FDA Deeming Regulation - What we know so far

[Compenstine]

Just now, jasonculp said:

Why didn't I think of this?  I have a vacuum/heat sealer at home, and we have a big one at work....  I have just been using ziplocks.

You wouldn't believe how often people say...."If I don't pull a Jason...."

LOL Your welcome. LOL

LMAO... I'll be sure not to pull my Jason.

 

[jasonculp]

5 minutes ago, cany said:

LMAO   You ever win a Darwin award

I haven't yet, but probably should have got an "Honorable Mention" a few times....

5 minutes ago, Compenstine said:

 

LMAO... I'll be sure not to pull my Jason.

 

LMAO!

[Robinox]

1 hour ago, Compenstine said:

I have been making E-Liquid since 2009. If you are working with Higher than 100mg then you should have a respirator. I always wear gloves but, they are not really needed for 25mg and below. You just need to wash it off. The absorption rate is very slow when diluted that far. If you were to get pure nic (100%) on your skin it much different and you could die.

@canyMixed 1-2 years depending on how you store it.

I will add that if you look at the amount of nicotine in a patch it is around 2.1%

"The first 6 weeks use the 21mg patch, then for the next 2 weeks it decreases to 14mg, and the final 2 weeks have a 7mg patch."

You could die, wow, so when you get the nicotine it's 100% and than you dilute yourself with water? What about ventilation if you have others in the house with you that can be affected by the fumes? 

Edited May 16, 2016 by Robinox

[Compenstine]

No, I get it pre diluted from a Lab to 100mg or 10%. It is diluted with VG PG or combo of PG/VG. I like it diluted with 100% VG myself. Nicotine is not diluted with water.

But Yes Pure Nicotine is deadly.

[Robinox]

58 minutes ago, FXRich said:

How dangerous nicotine is depends on who you listen to, some say it a drop will kill you others say it takes a lot to kill a adult. I had something happen last summer that shouldn't have but did, I was sitting outside having a beer, and vaping, went to refill my tank and dropped the half full 30ml bottle on the concrete, before I could get back with some paper towels and a dustpan, the dog had lapped most of it up, he's only 20 lbs. so I figured it might be over for him, not the case at all. He didn't even throw up or anything, didn't seem to affect him at all, kept a eye on him for awhile, but no ill affects. 

That must have been really scary. I am lucky for some reason all four of my little dogs HATE eliquid. If I put it near them they run from it. They don't like the vapor either so I have to make sure that I don't exhale near there faces.

[jasonculp]

2 minutes ago, Robinox said:

You could die, wow, so when you get the nicotine it's 100% and than you dilute yourself with water? What about ventilation if you have others in the house with you that can be affected by the fumes? 

Most of the time it is diluted with Propylene Glycol or Vegetable Glycerin, or a combination of both.  Most people I know only use 100mg/ml Nicotine or lower.  100mg/ml is a 10% solution and while it is still dangerous, it is much safer than 999.9mg/ml which is the 99.99% pure nicotine.

Nicotine solutions such as the 10% that i use are very thick and do not produce volatile fumes.  This is why we must turn it into an aerosol using heat in our vape mods.

When I mix, or even fill my tanks at home, I use my office.  I have a cat that is super curious and likes to get into anything that he can.  @Compenstine suggested that I use a tote to store my stuff with a latching lid.  I also keep all bottles sealed, and everything cleaned such as beakers and graduated cylinders inside this box.

[Compenstine]

Has the latch-able tote worked for you?

[FXRich]

Another reason I prefer a 100mg base is for ease of measuring, when mixing a 30ml batch of 4mg using a 100mg base you add 1.2ml base, if you use pure nicotine you would have to measure .12ml, which can be done with the right equipment but not something I want to do. Besides pure nicotine is hard to come by, but you can get it.

[jasonculp]

2 hours ago, Compenstine said:

Has the latch-able tote worked for you?

Yes it has worked super!  So far it has only kept dust off of my supplies, and my cat (Duct Tape) away from anything that might contain nicotine.  It really isn't a problem, because he can't stand the fruity flavors I use.  He dosn't mind "vapor" because he has been hanging out under a vaporizer for the last week recovering from an upper respitory infection.  If I am vaping he runs from the vapor.  I have to assume it is the smell of the fruit flavors...lol

[Earthling789]

9 hours ago, jasonculp said:

Yes it has worked super!  So far it has only kept dust off of my supplies, and my cat (Duct Tape) away from anything that might contain nicotine.  It really isn't a problem, because he can't stand the fruity flavors I use.  He dosn't mind "vapor" because he has been hanging out under a vaporizer for the last week recovering from an upper respitory infection.  If I am vaping he runs from the vapor.  I have to assume it is the smell of the fruit flavors...lol

My dogs are indifferent to vapor, but my cat... well, he LOVES it, lol... At first I always thought he was just being a cat and chasing the cloud, but soon I figured out he was actually liking it.  Fruit flavors, bakery flavors, vanilla... he likes them all He also use to grab the smaller 10ml bottles and run off with them... well, he use to, that is...  Now, I only use 60ml glass bottles for my personal mixes, and I keep all my flavors, VG, PG, and Nicotine in the freezer (upright, that is, lol).   There's a few bottles of mixed liquids on the shelf next to my work-desk, but he doesn't bother them now that they are in glass, but he still chases the vapor around the room

[Compenstine]

There has been a lot of talk about having 2 more years before things can get better or worse. I have been hearing that manufactures have until Dec 31st of 2016 to register their companies. This will involve a cost. Unsure of what that amount will be. Then there is a Feb date in 2017 that manufactures need to submit a list of every product sold, Ingredient of each product, where you buy the ingredients and testing results on each ingredient yada yada.

Start watching this video at around 1:11:00 They do talk about what is coming in August before this, this is where Demitri and Phil start talking about the other upcoming dates.

 

I'm in no way inciting a panic. Please understand we are all trying to understand what is coming down the pike so to speak. You may or may not see a large drop in stores because of this alone. When things affect suppliers they affect consumers. Please take the time to learn what is ahead. Most of all support the fight as best you can.

 

[iQuit]

Thanks for the heads-up, comp. If what I am reading is correct, it starts earlier than that.

REGULATION COMPLIANCE CALENDAR May 13, 2016, Page1of 5DeadlineRule Implemented / RequirementsCitation August 8, 2016
Effective Date of FDA Authority over Electronic Nicotine Delivery Systems–Newly deemed “tobacco products,” including Electronic Nicotine Delivery Systems (ENDS), become subject to FDA authority.21 CFR part 1100

Sale to Minors Banned –Sale prohibited to anyone under 18 years of age (or older if state law requires).  Retailers must see photo ID of anyone who appears 26 or under.21 CFR part 1140

Product Adulteration –All manufacturers must operate their facilities in a sanitary manner such that no products are manufactured or shipped that are contaminated in a manner that might injure the public health beyond the risks that may be inherent in the product. Food Drug & Cosmetic Act (FDCA)§902(1)

Modified Risk Claims –Companies may not make any advertising claims or other public statements directed to consumers that their product may have less risk, be less harmful, havefewer or no additives as compared to other tobacco products prohibited.  Prohibition on use of “light,” “low”, “mild” or similar descriptors.For packaging and labeling deadlines, see August 8, 2017 below.FDCA §902(8)

New Products –No new products can be introduced until FDA has issued a marketing order authorizing sale based on an SE or PMTA.FDCA §910(2)(A)Misbranding –FDA will begin enforcement on false or misleading labeling and advertising.FDCA §903(a)(1)

Vending Machines –Vending machines are prohibited except in facility where retailer ensures that no one under 18 (or higher legal age) is present or permitted to enter at any time.  21 CFR 1140.14(b)

 

Got this from ECF (where credit is due...)  No new products is interesting

[Compenstine]

Yes these are all in affect now to some degree. Manufactures have till Aug 8th to full comply to these. As of Aug 8th there is a new product freeze. After Aug 8th no new products may be offered unless they have gone through the PMTA process and have FDA approval.

[cany]

We can still get old products?

[Compenstine]

See page 2 of the PDF from SAFATA

http://sfata.org/wp-content/uploads/2016/05/SFATADeemingReuglationsAnalysis.pdf

[cany]

1 minute ago, Compenstine said:

See page 2 of the PDF from SAFATA

http://sfata.org/wp-content/uploads/2016/05/SFATADeemingReuglationsAnalysis.pdf

Im no good at reading legal mumbo jumbo

[Compenstine]

It is in an easy to understand wording. Best guess to your question. It would depend on if the company you are buying from registers in Dec of this year.

[cany]

10 minutes ago, Compenstine said:

It is in an easy to understand wording.

For you not me

[Tam]

2 hours ago, Compenstine said:

It is in an easy to understand wording. Best guess to your question. It would depend on if the company you are buying from registers in Dec of this year.

The wording was vague at best for me as I read it anyway. 

The following gave a little more information:  (My thoughts/opinions in bold)

Legislative fix: Cole/Bishop amendment was approved by the House Appropriations Committee last month. If signed into law, it would, among other things, move the February 15, 2007 grandfather date, allowing some or all ecigarettes and vapor products currently on the market to serve as "predicates" for products introduced after the Deeming Rule's effective date. (If Cole/Bishop is approved, we will see what gets "grandfathered" in as far as old equipment is concerned -- that's the stuff we're currently using I think, but there's not anything more detailed than that right now.)

▪ It remains to be seen whether this provision will stay in the Agriculture Appropriations Bill, let alone whether the House and Senate will even vote on a standalone Agriculture Appropriations Bill during this Congress. (Passing of Cole/Bishop is still up in the air.)

▪ SFATA is also working to get support for the Cole/Bishop amendment to increase the chance of passage through Congress. In addition to the Cole/Bishop language, SFATA is currently working with other interested organizations and legislative leaders to develop a more comprehensive regulatory framework that will better serve the industry into the future. (SFATA is working to get extra support for Cole/Bishop so it stands a better chance to get through the political boloney and to get the politicians to change the wording into something more understandable that will be better for the industry going forward.)

There. How was that, @cany ? Bottom line? We don't know anything yet as far as what will be approved or when.  

[cany]

Thanks Tam

[Compenstine]

Even if the Cole Bishop passes, this registration for the stores/manufacturers and the products still has to be done and it will not be free. As Demitri said in the video it will not be cheap either. If the store/manufacturer can not pay or choose not to, they must close.

Cole Bishop only would effect the PMTA process.

[cany]

Johnson Seeks Answers from FDA on Burdensome E-Cigarette Regulations

[Compenstine]

Liked times 2.5 Billion

[Tam]

I think I'm in love with Senator Ron Johnson right now. 

[cany]

Lets hope good comes from it