UPDATE: The FDA is no longer accepting comments for this hearing, however you can still sign this White House petition until February 13, 2013.
If you haven’t yet heard, the Food and Drug Administration (FDA) has announced its intention to regulate e-cigarettes under the Tobacco Control Act. The FDA held a public hearing on Section 918 of the Tobacco Act on December 17, 2012. Many tobacco harm reduction (THR) advocates testified. The FDA has extended the comment period for the notice of public hearing. The FDA will use the testimony that was given at the hearing and written comments for a report to Congress required by the Tobacco Act.
How to submit comments
On the website regulations.gov click the “Comment Now” button. The comment field is limited to 2,000 characters. Comments will be accepted until January 16, 2013.
1) When did you start smoking? How long and how much did you smoke?
2) How many times did you try to quit smoking? What different products and methods did you try? What did you like and dislike about the products/methods you tried?
3) If you stopped smoking completely some time in the past and experienced problems such as feeling depressed and/or anxious, getting along with others, concentrating, remembering, etc. describe those experiences.
4) Describe the effects switching to e-cigarettes has had on how much you smoke now.
5) Describe the health effects you have experienced as a result of switching to e-cigarettes.
6) Tell the FDA that there should not be any time limit on using nicotine replacement therapies (NRTs), but that it would be better to raise the amount of nicotine each piece provides than to have people use multiple types of products.
7) Tell the FDA that innovative products such as e-cigarettes should not be made less effective by setting nicotine doses too low.
8) If you use e-liquid that has a pleasant flavor added (such as fruit, coffee, or dessert), tell the FDA how this has helped you.
9) Urge the FDA to not propose the “deeming” regulation because it would ban e-cigarettes, and would sharply increase the price and reduce accessibility of the products even if FDA exempted e-cigarettes from the most onerous provisions in Chapter IX.
10) Ask the FDA to remove text from its website that is inaccurate and/or misleading.
On November 28, 2012 the FDA published a document announcing a public meeting on December 17, 2012, and the opening of a public docket to receive comments related to the implementation of section 918 of the FD&C Act, as amended by the Tobacco Control Act. Under Section 918(a), the Secretary of the Department of Health and Human Services is required to consider certain new approval mechanisms and more indications for NRTs. Several NRTs, including nicotine-containing gums, patches, and lozenges, are already marketed for smoking cessation. Section 918(b) requires that the Secretary, after consultation with recognized scientific, medical, and public health experts, to give a report to Congress examining how best to regulate, promote, and encourage the development of “innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments)” to better meet the following three goals:
1) total abstinence from tobacco use;
2) reductions in consumption of tobacco; and
3) reductions in the harm associated with continued tobacco use.
If you substitute the word “smoking” for the words “tobacco use” in these three items, they fit the goals of the THR community. Until now, total abstinence from all tobacco use (not just from smoking) was the only regulatory goal of our government. Sections 911 and 918 would change our focus to include measures to mitigate the harm caused by smoking.
The FDA will consider the information it obtains from the public hearing and related docket submissions in its implementation of the requirements of section 918, including in drafting the report to Congress required by section 918(b).