FDA Schedules Workshops on E-Cigarettes
Will cover design, liquids, aerosol, packaging, labeling, more
MINNEAPOLIS -- The Food and Drug Administration (FDA) has announced a series of three public workshops to gather scientific information and provide a forum for discussion of e-cigarettes and the public health.
These workshops will include presentations and panel discussions about the current state of scientific studies on e-cigarettes. The first workshop will be held Dec. 10-11, 2014, in Washington, D.C., and the agenda will include e-cigarette scientific studies, packaging, labeling of components and ingredients and environmental impacts. The second and third workshops will cover the topics of the health effects of electronic cigarettes on individuals and on the population as a whole.
In the announcement for the December e-cigarette workshop, the FDA lists five topic areas for consideration by speakers and panelists. Those topic areas include the following:
- Device Design: This topic area lists questions about: (1) the potential risks of different kinds of e-cigarettes (disposable sealed e-cigarettes vs. refillable tank-type e-cigarettes), (2) the potential for e-cigarettes to be manipulated by the consumer, (3) how the design of an e-cigarette modifies the delivery of nicotine, (4) the possible material hazards with e-cigarettes, (5) the current battery standards for e-cigarettes, and (6) the methods for measuring e-cigarette performance over time.
- E-Liquid and Aerosol Constituents: This topic area lists questions about: (1) the chemical composition of e-liquids, (2) the reasons for choosing one ingredient over another if both have the same characteristics (e.g., propylene glycol v. glycerin), (3) the stability of e-liquids and how does storage and packaging affect e-liquids, (4) the methods to measure and control impurities in e-liquids, (5) the chemical constituents of the e-cigarette vapor inhaled and exhaled, and (6) the existence of ingredients in e-liquids that increase toxicity levels in the vapor/aerosol.
- Interactions of Device Design, E-Liquids, and Aerosol: This topic area asks questions involving: (1) whether interchangeable parts increase product risk, (2) whether refillable e-cigarettes are a greater risk to users compared to disposable, closed system e-cigarettes that use sealed e-liquid cartridges, (3) whether there are maximum temperatures that should not be exceeded for e-cigarette materials, batteries and heating elements, (4) whether there is a maximum power/wattage rating for heating e-liquids, (5) what design features and manufacturing standards are needed to minimize risk to users and non-users (e.g., risk of explosion, leaking e-liquids), and (6) what are the quantitative and qualitative relationships between the chemical content in e-liquids and the chemical makeup of e-liquid vapor/aerosol.
- Packaging and Labeling: This topic area focuses on: (1) whether packaging methods minimize or eliminate risks such as accidental exposure to e-liquids or choking to users and non-users, including young children, and (2) do e-cigarette/e-liquid labels include a list of ingredients, hazards, and expiration dates.
- Environmental Impact: The final topic area includes questions on: (1) the environmental impact of manufacturing e-cigarettes compared to manufacturing traditional cigarettes, (2) the impact of manufacturing e-liquids on the cultivation of tobacco plants, (3) how are e-cigarettes disposed (e.g., recycled or disposed as regular trash), (4) whether e-cigarettes have components that could be considered to be hazardous waste, and (5) the methods available to reduce environmental waste from e-cigarette use.
The FDA indicates that the scientific information obtained through the workshops will not be used as a part of the process to finalize the agency’s proposed deeming regulations since the public comment period for the deeming regulations ended on Aug. 8. Rather, the FDA intends to use the scientific information obtained through the workshops to carry out its authority to regulate e-cigarettes with potential additional regulations at some time in the future.
The public can attend the workshop in person or via live webcast. If you want to attend the workshop in person or by webcast, you must register by submitting a request no later than Nov. 25, 2014 on https://www.surveymonkey.com/s/CTP-December-Workshop.
Click here for a full copy of the FDA’s announcement about the e-cigarette workshops.