Deeming Regulations have been released!!!!

[zoiDman]

It's a form with Name, Address and Birth date. I didn't fill it out or go any further in the checkout process to see if there was anything else they wanted because I didn't need anything. This was at the top of the form:

In accordance with US law, MyFreedomSmokes must first verify your age before you may check out. Once successfully validated, your account will be verified and you will not need to submit this verification check again.
Please enter your First and Last Name as it appears on an official ID (i.e. driver‘s license or passport). For instance, if your ID shows a First Name of Robert, use Robert instead of Bob.
- If you have moved recently, please try with your previous address.
- If you have recently married, please try with your maiden name.

Gotcha.

Thank house mouse. We'll have to see how well it works Moving forward.

 

[Kent C]

8/8/16 was my understanding, from that date, as long as they're not manufacturing, they can sell what others are manufacturing, as long as it's something that was already on the market.

I would think that selling others' stuff, they would have to know that the others have submitted PMTA's and have paperwork regarding that. I don't think "as long as it's something already on the market" is any standard that I've seen.

 

[Lessifer]

I'm sorry to say that I don't know that much about these new regulations, but doesn't it place vaping in the same classification as tobacco products? If this is the case, how do cigarettes pass the approval process? I know BT has tons of money and all, but as poisons as cigarettes are, how could they pass and e-liquids not pass. What kind of criteria would support that?

All cigarettes that are currently on the market were either on the market before 2007, meaning they are exempt from the application process, or are "substantially equivalent" to a product that was on the market prior to 2007, meaning they too are exempt from the bulk of the application process. The only "new" products that have been approved through the PMTA process are 8 variations of snus(smokeless tobacco).

 

[Kent C]

Americans are also fascinated with mobsters

Some Americans are.

 

[Sugar_and_Spice]

Got this from Nicotine River

Dear NicSelect Customers and Potential Customers,


The next several months will be a challenge for many of you as you prepare to adhere to the FDA regulations and the PMTA (pre-market tobacco approval) requirements. Naturally, we all hope that our industry can successfully challenge the grandfather date and bring about other modifications we believe are needed.


Regardless of what may come, we and Alchem International, makers of NicSelect® 100% Pure Nicotine USP, will do whatever we can to assist with your compliance efforts. We will soon be submitting a TPMF (tobacco products master file) on NicSelect® to the FDA that you can reference in your PMTA applications. And if you are selling products in Europe, we assure you we are REACH compliant and can help you with your TPD (Tobacco Products Directive) dossiers. We can also refer you to associations/consultants in Europe that can assist you with that process.


Alchem International has been making plant-based extracts for the pharmaceutical, nutritional, cosmetic and e-cigarette industries for over 75 years. Unlike newcomers to the market, we are thoroughly versed and experienced in dealing with regulatory agencies both here and abroad. We are regularly inspected by FDA and we currently have 4 active DMF’s (Drug Master Files) in place at FDA for pharmaceutical API’s (Active Pharmaceutical Ingredients).


We are committed to the long-term success of this industry. In fact, because of current and projected future demands in the US and Europe, we are preparing to double our current capacity of NicSelect® to continue to be able to supply your needs. Please feel free to call me to discuss how we can help you succeed in this ever-changing regulatory landscape.


Sincerely,

Thomas H. Schrier

Vice President of NicSelect

Business Development & Sales


Alchem USA, Inc.

5819 Highway 6 South

Suite 140 Missouri City,

TX 77459

 

[Lessifer]

I would think that selling others' stuff, they would have to know that the others have submitted PMTA's and have paperwork regarding that. I don't think "as long as it's something already on the market" is any standard that I've seen.

From what's currently out and has been dissected, the companies have two years to file a PMTA, and as long as the product is on the market as of 8/8/2016 it can be sold until 8/2018 or until a filed PMTA is rejected. Or are you saying nothing will be legal to sell as of 8/8/2016?

 

[VNeil]

Some Americans are.

Enough are to make it a hit TV series

 

[Kent C]

From what's currently out and has been dissected, the companies have two years to file a PMTA, and as long as the product is on the market as of 8/8/2016 it can be sold until 8/2018 or until a filed PMTA is rejected. Or are you saying nothing will be legal to sell as of 8/8/2016?

No, I agree. But then it seems he could still continue to sell his stuff until 8/2018. He would have 2 years to file a PMTA. So he just doesn't file a PMTA but still sells anyway. ??? If that is not the case, then selling others' stuff would be in the same situation.

 

[Kent C]

Enough are to make it a hit TV series

Agreed... just not all Americans. Same for politics.

 

[Ed_C]

All cigarettes that are currently on the market were either on the market before 2007, meaning they are exempt from the application process, or are "substantially equivalent" to a product that was on the market prior to 2007, meaning they too are exempt from the bulk of the application process. The only "new" products that have been approved through the PMTA process are 8 variations of snus(smokeless tobacco).

Thank you for the explanation. That's a pretty convenient date for grandfathering in products for BT and not so convenient for the vaping industry, as most products weren't in production. So wouldn't most similar e-juices be considered "substantially equivalent" once the first one passed?

 

[DC2]

Thank you for the explanation. That's a pretty convenient date for grandfathering in products for BT and not so convenient for the vaping industry, as most products weren't in production. So wouldn't most similar e-juices be considered "substantially equivalent" once the first one passed?

Click here to read about how substantial equivalence works...
You're not going to like this

We can start talking about the concept of "once the first one passed" after you read that.
But I warn you, it's not any prettier.

 

[Lessifer]

No, I agree. But then it seems he could still continue to sell his stuff until 8/2018. He would have 2 years to file a PMTA. So he just doesn't file a PMTA but still sells anyway. ??? If that is not the case, then selling others' stuff would be in the same situation.

Well, choosing to only sell retail takes out all of the considerations of being a manufacturer. This is especially important for anyone who mixes liquid in house. Unless you have a full scale manufacturing process, how do you prove that your product made 8/9 is the same as one that was made 8/7? This is why I've said custom mixes will be a thing of the past. There will be no more small batch mixing. It will have to be consistent large batch productions, with verifiable sourcing. At least that's how I understand it.

 

[Lessifer]

Thank you for the explanation. That's a pretty convenient date for grandfathering in products for BT and not so convenient for the vaping industry, as most products weren't in production. So wouldn't most similar e-juices be considered "substantially equivalent" once the first one passed?

As is discussed in what DC2 linked to, substantial equivalence really means that it is the same exact product. Changes such as a different flavor would definitely be considered NOT substantially equivalent.

 

[Bronze]

Some Americans vote for crooks.

You and anyone else following this have my permission to use your statement in place of mine.

 

[Kent C]

Well, choosing to only sell retail takes out all of the considerations of being a manufacturer. This is especially important for anyone who mixes liquid in house. Unless you have a full scale manufacturing process, how do you prove that your product made 8/9 is the same as one that was made 8/7? This is why I've said custom mixes will be a thing of the past. There will be no more small batch mixing. It will have to be consistent large batch productions, with verifiable sourcing. At least that's how I understand it.

How I understand it as well. There's a local here who has 5 or 6 stores but also has a lab for mixing their own juices. Don't know which way they are going but likely more precise in their own retail product. And I agree custom mixing is done and probably all levels of nic as well.

 

[Ed_C]

I could almost swallow this if all the pre-2007 Tobacco produces had to pass these same regs. It's ironic that the only products that seem to be safe are those that have been proven to be deadly.

 

[Kent C]

I could almost swallow this if all the pre-2007 Tobacco produces had to pass these same regs. It's ironic that the only products that seem to be safe are those that have been proven to be deadly.

Our gov't can't (usually) pass laws that are retroactive, which is why some tobacco products aren't affective. And we definitely don't want retroactive laws regardless of the situation.

Ex post facto law - Wikipedia, the free encyclopedia

An ex post facto law (corrupted from Latin: ex postfacto, lit.'out of the aftermath') is a law that retroactively changes the legal consequences (or status) of actions that were committed, or relationships that existed, before the enactment of the law.

I'd actually like some of the lawsuits to address this.

 

[Ed_C]

They remove chemicals that are considered unsafe from the market all the time (Pb from paint for example). If it wasn't BT don't you think cigs would have been taken off the market a long ago?

 

[satchvai]

They remove chemicals that are considered unsafe from the market all the time (Pb from paint for example). If it wasn't BT don't you think cigs would have been taken off the market a long ago?

It's all about the Benjamin's. $$$$$

 

[r055co]

Since the FDA regulations restrict shops and employee's from saying vaping can help you quit, prevents them building, etc nothing restricts us. I have been thinking about printing out flyers with real legit information and how I and millions of others have quit smoking through vaping. I also plan on when ever I'm in a B&M insuring I pass knowledge on. If a fraction of the vapers do this we can significantly reduce the damage from the regulations. It will also be a massive middle finger to them.

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