This morning, the FDA Center for Tobacco...

This morning, the FDA Center for Tobacco Products (CTP) noticed the opening of a public docket, in conjunction with its public workshops, for research and scientific data on e-cigarettes.

The focus of the first workshop is product science (specifically device designs and characteristics, and e-liquid and aerosol constituents), product packaging, constituent labeling, and environmental impact. This workshop takes place Dec 10/11.

Questions the FDA seeks input on are as follows:

Device Design and Design Characteristics:

  • What are the potential risks associated with different device characteristics (e.g., disposable versus refillable tanks and cartridges, variable voltage capabilities, coil resistance, interchangeable parts)?
  • How can products be manipulated by users? Are there hazards associated with certain manipulations?
  • What are the significant design characteristics of e-cigarettes that modify the delivery of nicotine and other constituents to users?
  • What are the potential material hazards (e.g., leaching, metal particle deposition) associated with e-cigarettes? Do these hazards change with product aging or storage conditions?
  • What are the information collecting capabilities of current devices? Can the function of the devices be modified by a 3rd party or software communications? What are the potential benefits and concerns associated with software, data collection and electronic communications in e-cigarettes?
  • What currently available design or product standards (e.g., battery standards) are relevant to e-cigarettes?
  • What methods exist for evaluating e-cigarette performance? How does an individual product’s performance change over time?

E-Liquid and Aerosol Constituents:

  • What is the chemical composition of e-liquids?
  • When several ingredients can serve the same function, what are the reasons for preferring or avoiding a specific ingredient (e.g., propylene glycol vs. glycerin)?
  • What is the stability of e-liquids? How do storage conditions and packaging affect e-liquid composition?
  • What methods can be used to evaluate the constituent in e-liquids?
  • How are impurities and contaminants (including e-liquid ingredients and potential microbial contaminants) identified and controlled?
  • What are the identities, quantities and origins of the chemical constituents of the e-cigarette aerosols inhaled and exhaled aerosols by users?
  • What methods exist to measure chemicals in aerosols (including particle size distribution)?
  • What aerosol-generating regimens exist for e-cigarettes? What validation of aerosol-generating regimens has been carried out?
  • How do aerosol constituent yields vary puff-by-puff?
  • Are there particular ingredients in e-liquids that increase the toxicant levels in the aerosol? Are there alternative e-liquid ingredients (i.e., USP Grade) that are considered to produce lower levels of toxicants in the aerosol than some widely used ingredients? What are the potential toxicological risks associated with flavorings?
  • Which e-liquid and aerosol constituents, toxicants, and impurities are or can be routinely evaluated? How can impurities, contaminants and toxicants in e-liquids and aerosols be identified and controlled?
  • Given that the e-liquids and aerosols contain varying mixtures of toxicants, what comparative toxicity evaluations could be conducted between different e-cigarette products?

Device Design, E-Liquid and Aerosol Interactions:

  • What design features are potential sources of risk?
  • Do interchangeable parts increase product risk? (Address potential to modify or tamper with devices and associated risks.)
  • Are refillable systems more risky to users compared to closed systems? More risky to nonusers? (Address potential use as “not intended”, e.g., “dripping”, use with marijuana waxes/oils.)
  • Are some refillable systems, such as dual tank systems, more risky than others?
  • Are there maximum temperatures that should not be exceeded for product components, such as surfaces, materials, batteries and heating elements?
  • Is there a maximum power/wattage for heating e-liquids?
  • What design features and manufacturing standards/tolerances are needed to minimize or mitigate risk to users and nonusers, especially risk of explosion, leaking of e-liquids, increased toxicant exposure (i.e., chemicals, metals, leachables)?
  • What design features may alter the abuse liability of e-cigarettes (e.g., user electronic adjustments, constituent delivery modification)?
  • What are the quantitative and qualitative relationships between the chemical contents in e-liquids (e.g., nicotine, humectants, flavorings) and chemical constituents in aerosols inhaled by users?
  • What are the determinants of the quantitative and qualitative relationships between the chemical content in e-liquids and chemical constituents in delivered aerosols (e.g., device design effects on delivered aerosol particle characteristics including the impact of varied voltage and differences in coil resistance)?

Packaging and Constituent Labeling:

  • Are there e-cigarette and e-liquid packaging characteristics (including design, size, product quantity) that minimize or eliminate risks (e.g., accidental exposures to e-liquids, choking) to both users and nonusers – especially young children?
  • Do chemical constituents, product hazards, and expiration dates appear on e-cigarette and e-liquid labels?

Environmental Impact:

  • How can the environmental impact of manufacturing e-cigarettes be compared to that of traditional cigarettes?
  • Given that tobacco plants are the source of nicotine in e-liquids, what is the impact of manufacturing e-liquids, especially with increasing e-cigarette market volume, on the cultivation of tobacco plants? Will land be converted to support the market growth of e-cigarettes?
  • How are e-cigarettes, especially non-reusable products, disposed? Are they recycled or are they disposed as regular trash?
  • Do e-cigarettes have components that are considered hazardous waste?
  • Are disposal instructions for other products relevant to e-cigarettes?
  • Are there ways to reduce the environmental waste and pollution from e-cigarette use?

Two additional e-cigarette workshops; one on individual health effects and one on population health effects, will follow (dates and time TBD).

It isn’t necessary to attend any of these workshops to contribute data and comment to the public record. Archived copies of the webcasts will be located at the CTP website. While pre-registration is required to attend the workshops or view them live via webcast, non-registered entities can possibly view the webcast at the site, but if capacity is reached, non-registered viewers will be disconnected from the transmission,

The opening of this public docket presents a good opportunity for members of the TVECA community to package and present appropriate information to the CTP. TVECA members are encouraged to comment.

The comment period is open for 130 days, or until April 15, 2015.

The link for the submission of comments will be announced in the Federal Register notice the morning of the first workshop.

Stay tuned for information on where to submit comments!


Awesome Keith! Thank you for Posting this Article

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