Thank you Julie for bringing this to everyone's attention here, and for the amazing (and overwhelming) work that CASAA is doing.
Time is running very short on the government's calendar, and a lot of nasty issues are being pushed on a fast-track "under the radar" due to legislative time constraints.
Every one of us needs to be ready to respond immediately to all future CASAA CTA's as they are announced because by the time they are publicly posted here, our window of opportunity might only be measured by a few days.
This proposed amendment is particularly nasty as it has the power to completely censor any business from comparing smoking to vaping or even from sharing the most basic scientific facts about smoking with customers and current smokers.
If this amendment makes it through unopposed, it will essentially make educating our consumers illegal and circumvent the very limited protections we gained in 2009 under Judge Leon's ruling.
A vape business will not even be allowed to mention any of the hundreds of published and publicly available scientific data showing vaping is less harmful than smoking without violating the law.
Even posting a customer's comment that they stopped smoking with the help of ecigs will be a violation of the tobacco product/illegal medical product barrier that currently protects our industry.
When and if the comment period is re-opened, everyone needs to be ready to submit a comment no matter how long or short. Just make sure you submit something to be counted.
Please take 5 minutes to read the CASAA guidelines on each CTA to meet the basic requirements to make your comment count.
I'm attaching my own submitted comment on this CTA below.
Please feel free to publicly critique it, steal from it, personalize it, or use it as guidance for your own comment.
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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)
My name is John MacLeod, and I am a former smoker of 35 years.
I am just one of millions of Americans that have successfully reduced or quit smoking cigarettes due to e-cigarette vapor products, and I have been completely smoke-free for over 6 years now. I owe 100% of my success in quitting traditional cancer-causing cigarettes to the use of e-cigarette vapor technology.
Both my grandfather and my father lost their lives to smoking related illness.
I am the first in three generations to successfully break that deadly legacy.
I have personally wasted more than $5,000 over the years on multiple attempts to use traditional NRT patches and gums with zero success.
E-cigarette vapor technology is the only product that was able to eliminate my smoking habit from day one.
The only reason I decided to try an e-cigarette was out of the desire and desperation to quit smoking.
It is only due to the hundreds of scientific studies overwhelmingly proving e-cigarettes to be at least 95% less harmful than smoking, and the millions of testimonials online from other former smokers who had successfully quit smoking, that caused my decision to make my initial e-cigarette purchase.
Without access to this information, the true scientific facts, and the availability to first-hand evidence from other successful ex-smokers, I would still be smoking more than 2 packs a day of life-threatening tobacco cigarettes.
The severe restrictions caused by the proposed regulations regarding 'Intended Uses' infringes not ony on the right to Free Speech, but has the deadly potential to further confuse current smokers on the reduced risks associated with vapor products compared to traditional smoking.
This is contrary to the purpose and duty of the FDA in the role of protecting public health.
This proposed regulation will in fact suppress consumer access to verified scientific evidence, personal testimonials of ex-smokers, and will be directly responsible for millions of current smokers to remain practicing a tobacco habit that will contribute to the early death of one out of every two users.
E-cigarette advertising should never be prevented or censored from publishing scientific facts, consumer testimonials, or truthful data such as the number of carcinogens in vapor products compared to cigarette smoke.
These statements are information and independent data that consumers have a right to know.
To censor this type of information is analogous to prohibiting seat belt manufacturers from stating that seat belts have been shown to reduce the number of deaths from automobile accidents.
This type of proposed censorship is not only unethical, and a violation of the purpose of the FDA, but could also be considered as criminal in nature by directly causing millions of Americans to continue smoking and dying under false pretenses.
Recent surveys have shown a dramatic shift toward the false public perception that e-cigarettes are as harmful as or more harmful than smoking cigarettes in complete opposition to all of the growing available and substantial scientific evidence to the contrary.
This is a gross injustice to public health due to a politically-motivated misinformation campaign aimed at protected the status quo in regards to traditional tobacco industry and NRT pharmaceutical industry market share.
Just as nutritional supplement advertising fully disclaims that their promotional statements "have not been proven by the FDA", e-cigarette advertising should be required to carry no more than a substantial disclaimer.
Any regulations or censorship more restrictive than the above has the potential to cause massive and irreparable harm to the public health and further spread misinformation and fear to current and future at-risk smokers that will not have freely available access to the facts.
I would respectfully urge the FDA to take a more responsible approach to this issue, and not implement such drastic actions which will further confuse consumers as to the actual risks associated with smoking versus vapor products, and directly or indirectly cause the deaths of millions of more Americans who might otherwise switch to a product that has been proven to be 95% less harmful than smoking.
Thank you for your consideration on this life threatening public health issue.
Sincerely,
John MacLeod
Ex-smoker of 6 years due to e-cigarettes.
