Is this the CASAA studied views? From a regulatory and legal prospective there is much good news, and I am concerned that what is being offered out, is fear based, and not within the legal frame that provides for what is possible. There are many scholarly articles on the web that reject the below presentation, and it is clear that the V2 and BLUs of this world, along with Apollocigs are not paniced about the FDA. Apolloecigs says they are ready now,
Apollo E-Cigs Proudly Produces Their 'Juice' In-House -- CONCORD, Calif., Nov. 13, 2013 /PRNewswire-iReach/ --
Let me go through the problems of the below,
mine in BOLD
QUOTE=Vocalek
Did you miss the description of how this is currently working in practice?
The practice for analog Tabacco, and E-Cigs will be vastly different because of the thousands of chemicals, being burned and inhaled in analogs. E-Cigs do not burn, and the E-Cig/Juice constitutions are only a handful.
There is no "clear sailing." No matter how simple or obvious it seems to you or I that two products are comparable, the FDA has been asking for minute details, not just on the product being submitted, but on the predicate product. You have to pony up extremely detailed specifications for that earlier product. If that product was produced by some other company, not your own, you might not have all that information or be able to get it.
Again this is for analogs with thousands of items being burned into a single smoke inhaled. An E-Cig is a simple devises, with a handful of parts, and with a simple liquid. Every E-Cig manufacturer knows exactly what the others product is, and what it made, how it functions. Liquids are known to be made from the same variety of basics where are sourced from the same suppliers in many cases.
"It is important, therefore, that you submit sufficient information to enable FDA to determine whether the new tobacco product has the same characteristics (defined as the materials, ingredients, design, composition, heating source, or other features of a tobacco product) as the predicate tobacco product, in accordance with 910(a)(3)(A)(i), or has different characteristics but it is not necessary to regulate the product under section 910(c)(1)(A)(i) because it does not raise different questions of public health, as required by 910(a)(3)(A)(ii). FDA understands this to mean that 905(j) reports are to be organized based upon the list of characteristics as set forth in section 910(a)(3). In addition to these characteristics, for products that have different characteristics, FDA may determine that additional information is needed to determine whether the products raise different questions of public health."
As the E-Cigs are the same, in principle and often in exact composition, there will be no basis to say they are different, even in the worse case of an Angry FDA. The FDA has said, it is more concerned about analogs, and how some are skirting rules and putting them in the hands of teens.
See pages 9 through 13 of the Guidance document for the details.
The FDA has received at least 3,500 SE applications and has acted on no more than a few dozen of them.
And these products are being sold today, still. Analogs are a widly more complex and different product than E-Cigs, there are not 3500 substantial variants in E-Cigs. You have to assess what E-Cigs are before you have a very fearful and legally compromised analysis of the industry. Apolloecigs would be a good company for CASAA to start a dialogue with, they are not expressing the same FUD, and they sell the entire gambit of products.
A single predicate product does not mean that multiple companies can all use the same predicate product.
Yes it absolutely does, please speak with a lawyer and they will confirm. These applications contain proprietary information that the FDA is obligated to keep securely. You cannot grab another company's document and copy/paste. That would be considered corporate espionage.
T
hat is just farcical. One E-cigs is entirely understood and known to all other companies, without secrecy. (especially since so many are the same but rebranded, but lets not even go that route). A company's filings to the FDA will most likely be public record, I do want to double check that. And there will be cooperation by companies, especially the rebranders. The forms to fill out won't be earthshattering. Most of the premise of the concern is that E-Cigs are just like Analog Tobacco....its just not that way, the comparisons are not appropriate at all, can cause needless FUD.
"FDA believes that a meaningful scientific comparison intended to determine whether the characteristics of the products are the same or are different but present no different questions of public health cannot be made between a new tobacco product and multiple predicate products."
You can not take a bunch of various parts of cigerettes, analogs, and then claim its just these parts in our cigarette. You can not take a filter off a Malburo, stick it on the end of a cigar, wrap the cigar in a flavored paper, and say we are just using approved parts. The reason, they all get burned into one single smoke and inhaled. E-Cigs don't have this problem, its just the Vapor of the liquid, nothing else. The liquid is 4 core ingredients. You are talking an apple, and comparing it to something far more complex. E-Cigs just don't have the designs and chemicals inside them, that make it a regulatory nightmare.
What the "clear language" means is that they want each application to use only ONE predicate product. In other words, you can't claim that features 1-10 of your new product are comparable to features in Predicate Product X, but that features 11-20 are comparable to features in Predicate Product Y. Get it?
Yup, and is not problem at all
This current guidance does not apply to products that are not regulated yet as tobacco products. No doubt they will need to write a separate SE Guidance document to cover e-cigarettes, since they are very different from tobacco cigarettes.
They may or may not, However the guidance on substantially equivalence, does not need to be changed, its based on the same principle for any Tobacco product. And by ANY measure all E-Cigs and Vaping is Subtainly the same. electric coil, liquid, vapor, unfiltered. Our concern is that so far, the FDA has been very, very picky, sending back SE applications asking for more and more detailed information.
Not for E-Cigs, your example is Analogs, so who cares about those applications, not the same problems....but seriously I can go to any 7-11 and get a cigarette, its not like the FDA has removed them
"A coil is a coil is a coil" very likely will not cut it with tobacco regulators. If they follow the same pattern as this document, they will be asking for all of the metals that went into making a coil, design drawings, etc., and will want the new product to be identical in every way with the predicate product, unless the applicant can pony up proof that the new design does not present any changes in health risks.
A coil is a coil, will have to be accepted, because they are. I am not sure what manufacturing experience is being used to come up with the theory that the metal coils will be a huge barrier. I think its this type of FUD that should give Vapers some ease of mind to the regulators. I mean its a wire, wrapped around a wick, their are no specal drawings needed for 3 or 7 windings
The coil material, its the same, because its the the same, and with just a few options.
Nichrome: Most heating elements use Nichrome 80/20 (80% nickel, 20% chromium) wire, ribbon, or strip. Nichrome 80/20 is an ideal material, because it has relatively high resistance and forms an adherent layer of chromium oxide when it is heated for the first time. Material beneath this layer will not oxidize, preventing the wire from breaking or burning out.
Resistance wire: Metallic resistance heating elements may be wire or ribbon, straight or coiled. They are used in common heating devices like toasters and hair dryers, furnaces for industrial heating, floor heating, roof heating, pathway heating to melt snow, dryers, etc. The most common classes of materials used include:
Kanthal (FeCrAl) wires
Nichrome 80/20 wire and strip
Cupronickel (CuNi) alloys for low temperature heating
These are safe metals. You can check.
Tobacco companies might be able to absorb all these costly analyses, but those e-cigarette companies not owned by a tobacco company could be bankrupt by this process if it continues to be administered in this fashion.
Apolloecigs, is no giant, they are just a run of the mill, small corp trying to become a mid sized corporation, and THEY are not worried like you are. I wonder why contacts with these company's is not being done, if it is being done, why do some many E-Cig welcome normal regulations. Clearomizers, Batteries, APV raw hardware, is well outside of scope of the FDA. When CASAA presented that a Provari battery could be banned, it just is not in the context of the real world. There are plenty of examples of other varieties of hardware, absent of consumables, remains legal...those are non-E-cig examples should make it entirely clear, that a Provari is not going to or be able to be banned by the FDA, in ANY manner. Saying that a Provari is going to get banned, demonstrates a complete misunderstanding of the facts of the matters.
The main legislative issue is that of localized ban, or ordinance making E-Cigs only able to be used in Analog Smoking allowed areas. Right now there is no successful push back organization focused on these bans. I have read the CASAA success stories, and if I remove CASAA's actions, I think its pretty clear the same outcome would have occurred with the local efforts by themselves. Local stores get the word out, best, as it affects them. With social media, email blasts are covered, pretty well, and redundantly on top of themselves.
Meanwhile the likes of Stanton Glantz are entirely ignoring FDA and getting things like Bans of E-Cigs in all the California Universities. If the action was at the FDA, those people would be working it hard, but just like Cigarettes, with the Major Loss from Sottera, E-Cigs are on the market, like Tobacco.
Attendance does not Equal Accomplishment, and right now the local bans are picking up volume. Getting the word out, is not the same as getting the job done.
