FDA opens comment periods on two issues regarding Substantial Equivalence Requirements

[Fanny Pack]

The first, 78 FR 76838, requests comments about possibly exempting manufacturers from the Substantial Equivalence Requirements
Federal Register, Volume 78 Issue 244 (Thursday, December 19, 2013)

The second, 78 FR 78974, requests comments about the guidance that the FDA provides to assist manufacturers in filling out their Section 905(j) Reports when they claim that a new product is Substantially Equivalent.
Federal Register, Volume 78 Issue 249 (Friday, December 27, 2013)

I wonder if they're trying to slip something in before it gets deemed as applicable to vaping.

 

[tombaker]

Thank you very much for this information......Commenting by Vendors to via these avenues would be very productive IMO.

I was interest in this language which fly in the face of some of the fears by CASAA and others.

============

An order under section 910 is not required, however, if a manufacturer
submits a report under section 905(j) of the FD&C Act (21 U.S.C.
387e(j) demonstrating the new tobacco product's substantial equivalence
to an appropriate predicate product, and FDA issues an order finding
the new product to be substantially equivalent to the predicate product
and in compliance with the requirements of the FD&C Act.

This suggest that deleting items from an E-Cig would be equivalent to the prior legal products, and nearly all E-Cig Liquid is made from the same ingredients the above would be applicable and the below is a fall back.

FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec. 1107.1 (21 CFR 1107.1) of the Agency's regulations. As
described in Sec. 1107.1(a), FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, from the
requirement of demonstrating substantial equivalence if the Agency
determines that: (1) The modification would be a minor modification of
a tobacco product; (2) a report demonstrating substantial equivalence
is not necessary for the protection of public health; and (3) an
exemption is otherwise appropriate.

 

[milo hobo]

As I've understood, the FDA has been slow to provide the exemptions for tobacco related products, as in several years slow. The idea that we would be required to seek the FDA to be granted an exemption is terrifying and would likely lead to more legal issues and a near collapse for everything except cig-a-likes. Generation 1 e-cigs would be the only option.

 

[tombaker]

As I've understood, the FDA has been slow to provide the exemptions for tobacco related products, as in several years slow. The idea that we would be required to seek the FDA to be granted an exemption is terrifying and would likely lead to more legal issues and a near collapse for everything except cig-a-likes. Generation 1 e-cigs would be the only option.

The information that I found, and will have to find again to post, is that while the FDA has a backlog of applications, those products remain being sold. The rejections have only been a handful, while some 500 products have applications in place and are being sold on the market currently.

The good news IMO is that because of the substantial equivalence dictates, nearly all E-Cigs will be substantially equivalent to each other. Some core technology, electric coil, fluid, vapor. And the ingredients of nearly all e-Liquid are 4 PG VG Food grade flavorings, and nicotine. So I believe it to be a giant stretch to claim that these products are not equivalent.

Most of the Tobacco control Act, is generated at Marketing and Selling to Kids. The Act itself agrees that the Tobacco products it sells, are legal. And it specifically says they can not be banned. Every court would instantly see the Congressional intent, and stop actions of banning.

Given that E-Cigs will be legal in some form, one or more of them, the barrier to push the paperwork to get a Substantial Equivalent designation will be fairly easy. And I think that is exactly what the languge of the test I snipped out, is presenting. This seems like good news. If something is the same, its gonna be equivalent. There are some folks thinking a Provari battery is doing a different job than a NJOY, thinking they can regulate the source of Electricity to the coil, in an APV......funny.

They are asking for comments, which we all can do.

 

[Uma]

Bumping til the gibberish sinks in.

 

[Sundodger]

I was interest in this language which fly in the face of some of the fears by CASAA and others.

Really? Ever think that maybe, just maybe those fears got people to contact their Reps/Senators and relay their fears, that without such changes that the FDA would just do what they want? Without the people contacting and putting pressure on the pols do you think the FDA just willy nilly came out and said "oh boy, we have to give those vapers an out and make it easy for them to continue what they are doing"? I think not.
While this looks good on paper, looks like the FDA is trying to work to help vapers keep their products that they use today and not pre 2007, it is what it is, just words on paper. They don't have to side with any modification they deem go to far. It's the FDA's opinion in the end that counts, not ours, unless the pressure, along with good scientific evidence, is kept up by us and people like Bill Godshall and the good work from groups like CASAA.

But, I know some think we should just sit around and wait and see what the FDA does and then react. That in the history of government has always worked out real good for the people. NOT!

Happy New Year to ALL.

 

[rothenbj]

Tom you really are wasting a lot of time trying to convince everyone that there's nothing to worry about. You remind me a lot of the fellow that spend a lot of time writing that e cigs would and should be classified as a drug and a drug delivery system back when the FDA was attempting to do just that. He went on and on arguing his position in long winded rhetoric. Of course once the legal system sent the FDA packing in their attempt, he disappeared very quickly I haven't seen a single post in years now.

Considering you feel the sky is blue and the sun is out, why are you so concerned that someone else looked at the weather forecast and saw the potential for a hurricane in the near future and is preparing for it. Instead of just going out and enjoying the beautiful weather, you're sitting in your house endlessly informing everyone there's no need to worry or prepare and criticizing Accuweather for not seeing that everything will be fine because everything is fine today.

Since you've convinced yourself that there's nothing the FDA can do to trip up your euphoria, why do you spend so much time interpreting what the are doing to support your position?

 

[tombaker]

Tom you really......snipped yada yada yada......why do you spend so much time interpreting what the are doing to support your position?

If regulators such as the FDA are not enabled to control something, as struck down by the court, they can only use the laws available to them. If the FDA could ban analog tobacco they would. They can not. Agree? If you don't agree, don't bother to read any further.
There is no reasonable legal interpretation that under the Law that FDA can ban e-Cigs (a deemed Tobacco Product), because the controlling Tobacco control act prohibits it. Given this, people are trying to manufacture reasons why one E-Cig would not be equivalent to another. The OP has posted the actual legislation being asked for public comment.
Its been 4 years since the FDA was given the Tobacco Control Act, they have attempted to designate E-Cigs as something outside of it, and failed.
If you read the text of the substantially equivalent proposals you can see where they will easily allow approval of one e-Cig to the next, without much fanfare.
Perhaps you would like to explain why you think the FDA will have uber powers over E-Cigs, where they don't have those powers over analog Cigarettes????? Please no more yada yada yada

 

[Sundodger]

If regulators such as the FDA are not enabled to control something, as struck down by the court, they can only use the laws available to them. If the FDA could ban analog tobacco they would. They can not. Agree? If you don't agree, don't bother to read any further.
There is no reasonable legal interpretation that under the Law that FDA can ban e-Cigs (a deemed Tobacco Product), because the controlling Tobacco control act prohibits it. Given this, people are trying to manufacture reasons why one E-Cig would not be equivalent to another. The OP has posted the actual legislation being asked for public comment.
Its been 4 years since the FDA was given the Tobacco Control Act, they have attempted to designate E-Cigs as something outside of it, and failed.
If you read the text of the substantially equivalent proposals you can see where they will easily allow approval of one e-Cig to the next, without much fanfare.
Perhaps you would like to explain why you think the FDA will have uber powers over E-Cigs, where they don't have those powers over analog Cigarettes????? Please no more yada yada yada

This from the guy who today on January 2, 2014 had to google Stanton Glantz? I'm terribly disappointed, well, not really.
The poster asked you a question, why are you so worried about this if nothing is going to happen?
You should be asking why can't the FDA outlaw analogs? Try following the money, the same money in play to restrict ecigs.

 

[DustyZ]

If regulators such as the FDA are not enabled to control something, as struck down by the court, they can only use the laws available to them. If the FDA could ban analog tobacco they would. They can not. Agree? If you don't agree, don't bother to read any further.
There is no reasonable legal interpretation that under the Law that FDA can ban e-Cigs (a deemed Tobacco Product), because the controlling Tobacco control act prohibits it. Given this, people are trying to manufacture reasons why one E-Cig would not be equivalent to another. The OP has posted the actual legislation being asked for public comment.
Its been 4 years since the FDA was given the Tobacco Control Act, they have attempted to designate E-Cigs as something outside of it, and failed.
If you read the text of the substantially equivalent proposals you can see where they will easily allow approval of one e-Cig to the next, without much fanfare.
Perhaps you would like to explain why you think the FDA will have uber powers over E-Cigs, where they don't have those powers over analog Cigarettes????? Please no more yada yada yada

Actually I am real curious to know what your level of Legal Expertise is as I see that you continue to assert yourself in such as that begs the questions as to what your qualifications are to make the interpretations that you are making in these threads. Instead of down playing CASAA and stating they pretty much don't understand the legal aspects, it makes it appears as though you think you have a better handle on what the FDA can, can't, will or will not do concerning these issues. How much effort have you actually put forward in relation to helping the cause other then trying to convince people that CASAA and others just don't know what they are doing yet you seem totally convinced that you know for a fact of what the FDA is, can or will not doing concerning E-Cigarettes?

 

[Vocalek]

The first, 78 FR 76838, requests comments about possibly exempting manufacturers from the Substantial Equivalence Requirements
Federal Register, Volume 78 Issue 244 (Thursday, December 19, 2013)

The second, 78 FR 78974, requests comments about the guidance that the FDA provides to assist manufacturers in filling out their Section 905(j) Reports when they claim that a new product is Substantially Equivalent.
Federal Register, Volume 78 Issue 249 (Friday, December 27, 2013)

I wonder if they're trying to slip something in before it gets deemed as applicable to vaping.

It is important to note that the second link you posted is only the Federal Register notice that they are looking for comments. I had to do a Google search to track down the document that is the subject of the requested comments. Found it here: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf

The first notice is related, in that it announces the FDA is seeking comments on a plan to grant exemptions from the requirement to submit a substantial equivalence report. This RFC is self-contained.

By the way, be sure to find the "Estimated Annual Reporting Burden". For filing a Substantial Equivalence report (second link), they have estimated that it would take 340 hours to prepare. So far, that estimate has proven to be grossly underpowered. One tobacco company reported that they were making a minor change: Removing one ingredient, and substituting a different type of paper. The initial submission required 150 hours of employee time, plus seeking the assistance of outside consultants. The FDA returned their report and insisted that much more detail was required. It wasn't sufficient to list, "Flavor X" from Company Y. They had to find out every single ingredient in "Flavor X" (and pray that Company Y would be willing to give up this information.) The updated report took 6 weeks of 6 full time people, plus consultations with attorneys, etc. It ran over 2,000 pages. If, in the future, they were to change one tiny thing--let's say Company Y went out of business and they needed to find a new supplier for "Flavor X"--that would be considered a new product. Assemble the troops for another round of paperwork.

In their own self defense, I believe it would be in the best interests of e-cigarette companies to assume that if e-cigarettes are deemed, and the FDA decides to apply all of Chapter IX of the FD&C act (as indicated here View Rule) to newly deemed tobacco products, the Substantial Equivalence requirements would automatically apply to their products. So they need to give that some thought and consider commenting on the current rules ("Guidance").

 

[LaraC]

Please no more yada yada yada

ROTFL !!

 

[tombaker]

It is important to note that the second link you posted is only the Federal Register notice that they are looking for comments. I had to do a Google search to track down the document that is the subject of the requested comments. Found it here: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf

Your link provides the following:
A tobacco product manufacturer must show that a new tobacco product is “substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that is in compliance with the requirements of this Act.” (Section 905(j)(1)(A)(i) of the Act.) The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product.

For the purposes of this guidance document, FDA refers to predicate tobacco products that were commercially marketed (other than for test marketing) in the United States as of February 15, 2007 as “grandfathered tobacco products.”

For the purposes of 905(j) reports, the new tobacco product is compared to a predicate tobacco product in determining substantial equivalence (section 910(a)(3)(A) of the Act). FDA interprets this to mean that a single predicate tobacco product should be used for comparison purposes, as FDA believes that a meaningful scientific comparison intended to determine whether the characteristics of the products are the same or are different but present no different questions of public health cannot be made between a new tobacco product and multiple predicate products.


This should provide clear sailing for any E-Cig to get full approval via the FDA. Without going into the 2007 date, or if that date for E-Cigs will be 2011 or 2013 in the final draft. There are enough predicate products in 2007 to compare all E-Cigs from V2 and the rest. There are no substantial differences in the product, and especially the end Vape to the user, in the form of content.

This clear language will hopeful alleviate the concern that existing E-Cigs will be stopped from selling, and the formality of the paperwork will be easy enough. Once one example application is available, the rest can be modeled upon it, with minimal hours of time to generate easy multiple applications. Good ol cut and paste will be at the ready. If one E-Cig is legal, the door is open and wide for all the rest to come in. Nice find.

 

[Talyon]

Your link provides the following:
A tobacco product manufacturer must show that a new tobacco product is “substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that is in compliance with the requirements of this Act.” (Section 905(j)(1)(A)(i) of the Act.) The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product.

For the purposes of this guidance document, FDA refers to predicate tobacco products that were commercially marketed (other than for test marketing) in the United States as of February 15, 2007 as “grandfathered tobacco products.”

For the purposes of 905(j) reports, the new tobacco product is compared to a predicate tobacco product in determining substantial equivalence (section 910(a)(3)(A) of the Act). FDA interprets this to mean that a single predicate tobacco product should be used for comparison purposes, as FDA believes that a meaningful scientific comparison intended to determine whether the characteristics of the products are the same or are different but present no different questions of public health cannot be made between a new tobacco product and multiple predicate products.


This should provide clear sailing for any E-Cig to get full approval via the FDA. Without going into the 2007 date, or if that date for E-Cigs will be 2011 or 2013 in the final draft. There are enough predicate products in 2007 to compare all E-Cigs from V2 and the rest. There are no substantial differences in the product, and especially the end Vape to the user, in the form of content.

This clear language will hopeful alleviate the concern that existing E-Cigs will be stopped from selling, and the formality of the paperwork will be easy enough. Once one example application is available, the rest can be modeled upon it, with minimal hours of time to generate easy multiple applications. Good ol cut and paste will be at the ready. If one E-Cig is legal, the door is open and wide for all the rest to come in. Nice find.

Wow Tom, u are a genius and what I don't understand is why CASAA for one has not hired you "yet" to represent all us feared and worried Vapers. Truly u have a unique perspective on language reading, man I wish I had your skills.

TY, Tom I for one am now finally not worried any longer about what the FDA is going to do, I can now step freely out my front door and Vape with ease.

But alas I live up north here in Canada, can u perhaps go through our laws and such and possibly dig up similar good news, please pretty please....... Sorry I can't supply links, but a person of your talents which are so obvious should have no problem doing this. Ty Sir as I would really appreciate this.

All Vapers should rejoice in the knowledge u have provided Tom. We are now free, finally........

I'm just so excited now, I'm at a loss for words as to how much better I feel it's almost euphoric.

Yours truly Sheldon Cooper signing off to spread the Gospel. TY Tom.

 

[Harlen]

Money money money that's what it always is here in the US

 

[YKruss]

Perhaps you would like to explain why you think the FDA will have uber powers over E-Cigs, where they don't have those powers over analog Cigarettes?????

You should be asking why can't the FDA outlaw analogs?

Is FDA going to ban tobacco?

No. The Family Smoking Prevention and Tobacco Control Act specifically states that FDA cannot ban an entire category of tobacco products, such as cigarettes.

Source: Is FDA going to ban tobacco?

Note that the above only applies to cigarettes, not e-cigarettes.

 

[Sundodger]

Source: Is FDA going to ban tobacco?

Note that the above only applies to cigarettes, not e-cigarettes.

I totally understand this, that was the point, why was this passed? To protect big money, no way are they going to allow the FDA to shut down BT. Like I said at the end of the OP, follow the money.

 

[YKruss]

^^^ I totally agreed.

 

[Vocalek]

This should provide clear sailing for any E-Cig to get full approval via the FDA. Without going into the 2007 date, or if that date for E-Cigs will be 2011 or 2013 in the final draft. There are enough predicate products in 2007 to compare all E-Cigs from V2 and the rest. There are no substantial differences in the product, and especially the end Vape to the user, in the form of content.

This clear language will hopeful alleviate the concern that existing E-Cigs will be stopped from selling, and the formality of the paperwork will be easy enough. Once one example application is available, the rest can be modeled upon it, with minimal hours of time to generate easy multiple applications. Good ol cut and paste will be at the ready. If one E-Cig is legal, the door is open and wide for all the rest to come in. Nice find.

Did you miss the description of how this is currently working in practice? There is no "clear sailing." No matter how simple or obvious it seems to you or I that two products are comparable, the FDA has been asking for minute details, not just on the product being submitted, but on the predicate product. You have to pony up extremely detailed specifications for that earlier product. If that product was produced by some other company, not your own, you might not have all that information or be able to get it.

"It is important, therefore, that you submit sufficient information to enable FDA to determine whether the new tobacco product has the same characteristics (defined as the materials, ingredients, design, composition, heating source, or other features of a tobacco product) as the predicate tobacco product, in accordance with 910(a)(3)(A)(i), or has different characteristics but it is not necessary to regulate the product under section 910(c)(1)(A)(i) because it does not raise different questions of public health, as required by 910(a)(3)(A)(ii). FDA understands this to mean that 905(j) reports are to be organized based upon the list of characteristics as set forth in section 910(a)(3). In addition to these characteristics, for products that have different characteristics, FDA may determine that additional information is needed to determine whether the products raise different questions of public health."

See pages 9 through 13 of the Guidance document for the details.

The FDA has received at least 3,500 SE applications and has acted on no more than a few dozen of them.

A single predicate product does not mean that multiple companies can all use the same predicate product. These applications contain proprietary information that the FDA is obligated to keep securely. You cannot grab another company's document and copy/paste. That would be considered corporate espionage.

"FDA believes that a meaningful scientific comparison intended to determine whether the characteristics of the products are the same or are different but present no different questions of public health cannot be made between a new tobacco product and multiple predicate products."

What the "clear language" means is that they want each application to use only ONE predicate product. In other words, you can't claim that features 1-10 of your new product are comparable to features in Predicate Product X, but that features 11-20 are comparable to features in Predicate Product Y. Get it?

This current guidance does not apply to products that are not regulated yet as tobacco products. No doubt they will need to write a separate SE Guidance document to cover e-cigarettes, since they are very different from tobacco cigarettes. Our concern is that so far, the FDA has been very, very picky, sending back SE applications asking for more and more detailed information. "A coil is a coil is a coil" very likely will not cut it with tobacco regulators. If they follow the same pattern as this document, they will be asking for all of the metals that went into making a coil, design drawings, etc., and will want the new product to be identical in every way with the predicate product, unless the applicant can pony up proof that the new design does not present any changes in health risks.

Tobacco companies might be able to absorb all these costly analyses, but those e-cigarette companies not owned by a tobacco company could be bankrupt by this process if it continues to be administered in this fashion.

 

[patkin]

I'm a simple person who knows how the FDA-mandated modified cigarettes affected my lungs and made it go out if I didn't constantly puff on it. I also know that had this "substantial difference" thing been already in place last year, it would still be years in the future before vapers got pyrex tanks instead of polycarbanate ones or, worse, would still be vaping with cartos. I have friends in other countries who can get life-saving meds that I can't because of the FDAs red tape and snail-like pace. Why is it that all of a sudden the FDA has become some kind of rational, saintly, organization? They never have been or at least haven't since I've been an adult.