FDA sends letter to e-cigarette company(ies) requesting info on adverse events

[Bill Godshall]

On February 27, the FDA sent a letter to at least one e-cigarette manufacturer requesting information on adverse events of e-cigarette products.
http://www.tveca.com/PDF/fda-letter.pdf

I sent a copy of this letter to numerous e-cigarette companies inquiring if they received the same or similar letter. But so far, all of the replies I've received from e-cigarette companies stated that they did NOT receive the letter.

Since the FDA doesn't currenty regulate e-cigarettes, there is no legal requirement that recipients of the letter comply with FDA's request.

But if any recipient of this letter chooses to comply with FDA's request, I suggest they send the agency all reports from customers regarding health and safety effects of the products (i.e. including beneficial effects).

Its truly unfortunate that the FDA has chosen to:
- continue its three year witch hunt against e-cigarettes,
- not correct or clarify any of its website's inaccurate and misleading fear mongering claims about health risks of e-cigarettes,
- not correct or clarify its website's false allegations that e-cigarettes are target marketed to youth,
- not correct or clarify its website's false claim that all e-cigarettes are unapproved drug delivery devices,
- continue denying the many health benefits e-cigarettes have provided for smokers who switch to e-cigarettes,
- fail to inquire about or study any health benefits e-cigarettes provide for smokers who switch, and
- repeat the agency's intent to propose a "deeming" regulation to apply Chapter IX of the FSPTCA tor e-cigarettes, which could ban most of the products and otherwise decimate the industry.

 

[mwa102464]

Bill,

Not for nothing but there only asking for negative input from this company, does this not sound odd to you ? why would they want to learn more about electronic cigarettes and only ask for consumer complaints and adverse event reports along with misuse and the consequences to the user ?

I would advise all manufactures to not give this information for the simple purpose of the FDA using it against the e-cig industry. It's not like they asked what positive things they have seen from the manufacturing and use of e-cigs. There snakes and will use this against the industry we already know who's side there on. Tell this vendor not to comply as well as all vendors or have the vendors send them there spec sheets and let the FDA find something wrong, why give them one iota of information , make them do there own homework seeing how they are. I think that's what your saying more or less anyways right.

 

[John1952]

Bill,

Not for nothing but there only asking for negative input from this company, does this not sound odd to you ?

Of course it's odd. As with most things, if you follow the money it will become clear.

 

[dlsw]

Wow, weird... Maybe they want to include it in the "scientific study"? Wouldn't that be anecdotal evidence?

 

[house mouse]

Are the vendors aware that they are under no legal obligation to reply? If I was a vendor and received a letter like that, it would certainly give me pause and make me wonder about what I needed to do. I'm sure the larger companies are aware of what they have to do vs. what they don't have to do, but I worry more about some of the smaller mom and pop type vendors out there caving in to their requests just because they don't realize that they don't have to.

 

[zoiDman]

I would suggest that anyone who receives this type of correspondence that they consult with their attorney as to the best way to reply.

 

[nerofiend]

Just remember, in all my life i have never found a more true statement than this one.

"Anything you say can and WILL be used AGAINST you in a court of law"

I have never seen this disproved in my life.

 

[Uncle Willie]

Just a little FYI ...

Center for tobacco Products Selects Dr. David L. Ashley as First Director for the Office of Science
Wednesday, April 14, 2010

The Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA) has selected Dr. David L. Ashley (CAPT, USPHS) as the Center’s first Director for the Office of Science.

As a science-based and science-led Agency; science provides the foundation for our regulatory decisions and the work we do on a daily basis to promote and protect the nations' health. As the Director of Science, Dr. Ashley will provide leadership and management of many scientific domains including tobacco product science, tobacco product review, epidemiology and metrics, as well as social and behavioral sciences.

His leadership, coordination, and support will also be crucial for the scientific activities and advice from the Tobacco Product Scientific Advisory Committee, establishment of tobacco product standards, integration of the public health/population health priority of CTP activities and coordination within the Office of Science.

Throughout his professional career, Dr. Ashley has performed research in the field of tobacco and developed specific expertise in determining the relationship between tobacco product design, contents, emissions, and biomarkers. His research has focused on the impact that the contents of tobacco products and design features such as ventilation and filter components have on the emissions from the product, how the product is used, and exposure of people who use the product or are exposed to second-hand smoke.

His depth of knowledge and expertise has led to his involvement as a member of the World Health Organization (WHO) Study Group on Tobacco Product Regulation and as chair of WHO’s Tobacco Laboratory Network.

Prior to this role, Dr. Ashley worked his way up at the CDC from a bench scientist to chief of one of the largest branches in the agency. These positions gave him the skill and expertise needed to lead a scientific organization.

Dr. Ashley will join CTP in June after serving as the Chief of the Emergency Response and Air Toxicants Branch, Division of Laboratory Sciences, National Center for Environmental Health at the Centers for Disease Control and Prevention (CDC) for the last decade.

In addition, Dr. Ashley has been the recipient of many awards during his federal career including numerous Public Health Service awards and the NCEH/ATSDR Director’s Award in 2009. Dr. Ashley received his Ph.D in Physical Chemistry from Emory University in 1982.

 

[Horseman9]

Ack, just another example of our government looking at citizens private lives (& thru their slanted glasses) instead of doing anything positive

 

[tommy2bad]

So if you felt inclined to answer this request, what would you say were the adverse effects?
Cotton mouth, mod envy, postman stalking?
How could any vendor know the adverse effects without conducting the research? Surely this should be aimed at manufactures, oh wait their in China and would bin this piece of spam.
My sugestion ! "Call me back in 20 years, we will know more then, in the mean time theirs lots of info on ECF, Thank you for calling"

 

[zoiDman]

... My sugestion ! "Call me back in 20 years, we will know more then, in the mean time theirs lots of info on ECF, Thank you for calling"

I think most Lawyers would advise you that Failure to Reply might not be a very good Option.

Now as to what to say when you reply, I would want to speak with My Attorney as what the exact wording might be.

 

[Dogman]

E-Cigs pose a serious threat to government's of the world's ability to "TAX" the living hell out of the "smokers". they spent allot of time and effort over the years making it politically acceptable to discriminate against that group. and for them there's big money involved.

Now call me a pessimist. but i don't think Science, common sense, facts or anything else will stop them from attacking us eventually. there sharpening there knives, and waiting for the opportunity to make hay in the press, and public opinion. hopefully we can get enough good press, and or educate enough people so when the crap hit's the fan they know better.

not that i think anyone here is under any false illusions when it comes to the governments greed and corruption, as we were (not so long ago) all members of the previously mentioned group "Targeted for Discriminatory Taxation" I suspect the memory is still fresh enough.

just my two cents.........

 

[kia2]

Well, I probably marked myself for life, and I sent an inquiry to the FDA stating my position on the tobacco industry as well as my pro stand on electronic cigarettes and asked where I should direct FOIA inquiries regarding FDA approved/nonapproved studies, funding and fact finding on the same. Meh, I'm already a govt peon at the bottom of their food chain (28 years) and they know everything about me, so I don't figure I'll be on any more watches than I already am.

 

[kia2]

And, here is the response:

Thank you for your email.

The following web address will help explain the current information regarding e-cigarettes and FDA. Electronic Cigarettes

As for information on FOIA request. Your request would need to be submitted under the Freedom of Information Act (FOIA). The following link provides more details regarding FOIA requests, Freedom of Information.

We encourage you to visit our website (Tobacco), which includes up-to-date information about the regulations that have been promulgated and actions CTP is taking regarding requirements for industry. You can sign up for automatic notification when there is any new information on the website (Sign Up for E-mail Updates on Tobacco Products).

Center for Tobacco Products/FDA
CTP Call Center: 1.877.CTP.1373 Tobacco

 

[Motivaper]

E-Cigs pose a serious threat to government's of the world's ability to "TAX" the living hell out of the "smokers". they spent allot of time and effort over the years making it politically acceptable to discriminate against that group. and for them there's big money involved.

Now call me a pessimist. but i don't think Science, common sense, facts or anything else will stop them from attacking us eventually. there sharpening there knives, and waiting for the opportunity to make hay in the press, and public opinion. hopefully we can get enough good press, and or educate enough people so when the crap hit's the fan they know better.

not that i think anyone here is under any false illusions when it comes to the governments greed and corruption, as we were (not so long ago) all members of the previously mentioned group "Targeted for Discriminatory Taxation" I suspect the memory is still fresh enough.

just my two cents.........

I agree wholeheartedly Dogman - well said! If it were about "science", or a "genuine" concern for safety, then that's where
their efforts would be directed! But since none of the results of the numerous research studies, lab tests, and other scientific evidence available has been "satisfactory" to opponents of e-cigs - it's clearly not about science or safety.

For e-cig opponents to (pretend to) make the problem (appear to) be about science or safety, when we know it's about the potential loss of billions of dollars, is called a smoke screen!

Just my .02 cents - now we almost have a nickel!

 

[Bill Godshall]

The following web address will help explain the current information regarding e-cigarettes and FDA. Electronic Cigarettes

Except that the FDA's e-cigarette webpage at Electronic Cigarettes
contains lots of false and misleading fear mongering claims about e-cigarettes, and fails to cite any scientific research.

 

[hoogie76]

Just thinking out loud for a minute but...

Maybe it wouldn't be a bad idea to voluntarily respond to the letter even though we didn't get one. There's a name and address and possibly a captive reader. After reading response after response of no complaints other than the customer didn't like the flavor of e-liquid they bought it might shed some light on the actual workings of the industry.

It might also be a good idea for vendors to share the procedures and testing we're doing and tell them to stop promoting the 2009 test results and point them in the direction of more recent testing (including your own if available). It seems strange that with all the hoopla created by the 2009 test, that they haven't tested again or is it possible that testing again may negate the original findings and create a more optomistic result?

Does anybody know what David Ashley's agenda is or can we safely assume it's the same position of the FDA in general? I'm just asking as I'm not familiar with his personal position on the e-cigs.

hoog

 

[Vocalek]

They don't need to test again. All they need to do is tell the truth, the whole truth, and nothing but the truth regarding their 2009 testing.

Oh, did they "forget" to mention the quantity of "carcinogens" they detected? Did they "forget" to point out that the 8 nanograms of Tobacco-specific Nitrosamines in a ml of liquid is no higher than the 8 nitrosamines in a 4 mg nicotine patch? Does the public know that a pack of Marlbors contains 126,000 nanograms of nitrosamine?

It's like going to your mother and complaining that your little sister socked you, and "forgetting" to mention that you pinched her first. Yes, I am accusing the FDA of behaving like a bratty bully.

 

[zoiDman]

From the FDA's web site.

---

"Because clinical studies about the safety and efficacy of these products have not been submitted to FDA, consumers currently have no way of knowing

whether e-cigarettes are safe for their intended use,
what types or concentrations of potentially harmful chemicals are found in these products, or
how much nicotine they are inhaling when they use these products."

---

Electronic Cigarettes

What I would like to know is are there currently ongoing Studies that might be Submitted in the Future?

I'm sure if there were Finished Studies, Someone would have Submitted them Already. Right?

 

[Dogman]

Just thinking out loud for a minute but...
Does anybody know what David Ashley's agenda is or can we safely assume it's the same position of the FDA in general? I'm just asking as I'm not familiar with his personal position on the e-cigs.

hoog

Well I'm not familiar with David Ashley"s agenda Per-Ce. but I do know a little about the inner workings of government having worked in "the system" for several years. If "David" didn't "drink the cool aid" so to speak, he would not have been hired in that capacity.(IMO) and when the time comes that he starts choosing which cool aid to drink and which not to, he will be replaced. in the meantime they get to use his name and his credentials as credibility. But when the cool aid pitcher gets passed down from Washington, it's either drink you share or go home......

Theoretically he could surprise us and go off the reservation, go public, if it's what he believed, and cared enough about doing the "right thing". But it would most likely cost him his career. depending on the political landscape at the time.

Call me a pessimist, but I'm not very optimistic when it comes to science, fact's, or truth trumping political will anymore.......

Who needs facts when we got demagoguery.