FDA Deeming regulations are published

For those in the 4th district OK, Congressman Cole is working to stop this. Unfortunately you can’t email unless you’re a constituent (which I’m not) but I will send him snail-mail showing him my support. If you’re interested you can read about it here:

If anyone has similar links, please post them as I will mail letters out to them as well. It’s my hope that they will dump them on the desks of those congresspersons that aren’t willing to fight against this (I’m looking at you, California).

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Quick and dirty notes from the SFATA teleconference:

  1. 0mg juice does not count as tobacco, and is basically therefor not affected by these new regs
  2. because of #1, the ban on samples and testers will also not apply to 0mg juice. No more free juice giveaways or testers in store unless its 0mg, but 0mg is ok for the time being until the devices are regulated in 2 years
  3. online selling of juice seems to be regulated less than face to face sales. This does not affect anyone who makes their own juice or hardware, as you are still held to the standard of a tobacco manufacturer. But for those who simply buy and resell, its ok. This point is unclear and will require more study of the regulations.
  4. Clarification has been made that state laws that specifically say that ecigs are not tobacco are superseded by the new regulations. The Federal Government says its tobacco, so it doesn’t matter what the states say.
  5. clarification that if stores tell customers “you can add nicotine to this 0mg juice”, that 0mg juice then becomes a tobacco accessory and falls under the FDA’s regulatory power.
  6. non tobacco extracted nicotine (such as eggplant nicotine or synthetic nicotine) will most likely not count as tobacco, but SFATA expects that the FDA would respond by saying that nicotine itself is a drug and close the loophole by regulating it as a drug delivery device.
  7. SFATA will be releasing a “FDA regs for dummys” document next week, explaining all these shenanigans to those of us who are not lawyers or politicians. Even though the regs state that ecig juice and hardware is classified as tobacco, the states will all have to specifically tax and license retailers for ecig stuff. It is not included automatically.
  8. out of country hardware manufacturers are still required to get FDA approval for ecig stuff. Generic items like batteries are exempt since they’re not specifically made for ecig use.
  9. If you are a straight retailer, who only buys product from other companies to resell, the only things the regs means to you is that you must ID everyone, and cannot alter products, and will most likely have to register as a tobacco retailer in your state. Also there will be no sampling. So you can’t let the customer sample the juice before they buy it.
  10. Building coils counts as altering a product, which makes it a new product, and since it’s a tobacco accessory, building coils makes you a tobacco manufacturer.
  11. 90 days starts the law, any products not for sale in the market will require a PMTA
  12. No free samples
  13. 2 years to file your PMTA, 1 year to get an approval, if no approval is received within the 12 months following you will have to remove your product from the market while you wait for FDA approval
  14. Mandatory ID, Child Proof Caps, Warning Labels and Marketing Ban go into effect in 90 days
  15. Litigation is HIGHLY unlikely to be successful and SFATA strongly suggests against it.
  16. Software upgrades to mods would need a PMTA
  17. Verbiage on how we talk about e-cigarettes have to change: no longer healthier, not smokeless, not a way to quit smoking, etc…
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You can leave comments on his Facebook page if you like. There a link to his FB page from the link you left for us…

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I did. Still sending a snail-mail letter as well. I believe we have to thank those that are working on our behalf as well as chastising those that aren’t. Any form of correspondence would only help IMO. Shock and awe for all!

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So are we saying here that a Vape Shop could

1: legally blend and sell only 0mg nic juices made by said Vape Shop
2: legally sell equipment to vape it regardless of August 8 because it is not tobacco?
3: Allow tasting of ONLY 0mg nic juice regardless of who made it?

In the case a Vape shop wanted to sell with nic can they

1: sell juice with nic made by others (suicide bunny, cutwood, ect) even though not yet FDA approved ?
2: sell equipment to vape it pass August 8 provided all rules are followed?

Lastly what is the PMTA abbreviation mean?

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@sillyrabbit
Observations on specific points:

  1. So I’m assuming flavorings, VG, and PG don’t fall under these regs. Good.
  2. I’m okay with that, since testing a flavor without the nicotine is often a better guide to whether you will like it or not.
  3. Any reason why online sales would be less affected?
  4. This is just ridiculous. That’s like saying that if a bakery supplier tells a customer that the customer can add hashish to the brownie batter they bought, then brownies become a marijuana accessory. Truly strange logic.
  5. Well, then FDA would be contradicting its own previous decision not to regulate e-cigs as a drug delivery device.
  6. Still shaking my head at the notion that vaping hardware is classified as “tobacco”.
  7. When FDA regulates U.S. suppliers, they can claim to be regulating the producer; when they try to regulate foreign suppliers, they’re clearly trying to regulate the American consumer (though in practical application that’s true in both instances).
  8. Same twisted FDA “logic” as #7.
  9. Any particular reason why litigation would be unlikely to be successful?
  10. I’m okay with changing the verbiage, since those claims really need a lot more hard evidence to back them up.
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@ringling
PMTA - Pre-market tobacco product application. (The acronym is not exact, but then neither is NORAD.)

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@sillyrabbit

As to your numbered points:

  1. I don’t see how the FDA can regulate consumer free speech, and I have a real problem with that, if that is the case. I can understand that the speech could be regulated for marketing purposes; but to presume the FDA is trying to tell ME PERSONALLY (or anyone else) that we cannot say to others that vaping has helped us cut down or stop smoking cigarettes, health is improving, etc. is beyond authoritarian, and downright tyranny.

  2. You’ve got to be kidding me, right? Congressional Review or legal action is the ONLY way these regulations or a portion thereof, will be rescinded, or at least “toned down.”

  3. INCORRECT - batteries are explicitly defined as a “component” or “part,” and therefore, in-scope.
    From pg. 160: “Many comments also sought clarification and examples as to which objects used with ecigarettes
    would be considered components, parts, and accessories. The following is a
    nonexhaustive list of examples of components and parts of ENDS (including e-cigarettes):
    Atomizers, flavors used or intended to be used with ENDS (with or without nicotine), e-liquid
    solvents, tanks and tank systems, batteries (with or without variable voltage), coils, cartomizers,
    digital display/lights to adjust settings, clearomisers, and programmable software.”

As for #1 & 2 - INCORRECT
According to pg. 222, and I quote:
“Also, as stated earlier, nicotine-free
e-liquid that is intended or reasonably expected to be used with or for the human consumption of
tobacco products in most cases would be a component or part of a tobacco product and,
therefore, within the scope of this rule. These products will be evaluated on a case-by-case basis.”

I anxiously await the “for Dummies” analysis from SFATA.

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You and me both. Perhaps there is a little hope for Vape Shops and Juice Companies. I would love being proven wrong in this case…

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Well then, I guess that covers every f—ing thing, don’t it? Will the word “Clouds” be stricken from the English language as well? So much for the pursuit of happiness and freedom of choice.
Bastards…

BTW, thank you for posting what you have so far. It really helps.

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Bootleggers and Baptist! It is about MONEY! http://papers.ssrn.com/sol3/Papers.cfm?abstract_id=2557691
I read all 52 pages. It pretty much sums it up!

@ZeroedIn
Referring to your numbered points referring to @sillyrabbit’s numbered points:

  1. I’m pretty sure @sillyrabbit misspoke when using the term “we”; surely the intended pronoun should have been “they”, in the sense of manufacturers, suppliers, retailers, etc. The only case where consumer speech is (even currently, see below) controlled on this issue is not by the government, but by marketers themselves, as in the case of e-cig companies who censor product reviews by consumers on their websites that mention having quit smoking by vaping, and those company policies are in place because they don’t want the FDA to say that their website is indirectly promoting their products as smoking cessation devices by publishing customer reviews touting them as such:

For example, from Halo’s (NicoPure Labs) website on their customer review policies:
"Disallowed Content: . . . Our products are a tobacco alternative and not a smoking cessation device. We reserve the right not to post reviews that reference quitting smoking."


Obviously, respect for freedom in the private sector includes respect for a company’s right to decide what is and isn’t published on their website.

But as far as you or I personally witnessing to others about a successful quit with vaping, we’d truly be in bizarro-world if that were to fall under government regulation. (Of course the more Libertarian among us might say that the government already oversteps its boundaries when regulating speech, but that’s a whole other discourse.)

  1. Exactly. I was truly jaw-dropped by the assertion that we need not bother with legislation or litigation. What conceivable alternative is there? Prayer?

  2. In all fairness, @sillyrabbit did say “generic batteries”. The 18650, for example, is not just used in vape mods, but also, among other things, some computer batteries, some LED flashlights, and the Tesla Roadster. The problem I see with some of the listed components is determining “intended use”. With flavorings, for example, how does the FDA know when you order some Capella Vanilla Custard flavoring that you’re going to use it in a vape and not in a cake? With “e-liquid solvents” (i.e., PG and VG), how does the FDA know you’re going to use them to make e-liquid and not homemade mouthwash? If you order a small funnel for bottling e-liquid, how do they know you’re not using it for sand art? With something like a cartomizer, it’s obviously a lot more straightforward, as it has no other use except for vaping.

  3. and 2) - The FDA is really twisting itself into a pretzel trying to justify this one. The only way 0-mg nic liquid would be “used with or for the human consumption of tobacco products” is if the customer purchased 0-mg liquid and added their own nicotine, and how is the FDA omniscient enough to know that that’s the consumer’s intention? As I said, that’s like reasoning that because some people put hashish in their brownie batter, therefore brownies themselves should be regulated as a controlled substance. Perhaps they’re really gone off their rocker and reason that the liquid is going into a vape mod, which they’ve decided is a tobacco product, and therefore the 0-mg nic liquid is a tobacco product. That takes bizarro logic an order of magnitude further - it’s like first saying that because people cook heroine using a teaspoon, therefore teaspoons are a narcotic accessory, and then concluding that because people also eat peanut butter from a teaspoon, that peanut butter is also a narcotic and should be regulated as such. To put it concisely, the FDA has lost its collective mind.

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No sir I didn’t. I posted as I seen them. Just thought I would share what I seen is all.

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You didn’t what? I’m confused.

I just shared what I read. That’s was from the SFATA As we all are going to see a lot of different things coming out. There is a lot of gray area in that by it self.

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To make the example totally fair, it would need to be 0-THC brownie batter sold by a MJ dispensary…

To that point I think one bizarre concern the ANTZ have is that 0 mg juices aren’t always really 0 mg. There’ve been scare stories about this since like '09 (particularly with Chinese e-liquids). For some reason they really jump on these stories because I guess they think it’s more evidence of some big conspiracy to hook kids (OH NOE THE CHILDRENS!!) on nicotine.

I don’t see this is as cut and dry as some. The concern of “we don’t really know what’s in a bottle of any given manufacturer’s e-liquid” has been overblown, but isn’t completely unreasonable.

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Even though certain states made weed legal. It’s still illegal on a federal level. And we find that were may bad I say MAY see that on the juice level But it’s way to soon to tell

In a nutshell, Big Pharma knows that transitions to vaping will cause former smokers reduced Doctor visits. So less visits the less scripts are written. Big Pharma is using the FDA to ensure that future scrips are written, thats the truth of most of it but they don’t want you to know that.

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As a retailer, I’m actually good with this terminology. This actually says it can help quit smoking cigarettes without really saying it. This will be my future responses to the customer. I had been wrestling with what I could say to them…

Actually only semi true. Can be used for CBD mixes which are not tobacco…[quote=“MarkM, post:113, topic:64265”]
To put it concisely, the FDA has lost its collective mind.
[/quote]

Oh they know what they’re doing. They just know they can get away with it…

If evidence of THC was found in batter or mix advertised as THC-free, then that falls under the heading of cross-contamination either deliberately or through willful negligence, but it still doesn’t justify regulating brownie batter per se as a drug across the board, whether it’s sold at a MJ dispensary or at a grocery store.

Like you, I don’t see this as cut and dried, either. I’m kind of on the fence about some aspects of this issue. At some level, it’s common sense that consumers have a right to know what it is they’re putting into their bodies - that’s why the FDA was created in the first place. Remember the very real horrors regarding food contamination described in Upton Sinclair’s novel “The Jungle” back in 1906, which in part was instrumental in the creation of the agency? No, I don’t want to live in some sort of “Wild West” culture where anything goes. My problem with the FDA right now is that they’re using a sledge hammer when then really ought to be using a scalpel.