Tuesday, September 3, 2013

CASAA gives presentation in FDA 'Listening Session'

Dr. Carl V Phillips
CASAA Scientific Director

Rockville, MD -- On August 26, 2013, CASAA had the opportunity to have a "Listening Session" with policy staff from the FDA's Center for Tobacco Products (CTP).  CASAA directors Elaine Keller, Carl V Phillips, Ronald A Ward, and Julie Woessner gave a presentation and answered questions for little over an hour.

Listening Sessions are an opportunity for stakeholders and others to communicate their views to FDA staff.  They primarily consist of one-way communication, though the staff typically ask questions.  They do not, however, answer questions or provide direct feedback, which would be inappropriate for government decisions-makers to do in a private meeting (consider what would happen if they gave information to a company and not its competitors).  Moreover, the participants are asked not to disclose information about the FDA's questions or any suggestions about the implications of their reactions.  Without such an agreement, FDA would not be able have sessions like this for obvious reasons.

CASAA focused on two messages:  (1) Consumers are the primary stakeholders in discussions of tobacco harm reduction (THR) and need a formal seat at the table, which they do not currently have.  (2) Specific insights we could offer about THR consumer preferences and behavior and the implications of these for making good and avoiding bad regulation.  CASAA advocates for consumers and potential consumers of all smoke-free alternativers, but the presentation was focused on e-cigarettes because regulation of this category is currently most in play.

We pointed out that formal consumer representation is mandatory in other health regulatory processes (patient group representatives, etc.), and the "nothing about us without us" principle has been accepted by the FDA for decades.  And yet, consumers' only voice in the CTP process is via mass protest, which is not terribly efficient and not enough.  The supposed consumer representatives are actually tobacco control special interests whose interests are actually diametrically opposed to those of consumers.  We pointed out that a formalized seat at the table allows effective two-way communication and is in everyone's best interest.  The alternative, with the consumer voice being entirely in the form of mass protest and everything that comes with it, makes it difficult to make good regulations and is more costly to the FDA.

We argued that we and most consumers see proper regulation of smoke-free alternatives as more similar to that for foods and cosmetics (which FDA also regulates) than drugs.  Consumers appreciate having an invisible regulatory process that ensures universal and accurate labeling of contents, along with the quality control needed to ensure general safety.  But once that is in place, individual consumers are the best judge of whether to consume the product, how much, and what particular varieties.

We pointed out the counter-productivity (in terms of serving the citizens they are supposed to be benefiting, including consumer benefits of public health) of restrictions on flavors or nicotine strengths.  In particular, we emphasized that any regulation that was (or appears) intentionally designed to lower the quality of the products in order to discourage use (a description of such policies as banning menthol in cigarettes) is inappropriate for low-risk alternatives and would likely lead to massive protest and organized resistance.

In terms of specific points about consumers, we emphasized the vapers are very motivated, and why and how this translates into mass political mobilization.  We explained how many e-cigarette users find "cig-a-likes" unsatisfying in terms of flavor, delivery, or purchase price.  Thus someone who does not have access to other products (or does not know their advantages) faces a major barrier to completely quitting smoking.  In particular, we emphasized that appealing flavors were the difference between continuing to smoke and quitting for many switchers (and, of course, that flavors appeal to adults, and there is not a shred of evidence they are attracting children to e-cigarettes).  Similarly, adequate delivery (in terms of not just nicotine concentration, but also sufficient batteries) is important.

We pointed out the importance of the internet in giving consumers – most of who are not near an e-cigarette specialty store – access to better quality products.  As an aside, we pointed out that any regulations that favored low-quality devices over better ones, as well as imposed onerous mandatory requirements, would favor the cigarette companies' products – both their cigarettes, by making the alternative less appealing, and their e-cigarettes because they would be best able to comply with the regulations.

We addressed the common rhetorical point about "dual use" (and the related point about "gateway" effects) by reframing them more usefully as "transition."  We pointed out that there was nothing inherently harmful about dual use, of course, and that FDA officially agrees.  But we emphasized that anyone who is using e-cigarettes but still smoking should be thought of as one of the many switchers who used both for a while before quitting smoking.  With that, we could emphasize that making sure people have access to better e-cigarettes, as well as better communicating the comparative risks, is the key to helping complete the transition (and to ensure that no one makes the mistake of transitioning in the wrong direction).

 We have every reason to believe that the FDA was interested in what we had to say and paid attention.  Their questions focused on what we presented.  We, of course, know nothing about how seriously they will take it.  We remain guardedly optimistic.  However, we believe we presented the best possible case for giving consumers a formal seat at the table.  If they do not move forward to making that happen, we can safely conclude that they are actively refusing to provide such a seat, in which case we will know that we need to fully mobilize for fighting from the grassroots level and pull out all the stops.

(Note: The FDA has stated its intent to issue its proposed "deeming regulations" for electronic cigarettes sometime in October 2013. After reviewing the proposed regulations, CASAA will issue a Call to Action, as needed. Please watch for future updates on this blog or via your email, if you are a registered CASAA member.)


Wolfie said...

Thank you for being my voice.

Tom Black said...

Yes, Thank you so much for fighting for our rights to not kill ourselves with cigarettes.

Stephen Swen said...

Good Job!! Thank you for helping me to continue to be an ex-smoker.

Van said...

Excellent. Thank you CASAA.

Jamie Walker said...

I could never thank you all enough for everything you do!! I have been without a cigarette for almost 2 years now thanks to e-cigs. Hopefully I will continue from the efforts put forth by CASAA.

laura evans said...

Thank you CASSA for looking out for us e cig users.The e cig has helped me to become a ex smoker and I want to remain that away.

Connie Merrihew said...

I would still be smoking if it wasn't for electronic cigarettes and for certain e-juice flavors. Thank you for being our voice. It's appreciated more than you know!!!

Robert myers said...

Thank You! Cassa for fighting for a place at the table where we can finally have our voices heard.