Friday, December 11, 2015

FDA Call to Action: Submit Comments on FDA's Proposed Intended Use Regulation

Update 12/11/15: The FDA has reopened the comment period for this proposed rule. The new deadline is Wednesday, December 30th, 2015. Please follow the instructions in the post below to submit your comment.

Update 11/25/15: Yesterday, FDA announced, "In response to a request for more time to submit public comments, the FDA will be issuing a notice in the Federal Register re-opening the public comment period for the proposed rule." We will update this Call to Action when the docket is reopened for public comment.

DEADLINE for Comment is TUESDAY, November 24, 2015.

I. Background
The FDA is requesting comments on a proposed rule about “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses.'”

By way of background, FDA considers nicotine-containing products to either be pharmaceuticals (regulated as a drug, device, or combination product) or tobacco products. Pharmaceuticals are subject to a lengthy and expensive approvals process, and any e-cigarette products treated as pharmaceuticals would be immediately removed from the market as unapproved drugs/devices. Regulation as a tobacco product is problematic as well1, but regardless, it is imperative that if e-cigarettes are to be marketed as tobacco products, manufacturers2 be permitted to make reasonable claims in their marketing and not be hamstrung by FDA’s over-zealous regulation. Prohibiting manufacturers from providing honest and helpful information is bad for consumers and bad for public health.

Ostensibly, FDA is doing this to help avoid consumer confusion. We believe that this will actually increase confusion and will dramatically limit the ability of consumers to make informed decisions about the products they use.

To help you understand the effects of this proposed rule (“Intended Use Regulation”), manufacturers would be prevented from making any substantive claims about the value of e-cigarettes for smoking cessation or suggesting that they are less harmful than smoking.3 Urging consumers to make the switch from smoking to vaping is potentially problematic if FDA determines that it suggests an intended use of smoking cessation. FDA is even going so far as to invite comments on whether manufacturers should be able to make claims such as "satisfying smoking alternative," "provides all the pleasure of smoking, "get your nicotine fix," or "provides smokers the same delight, physical and emotional feelings" as smoking.”4

The Intended Use Regulation would not be limited to statements contained on labels, packaging, and traditional advertisements. The FDA is casting a wide net. For example, even posting a consumer testimonial on a company’s website would be potentially problematic since FDA could use that as "evidence" of intended use.

This is your chance to make the consumer voice heard.

As you probably know, the deeming regulation as currently proposed will effectively ban nearly ALL e-cigarette products after a grace period.5 The Intended Use 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.

As individual consumers, there are useful observations you can submit as comments on this proposed rule in advance of the deadline of TUESDAY, November 24, 2015.

Part A - Submission
If you have quit or substantially reduced your smoking by using e-cigarettes, please take a moment to recall whether any information provided by a manufacturer or retailer helped you make the transition. If so, please let FDA know.

Please let the FDA know about how you quit (or reduced) your smoking thanks to e-cigarettes and the role that information from the manufacturers and retailers played. In particular, let them know if some statements that would be illegal for manufacturers and retailers to make if this Intended Use Regulation is adopted were important on your path to quitting or reducing your smoking.

This could include:
  • First learning that e-cigarettes were an effective alternative to smoking from an e-cigarette advertisement (even if it was for a specific product you did not end up using).
  • Being persuaded to try e-cigarettes based on information on a manufacturer’s webpage.
  • Being inspired to switch by testimonials on a manufacturer’s website.
  • Receiving information at a vapor shop regarding how these products are an effective alternative to smoking and/or information about how you can successfully quit smoking using e-cigarettes.

If you believe this information was vital to your quitting or reducing smoking and that you might have continued smoking without it, please make sure to say so.

Also, if you believe that FDA imposing this kind of rule is bad for consumers and represents suppression of information that you believe you are entitled to receive from manufacturers, let FDA know that.

Part B  - 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 the Proposed Rule “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’”(Docket No. FDA-2015-N-2002)

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 the FDA 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, use the button labeled “choose files” which is immediately beneath the comment box. Click on that box and select the document containing your comment. Detailed tips can be found here under “Commenting.”
  • For individuals, uncheck the box that says "I am submitting on behalf of a third party." On the drop-down menu below, a category box will appear. You are an "individual consumer."


1 See CASAA’s comment to the FDA regarding the problems associated with deeming.

2 ”Manufacturer” is broadly defined so that it includes most specialty retail shops. For example, if a retail shop repacks or relabels tobacco products, or assembles, processes. or labels a tobacco product, or imports a finished tobacco product for sale or distribution in the United States, it is considered a “manufacturer” for these purposes.(Section 900(20) of the FD&C Act, 21 U.S.C. 387(20)).

3 There is a separate process (MRTP approval) to obtain authority to make "modified risk" claims that would allow a manufacturer of a specific product to make certain statements about how that particular product might pose fewer risks to the consumer, but that process is cost prohibitive and extremely burdensome, essentially closing it to all but the wealthiest of companies (and even those wealthy companies would have an incredibly uphill battle in gaining MRTP approval).

4 Predictably, UCSF TCORS (Stanton Glantz)  has filed a comment stating, “Cessation and ‘satisfaction’ claims cause confusion for consumers.”

5 The grace period set forth in proposed regulation was 2 years. However, there is some indication that FDA is seeking to shorten the grace period to 21 months and possibly even 6 months for flavored products..

No comments: