FDA FDA Released New Interpretation of Compliance Policy Guidance PDF

[Lessifer]

Didn't know, haven't been following the law suites.

Zoi's post was the first that I'd seen anything about a recent challenge, but I wasn't aware they were already in litigation and arbitrarily lost.

Anybody know of other suites that have lost as well?

Line up the dominoes, they'll probably all lose....

That's the FDA's response, not the Judge's decision. They're asking the judge to rule that way.

 

[Shekinahsgroom]

That's the FDA's response, not the Judge's decision. They're asking the judge to rule that way.

So where's the ruling doc?...or is it still ongoing?

 

[Shekinahsgroom]

This one should be interesting..

Cigar Industry Lawsuit Against FDA Regulation Slated for July 2017 | halfwheel

• The classification of retailers who blend their own pipe tobacco as “manufacturers”

____

And where have I seen this before?

The agency largely turned to three responses in its reply:

• Denied.
• This paragraph contains argument and conclusions of law, not allegations of fact, and thus no response is required.

(Hiding information and their intentions)

 

[Lessifer]

So where's the ruling doc?...or is it still ongoing?

The case is still ongoing. I'm not sure when the next time we'll hear anything is.

 

[Shekinahsgroom]

The case is still ongoing. I'm not sure when the next time we'll hear anything is.

Okay...thanks Less.

 

[Lessifer]

There's that pesky word, retailers.

You do realize that your definition of manufacturer would not only include DIY mixers, but also anyone who replaces their own coil, or fills their own tank with liquid, right?

 

[Shekinahsgroom]

There's that pesky word, retailers.

You do realize that your definition of manufacturer would not only include DIY mixers, but also anyone who replaces their own coil, or fills their own tank with liquid, right?

I'm sure there's a point coming, right?

(Looks like you're back in the fray, here we go!)

Glad to see ya Less, I enjoyed our.....discussion.

The FDA isn't going to sanction DIY'ers for personal use, it'll never happen...even if registration is required. Personal use is NOT the issue, it's distribution.

 

[Lessifer]

I'm sure there's a point coming, right?

(Looks like you're back in the fray, here we go!)

Nope, I've made all of my points before.

One thing I did find interesting about the guidance mentioned in the title of this thread. It appears that the FDA expects vape shops to self regulate in the case of replacing coils. They say they do not plan any enforcement actions on vape shops who replace coils in an atomizer for customers, as long as the replacement coil is exactly the same as the one they're replacing. So, replace a 1.0ohm coil with a 1.0ohm coil, you're golden. Replace a 1.0ohm coil with a 0.5ohm coil and you've now manufactured a new product, and if you've done this without a marketing order, you've broken the law.

 

[Shekinahsgroom]

Nope, I've made all of my points before.

One thing I did find interesting about the guidance mentioned in the title of this thread. It appears that the FDA expects vape shops to self regulate in the case of replacing coils. They say they do not plan any enforcement actions on vape shops who replace coils in an atomizer for customers, as long as the replacement coil is exactly the same as the one they're replacing. So, replace a 1.0ohm coil with a 1.0ohm coil, you're golden. Replace a 1.0ohm coil with a 0.5ohm coil and you've now manufactured a new product, and if you've done this without a marketing order, you've broken the law.

That is interesting, wonder what else they're gonna change and then issue the statement "Non-Binding Recommendations Draft".

Based on the very little that I did read, nothing in there is set in stone. Not even sure why they released it if it's not going to be added to the law?

 

[Lessifer]

That is interesting, wonder what else they're gonna change and then issue the statement "Non-Binding Recommendations Draft".

Based on the very little that I did read, nothing in there is set in stone. Not even sure why they released it if it's not going to be added to the law?

That's how nearly all of tobacco regulation is. They issue guidance letters, all non-binding, but while they're in effect they are the basis of enforcement actions. The rule itself is vague, the guidance is meant to clarify, but they can issue new guidance at any time.

 

[Shekinahsgroom]

That's how nearly all of tobacco regulation is. They issue guidance letters, all non-binding, but while they're in effect they are the basis of enforcement actions. The rule itself is vague, the guidance is meant to clarify, but they can issue new guidance at any time.

How convenient...

I was just reading this article about issuing violations:

55 Warning letters issued to U.S. retailers for violating FDA deeming regulations

Haven't finished reading it yet...

 

[Shekinahsgroom]

Dead link in that article, here's the downloads page for tobacco products:

Search Results: downloads

It would be interesting to see how many violations to date?

I found it especially interesting that Walgreens was hammered 3 times, especially being a pharmacy.

https://www.fda.gov/downloads/Tobac...nceRegulatoryInformation/Retail/UCM520813.pdf

 

[Verb]

It would be interesting to see how many violations to date?

That's it. No other federally backed enforcement action has taken place.

Edit: I was totally wrong on this comment.

 

[skoony]

Tobacco is a raw material, not nicotine. It's a component of tobacco and is age-requirement regulated (extremely deadly poison). Pure nicotine was regulated long before vaping was even a word, that's why it doesn't require a PMTA because it was already on the market before 2007. It's widely used in the patch, nicotine-laced gums, lozenges, etc. and why you need a prescription to obtain it (mixed). And before cessation products, it's used as an insecticide for crops.

Pure nicotine was regulated as a pesticide and for purity,health and,safety.
never as a tobacco product.
Tobacco and everything in it is a raw material. Tobacco products are regulated not,the tobacco itself.
When used in smoking cessation it is regulated as a medical device and or medicine. Most patches
and gum no longer require a prescription. Age requirements are required for tobacco products.
Nicotine was never considered for regulation.
Mike

 

[skoony]

It actually surprised me that they went the route of regulating absolutely everything when there was a far simpler way to destroy vaping right in front of them.

The reason they are not going to regulate nicotine is the same reason they didn't regulate
raw tobacco leaf prior to vaping. To keep the manufacturing costs low and allow more room
for taxation at the finished product end. If raw tobacco leaf was regulated the same way
cigarettes are, the cost would make it very expensive to manufacture tobacco products
eliminating producers and buyers and, reducing the tax revenue streams before they could
be created. Cigarette manufacturers do not pay the Federal and state taxes. It is added to
the cost at various points along the distribution chain. In my state state authorized
tobacco wholesalers collect the state tax and pass the cost on to the retailers who
pass the cost onto the end user.

I am not sure at which point the Federal tax is collected. I do know those taxes are collected before the retailers sell to a customer.

Mike

 

[Shekinahsgroom]

That's it. No other federally backed enforcement action has taken place.

Compliance Check Inspections of Tobacco Product Retailers (through 01/31/2017)

Ummm...59,590 sales to a minor from 12/29/10 - 1/31/17

Wow...that's a crapload and that's just how many times they were caught!

If a first time offense is $250 (??), that's $15,000,000.00

More serious violations/actions might not be published?

 

[Verb]

Compliance Check Inspections of Tobacco Product Retailers (through 01/31/2017)

Ummm...59,590 sales to a minor from 12/29/10 - 1/31/17

Wow...that's a crapload and that's just how many times they were caught!

If a first time offense is $250 (??), that's $15,000,000.00

More serious violations/actions might not be published?

I stand corrected. There were a couple of FDA sting sales to a minor for eliquid since September.

 

[Lessifer]

The reason they are not going to regulate nicotine is the same reason they didn't regulate
raw tobacco leaf prior to vaping. To keep the manufacturing costs low and allow more room
for taxation at the finished product end. If raw tobacco leaf was regulated the same way
cigarettes are, the cost would make it very expensive to manufacture tobacco products
eliminating producers and buyers and, reducing the tax revenue streams before they could
be created. Cigarette manufacturers do not pay the Federal and state taxes. It is added to
the cost at various points along the distribution chain. In my state state authorized
tobacco wholesalers collect the state tax and pass the cost on to the retailers who
pass the cost onto the end user.

I am not sure at which point the Federal tax is collected. I do know those taxes are collected before the retailers sell to a customer.

Mike

They are regulating nicotine. However, if it's a raw material(nic) and you are only selling it to another manufacturer who will then turn it into a finished tobacco product, then you do not need a PMTA. I am 99% positive that come 2018, anyone selling nic directly to consumers will require a PMTA.

 

[SteveS45]

I am very skeptical of what the FDA provides for documentation of facts and I remember a post on another forum debunking that list.

 

[skoony]

They are regulating nicotine. However, if it's a raw material(nic) and you are only selling it to another manufacturer who will then turn it into a finished tobacco product, then you do not need a PMTA. I am 99% positive that come 2018, anyone selling nic directly to consumers will require a PMTA.

How is it being regulated other than as a pharmaceutical or in use in a ENDS product made for
sale or distribution? My analogy being anyone can get tobacco seeds and grow tobacco.
Any one can carve their own tobacco pipe.Any one can buy of the shelf components and
make their own vaping device. Isn't nicotine just another component in and of itself?
I can see requiring one to aver to not use the product for sale or distribution. You may be
right in assuming the FDA will assert it's authority over nicotine. I have always
said if a lot of people turn to DIY to the point of affecting the retail market it probably will
become an issue. Remember the FDA in its infinite wisdom has said raw tobacco leaf
is not a regulated tobacco product. At the same time they say nicotine as a component
of a ENDS product made for sale or distribution (by their own definition) is a tobacco
product and thus under regulatory restriction. This implies DIY which is not for sale or
distribution is not a regulated product. RYO is a issue because most if not all that RYO
buy there materials at the retail level specifically sold as RYO. There is nothing that says one can't go to the source.

I of course am assuming that making your own e-liquid is the equivalent of growing and
curing your own tobacco. Hard liquor is illegal to make in Minnesota (I assume in most if not all states)
but,there doesn't seem to be much regulating going on here.
Moonshine Still Kits|Complete Still Kits
Regards
Mikw