23 posts tagged FDA
*Concerns growing around seized pharmaceutical nicotine *
“Unfortunately, there isn’t a lot of information to go on. However, the
following if likely something the electronic cigarette community would be
interested in learning about. Sounds like the FDA has been seizing
shipments of pharmaceutical nicotine for undetermined reasons.
Tasty Vapor owner Geoff Braithwaite has confirmed that a shipment of 12
kilograms of pharmaceutical nicotine was seized. That’s about 3 one-gallon
jugs by our calculations. According to Braithwaite, the seizure may
have occurred because the content was mislabeled as multi-purpose cleaner.
But his company isn’t the only victim.
There are unconfirmed reports that many bigger companies have lost
shipments to the FDA. Among them possibly, pharmaceutical company
Glaxosmithkline (makers of Nicorette gum), tobacco company R.J. Reynolds,
and electronic cigarette vaporizing liquid supplier Johnson Creek. A
recent shipment to Johnson Creek that was seized is believed to have been
around 240 kilograms (that about 550 pounds).
Initial rumors seemed to suggest that the FDA was targeting electronic
cigarette company shipments as a way to slow down and impede growth of the
industry. However, it now appears that the FDA is targeting any
pharmaceutical nicotine shipment and has been doing so since about
November. Some industry leaders in the e-cig world have yet to have this
problem. Others did not respond by the time of this post.
We’re continuing to dig for information. Has the FDA decided all
pharmaceutical nicotine is to be tested and checked out? Or is there
something more concerning at play (like, say, contamination) that the FDA
isn’t talking about yet? This is all conjecture right now. Hopefully we’ll
have more for you soon.”
Rob, of BlueMist Vaping commented on this article further down the page and
said, “Unfortunately, this isn’t new. I own BlueMist Vaping, and we had a
total of 15kg of pure nicotine seized over a few shipments. Customs
officials in one case sent no notice to either me or the shipping company,
and in the rest the notices arrived too late to do anything (30 days to
appeal, letter with case number and location postmarked a day before the
deadline and sent first class). The FDA is leaning on customs to make life
It really is speculation at this point. I will be continuing to follow this
story on my own and post an update as soon as I receive one.
SIGN THIS, GET YOUR FRIENDS TO SIGN THIS, SPREAD IT AROUND
SIGN THIS PETITION, SERIOUSLY NOW
If you do nothing else today, please click the link below and sign this petition right away. Like site says, the FDA is intending to propose DEEMING regulations on electronic cigarettes.
What does that mean? the problem is nobody knows. Taxes that will drive the price of juice way up? no more flavors except tobacco and menthol? They truly want to make vaping as hard as possible for us. The vape world we have come to know and love is being shaken at the foundation.
Make your voice heard today. Don’t let me down troops
This week, the American Council on Science and Health (ACSH), a consumer education and nonprofit advocacy group devoted to the promotion of sound science in public health policy, urged the FDA to reconsider their overly cautious stance on e-cigs. Like many of us in the vaping community have long since realized, the ACSH firmly believes that e-cigs have great potential to help Americans kick their cigarette habit. While the FDA cautions that e-cigs may contain unsafe components, the ACSH rightly points out that cigarettes DO contain dangerous ingredients, and are NOT safe. The ACSH is committed to truthfully communicating with smokers about the benefits of a harm reduction approach and promoting e-cigs to combat the negative health effects of smoking. Bottom line…e-cigs help people quit, myself included. Cessation products currently approved for use by the FDA (gums, patches, inhalers, etc.) did NOT work for me, and they don’t work for a lot of people. The ACSH believes that “a product that can end a smoker’s exposure to the carcinogenic products in tobacco smoke is not one that can be dismissed lightly. It should not be rejected based upon ideology or unscientific extrapolation and insinuation.” Well said! Kudos to the ACSH for their support of e-cigs as effective tobacco cessation products. Follow the link below to read the ACSH’s full statement. http://www.acsh.org/news/newsID.1995/news_detail.asp
Via their website, the FDA is now warning smokers against the use of electronic cigarettes, because the risks of such nicotine delivery systems are not precisely known. The statement reads, “e-Cigarettes may contain ingredients that are known to be toxic to humans, and may contain other ingredients that may not be safe. Additionally, these products may be attractive to young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.” It continues, “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.” I found the Google “Lay Person Translation”, found in the second half of the blog write up, to be very amusing. It was a much needed laugh after trying to digest the FDA’s point of view. Link to the full blog article: http://tobaccoanalysis.blogspot.com/2012/05/fda-warns-smokers-against-using.html Link to the FDA web page: http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm Link to the Polosa Study (Clinical Trial) mentioned in the blog article: http://www.biomedcentral.com/1471-2458/11/786
CASAA AND THE FDA
CASAA is currently organizing vapers to attend and testify at a public meeting that is being held at the FDA Center for Tobacco Products in Rockville, MD on January 19, 2012. Testimony will be taken from 3-4 PM.
It is CRITICAL that the FDA’s Tobacco Products Scientific Advisory Committee meet people who have had their lives changed by e-cigarettes. Even speaking for ONE MINUTE is enough. Please Facebook message Gregory Conley or e-mail him at email@example.com for more details.
Link on the FDA site is HERE
Smoke and mirrors behind FDA report on e-cigarettes An FDA-authored analysis of electronic cigarette contents has just appeared in the Journal of Liquid Chromatography and Related Technologies. The agency has, in the past, gone out of its way to find hypothetical dangers of e-cigarettes — even going so far as to try to bar their importation (a Federal judge stopped that attempt). This most recent article’s slant is in keeping with the FDA’s enduring prejudice against this clean nicotine delivery device. Thanks to Kate from VapersNetwork for the link
The study, performed by the the agency’s Division of Pharmaceutical Analysis, aimed to determine the levels of nicotine and nicotine-related by-products in the cartridges, refill solutions, and vapor of e-cigarettes from three different manufacturers. They report that nicotine content labeling was not always accurate, that nicotine is present in the “smoke” emitted, and that nicotine-related impurities in the contents of cartridges and refills varied from one manufacturer to another.
Unfortunately, observes ACSH friend and colleague Bill Godshall, Executive Director of Smokefree Pennsylvania, the findings are stated in a misleading and negative way, unnecessarily obscuring the actual benefits of e-cigarettes as a smoking cessation device. (For instance, the agency’s consistent referral to e-cigarette vapor as “smoke” suggests that it is similar to the carcinogenic combustion of cigarettes — which is not at all the case.) Such official misrepresentation is not surprising, he notes, considering that the report was written by those involved in the FDA’s biased 2009 report during their ill-fated attempt to ban such products.
“The variable level of nicotine in e-cigarettes doesn’t mean that they’re less helpful, or dangerous,” says ACSH’s Dr. Gilbert Ross. However, he notes, there is almost always some level of agenda-based misinformation present when the FDA discusses e-cigarettes. (See, for instance, the agency’s often cited — yet incorrect —claim to have detected one of the ingredients of antifreeze in some e-cigarettes.)
“The truth is,” says Dr. Ross, “the amount of so-called ‘carcinogens’ in e-cigarette vapor is no greater than in any other nicotine replacement product. The e-cigarette happens to be a very useful smoking cessation device that is much, much less toxic than cigarettes. We don’t yet have all the answers about their benefits and risks; these data are being accumulated now. For government authorities and other groups to condemn and attempt to ban them makes no sense: it blocks a product that’s clearly safe in the short term, while another, highly dangerous one remains on the market.”
Smoke and mirrors behind FDA report on e-cigarettes
An FDA-authored analysis of electronic cigarette contents has just appeared in the Journal of Liquid Chromatography and Related Technologies. The agency has, in the past, gone out of its way to find hypothetical dangers of e-cigarettes — even going so far as to try to bar their importation (a Federal judge stopped that attempt). This most recent article’s slant is in keeping with the FDA’s enduring prejudice against this clean nicotine delivery device.
Thanks to Kate from VapersNetwork for the link