Fda Replies To My Letter!

[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!

[Lily]

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 loved what you wrote to the FDA! It was succinct! You know what's interesting in their cease and desist letters to the five suppliers is all the presumed testing they've done on them. It's so bogus. Just thought I'd give you a

[Uma]

Sometimes I wonder if their goal is to ban cigarettes.

[bmeyer46]

I got the same letter back from them also....it's what we in government call a "canned" letter.

[girldragon]

I got the same letter back from them also....it's what we in government call a "canned" letter.

Ditto-wow, and I thought I was special rofl!!!

[Jkimbo]

Ditto-wow, and I thought I was special rofl!!!

May be we are all saying the same thing? They seemed to be addressing the key points I made.