WARNING LETTER

September 8, 2010

Ms. Shena Malave
President
Gamucci America
c/o Smokey Bayou, Inc.
9838 Old Bay Meadows Road, Suite 332
Jacksonville, Florida 32256

Dear Ms. Malave:

This letter concerns products marketed by your firm under the “Gamucci” name, including the components thereof. According to your Internet website, www.gamucci-america.com, Gamucci America is an authorized distributor of Gamucci Electronic Cigarettes and Cigars and is owned and operated by Smokey Bayou Inc.

September 8, 2010

Mr. Matt Salmon
President
Electronic Cigarette Association
1401 K Street, N.W., Suite 600
Washington, DC 20005

Dear Mr. Salmon:

FDA today has taken enforcement action against five distributors of electronic cigarettes and related components, for practices which violate various provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). The warning letters issued today involve violations of good manufacturing practices, making unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical ingredients like rimonabant and tadalafil.

Over at the Electronic Cigarette Forum's Smoking Everywhere V. FDA Daily Docket Sheet Update there has been great debate this week about how the vaping community should respond and proceed after the U.S. Court of Appeals sided with the FDA in the Smoking Everywhere vs FDA case resulting in a stay of Judge Leon's previous ruling denying their jurisdiction over ecigs until at least September when the court will hear arguments and make a final ruling.

Needless to say most people are outraged, some are confused and sadly many of those the vaping community looks up to as leaders have been arguing with each other instead of taking action while some vendors seem to be finally ready to challenge the FDA themselves.  

As usual in matters this important regarding things I've taken hours to consider and write my thoughts about, I figured I'd share here as well.

Breaking news on the vaccine front!! If I were John Banzhaf I'd be sending out press releases saying "in response to my recent blog posts regarding vaccines, the National Institute of Health announced they are giving a $10 million dollar grant to the developers of NicVAX, the anti smoking vaccine, to fund phase III testing." But I won't.

What is NicVAX? An anti-smoking vaccine?

NicVAX is a new injectable vaccine developed by Nabi biopharmaceuticals of Rockville Md which the FDA has already granted "fast track status" to that researchers claim will help people quit smoking and prevent them from relapsing.

NicVAX has already passed initial regulatory hurdles to show the idea is sound and now move to clinical trials where patients are given six monthly shots. Early results show that smokers using the vaccine had a higher rate of success at abstinence from tobacco than those given the placebo.

My report on an article claiming E Cigarettes May Be More Effective Than Swine Flu Vaccine got me to thinking about how the FDA has responded to the public health threat of the swine flu in comparison to the public health threat of smoking. The differences are astounding.

The H1N1 Swine Flu Pandemic has now been declared a "National Emergency" and as the article pointed out

According to President Obama's Council of Advisers on Science and Technology on H1N1, "A plausible scenario is that the epidemic could cause between 30,000 and 90,000 deaths in the United States."  

Many doctors questioned the validity of these numbers and in October CBS News pointed out in a scathing report that the CDC had absolutely no idea how many actual swine flu cases there were because they had simply stopped testing people for the virus months ago.

Ok, so i'm doing a search and what do i see in the News section? "E Cigarettes May Be More Effective Than Swine Flu Vaccine". Now you know I have to read this. What? Talk about outrageous health claims. Holy Swine Flu Batman!

As I expected, this press release published in the Earth Times is referring to the study in 1942 conducted by Dr. Oswald Hope Robertson of the University of Chicago's Billings Hospital. He was studying the effects Propylene Glycol might have as a germicide. It's really a fascinating study which is being pointed at more and more lately by electronic cigarette supporters. While it's old and the FDA probably doesn't consider it valid research and anti smoking activists just roll their eyes, it is interesting to look at. I'll have to do a more in depth analysis of the entire study sometime.