufacturers as to what will and will not be acceptable | Regulations specific as to what manufacturers must comply with |
E-cigarette regulated as: | Tobacco product. In the final Deeming Rule, FDA stated that all Electronic Nicotine Delivery Systems (ENDS) are subject to the Tobacco Control Act. | Tobacco product. Generally, zero-nicotine e-liquids are regarded as outside the scope of the TPD. However, EU Member State may contain provisions relating to zero-nicotine e-liquids. The TPD excludes e-cigarettes and e-liquids regulated as medicinal products or medical devices. |
What local governments can do? | Cities and States can regulate age restrictions on sale above age 18, places where e-cigarettes are not allowed and taxation. | Member States can regulate further without going contrary to supranational framework. For example, they are responsible for adopting rules on flavors and age limits and can ban cross-border distance sales |
Specific requirements | The Tobacco Control Act (TCA) requires that the marketing of a new tobacco product is appropriate for the protection of the public health, with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product. E-cigarettes and e-liquids are subject to the Tobacco Control Act requirements, including U.S. manufacturing establishment registration and product listing, ingredient reporting, health document submissions, testing for harmful and potentially harmful constituents (HPHCs), nicotine addiction warning requirements, age restrictions, prohibition of free samples, and premarket authorization. The TCA requires that all tobacco products not on the market as of 15 February 2007 submit a Premarket Tobacco Product Appication (PMTA) within two years of 8 August 2016 to remain on the market. All e-cigarettes products now on the market must meet this application. E-cigarettes companies that submit PMTAs by this deadline can continue marketing their products for an additional 12 months until 8 August 2019. If FDA is unable to complete its review during this 12-month period, the product will have to be removed from the market until FDA completes its review. Section 911 of the TCA specifies that no product can claim lower risk than any other product on the market (i.e., e-cigarettes cannot claim to be lower in risk than cigarettes) without submitting a Modified Risk Tobacco Product Application (MRTP). Requirements, application procedure and lack of guidance to manufacturers basically identical to the PMTA application. Section 911(a)(2)(C) of the TCA specifically prohibits any smokeless tobacco product from claiming lower risk just because it is smokeless. | Specific safety and quality requirements for every nicotine-containing EC (Article 20):
The TPD has no regulations requiring application or otherwise addressing claims of reduced risk. |
Process of product approval | PMTA required of all e-cigarette products [33]
| No new product application required for current or newly introduced products, but authorities must be notified [34]
|
Under-age sales |
| TPD makes no explicit prohibition, but Member States are responsible for adopting age limits. |
Marketing |
|
|
Labelling and packaging |
| Any outside packaging of e-cigarettes and refill containers must have the following details:
|
Probability of Occurrences | Impact | ||||||
---|---|---|---|---|---|---|---|
Catastrophic | Critical | Moderate | Minor | Negligible | |||
Definition | Meaning | Value | (A) | (B) | (C) | (D) | (E) |
Frequent |
| 5 | 5A | 5B | 5C | 5D | 5E |
Likely |
| 4 | 4A | 4B | 4C | 4D | 4E |
Occasional |
| 3 | 3A | 3B | 3C | 3D | 3E |
Seldom |
| 2 | 2A | 2B | 2C | 2D | 2E |
Improbable |
| 1 | 1A | 1B | 1C | 1D | 1E |
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Saitta, D.; Chowdhury, A.; Ferro, G.A.; Nalis, F.G.; Polosa, R. A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes. Int. J. Environ. Res. Public Health 2017, 14, 363. https://doi.org/10.3390/ijerph14040363
Saitta D, Chowdhury A, Ferro GA, Nalis FG, Polosa R. A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes. International Journal of Environmental Research and Public Health. 2017; 14(4):363. https://doi.org/10.3390/ijerph14040363
Chicago/Turabian StyleSaitta, Daniela, Azim Chowdhury, Giancarlo Antonio Ferro, Federico Giuseppe Nalis, and Riccardo Polosa. 2017. "A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes" International Journal of Environmental Research and Public Health 14, no. 4: 363. https://doi.org/10.3390/ijerph14040363