AP: FDA Sending Warning Letters

[Hudsonkm]

Campaign for Tobacco-Free Kids applauds FDA for action against electronic cigarette distributors



The sad face is for the sheer amount of erroneous info in that article.

And from another article,

91 percent of adults in the U.S. think manufacturers should be required to test e-cigarettes for safety
82 percent think that the FDA should regulate e-cigarettes like other nicotine-containing products
68 percent of adults think e-cigarettes should have health warnings like tobacco cigarettes and other nicotine products

Now I'm not complaining about what it is they claim people want. Instead I am wondering where they drew these supposed percentages from.

http://www2.med.umich.edu/prmc/media/newsroom/details.cfm?ID=1711

 

[HighHeeledGoddess]

91 percent of adults in the U.S. think manufacturers should be required to test e-cigarettes for safety
82 percent think that the FDA should regulate e-cigarettes like other nicotine-containing products
68 percent of adults think e-cigarettes should have health warnings like tobacco cigarettes and other nicotine products

Now I'm not complaining about what it is they claim people want. Instead I am wondering where they drew these supposed percentages from.
e-Cigarettes: Support strong for health warnings, banning sales to minors | University of Michigan Health System

Those percentages of adults have never even heard of e-cigs! Who did they poll, themselves?

 

[cozzicon]

Those percentages of adults have never even heard of e-cigs! Who did they poll, themselves?

It's a complete astroturf job.

 

[Hudsonkm]

LAME! Ugh this is annoying... But then again we keep having stuff like this happen every so often so I guess I should be used to it by now and learn to deal with it.

 

[kristin]

And from another article,

91 percent of adults in the U.S. think manufacturers should be required to test e-cigarettes for safety
82 percent think that the FDA should regulate e-cigarettes like other nicotine-containing products
68 percent of adults think e-cigarettes should have health warnings like tobacco cigarettes and other nicotine products

Now I'm not complaining about what it is they claim people want. Instead I am wondering where they drew these supposed percentages from.
e-Cigarettes: Support strong for health warnings, banning sales to minors | University of Michigan Health System

I'd like to see the results of those questions in a survey of e-cigarette USERS. If you don't smoke and don't use ecigs, it's easy to give an opinon on how they should be regulated. Would they like me to vote on which alternative treatments should be allowed for their kids with cancer? Since my kids (thank god) don't have cancer, am I really the best qualified to make that decision for them?

I'm sick and tired of people who have no vested interest in my health making kneejerk decisions about my future. NO ONE - not the FDA, not the public health groups nor the media - has approached the e-cigarette community to see how WE feel about the matter. They ask non-smokers to weigh in on regulation of e-cigarettes, they ask smokers to test and report on how the devices work, they ask doctors to give inexperienced opinions on health benefits...if they would just ask US and our loved ones, they'd have all of the answers they need!

 

[jtcaseyjr]

I'd like to see the results of those questions in a survey of e-cigarette USERS. If you don't smoke and don't use ecigs, it's easy to give an opinon on how they should be regulated. Would they like me to vote on which alternative treatments should be allowed for their kids with cancer? Since my kids (thank god) don't have cancer, am I really the best qualified to make that decision for them?

I'm sick and tired of people who have no vested interest in my health making kneejerk decisions about my future. NO ONE - not the FDA, not the public health groups nor the media - has approached the e-cigarette community to see how WE feel about the matter. They ask non-smokers to weigh in on regulation of e-cigarettes, they ask smokers to test and report on how the devices work, they ask doctors to give inexperienced opinions on health benefits...if they would just ask US and our loved ones, they'd have all of the answers they need!

Not that I disagree with you at all, however if they surveyed smokers before all the regulations, and they went buy those surveys, there would probably be FAR less smoking regulations then there are now. We have a very biased opinion for our side. Just as anti-smoking advocates have a very biased opinion on their side. In order to get true fair results they need to have people that don't have strong opinions either way. Which unfortunately is almost impossible to do.

because we blow out something that looks like smoke visually speaking, you are going to get fanatics saying it's infecting their space and they shouldn't have to deal with it. Education and science is key for us.

 

[Vocalek]

Not that I disagree with you at all, however if they surveyed smokers before all the regulations, and they went buy those surveys, there would probably be FAR less smoking regulations then there are now. We have a very biased opinion for our side. Just as anti-smoking advocates have a very biased opinion on their side. In order to get true fair results they need to have people that don't have strong opinions either way. Which unfortunately is almost impossible to do.

because we blow out something that looks like smoke visually speaking, you are going to get fanatics saying it's infecting their space and they shouldn't have to deal with it. Education and science is key for us.

One more thing would be required: Sufficient factual information on which to base an opinion. I looked at how the questions were worded. They could not possibly have gotten an unbiased response to "FDA should regulate e-cigarettes like other nicotine-containing products" because they never informed those taking the poll that e-cigarettes can be regulated just as effectively under the Tobacco Act, and that regulating them "like other nicotine containting products" (ie. like NRTs) would result in the products disappearing from the market.

 

[jtcaseyjr]

One more thing would be required: Sufficient factual information on which to base an opinion. I looked at how the questions were worded. They could not possibly have gotten an unbiased response to "FDA should regulate e-cigarettes like other nicotine-containing products" because they never informed those taking the poll that e-cigarettes can be regulated just as effectively under the Tobacco Act, and that regulating them "like other nicotine containting products" (ie. like NRTs) would result in the products disappearing from the market.

Agreed, How the questions are worded and what information they give or leave out, can make a world of difference in the answers.

 

[Hudsonkm]

I'm sick and tired of people who have no vested interest in my health making kneejerk decisions about my future. NO ONE - not the FDA, not the public health groups nor the media - has approached the e-cigarette community to see how WE feel about the matter. They ask non-smokers to weigh in on regulation of e-cigarettes, they ask smokers to test and report on how the devices work, they ask doctors to give inexperienced opinions on health benefits...if they would just ask US and our loved ones, they'd have all of the answers they need!

That right there is pretty much exactly how I feel about this.

Agreed, How the questions are worded and what information they give or leave out, can make a world of difference in the answers.

Yes and as recent articles have demonstrated, they most likely were taking that survey with knowledge based off of erroneous info. A recent article I read actually stated clear as day that Big Tobacco is the one making and marketing E-Cigarettes as a socially acceptable alternative to smoking. REALLY annoyed me to see that when it wouldn't take much research to find out that Big Tobacco has NOTHING to do with it and in most cases would like to stomp out the Vaping industry.

--
Also Kristin brings up another good point.

I may not have stuck with E-Cigarettes if it wasn't for sites such as the ECF. Surprisingly enough there can actually be a learning curve with Vaping and many people might try it once then give up on it if they didn't know where to go for advice. I had problems with the first E-juices I tried and may not have ever known that there were TONS of other companies that I could try and/or get reviews on from people in the vaping community. I also had major issues with automatics and it wasn't until I read other peoples experiences that I decided to purchased some manual batteries. These made a world of difference when it came to deciding if I was going to stick with E-Cig's or not.

Yet, the smokers they use as survey candidates in researching the effectiveness of E-Cigarettes likely have no idea that there is a wealth of resources scattered all over the web to help them along.

 

[trying]

No replies ? the 15 day deadline has passed.
Only E-cigarette Direct posted something, and it looks more like it is for their customers than an officail reply to FDA.
Electronic cigarette | E-Cigarette Direct

 

[Vocalek]

This links to the page where the FDA issues are discusssed: Electronic Cigarette Media | E-Cigarette Direct.com

They have a lengthy disclaimer on the bottom of each page regarding intended use and containing health warnings, including the California clause now included on NJOY packaging as a result of the Consent Judgement.

I have to wonder how many extra lives have been saved by including the words, "Warning for California residents regarding Proposition 65: This product contains nicotine, a chemical known to the State of California to cause birth defects or other reproductive harm."

I wonder if those words are required on Nicorette, Nicoderm, and Nicotrol products sold in California? Does anyone know? The wording makes it appear as if the State of California has some health knowledge that has been kept a secret from the other 49 states.

I have a box of Nicorette and the pregnancy warning reads as follows:

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

So what about these birth defects? I found this on the ASH web site

Women who use nicotine gum and patches during the early stages of pregnancy face an increased risk of having babies with birth defects, says a study that looked at about 77,000 pregnant women in Denmark.

The study found that women who use nicotine-replacement therapy in the first 12 weeks of pregnancy have a 60 percent greater risk of having babies with birth defects, compared to women who are non-smokers, the Daily Mail reported. The findings were published in the journal Obstetrics and Gynaecology.

I tracked down the original journal article: Smoking Habits, Nicotine Use, and Congenital Malformations : Obstetrics & Gynecology

Isn't it interesting that ASH left out this part?

Our results showed no increased overall prevalence of congenital malformations among smokers. We found a slightly increased relative prevalence ratio for major malformations, but with no dose-response pattern.

Our findings indicate that nicotine may be teratogenic when used in nicotine substitutes, although they are based upon small numbers. If nicotine is teratogenic, why is this not seen for smokers? The reasons could be that inhaled heated nicotine in tobacco smoke is absorbed by a different route (ingested or transdermal).26-29 Nicotine used to substitute tobacco smoking may furthermore reach higher peak doses than we find for smokers, and nicotine in substitutes is not heated as in tobacco. Furthermore, chewing nicotine gum may also increase exposure to mercury, for example, from amalgam dental fillings.30

A slight change in the RPR was observed after eliminating minor congenital malformations. The overall RPR dropped from 2.63 to 2.05, indicating that nicotine may be more strongly associated with minor congenital malformations that are difficult to diagnose.

These results would seem to indicate that there is a chance that inhaling heated nicotine via a PV will show no increase in birth defects. We won't know until someone actually collects the data.

 

[BCB]

Excellent detective work, Vocalek! Keep up the good work.