Jkimbo

I sent the FDA a short message while at work and when I got home I got this reply. My orig message is included in the end. Sounds like they are trying to keep the door open for e-cigs just want to control it's every step. ----------- FDA reply below ------------ Dear *******, Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research. Please note that the FDA has not issued a "ban" on electronic cigarettes. The U.S. Food and Drug Administration issued warning letters to five electronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices. In a letter to the Electronic Cigarette Association, FDA said the agency intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health. The letter outlines the regulatory pathway for marketing drug products in compliance with the FDCA. For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use. The company must also demonstrate that manufacturing methods are adequate to preserve the strength, quality and purity of the product. "FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," the letter to the association read. FDA has determined that the electronic cigarette products addressed in the warning letters to the distributors, and similar products, are subject to FDA regulation as drugs. Under the FDCA, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug's safety and effectiveness have been proven. Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes. The companies receiving warning letters today are: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson's Creek Enterprises LLC. Certain companies received warning letters for additional reasons. For example, E-Cig Technology markets drugs in unapproved liquid forms, such as tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that has not been approved for use in the United States. These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so that the drugs can be vaporized and inhaled. You can locate more information at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm . Also, please note that prior to June 2009, the FDA did not have the regulatory authority to oversee tobacco products. On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act (FSPTCA, also known as the Tobacco Control Act) granting the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products. The Act establishes a new standard: to regulate tobacco products based on a public health and population health standard and authorizes the FDA, among other things, to set standards, require product listing and registration, revise health warning labels, create manufacturing standards, and review products intended to modify the risk of tobacco use. The Act specifically states that the FDA is not authorized to ban tobacco products. Best regards, CAO Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. -----Original Message----- From: druginfo@fda.hhs.gov [mailto:druginfo@fda.hhs.gov] Sent: Friday, September 10, 2010 12:59 PM To: CDER DRUG INFO Subject: DrugInfo Comment Form FDA/CDER Site Name: ******* E-Mail: ********** Comments: I object and am offended by your hard on to smash electronic cigarettes. I rely on them as an alternative to the more dangerous cigarettes I been smoking for 30 years! I finally was able to give them up and am getting my health back. If you ban ecigs I will no doubt have to go back to cigarettes. The messaging you are sending is quit or die! I fail to see how cigarettes are perfectly legal with over 4000 chemicals in it and your worried about a couple in electronic liquids. I feel your department is in the tobacco companies pockets!

I love vaping and drinking, better then analogs at 36mg!

Two words best describe the FDA, Nanny State

My FAVORITES are Marlboro and RY4, madvapes, and vaporgalaxy, and a few other places I can't think of right now. RY4 is the strongest, but u either like or or hate it

I love vaping and drinking! I have no probs. But I only vape tobacco flavor, no candy juices and at 24-36mg. I find alcohol intensifies the vaping. Yea, I like vaping and drinking

It happens to us at one time or another. Actually can happen easily if you have a number of cartos around or u forget when the last time u filled was. I use the condom method of refiling. Listen for a gargling sound, if u hear that stop! Then blow thru the mouth piece, should be find then. I hate when that happens but what you gonna do

No second hand smoke, smell or contaminants and it disappears quickly in the air. That should be all they care about I would think. But some people are a trip. I think the biggest issue about vaping indoors is the confusion it may have on people. It doesn't help that a lot of these devices look like cigarettes too.

Sort of like practicing a "don't ask, don't tell" policy are you?

IMHO, There are basically only to two kinds of liquids out there. Candy and tobacco. While the candy tasting kind are fun to try out and some are just fantastic for space juice! I can only use tobacco for all day vaping. But that's just me Also, I found I had to add to carts quicker, doesn't hold as much as cartomizers. I usually take two cartomizers filled with tobacco flavor and one cart in case I want a spacer flavor in between. This will last me on my way to work and get home too. When I get home I do direct drip and it really does taste better and hit better that way. I get about 10 good hits from 3 drops. But I prefer carring my ego in my pocket loaded with a tobacco cartomizer. Again that's just me

Madvapes smokes their prices. $10 for 50ml

Opposite for me. I NEED to vape before sleep and also during, I keep my ego on a stand next to my bed in arms length. I sleep better this way. Without vaping I have trouble sleeping. However I have always had a sleeping disorder. Vaping seems to help me.

I didn't trow out my last analogs. I saved them for emergencies. In 3 1/2 weeks I only had one and that was early on when my KR808 batt ran out. The cig tasted like crap and stunk, but satisfied my craving until my batt was recharged. Now I have a ego and so far have not had a batt prob. But the feeling of wanting to throw them out is certainly there. Analogs taste like crap and stink now

The best way to intake nicotine is to mainline it, and it's prolly approved by the FDA that way too

Energy Cow is very close to Red Bull energy drink. Taste great if you like Red Bull which I love. When I first started vaping it I couldn't stop. I was thinking of buying a quart of it lol. But then after a few hours of vaping it or about a half a day I got sick of it. It's not a all day vaping juice Great spacer juice! I also like adding a couple of drops to my Marlboro juice for a hint of flavor. Nice for mixing and str8 up but not for vaping all day if you know what I mean. Tried Clove too. Not bad, but tired of it all day. I prefer Marlboro with a hint of menthol for all day vaping.

Thank you. I direct drip at home and use cartos for on the go, but honestly I think carts vape more clouds then cartos and taste better. At least my original ones tasted better lol. I will check out petsmart!

So far my favorite is the Ego. Small enough to carry in shirt pocket but powerful and battery lasts nearly all day. It doesn't look like a cigarette can easily vape in stealth with it or vape clouds of smoke.

I bought 1 pound of polyfil from walmart for $3 but it has a funny taste to it. Where can I buy polyfil that doesn't taste funny or what filler can I use and where can I get it to refill carts? thx

I been vaping non-stop for the past 3 weeks. I feel like a freaking crack head! lol

What really sux is too little or too much juice produce same results, little vapor Finding the right amount, now that's the trick. Get a drip tip, it smokes carts and cartos!!!!

I recommend more nicotine

I started with the basic cigarette looking KR808 style by a company called Elektro. Over priced but performed good enough for me to know this was definitely the direction I want to go in! Then I upgraded to the ego last week, love it. I use cartomizers for on the go and refill carts at home, prefer the carts better vapor production! I am of course already thinking of another model to get. I considered the Hello16 but it looks too much like my ego so why bother lol? I love the way a silver screwdriver looks and do want to try out the 901 accessaries so it may be next for me. I also want to get a good 5 volt passthru next too. As for mods, I am still undecided. But I am sure the ego will remain my favorite for on the go. Great bang for the buck, I got the delux kit which contained two of every thing so in effect I got 2 egos! And it cost less then the crappy Elektro did! Live and learn! And then vape!

As crappy as it is and a rip off to, I'm glad it's happening. It brings public awareness to vaping and once you get started you move up. I started off much the similar way! very few people decide to actually research some thing first, specially if your out shopping any way. I'm sure the prices of those crappy stick ecigs will drop.

Agreed. this is over the top for like 90% of vapor heads but right up the alley for geeks and techno junkies! What I am curious about and have not found too much information regarding this is how to make your own "juice" from other questionable compounds. I would imagine the possibilities are there and certainly would interest more people then high tech vaping

Is there a break down some where on how many actual manufacturers there are and how many are from China? If not that would be nice stats

Wait a minute, a rock concert and the worse vice there was vaping? You sure about that?