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

[Vocalek]

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?

At the time that FDA wrote the quoted text, they were trying to regulate electronic cigaettes as a drug & drug-delivery device combination. In that context, conducting clinical trials and submitting them to FDA would be a prerequisite for obtaining approval to market this new "treatment". Judge Leon's ruling changed all that. If there is any public health concern, according to the judge, FDA could take care of this by regulating the products under the (then) newly-passed tobacco Act.

How many clinical trials do you suppose RJ Reynolds submitted to FDA before beginning to sell Camel cigarettes, Camel snus, orbs, strips, and sticks? Zero. In the past there was never any requirement to submit a new tobacco product to the FDA.

Several small studies of e-cigarettes have been completed by independent researchers. These have been published in scientific journals or presented at scientific conferences such as the SRNT conference I am attending as I write this. The FDA staff is fully aware of these, as they read all the scientific journals and they have at least a dozen employees at attendance in conferences such as this.

Nobody just "submits" the results of studies on an ad hoc basis to FDA.

There is an entire New Drug Approval (NDA) process in place for pharmaceutical companies to seek approval for a new medical drug or device. It begins by ponying up a large sum of money to the FDA to kick off the process and then completing a series of safety and efficacy (to see whether the drug works as intended) studies, starting with testing on animals and ending with large clinical trials.

Under the tobacco Act, all products that were on the market as of February of 2007 can stay on the market as-is. Any new tobacco products will need to go through an approval process that has not yet been defined by FDA. Any product that the manufacturer wants to make reduced-exposure or reduced risks claims about will need to go through an approval process that, again, the FDA has not yet defined.

So the answer to your questions are "Yes" some studies are going on, and "No" they are not being submitted to the FDA, as there is no vehicle in place, no standards for what tests are needed and how they should be conducted, no rules, and no regulations.

 

[Docliv]

The FDA is like a nightmarish broken record. One point of view, one agenda bla, bla, bla. I still think that an ECF member request to CBS 60 minutes to do a report on E-cigarettes would be the most helpful activity to promote the cause. They have the integrity (and power) to do the job properly. I have made several requests, but as yet have received no response. IMHO this story has all the components for a great 60 minutes report: Money, Power, Corruption, Life & Death, David and Goliath, etc. What do you think?

 

[zoiDman]

...

Several small studies of e-cigarettes have been completed by independent researchers. These have been published in scientific journals or presented at scientific conferences such as the SRNT conference I am attending as I write this. The FDA staff is fully aware of these, as they read all the scientific journals and they have at least a dozen employees at attendance in conferences such as this.

Nobody just "submits" the results of studies on an ad hoc basis to FDA.

...

Thank you for the Information Vocalek

It seems that Studies would be Key in this Issue.

 

[t9c]

I would love to see 60 Minutes, Frontline, Dan Rather Reports, or Stossel take on the whole issue. We can assume they know about the e-cig debate as there's been thousands of shorts aired on the subject and plenty of reported court & state congressional proceedings. So why are they balking? Perhaps their boardrooms are afraid of the anti's & FDA and the power they wield over them? Maybe they have drank the cool aid themselves?

The FDA is like a nightmarish broken record. One point of view, one agenda bla, bla, bla. I still think that an ECF member request to CBS 60 minutes to do a report on E-cigarettes would be the most helpful activity to promote the cause. They have the integrity (and power) to do the job properly. I have made several requests, but as yet have received no response. IMHO this story has all the components for a great 60 minutes report: Money, Power, Corruption, Life & Death, David and Goliath, etc. What do you think?

 

[tommy2bad]

I would love to see 60 Minutes, Frontline, Dan Rather Reports, or Stossel take on the whole issue. We can assume they know about the e-cig debate as there's been thousands of shorts aired on the subject and plenty of reported court & state congressional proceedings. So why are they balking? Perhaps their boardrooms are afraid of the anti's & FDA and the power they wield over them? Maybe they have drank the cool aid themselves?

Well not drank the cool aid exactly but the do sell advertising space to the kool aid manufactures.

 

[mwa102464]

The FDA is like a nightmarish broken record. One point of view, one agenda bla, bla, bla. I still think that an ECF member request to CBS 60 minutes to do a report on E-cigarettes would be the most helpful activity to promote the cause. They have the integrity (and power) to do the job properly. I have made several requests, but as yet have received no response. IMHO this story has all the components for a great 60 minutes report: Money, Power, Corruption, Life & Death, David and Goliath, etc. What do you think?

Once this documentary is complete I hope it really gets picked up by one of the major news affiliates and a special is done on this, I think it is likely = http://www.youtube.com/watch?v=9bXG7yXzr0Y

 

[Bill Godshall]

zoiDman wrote:

It seems that Studies would be Key in this Issue.

No, that is wrong. The FDA is not interested in any scientific or empirical evidence that contradicts the agency's intolerant abstinence-only policy, and the agency's false claims that all tobacco products are as just hazardous as cigarettes.

More than a dozen studies have been conducted and published (that found e-cigarettes provide many health benefits to consumers, and virtually no risks) snce then Deputy FDA Commission Josh Sharfstein banned e-cigarette sales in 2009, and held the press conference where he and others made many false and misleading fear mongering claims about e-cigarettes (in his failed attempt to win the lawsuit against SE and NJOY).

 

[zoiDman]

zoiDman wrote:



No, that is wrong. The FDA is not interested in any scientific or empirical evidence that contradicts the agency's intolerant abstinence-only policy, and the agency's false claims that all tobacco products are as just hazardous as cigarettes.

More than a dozen studies have been conducted and published (that found e-cigarettes provide many health benefits to consumers, and virtually no risks) snce then Deputy FDA Commission Josh Sharfstein banned e-cigarette sales in 2009, and held the press conference where he and others made many false and misleading fear mongering claims about e-cigarettes (in his failed attempt to win the lawsuit against SE and NJOY).

Wrong? OK

So how is this fight going to be Won?

 

[sailorman]

Vapers should write to vendors and e-cig product companies describing the impact of e-cigs on their lives, including any adverse effects. Be sure to include on line mentioning the need to drink more water, or another minor side effect such as a symptom of cigarette withdrawal. When vendors are asked to provide accounts of adverse effects, they should be capable of providing them, in the form of hundreds of letters from users. The FDA should be forced to cull through all these accounts of how e-cigs have changed peoples lives and health for the better in order to find the odd account of dry mouth or minor throat irritation. The FDA can't force the vendors to redact positive information in order to highlight the negative information.

When a corrupt corporation is forced to turn over documentation by an investigating agency, it is a legal and standard tactic to flood the inquiring agency with millions of documents, within which the desired information may, or may not, be contained. Vendors should take a lesson from this and adopt the same tactic when faced with inquiries from the FDA.

So, I say let the vendors respond. But put them in a position that the only response they'll be able to make is to bombard the FDA with thousands of positive accounts; thousands of heart wrenching letters extolling the virtues of making the switch from smoking to vaping. Force the FDA to hunt long and hard to find that tiny needle they seek in a very, very large haystack.

 

[sailorman]

I would love to see 60 Minutes, Frontline, Dan Rather Reports, or Stossel take on the whole issue. We can assume they know about the e-cig debate as there's been thousands of shorts aired on the subject and plenty of reported court & state congressional proceedings. So why are they balking? Perhaps their boardrooms are afraid of the anti's & FDA and the power they wield over them? Maybe they have drank the cool aid themselves?

Notice how much advertising BP does on T.V.? There's your answer, in a nutshell. The only media that would touch a story like that would be CPB through Frontline. Even that is doubtful because they too are dependent on grants from BP, a result of huge cutbacks in the government support that maintained their independence for decades. It's not the FDA or the anti's that are the problem. The FDA has no power over media. The ACS or ALS has no power over the networks. Corporate America calls their shots, and that includes BP.

Not to get political, (but, at the end of the day everything is politics) this is just an unintended consequence of the deregulation that allowed pharmaceutical companies to advertise to the general public. Before that deregulation, a production like "60 Minutes" might have been all over this issue. Now, they cower in fear, as do all the other networks, under the threat of losing tens of millions in advertising revenue for the latest cure for restless leg syndrome. The e-cig issue is only one of many issues that mainstream "investigative journalism", will never report on for fear of retribution by their corporate sponsors.

Remember when TV ads for cigarettes were banned? Before then, you never heard anything from 60 Minutes, or anyone else, about tobacco companies. After the ban, journalists were free to trash BT at will. And they did.

The only investigative journalists who remain independent enough from the influence of BP's massive advertising accounts are those who receive virtually no attention. There are many of them but they have a cumulative following that doesn't amount to 10% of a single night's sitcom audience. Unfortunately, that includes Dan Rather. He has the integrity but, in his current position, lacks the audience. It would take someone with the media clout and independence of the notorious Michael Moore to get enough airtime to make a whit of difference. I can't think of anyone else who would fit the bill. Even Stossel would never dare offend Fox's corporate masters so grievously, regardless of his personal convictions.

 

[mwa102464]

Vapers should write to vendors and e-cig product companies describing the impact of e-cigs on their lives, including any adverse effects. Be sure to include on line mentioning the need to drink more water, or another minor side effect such as a symptom of cigarette withdrawal. When vendors are asked to provide accounts of adverse effects, they should be capable of providing them, in the form of hundreds of letters from users. The FDA should be forced to cull through all these accounts of how e-cigs have changed peoples lives and health for the better in order to find the odd account of dry mouth or minor throat irritation. The FDA can't force the vendors to redact positive information in order to highlight the negative information.

When a corrupt corporation is forced to turn over documentation by an investigating agency, it is a legal and standard tactic to flood the inquiring agency with millions of documents, within which the desired information may, or may not, be contained. Vendors should take a lesson from this and adopt the same tactic when faced with inquiries from the FDA.

So, I say let the vendors respond. But put them in a position that the only response they'll be able to make is to bombard the FDA with thousands of positive accounts; thousands of heart wrenching letters extolling the virtues of making the switch from smoking to vaping. Force the FDA to hunt long and hard to find that tiny needle they seek in a very, very large haystack.

Agree, fight fire with fire against the FDA, and Bombard them, I'm so tired of watching them do what they do and post misguided information on there website against vaping and e-cigs as they continue to do, and plus they are on Big Tobacco and Big Pharma's sides, the vaping community needs to stand tall and fight fire with fire and not fall into there sneaky traps which this letter they sent out is for sure and they will use against the vaping community in my opinion when they gather info from vendors if they send back any negative feedback. Instead bombard the with all positive information as much as possible and the proper thing to do while vaping.

 

[rothenbj]

Well not drank the cool aid exactly but the do sell advertising space to the kool aid manufactures.

And therein lies the underlying reason for lack of a story. The journalists among them may want the story, the business man doesn't.

 

[sailorman]

And therein lies the underlying reason for lack of a story. The journalists among them may want the story, the business man doesn't.

Exactly. There are so few real journalists anymore anyway. The bad ones work for networks that are scared spitless to offend their big pharma advertisers. The good ones are all relegated to the backwater of independent media because the media moguls don't want them rocking any boats.

There are no investigative journalists with a big enough megaphone. Only an independently wealthy journalist who is also a producer and has a good nose for PR could ever tackle this story in a way that more than a handful of people will see it. The only people who could do this are Oprah, if she simply acted as a producer and hired a real investigative journalist, or Michael Moore and he's got his own issues even if he wanted to tackle a story like this.

 

[Dogman]

Well Obama is a smoker aint he? lets send him some ecigs and get him on our side.

Front page News: Pres flips FDA officials the bird in white house meeting, while smoking ecig in oval office.

I know.... I know..... just a though.....

 

[TennDave]

Adverse effects....hmmm, let's see. Besides not having any lighters around (sometimes it would be good to have one for reasons like lighting an outdoor fire pit), but not caring? I truly can't think of any other.

 

[DC2]

Thanks for the succinct explanation, I'm sure I'll be quoting this in the future!

At the time that FDA wrote the quoted text, they were trying to regulate electronic cigaettes as a drug & drug-delivery device combination. In that context, conducting clinical trials and submitting them to FDA would be a prerequisite for obtaining approval to market this new "treatment". Judge Leon's ruling changed all that. If there is any public health concern, according to the judge, FDA could take care of this by regulating the products under the (then) newly-passed Tobacco Act.

How many clinical trials do you suppose RJ Reynolds submitted to FDA before beginning to sell Camel cigarettes, Camel snus, orbs, strips, and sticks? Zero. In the past there was never any requirement to submit a new tobacco product to the FDA.

Several small studies of e-cigarettes have been completed by independent researchers. These have been published in scientific journals or presented at scientific conferences such as the SRNT conference I am attending as I write this. The FDA staff is fully aware of these, as they read all the scientific journals and they have at least a dozen employees at attendance in conferences such as this.

Nobody just "submits" the results of studies on an ad hoc basis to FDA.

There is an entire New Drug Approval (NDA) process in place for pharmaceutical companies to seek approval for a new medical drug or device. It begins by ponying up a large sum of money to the FDA to kick off the process and then completing a series of safety and efficacy (to see whether the drug works as intended) studies, starting with testing on animals and ending with large clinical trials.

Under the Tobacco Act, all products that were on the market as of February of 2007 can stay on the market as-is. Any new tobacco products will need to go through an approval process that has not yet been defined by FDA. Any product that the manufacturer wants to make reduced-exposure or reduced risks claims about will need to go through an approval process that, again, the FDA has not yet defined.

So the answer to your questions are "Yes" some studies are going on, and "No" they are not being submitted to the FDA, as there is no vehicle in place, no standards for what tests are needed and how they should be conducted, no rules, and no regulations.

Search words: studies clinical trials FDA drug approval process

 

[Vocalek]

Thanks for the succinct explanation, I'm sure I'll be quoting this in the future!


Search words: studies clinical trials FDA drug approval process

Good search string. And to find studies, go to clinicaltrials.gov and search.

e-cigarette = 5 hits
"electronic cigarette" = 7 hits (including the 5 above)
nicotine tobacco = 437 hits, some of which include putting smokeless tobacco products head to head with NRT products.
nicotine inhale = 18 results

Any others?

 

[DC2]

Good search string.

Oh sorry, that was just for me to be able to find this post again using the Advanced Search feature.

 

[sailorman]

Adverse effects....hmmm, let's see. Besides not having any lighters around (sometimes it would be good to have one for reasons like lighting an outdoor fire pit), but not caring? I truly can't think of any other.

Yep, I got "burned" by that one. I had to dig through all my camping gear for a my great big survival lighter to light my Hibachi. PVs also suck for lighting fireworks.

Ashtrays. You never realize what other things they can be handy for until you've thrown them all out.

No more burn holes in clothing. Those come in handy when you have two identical garments that you want to rotate and you can only tell one from the other by the burn hole.

Tick removal: Much harder to do with a PV than with the end of a lit cigarette.

When I buy sunglasses or other items and need to remove tags that are attached by those tough little plasic cords. Now I have to hunt for scissors or a knife. I used to melt them off with a cigarette cherry. Now, they gunk up my atty.

PVs are no good for repelling mosquitoes or biting flies. I don't think citronella e-juice would be an option.

Empty cigarette packs were useful for temporarily carrying certain other things. Now I have none.

Yeah.... I never realized all the negative impacts. I guess I should quit and just start smoking again.

 

[rothenbj]

Adverse effects....hmmm, let's see. Besides not having any lighters around (sometimes it would be good to have one for reasons like lighting an outdoor fire pit), but not caring? I truly can't think of any other.

Dave, I can't tell you how many times I've missed having that fire or light handy in my pocket. The light portion is pretty much handled as long as I have my Droid on me, but not having ready fire does get inconvenient. I used to carry 2 or 3 most of the time just so I could find one quickly.

@Sailorman, that's a pretty good list.