Thursday, August 13, 2015

FDA Call to Action: Submit Comments on FDA's Proposed Regulation of Safety Packaging and Labeling for E-Cigarettes and Dissolvable Smokeless Tobacco

Update August 21, 2015: The comment deadline has been extended to September 30, 2015. Update September 29, 2015: Updated to include a link to the comment CASAA filed.


DEADLINE for Comment is August 31, 2015 September 30, 2015.

I. Background

The FDA recently published an Advance Notice of Proposed Rulemaking (ANPRM) requesting comments on rules about “Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products.” As is obvious from the title, FDA is seeking comments on their plan to impose child-resistant packaging and accidental exposure/poisoning warning labels on e-cigarette refill products (liquid and cartridges), dissolvable smokeless tobacco products, and some other fringe tobacco/nicotine products. This is your chance to make the consumer voice heard. (There is enough information contained in this Call to Action for you to be able to comment without reading the full ANPRM, though reading it and/or CASAA’s comment will give you a more complete picture.)

As background, an ANPRM is a pre-draft of regulations that outlines the goals and approaches of the regulation, but often omits details and asks for input. If you recall FDA’s draft “deeming” regulation, it was really more of an ANPRM even though they released it as a draft regulation. You may also know that because the deeming regulation is not finalized, FDA does not yet have authority to implement the rules in this ANPRM, which comes only after they deem certain products to be under their authority. By putting this out, they are sending a signal that they will implement these rules as rapidly as possible after the deeming.

As you probably know, the deeming regulation as currently proposed will effectively ban most e-cigarette products after a two-year grace period. This regulation -- when and if it is implemented -- would apply to all e-cigarette products during the grace period and the few remaining non-black-market products after the grace period ends.

CASAA’s comment can be found here (at the time this CTA is going out, this is still a near-final draft text, as should be clear from looking at it; we will finalize and submit before deadline and post the final version). Our views can be summarized as:

CASAA's comment was filed September 27, 2015 and can be found here. Our views can be summarized as:

  • In order to implement these regulations, FDA will have to impose the deeming which -- unless there is some radical change in policy -- will effectively ban >99.9% of the e-cigarette products on the market by requiring filing and paperwork burdens that can be met only by the largest manufacturers, and only for a small number of closed-system products.
  • While we believe there are some genuine benefits to consumers from having federal-level rules mandating child-resistant packaging and providing honest and useful warnings, those benefits are very small compared to the devastating cost of the deeming. CASAA continues to object to the deeming regulations.

  • If we ignore that and consider accidental exposure warning labeling and child-resistant packaging in isolation, they are good ideas which offer modest net benefits so long as they are done right. It is better for consumers if e-cigarette refill products (liquid and cartridges) and dissolvable smokeless tobacco products are sold in child-resistant packaging. Warnings along the lines of “keep out of reach of children” are good advice for those who may not already know that and a good reminder to everyone else.

  • The potential benefits are modest because the accident hazards from these products are fairly minor, less than those from countless household products. Nicotine is far less toxic than is often claimed or believed.

  • It is inevitable that the ANTZ will encourage FDA to pervert the reasonable and pro-consumer intentions of safety labeling and packaging rules to try to vilify nicotine and make the products less appealing to consumers. This would be grossly inappropriate, but it is easy to imagine it occurring. Thus, we made numerous observations about what actions would be considered unacceptable burdens as opposed to legitimate regulation.

As individual consumers, there are several useful observations you can submit as comments on this ANPRM in advance of the deadline of August 31, 2015.


If you want to do a fairly quick and simple (but useful) comment, follow the instructions for Part A (“Simple Submission”), then skip down to Part C (“Submission Instructions”) and you’re done.

If you’re feeling more ambitious, you may choose to also follow the instructions for Part B (“Optional Additional Detail”).

Part C provides instructions on how to submit your comment.

Part A - Simple Submission
We encourage CASAA members to submit a comment that covers the following points:

  • State that as a consumer you support appropriate child-resistant packaging and appropriate safety warning labels in principle.
  • However, that you and your fellow members of CASAA strongly object to the deeming regulation that would effectively ban all e-cigarette products other than a handful of cigalikes. If you personally quit smoking or remain smoke-free thanks to other e-cigarette products, take this opportunity to briefly mention your story. Then tell FDA that no possible benefits of the proposed rulemaking could possibly offset the damage to consumers and public health from the deeming regulation.
  • Remind FDA that nicotine, in the low concentrations found in e-cigarette liquid and smokeless tobacco products, is not very toxic. If you use open-system e-cigarettes and, like most consumers, have had accidental exposure to the liquid (e.g., spilling it on your hands, getting it into your eye), point out that this has happened and that you suffered no ill effects. However, if you or a member of your family has ever experienced an accidental exposure that caused ill effects, please give details to better inform FDA about what circumstances caused it.
  • If you are a consumer of either e-cigarettes or dissolvable smokeless tobacco products, tell FDA about roughly what percentage of the products you buy or see for sale are already sold in child-resistant packages. This is important information that will help regulators know either (a) the packaging mandate is largely moot because it is already being done or (b) there is need for a requirement because too many manufacturers are not using proper packaging.
  • Remind FDA that you have many products in your home that pose greater accidental exposure hazard than the products in question.
  • If you are an open-system e-cigarette user, point out to FDA (if it is true) that if refill liquid bottles were made too difficult to open or were made unattractive due to mandatory labeling or other restrictions, you would be much more likely to transfer the liquid into a different bottle.
  • Tell FDA that if the warning labels contain information that you know is false or misleading, that this would make you less likely to trust other information from the FDA or warning labels on other products.

Part B - Optional Additional Detail
If you are inclined to delve deeper into the details, it is probably most efficient to:

  • Read the CASAA comment and see what ideas you would like to repeat. Feel free to borrow any of the points we make (you might want to rewrite them in your own words).

A few other specific points you might want to make:

  • Take a look at some packages you have at hand of over-the-counter medicines, cleaning products, or other products that have accidental poisoning warning labels. You will probably find “keep out of reach of children” and a poison control hotline and nothing more. You can point this out to FDA and remind them that there is no legitimate reason for the hazard labeling on e-cigarette liquid or other tobacco/nicotine products to go into any more detail.
  • If you have used products that would be covered by the packaging requirements (such as bottles of e-cigarette liquid) that already have child-resistant packaging, consider telling FDA your experience with it. Were you happy to see it? Did it create too great a burden for you? Did you ever consider emptying the contents into another container because you did not like the original packaging?
  • If you have encountered the over-the-top warning labels that some of the major tobacco companies have put on their e-cigarettes (examples here), tell FDA about your reaction to them. Did you treat them as a joke and ridicule them? Did you just ignore all of the content because you knew that some of it was false? Or perhaps you or someone you know felt intimidated by these warnings, so much so that they were dissuaded from using the product and decided to continue smoking instead.

Part C  - Submission Instructions
Follow these instructions to make sure your comment is properly submitted and reviewed. (You might also find it helpful to review FDA's Tips for Submitting Effective Comments.)

1. Make sure that you include the following statement at the very top of your comment because it is required:  
    • I am commenting on ANPRM “Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products” (Docket No. FDA-2015-N-1514)

2. Make sure that somewhere in the comment you describe yourself a bit:
    • Mention if you are an e-cigarette user and how long you have been using e-cigarettes. Go ahead and mention how long ago e-cigarettes allowed you to quit smoking if that describes you.
    • If you are a CASAA member, please mention that to remind them that there is an organized consumer voice they should be listening to. (If you are not, please go HERE and join. It is free and important.)

3. Close your comment with a simple, “Thank you.”

4. Submit your comments here. (We strongly recommend you compose your comment in a word processor rather than directly in the text box. If you have a long comment, you may get an error message when you try to copy and paste your comment into the comment box. In that case, type "My comment is attached" in the comment box, and then upload the document that contains your comment. To upload your document--immediately beneath the comment box is a button labeled "choose files" for uploading. Click on that box and select the document containing your comment.)

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