FDA Posts Draft Guidance on "Substantial Equivalence"

[Vocalek]

Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions

You should submit comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov2. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

 

[sqirl1]

sounds like they're gonna go after E-cigs.

A “new tobacco product” means:

any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

(Section 910(a) of the FD&C Act; 21 U.S.C. 387j(a).)

The liquid hasn't changed much since 2007 but the hardware is TOTALLY different. this could theoretically mean that any time somebody comes out with a new atomizer, cartomizer, battery, etc. they gotta report to the FDA. this is going to make E-cigs a bureaucratic nightmare.... if they allow them in the first place.


EDIT: also, it says marketed in THE UNITED STATES before 2007. I know e-cigs have been around since 2003, but have they really been in the US before 2009?

 

[Vap0rJay]

sounds like they're gonna go after E-cigs.

A “new tobacco product” means:

any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

(Section 910(a) of the FD&C Act; 21 U.S.C. 387j(a).)

The liquid hasn't changed much since 2007 but the hardware is TOTALLY different. this could theoretically mean that any time somebody comes out with a new atomizer, cartomizer, battery, etc. they gotta report to the FDA. this is going to make E-cigs a bureaucratic nightmare.... if they allow them in the first place.


EDIT: also, it says marketed in THE UNITED STATES before 2007. I know e-cigs have been around since 2003, but have they really been in the US before 2009?

The key component is "delivery or form of nicotine, or any other additive or ingredient" so provided there is no nicotine... what I have in my possession is no different than...

A mere childrens toy... Zero Vapor Toys: Zero Toys Online Store

 

[sqirl1]

The key component is "delivery or form of nicotine, or any other additive or ingredient" so provided there is no nicotine... what I have in my possession is no different than...

A mere childrens toy... Zero Vapor Toys: Zero Toys Online Store

no but here's the thing: cigarette rolling papers and filters are regulated like a tobacco product and subject to the same laws as whole cigarettes are right? couldn't the same prove true for atomizers, cartomizers, etc? those toys don't have the EXACT component of an E-cigarette

 

[Vap0rJay]

no but here's the thing: cigarette rolling papers and filters are regulated like a tobacco product and subject to the same laws as whole cigarettes are right? couldn't the same prove true for atomizers, cartomizers, etc? those toys don't have the EXACT component of an E-cigarette

I have an electric stove... which is nothing more than a big heating coil. I can take my liquid and drip a drop on the stove and inhale the vapor......... They gonna tax my stove too along with all other stoves made after 2007 as a tobacco product?

I dunno...... all im saying is i seriously do not know how in gods name they can regulate anything BUT the nicotine. I can go to the store and get a 12v car bat go to radioshack get some wire resisters and make a monster i can label as a hand warmer -- that also happens to atomize eliquid. I dunno I dunno...

Then if all else fails, chemical reations / pressure are other ways to heat liquids to vapor... if big bro continues to be goofy and ends up making *all* electronics fall into the cat. of "tobacco" products the end game still is only the liquid can truely be regulated as people often do... find legal loops around absurd barriers put in place for your childrens children (even if you never are going to have them you yourself!)

 

[Luvs5rugrats]

The key component is "delivery or form of nicotine, or any other additive or ingredient" so provided there is no nicotine... what I have in my possession is no different than...

A mere childrens toy... Zero Vapor Toys: Zero Toys Online Store

Here's from the toy site's FAQ's:

Q: What is in the fluid?
A: A water based non-toxic liquid that is similar to the fluid used in special effects fog machines. The Fluid consists of Distilled Water, Glycerin (a USP kosher food additive) and Propylene Glycol (a USP kosher food additive)

So I'd say you're right!

 

[sqirl1]

I'm telling you, atomizers and cartomizers are designed for a specific purpose, and there's really no getting around the FDA blocking them, the batteries we COULD be ok on, but I'm REALLY worried, especially about cartos that look like filters.

 

[LadyLynx]

Oy vey. Let's spend government (by that I mean taxpayer money) on something worthwhile. Let's feed some homeless, or neglected children. In fact there is a little child that runs around my neighborhood with no supervision (he goes 4 blocks to safeway across a busy street and is at MOST 5) can we provide him with some care? THIS is useless.

 

[MickeyRat]

Lots of people you no nic juice and a PV to diet. I don't think they can go after the hardware, the PG, VG or the flavoring. The only thing they can go after is the nic. I'm sitting on 1500 ml 100 mg now. Should be good for a couple years.

 

[sqirl1]

btw I remember Bill Godshall saying this only affects new products that are already regulated, (new brands of analogs, ST, etc) is this true or am I confusing it with something else?

 

[milo hobo]

I would i magine the only thing they can tough and tie down to cigarettes specifically would be nicontine. Nicotine can be derived from other plants too, so unless the FDA has jurisdiction over tomato plans, nicotine can be a free agent too. Beurocracy can be our friend or our enemy, just think outside the box!

 

[Vocalek]

Here is my concern: If they do decide to apply substancial equivalence to electronic cigarettes, we will be stuck with going back to the first ill-designed models with tiny leaky cartridges and batteries that die after just a few hours (think RN4081) and every hardware improvement since then will be verbotten unless and until they got approved as new products. But on the other hand, the e-cigar was marketed by NJOY before they offered the e-cigarette. And that baby is really well designed. Big cartridge and the battery lasts a long time.

 

[Hiryu]

Meh.... time to start stocking on hardware and juice. The FDA is gearing up to taking a lot of good people out of business.

 

[Uncle Willie]

I would i magine the only thing they can tough and tie down to cigarettes specifically would be nicontine. Nicotine can be derived from other plants too, so unless the FDA has jurisdiction over tomato plans, nicotine can be a free agent too. Beurocracy can be our friend or our enemy, just think outside the box!

Extraction of nic from anything but a real tobacco leaf is economically impossible in even tiny quantities ..

 

[Uncle Willie]

I believe the best we can hope for is regulation .. and that will require approval most likely by any maker of hardware and/or liquid .. I'm not going to sweat taxation, I just want to be able to get the goods ..

Regulation will esentially shut down the market until approval is obtained .. IMO .. however, I'm sure the good news is a more consistent marketplace as well as ingredient lists, etc on the liquids ..

The worst would be an outright ban .. but, with the Genie out of the Bottle (so to speak) .. it may be difficult to ban at this point .. and would still create a strong black market ..

 

[rothenbj]

btw I remember Bill Godshall saying this only affects new products that are already regulated, (new brands of analogs, ST, etc) is this true or am I confusing it with something else?

I believe you recall properly. Bill stated that substancial equivalency only applied to "the regulated products", cigarettes and smokeless products covered by chapter 9. I suppose time will tell.

 

[Vocalek]

Keep in mind that FDA has announced that it intends to issue regulations that would bring in all other tobacco products under to be regulated by the FDA under the Tobacco Act. The question is whether the law, as written, permits the FDA to do so. This amounts to government by fiat.

» Who Needs Congress: Legislation by Regulatory Fiat - Big Government

 

[mwa102464]

The FDA cant even stop all the illegal drugs you can order over the internet now like the 10's of millions of little blue pills there selling, so even if they do try to regulate it controlling it is a whole another animal. I think Nic will always be available from our Chinese friends if not right here in the good old U.S OF A, one way or another. As for hardware good luck on regulating flashlights too because all our great modders here will then be selling flashlight PV's with a funny little adapters to make your purchased flashlight into a PV. personally I really think they should try to fix our terrible economy before they make one new dam law for anything and the first move should be laying off half of these lazy fat bums called politicians who do nothing and get paid more than most that have the best medical and retirement plans in the world and vote these plans in for themselves. Gov't needs more regulation than anything else and if we all where smart we would start seeking more regulation on Govt and the people running it way before worrying about a small thing like vaping, Nic, and PV's let's start fighting fire with more fire here !

 

[MickeyRat]

The hardware can be used to vape no nic juice. It's not under the jurisdiction of the FDA. They can regulate tobacco products. There's no tobacco in the hardware. They can't touch it. The only thing they can touch is the nic.

 

[rothenbj]

Keep in mind that FDA has announced that it intends to issue regulations that would bring in all other tobacco products under to be regulated by the FDA under the Tobacco Act. The question is whether the law, as written, permits the FDA to do so. This amounts to government by fiat.

» Who Needs Congress: Legislation by Regulatory Fiat - Big Government

I totally agree Elaine and thanks for the link. That's the kind of information that seems lost on society and the agenda isn't just at the federal level. We're seeing it on both the state and local levels where unelected health departments are creating "law" based on "we don't knows" and "child protection".