FDA December 17 Public Hearing: Key Takeaways

Klaus Kneale
by Klaus Kneale
December 18, 2012

Yesterday, I listened to the entirety of the FDA’s public hearing on the future of tobacco and nicotine alternatives regulation.   Electronic cigarette advocates and adversaries spoke on the potential of the FDA to endorse or dismantle the industry.   At the end of the day, I can say that the experience was quite encouraging.   You can read my notes from the event here.

There were a number of well articulated arguments for less aggressive regulation of electronic cigarettes (when regulation does get implemented that is).  We thank those that went and put a real face to the industry in front of the FDA.  Here’s three things I took away that I felt worth noting first and foremost.

Everyone wants fast tracking.

A major subject at the hearing was whether new, innovative nicotine replacement therapies and cessation aids should be fast tracked.  A rather simple, undeniable argument was presented multiple times.  Cigarettes kill roughly 50% of their users.  In the U.S. that’s 443,000 deaths a year or about a fifth of total deaths.  There aren’t many alternatives to smoking that could possibly be as bad as this.  For this reason, a number of speakers felt that fast tracking should be a more accessible option for smoking alternatives and therapies.

Fast tracking would work on two levels.  First, products that the FDA would otherwise be tempted to ban until extensive clinical research is done could make their way to the market and be studied through post market surveillance.  Statistically, every cigarette smoked is time off a smoker’s life.  Bringing even the most experimental products to market (with a few preliminary examinations) is better done sooner than later.  Second, fast tracking could allow new, innovative products to label themselves according to intention — that is, electronic cigarettes could be sold with the intention of helping people reduce the amount they smoke, quit smoking, or cut back on the harm done by their smoking.  Claims could be updated to match the most recent post market surveillance and ongoing clinical testing.

This change — were it to be made — could mean that electronic cigarette sellers would no longer be forced to tip toe around the topic of smoking cessation or harm reduction.  This would make them more competitive with tobacco cigarettes and there are few that believe these claims would be detrimental to public health.  If anything, they would reflect a more accurate assessment of the product rather than a legally-responsible, inaccurate assessment.

Dr. Abrams is warming up to electronic cigarettes.

Dr. David Abrams has been a general adversary to electronic cigarettes for some time now.  In a recent interview on HuffPost Live, he made statements about the new technology that didn’t win him any friends in the e-cig crowd.  Essentially his arguments against e-cigs focused on the non-existence of extensive, reliable, and unbiased research supporting claims made about their success as cessation devices and their low harm.

Granted, in Dr. Abrams’s comments, he didn’t say precisely that he is in favor of electronic cigarettes.  But I for one got a sense that he is warming to the idea.  In particular, Abrams suggests fast tracking new, innovative technologies.  Interestingly enough, the panel actually asked Dr. Abrams for his thoughts on electronic cigarettes.  Abrams states that some research has been done, but he doesn’t feel it is sufficient to make any claims about electronic cigarettes.  He touches specifically on the idea that e-cigs — no matter how good that are — should not be allowed to bypass quality control standards (I don’t think many e-cig users would argue against this).

As for the research, he says, most of it is done with what he calls a “sample of convenience” which skews results dramatically in favor of electronic cigarettes.  Largely, this is correct.  New studies are fixing this, but preliminary studies of a new product will almost always be forced to use that product’s early adopters as the sample pool.  Still, with a little more information, Abrams says, electronic cigarettes are a definite candidate for fast tracking.

Chantix may actually be what sets back electronic cigarettes.

Chantix came up multiple times during the hearing.  It is a drug used to treat smoking addiction that was fast tracked to market due to demonstrated success helping smokers quit.  In the time since, a number of very concerning side effects have appeared — chiefly, massive mood swings, night terrors, cardiovascular disease, and suicide.  This has cast a very dark shadow on the fast tracking process and may lead the FDA to require even heavier proof before products can be granted market clearance.

Anything that messes with brain chemistry probably shouldn’t be a candidate for fast tracking.  One can hardly compare fast tracking a drug that fundamentally alters behavior with that of a device that simulates something already on the market.  And yet, the panel seemed to view fast tracking as an all or nothing process.  Either it’s available for everything, or nothing.  This could mean fast tracking isn’t fast tracked.  Fast tracking won’t help current products if the process is reviewed and scrutinized for the next 3 years before anything else can be fast tracked.

So electronic cigarettes branded as cessation devices or nicotine replacement therapy options might take some time to happen due to this blemish on the process.  I for one won’t mind a healthy and open fast tracking process as long as all thing fast tracked are clearly labeled as market review products — meaning we don’t know everything that these do, but preliminary evidence is promising.


29 Responses to “FDA December 17 Public Hearing: Key Takeaways”

      Johnathan Brown on December 18th, 2012 11:56 pm

      Man, scccrew chantix. I see it fail more often than people stick with it. Anyway, thanks for sharing.

        robovape on December 19th, 2012 12:32 am

        they put the wheels in motion but the tires are spinning over this fast tracking…

          slap_maxwell on December 19th, 2012 2:36 am

          There is a huge difference between fast-tracking chemical cocktails that screw with your brain chemistry to help you quit smoking vs. alternative nicotine delivery systems for sure–and Dr Abrams needs to be reminded of that.

          I would like to see an industry body set up for QA and research purposes, sort of like the ASTM, IEEE, etc. Specifically I’d like to see some studies regarding the inhalation of various flavorings and possibly even silica particles.

            Dahcwon on December 19th, 2012 4:04 am

            Hopefully the FDA rules in our favor.

              Amanda on December 19th, 2012 5:07 am


                Amanda on December 19th, 2012 5:08 am

                I tried to listen to some at work.

                  ManuDawg on December 19th, 2012 7:09 am

                  Fast tracking of alternative delivery nicotine products such as Snus and E-Cigs is much different than Fast Tracking of a drug that alters your brain chemistry. These are very different NRT or THR Products and should be easy for the FDA to identify. Should the FDA decide to classify E-Cigs as NRT I would hope they would not apply any restrictions as to the length of allowable use. I have read a few posts from people who have quit analogs with E-cigs, got rid of all their E-Cig gear and 6 months, one year, sometime later they decide they need nicotine and pick up the analogs again.

                    MrsCasey on December 19th, 2012 9:16 am

                    Thank you for touching on some of the important things that were discussed at the hearing. I was only able to listen to the hearing in the morning.

                      John on December 19th, 2012 10:30 am

                      Excellent Recap. If you didn’t get to check the hearings… there’s another post on them. Very nice

                        Karla Lyle (MsV8PR) on December 19th, 2012 12:25 pm

                        Hope this went better than that horrible interview on the Huffington post. At least they had some people knowlegeable on what the issues are. I really hope this ends in our favor and the FDA uses their minds.

                          Mike on December 19th, 2012 2:13 pm

                          We shall see

                            unclerj on December 20th, 2012 3:28 pm

                            Great article!

                            PS, I spent $110 on Chantix which did not work at all for me.

                            It would have been better spent on my first E-Cig kit and juice!

                              robovape on December 20th, 2012 5:14 pm

                              the greatest advantage to FDA regulation will be that it will help doctors feel more comfortable recommending ecigs it to patients who smoke… most seem to see it as at least a healthier alternative, it may soon be recognized as an effective treatment option…

                                sandi on December 21st, 2012 12:55 am

                                I have a friend who used to be on chantix. She definately went through severe mood swings and im sure she was showing signs of depression. i hadnt realised at the time she was on these tabs.
                                serious stuff. I hope the FDA see the right side of this.

                                  sandi on December 21st, 2012 12:56 am

                                  Oh forgot to say I saw the first of the archived pieces of the meeting and found it very interesting

                                    Mike on December 21st, 2012 1:36 am

                                    Chantex is the devil, been there done that

                                      Mike on December 21st, 2012 3:17 am

                                      Chantix is one the most evil drugs out there! I tried it and it DID help me quit smoking, but it also kept me awake for 9 days straight!!! My blood pressure shot up out of control, and I honestly thought I was going to die. I am so glad to be far, far away from that drug! Big Pharma is going to make their money because they have deep pockets and that is exactly what politicians like!

                                        mongrel on December 21st, 2012 4:29 am

                                        I understand there will be many more hearings in the next year. There is a venue for the general public to share their thoughts with the FDA, all e-cig smokers should make themselves heard written comments will be accepted untiol January 16th. Please visit CASAA’s website and follow the link to post your comment: http://blog.casaa.org/2012/12/call-to-awareness-fda-public-hearing-on.html

                                          Amanda on December 21st, 2012 1:48 pm

                                          ive commented

                                            saboinia on December 21st, 2012 6:01 pm

                                            i smoked on chantixx…..and after…………it is sooo expensive and did not work on me where as e ciggys did….and @ a conciderable savings….

                                              MorrinB on December 22nd, 2012 5:32 am

                                              Chantix is evil. I’d hate to see the fact that it was fast tracked do harm to the ecig industry. Hopefully someone out there can see the difference between the products. Overall, I see many positives coming out of the hearing and am hoping for the best.

                                                Steve Mitchell on December 22nd, 2012 5:56 am

                                                I hope it goes good

                                                  robovape on December 24th, 2012 4:22 pm

                                                  Chantix… someone told me about it when it first came out and i noticed the commercials, i can’t take it, so i’m glad i never bothered… depression, insomnia, mood-swings… that’s what happens when i come off the nicotine in the first place, last thing i need is a pill that boosts that…

                                                    Adam on December 28th, 2012 4:23 am

                                                    Funny how Chantix gets green lighted despite all of the side effects; yet e-cigs still have the taboo factor.

                                                      Chad on January 2nd, 2013 6:48 am

                                                      Chantix gets the green light because of donations to the political parties from pharma companies. E cigs can never compete with that on a political level.

                                                        Kristina Pennell on January 11th, 2013 4:52 am

                                                        Chantix almost killed my aunt , Than almost Caused my husband to have a Heart attack …. it’s crap ……

                                                          Lincoln pennell on January 11th, 2013 1:43 pm

                                                          Chantix made me Sick … Depressed and feeling really bad about everything …….

                                                            saboinia on January 28th, 2013 1:23 am

                                                            chantix boooo e ciggy yay…….id rather vape than analog

                                                              Sheryl on October 13th, 2013 2:16 am

                                                              My homepage – binary option strategy (Sheryl)

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