Response From My E-Mail To The Fda

[girldragon]

I wrote an e-mail to the FDA regarding the benefits of e-cigs for myself and my concerns re:bans-here is their reply-really just a regurge of what you all know

Dear Andrea,

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

The U.S. Food and Drug Administration today 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.

Also today, 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.

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

ETA-I am now getting ready to place my order for a BUTT load of nicotine liquid as that is what they will stop the sale of, not the products themselves or flavors or PG-People, get ready as they are going to ban the Nicotine liquid (that is what I think is going to happen-until they can prove it safe to inhale) anyone correct me if I am wrong.

Edited September 10, 2010 by girldragon

[Uma]

hmmm, but the drug "nicotine" HAS been approved and accepted... cigs, patches, gum, pills, ....

they still don't make sense.

[Christopher]

Hmm interesting and I admire the fast response.

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.

So as a user pointed out yesterday, it woulds seem for now, the FDA is going ofter electronic cigarette companies either A. Toting false health claims B. Offering up a product that helps to improve some type of health aspect.

This is certainly a difference approach to what we've seen months ago. With that said however:

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

This shows that perhaps regardless of whether a company is touting health claims they may very well STILL go after other companies as we've seen in examples of recent product seizers in U.S. Customs.

I suppose at the very least their view isn't quite as cold as it once was but we must definitely stay alert especially, with the court case coming up this month on the 28th. If the court rules that an electronic cigarette, without a doubt, is a drug delivery device, expect many more cease and desist letters.

[Uma]

If they ban our "devices" then maybe it's only fair that we do a huge major sit in strike and demand for coffee cups, candy bar wrappers, ice cream scoops, Ice Tea glasses, tomatoes, etc be banned from our world.

[girldragon]

Hmm interesting and I admire the fast response.

So as a user pointed out yesterday, it woulds seem for now, the FDA is going ofter electronic cigarette companies either A. Toting false health claims B. Offering up a product that helps to improve some type of health aspect.

This is certainly a difference approach to what we've seen months ago. With that said however:

This shows that perhaps regardless of whether a company is touting health claims they may very well STILL go after other companies as we've seen in examples of recent product seizers in U.S. Customs.

I suppose at the very least their view isn't quite as cold as it once was but we must definitely stay alert especially, with the court case coming up this month on the 28th. If the court rules that an electronic cigarette, without a doubt, is a drug delivery device, expect many more cease and desist letters.

Agree about the fast response, however; it could mean one of two things-1)They really DO care about the average American citizen OR 2) They want to keep us all calm and not cause an ordering of liquid nicotine JAM from all the current panicked "users" by using ambiguous wording (which IMHO is exactly what they did-under the guise of "just watch the labeling" then the quiet "small print" of the last portion you quoted. I do believe they will stop the nicotine liquid at the very least-I now have 800 ml of liquid coming (500 36mg that I can mix with caution of course) and the rest pre-mixed).

I think they just want a piece of the action-and complete world domination ) If I were a supplier, I would now be working out a way to find out who my customers were (perhaps something like a list of forum members and such-and really put some effort into how I might QUIETLY fill a probable supply shortage

[FTJoe]

hmmm, but the drug "nicotine" HAS been approved and accepted... cigs, patches, gum, pills, ....

they still don't make sense.

I believe the FDA has the mandate to make sure that if you are using something like gum to get nicotine, that the levels in it have been studied, effects, warnings, etc. They look at the study and determine if the drug/drug delivery system is okay to sell. One of the primary things that has to be in it is a package insert which they approve as well. How to use, how much to use, side effects, what to watch out for. In theory to protect you, in reality to protect the company. We have none of that. They also want people to say its a stop smoking aid for some reason even though I know tons of people that chew it all day long. it is marketed as a stop aid. I think if they want to, they will be able to be all over this from both initials, F (PG) and D (nic/delivery system).

As far as wanting a piece, they don't, not until a big boy gets it moving, then taxed. They have no problem if you keep smoking as long as you pay tax.

[girldragon]

"As far as wanting a piece, they don't, not until a big boy gets it moving, then taxed. They have no problem if you keep smoking as long as you pay tax."

Isn't that "as long as you pay tax" what wanting a piece implies?

Edited September 10, 2010 by girldragon

[FTJoe]

"As far as wanting a piece, they don't, not until a big boy gets it moving, then taxed. They have no problem if you keep smoking as long as you pay tax."

Isn't that "as long as you pay tax" what wanting a piece implies?

Sorry - someone posted this "I think they just want a piece of the action-and complete world domination"...

They don't want a piece, they are the rabid dog of the gov who wants to keep tax revenues up and lobby money in their pocket. once the big boys get involved they will be able to get it, it will cost more, and it will be taxed. JMHO

[girldragon]

Sorry - someone posted this "I think they just want a piece of the action-and complete world domination"...

They don't want a piece, they are the rabid dog of the gov who wants to keep tax revenues up and lobby money in their pocket. once the big boys get involved they will be able to get it, it will cost more, and it will be taxed. JMHO

Lol! I get it now