FDA issues Brief Summary of “Not Substantially Equivalent” Determinations delineating why deeming reg would ban all e-cigs

[Bill Godshall]

Today FDA issued a Brief Summary of “Not Substantially Equivalent” Determinations at
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM366584.pdf
that delineates why NO e-cigarette product currently on the market could be approved as “Substantially Equivalent” to a product that was on the market prior to Februay 15, 2007 (unless FDA exempts e-cigs from the 2007 grandfather date in Section 910).

The FDA also announced today that it had rejected two more SE applications for tobacco products (for a total of 10 NSE decisions by FDA). Meanwhile, the FDA has only approved 9 SE applications so far (2 for cigarettes, and 7 for RYO papers and tobacco)..
Tobacco Product Marketing Orders

Yesterday, the US GAO issued a scathing report saying the FDA needs to set time frames for its review process of Substantial Equivalence (SE) applications for tobacco products since agency has made final decisions on just 17 of 3,788 SE applications filed since 2010, Senator Burr comments
http://www.gao.gov/assets/660/657451.pdf
Richard Burr, United States Senator of North Carolina: Press Releases
New Report Highlights Shortcomings in FDA Review Process - Legislative & Regulatory News - Convenience Store News


Since it's not that long, I posted the full text of the FDA's Brief Summary of "Not Substantially Equivalent" Determinations below.
Do any vapers or vendors believe that FDA would approve an SE application for any of their e-cig products? Didn't think so.


10/25/2013

Brief Summary of “Not Substantially Equivalent” Determinations

FDA may find a new tobacco product to be NSE either because there is inadequate
information submitted, or because FDA finds that the new product has different
characteristics and information demonstrates that it raises different questions of public
health.

Tobacco products have been found to be not substantially equivalent to specific
predicate products due to factors such as inadequate evidence that the proposed
predicate products were valid predicates and lack of complete information on the
characteristics of the new products and the predicate products. After considering all the
evidence, the agency determined that there were differences in characteristics between
the new products and the predicate products, and there was not an adequate showing
that the new products do not raise different questions of public health requiring a
premarket tobacco product application.

The types of deficiencies FDA found in one or more of these are summarized below.

• Predicate

Insufficient information for FDA to determine whether or not the tobacco product
that was referenced as a predicate was predicate-eligible. Specifically, adequate
evidence was not provided to demonstrate that the predicate product was
commercially marketed in the United States as of February 15, 2007.

• Design Features

Inadequate information on design features such as ventilation and filter
efficiency. This information is needed to understand if any changes in these
characteristics are present and, if they are, whether the new product raises
different questions of public health.

• Tobacco Type

Inadequate information on the type of tobacco used in the cigarette. This is a
significant deficiency because the type of tobacco can alter the levels of harmful
and potentially harmful constituents. This information is needed to understand if
any changes in these characteristics are present and, if they are, whether the
new product raises different questions of public health.

• Added Toxicants

Where information was provided about the levels of specific ingredients showing
they were present at higher levels than in the predicate product, there was not
adequate evidence that the changes did not result in the new product not raising
different questions of public health. Moreover, some of these ingredients have
been shown scientifically to cause both toxicological and dependence concerns.
For example, some of these ingredients are listed in the Hazardous Substances
Data Bank and have known toxicities.

• Harmful and Potentially Harmful Constituents

Inadequate information regarding “Harmful and Potentially Harmful Constituents”
(HPHCs) in new and/or predicate tobacco products and tobacco smoke. Lacking
this information, FDA was not able to determine whether the new product raised
different questions of public health.

• Change in Burn Properties

Inadequate information regarding changes in additives that could change the
burning properties of a cigarette. Lacking adequate evidence, FDA was not able
to determine whether the new product raised different questions of public health.

• Increase in Free Nicotine

Inadequate information regarding the effect of increased free nicotine
(unprotonated nicotine) in smokeless tobacco products on initiation and
cessation. An increase in free nicotine may lead to a higher rate and amount of
nicotine absorbed in the body. An increase in free nicotine may cause the new
product to raise different questions of public health because initiation may
increase and/or cessation may decrease.

• New Characterizing Flavor

Inadequate information regarding the effect of a new characterizing flavor in
smokeless tobacco products on product initiation and cessation. Addition of a
new characterizing flavor may cause the new product to raise different questions
of public health because initiation may increase and/or cessation may decrease.

• Increase in Free Nicotine

Inadequate information regarding the effect of increased free nicotine
(unprotonated nicotine) in smokeless tobacco products on initiation and
cessation. An increase in free nicotine may lead to a higher rate and amount of
nicotine absorbed in the body. An increase in free nicotine may cause the new
product to raise different questions of public health because initiation may
increase and/or cessation may decrease.

• New Characterizing Flavor

Inadequate information regarding the effect of a new characterizing flavor in
smokeless tobacco products on product initiation and cessation. Addition of a
new characterizing flavor may cause the new product to raise different questions
of public health because initiation may increase and/or cessation may decrease.

• Differences in Tobacco Blend

There were significant differences in the tobacco blends between the predicate
and new tobacco products. Tobacco blend differences can result in different
levels of harmful and potentially harmful constituents.

• Health Information Summary

Submitted health information summary does not comply with section 910(a)(4) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act). Therefore, a marketing
order cannot be issued for the new tobacco product.

 

[trying]

At least we have a better idea of WHAT is coming but still no idea of WHEN it will arrive.

 

[Uma]

Bookmarking, thanks for the heads up, Bill.

 

[NorthOfAtlanta]

FDA may find a new tobacco product to be NSE either because there is inadequate
information submitted, or because FDA finds that the new product has different
characteristics and information demonstrates that it raises different questions of public
health.

The bold part of the first paragraph gives them a way to never approve anything as they are the ones who decide if enough information is given.

So the answer to Bills rhetorical question is h**l no.

 

[trying]

The FDA was going to issue a notice of proposed rule making by October 31, 2013.
Will this fulfill that deadline ?

 

[StormFinch]

Anyone else notice that the FDA can't even be depended upon to proof read their own documents? Repeat information much?

 

[RosaJ]

No wonder they're confused. They're still trying to figure out what the predicated predicate is in the first place!

Will they ever come to the conclusion that you can't shove a square peg into a round hole...

 

[Luisa]

Today FDA issued a Brief Summary of “Not Substantially Equivalent” Determinations at
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM366584.pdf
that delineates why NO e-cigarette product currently on the market could be approved as “Substantially Equivalent” to a product that was on the market prior to Februay 15, 2007 (unless FDA exempts e-cigs from the 2007 grandfather date in Section 910).

The FDA also announced today that it had rejected two more SE applications for tobacco products (for a total of 10 NSE decisions by FDA). Meanwhile, the FDA has only approved 9 SE applications so far (2 for cigarettes, and 7 for RYO papers and tobacco)..
Tobacco Product Marketing Orders

Yesterday, the US GAO issued a scathing report saying the FDA needs to set time frames for its review process of Substantial Equivalence (SE) applications for tobacco products since agency has made final decisions on just 17 of 3,788 SE applications filed since 2010, Senator Burr comments
http://www.gao.gov/assets/660/657451.pdf
Richard Burr, United States Senator of North Carolina: Press Releases
New Report Highlights Shortcomings in FDA Review Process - Legislative & Regulatory News - Convenience Store News


Since it's not that long, I posted the full text of the FDA's Brief Summary of "Not Substantially Equivalent" Determinations below.
Do any vapers or vendors believe that FDA would approve an SE application for any of their e-cig products? Didn't think so.


10/25/2013

Brief Summary of “Not Substantially Equivalent” Determinations

FDA may find a new tobacco product to be NSE either because there is inadequate
information submitted, or because FDA finds that the new product has different
characteristics and information demonstrates that it raises different questions of public
health.

Tobacco products have been found to be not substantially equivalent to specific
predicate products due to factors such as inadequate evidence that the proposed
predicate products were valid predicates and lack of complete information on the
characteristics of the new products and the predicate products. After considering all the
evidence, the agency determined that there were differences in characteristics between
the new products and the predicate products, and there was not an adequate showing
that the new products do not raise different questions of public health requiring a
premarket tobacco product application.

The types of deficiencies FDA found in one or more of these are summarized below.

• Predicate

Insufficient information for FDA to determine whether or not the tobacco product
that was referenced as a predicate was predicate-eligible. Specifically, adequate
evidence was not provided to demonstrate that the predicate product was
commercially marketed in the United States as of February 15, 2007.

• Design Features

Inadequate information on design features such as ventilation and filter
efficiency. This information is needed to understand if any changes in these
characteristics are present and, if they are, whether the new product raises
different questions of public health.

• Tobacco Type

Inadequate information on the type of tobacco used in the cigarette. This is a
significant deficiency because the type of tobacco can alter the levels of harmful
and potentially harmful constituents. This information is needed to understand if
any changes in these characteristics are present and, if they are, whether the
new product raises different questions of public health.

• Added Toxicants

Where information was provided about the levels of specific ingredients showing
they were present at higher levels than in the predicate product, there was not
adequate evidence that the changes did not result in the new product not raising
different questions of public health. Moreover, some of these ingredients have
been shown scientifically to cause both toxicological and dependence concerns.
For example, some of these ingredients are listed in the Hazardous Substances
Data Bank and have known toxicities.

• Harmful and Potentially Harmful Constituents

Inadequate information regarding “Harmful and Potentially Harmful Constituents”
(HPHCs) in new and/or predicate tobacco products and tobacco smoke. Lacking
this information, FDA was not able to determine whether the new product raised
different questions of public health.

• Change in Burn Properties

Inadequate information regarding changes in additives that could change the
burning properties of a cigarette. Lacking adequate evidence, FDA was not able
to determine whether the new product raised different questions of public health.

• Increase in Free Nicotine

Inadequate information regarding the effect of increased free nicotine
(unprotonated nicotine) in smokeless tobacco products on initiation and
cessation. An increase in free nicotine may lead to a higher rate and amount of
nicotine absorbed in the body. An increase in free nicotine may cause the new
product to raise different questions of public health because initiation may
increase and/or cessation may decrease.

• New Characterizing Flavor

Inadequate information regarding the effect of a new characterizing flavor in
smokeless tobacco products on product initiation and cessation. Addition of a
new characterizing flavor may cause the new product to raise different questions
of public health because initiation may increase and/or cessation may decrease.

• Increase in Free Nicotine

Inadequate information regarding the effect of increased free nicotine
(unprotonated nicotine) in smokeless tobacco products on initiation and
cessation. An increase in free nicotine may lead to a higher rate and amount of
nicotine absorbed in the body. An increase in free nicotine may cause the new
product to raise different questions of public health because initiation may
increase and/or cessation may decrease.

• New Characterizing Flavor

Inadequate information regarding the effect of a new characterizing flavor in
smokeless tobacco products on product initiation and cessation. Addition of a
new characterizing flavor may cause the new product to raise different questions
of public health because initiation may increase and/or cessation may decrease.

• Differences in Tobacco Blend

There were significant differences in the tobacco blends between the predicate
and new tobacco products. Tobacco blend differences can result in different
levels of harmful and potentially harmful constituents.

• Health Information Summary

Submitted health information summary does not comply with section 910(a)(4) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act). Therefore, a marketing
order cannot be issued for the new tobacco product.

Exactly what do they mean by all this nonsense? Are they just planning to just ban e-cigs?

 

[Uma]

How can they deem something a tobacco product if they can't regulate it? How can they regulate something they can't deem?
I don't know who's more confused, them or I.

 

[Ranic85]

So I read that entire thing, and I have no clue what it meant.

 

[JonnyRoBato]

Sounds like a confusing explanation that gives them the right to ban whatever they want.

 

[hlk]

So I read that entire thing, and I have no clue what it meant.

Holy conundrum Batman..

I'm with you Ranic.. I think it means there is not info to regulate.. or approve.
So not sure where this will wind up in the end.

But at least they are tipping their hand a little and hopefully come out with the regulations soon so we can sort out the future of the industry.

 

[soba1]

They are blowing vapors they have no idea what to do.....
Imo that written statement is so vague, there are no concrete statements.
To determine if yadda yadda.
Would love some attorney types if hey haven't to give their opinion on this

 

[Arnie H]

So I read that entire thing, and I have no clue what it meant.

Me too! I wonder what they are talking about?
I do not speak gibberish.

Gibberish -
1. Unintelligible or nonsensical talk or writing.
2. a. Highly technical or esoteric language.
b. Unnecessarily pretentious or vague language.

 

[Petrodus]

Me too! I wonder what they are talking about?
I do not speak gibberish.

Gibberish -
1. Unintelligible or nonsensical talk or writing.
2. a. Highly technical or esoteric language.
b. Unnecessarily pretentious or vague language.

Well ... It shouldn't come as a big surprise coming from a government agency ...
Controlled Confusion ... justifying the FDA will do as they please.

Ain't big government wonderful (sarcasm)

 

[Bill Godshall]

Luisa inquired

Exactly what do they mean by all this nonsense? Are they just planning to just ban e-cigs?

This document is the FDA's explanation for why they've rejected 10 SE applications so far (for cigarettes, smokeless tobacco, RYO tobacco and/or paper, which are regulated by Chapter IX).

But more importantly, this document explains why the FDA has only taken final action on 19 (approving 9 and rejecting 10) of the 4,321 SE applications that were filed with the agency from 2010 to February, 2013.

This document also explains why 69 SE applications were withdrawn by manufacturers (as FDA has demanded a truck load of research/data for each SE product application, and it appears that FDA keeps demanding more and more new data after previous data requests were satisfied).

Although this FDA document has nothing to do with e-cigs at the moment (since e-cigs aren't regulated by Chapter IX), it delineates the process that every e-cig product manufacturer and importer will face (if FDA imposes the deeming regulation) for every single one of their products. Even if FDA extends the 2007 grandfather date to 2013 for e-cigs (to avoid litigation), every e-cig manufacturer and importer would have to file an SE application for every new (i.e. even slightly different) e-cig product (or file a New Tobacco Product application, which has even greater hurdles and costs than SE applications) before it could be legally marketed in the US.

And if an e-cig company sells 5 different flavored products at 3 different nicotine strengths, 15 SE applications would have to be submitted to the FDA. So even if FDA exempts e-cigs from the 2007 date, and even if FDA's regs don't ban/restrict flavorings, nicotine levels, or other characteristics of e-cig products, no more than a few of the thousand plus e-cig products now on the market are likely to be on the market five years from now (if FDA imposes the deeming regulation).

JohnnyRoBato wrote

Sounds like a confusing explanation that gives them the right to ban whatever they want.

Precisely.

In an attempt to protect Big Pharma's unsafe and ineffective "smoking cessation" drugs from market competition, the Obama administration's unstated policy has been to prevent ALL new tobacco products from being marketed, which primarily protects cigarette markets and threatens the lives of smokers (and vapers if FDA imposes the deeming reg).

 

[DPLongo22]

Anyone else notice that the FDA can't even be depended upon to proof read their own documents? Repeat information much?

Keep in mind that the "F" stands for Federal (possibly contrary to some personal opinions and/or beliefs).

'Nuff said?

 

[DrBeaker]

I think the key is that an ecig is not a tobacco product and the FDA states clearly that they were not provided enough information to make that determination.

 

[DC2]

What was written was extremely clear to me, and it couldn't be any worse.

It basically says that unless the new regulations exempt electronic cigarettes from the 2007 grandfather date in Section 910 there will be no electronic cigarette products allowed on the market unless they are pretty much EXACTLY the same as something that was available and on the market in 2007 here in the United States. It even goes so far as to make it clear that a different flavor, or any changes in the level of ingredients will cause that product to be determined to not be substantially equivalent, and therefore banned. Even a change in airflow characteristics would cause the product to be banned.

What this basically says is that virtually all electronic cigarettes will be removed from the market.
This is essentially game over, a death sentence.

Bill has been right all along, the deeming regulations WILL nearly ban electronic cigarettes unless there are certain exemptions.
So now we better hope and pray that the FDA does make such exemptions regarding (or changes to) the grandfather requirements.

All that will be left is small, weak cigalikes, and nicotine refill juice will be a thing of the past.

 

[Cool_Breeze]

I don't know that any of our interpretations count towards what will actually happen. It's all a game of 'what if' at this point.