The Real Scoop on FDA & eCigarettes!

[Venuvious]

Hey There!
Here's the site that explains a lot about all this! It's the New Zealand Gov. Health Site.
Healthnz.co.nz/ecigarette.htm

Here's part of it:

United States As of March 2008, the Ruyan® E-Cigarette (REC) and its cartridges can be imported, distributed, marketed and sold in the US as a smoking substitute or cigarette alternative, but not as a smoking cessation device. RAI and its advisors cite compelling public health reasons to market the REC and its nicotine cartridges to smokers, to satisfy cravings and urges for nicotine, and without producing second hand smoke and without endangering the health or well-being of family members, associates and/or bystanders. Ruyan® America Inc says it will regularly evaluate the timing of and opportunities represented by seeking and securing FDA-approval as a smoking cessation product.

As a substitute or alternative, the products as of March 2008 are exempt from FDA regulations in that:

· The US FDA in 1996 assumed powers to regulate nicotine and tobacco. The US Supreme Court in 2000 reversed this assumption. Meantime, as long as Ruyan does not make therapeutic claims the drug is not regarded as a medicine and can be sold in the USA as a cigarette alternative.

The US Treasury’s TTB has determined that the products are exempt from tobacco-related controls, limitation and taxation in that neither the REC or its cartridges contain tobacco; and, US Customs and Border Security has also determined that the products are not tobacco related. As the products do not contain tobacco, it is not expected that the Ruyan® e-cigarette would not be prohibited from any advertising or marketing medium by regulation.

Hope this Helps!

[Elle]

Meantime, as long as Ruyan does not make therapeutic claims the drug is not regarded as a medicine and can be sold in the USA as a cigarette alternative.

HealthySmokeShop.com
"The Healthier Way to Smoke!"

....

warning, i'm about to state the obvious and point out the irony here: bottom line is don't market as nrt, and don't make health claims, off the FDA jurisdiction we stay.

i find it amusing this was posted by a supplier with a tagline advertising vaping as a "Healthier Way to Smoke!"

[SupplierX]

You rock man!! Exaclty what I was trying to get across in my earlier post. Hopefully people will read this.

[Venuvious]

HealthySmokeShop.com
"The Healthier Way to Smoke!"

....

warning, i'm about to state the obvious and point out the irony here: bottom line is don't market as nrt, and don't make health claims, off the FDA jurisdiction we stay.

i find it amusing this was posted by a supplier with a tagline advertising vaping as a "Healthier Way to Smoke!"

Yes, Elle, I love america!
However, I don't advertise it on my site to be used as a smoking cessation device, just that for people like me, who smoked for 25 years and stopped at 1 1/2 packs of Non-filtered cigarettes and starting using this instead, it is definately a "Healthier Way to Smoke!"
You see, I have no intention of stopping right now. Maybe later, but right now this is exactly what I need, a "Smoking Substitute or Cigarette Alternative!"

[Elle]

Venu- your company, totally your business how you want to market it.

my point was; wether or not you market it as nrt, saying its the "healthier way to smoke" is quite literally making a HEALTH CLAIM.

i'm totally with you- i have zero plans to quit nicotine, and i do personally like you believe it IS the healthier way to smoke.

but is it legal or ethical to market this way without the lab studies we all so desperately want to back it up? my opinion is no, and i'm betting that if (some) suppliers to continue to market this way eventually we will not have the luxury of having the FDA out of our hair regarding our choice of smoking alternative... due to unsubstantiated claims such as yours.

i see what you're saying- i feel the same way, i really do. but bottom line is thats what we "think"- at this point i have no medical proof and neither do you.

food for thought.

[LaceyUnderall]

Venuvious!

Welcome and Thank You for weighing in on this! As taleywhacker stated... we have been attempting to get this point across for a bit now...

[aasupplyny]

"Mechanism. Lip pressure on the mouthpiece activates the electric circuit, sparking vapourisation of nicotine in a mist of propylene glycol"

[SupplierX]

"Mechanism. Lip pressure on the mouthpiece activates the electric circuit, sparking vapourisation of nicotine in a mist of propylene glycol"

I tend to agree.....ummmm...what are you talking about?

[nicowolf]

Venuvious,
We have been through a number of discussions here very recently about why claims of being "healthy" or "healthier" or "an aid to quitting" are potentially harmful to the cause of widespread acceptance of our new habit.

It is a general consensus around here that we cringe when we read these words on suppliers' sites. We cringe because we can see a scenario in the not so distant future where a government agency or a court of law asks for proof to substantiate these claims. We have no proof. We have no scientific evidence that definitively says these are "safe", or "less harmful", or an "aid to stop nicotine addiction". We have common sense arguments -' no burning means no carbon monoxide means healthier', 'no known carcinogens means safe' type arguments, but these will not CYOA in a court of law and will not garner FDA approval if this is classified as a new drug instead of a tobacco product. It will not help when someone ODs on nicotine, or a child drinks nicotine liquid that smells good, or it is found that some nasty chemical reaction happens to the liquid when it reaches the temperature range our atomizers run at, or any other unforeseen event.

Could you just rephrase? Could you say "an alternative way to smoke", "we believe this is healthier than smoking cigarettes because....", "a cigarette replacement", "get nicotine in a less offensive way", "feel like you are smoking without actually burning anything", etc.?

Will you show us that you are willing to consider what we have to say? We have had others, recently, show us otherwise - that they were going to do what would bring in more newcomers, but not what would keep this legal and/or safe for ALL of us in the long run. Are you looking to be a supplier with loyal, longterm customers, or one with customers who buy once, learn from their mistakes, then inform others about those mistakes? These are choices for you to make. We make our choices based upon yours.

[Kate]

This is what the FDA say about your 'healthier way to smoke' Venuvious, you do fall under their jurisdiction according to them:

The "electronic cigarettes" that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action. These products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body. The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Thus, the "electronic cigarettes" that we have reviewed are intended for "drug" use. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed with FDA in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States is subject to enforcement action.
Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products."
Selling E-cigs in USA locations