FDA deeming rule could happen tomorrow

[skoony]

This is incredible.
"To obtain marketing 69 authorization under the PMTA pathway, manufacturers are required to establish, among other things, that permitting their products to be marketed would be appropriate for the protection of public health. In establishing this, manufacturers should take into account, and FDA will consider, the ways in which the new product is likely to be used. For example, PMTAs for these products should contain information on whether the product is likely to be used alone or together with other legally marketed tobacco products (such as available delivery systems), as well as the type and range of other products with which it is likely to be used.For example, where a manufacturer seeks authorization of a new e-liquid to be used with ENDS, the manufacturer may need to provide evidence and analysis of the product's likely impact when used in the range of delivery systems available. Similarly, a manufacturer seeking authorization of a stand-alone apparatus component--such as a heating coil or cartridge--may need to provide evidence and analysis of the product's likely impact when used together with the range of other components and liquids available."
In other words if it's for vaping one must also provide evidence of not only how
vaping affects health but how vaping/smoking cigarettes/smoking cigars/using snuss
or chew all together or in parts affects health. none of the later are required to do so
I assume unless it's a new product.
Mike

 

[skoony]

It does not mater that since I started vaping my persistent chronic bronchitis
has disappeared. I am nothing. I never had a seat at the table of stakeholders.
Not even the kiddy table.
"(Comment 15) Some comments asserted that under section 910(a)(3)(A)(ii) of the FD&C Act, certain categories of products should easily meet the SE standard because the products, overall, are beneficial to public health when compared to traditional, combustible cigarettes. (Response) The issue of whether a product or certain categories of products may be beneficial to an individual is different than whether a category of products, overall, has a net positive benefit on population health. As explained in the NPRM, a category of products may benefit some individual tobacco users but may not have an overall net population health benefit if it leads to increased tobacco product initiation or dual use. In any event, this is a consideration relevant under the PMTA standard, not the SE standard"
Mike

 

[skoony]

Here's a whopper.
"
(Comment 17) A few comments argued that section 910(a)(3)(A)(ii) allows for crosscategory comparisons (i.e., applicants may provide a comparison to predicate products from similar (but not identical) tobacco product categories). 72 (Response) It is up to the manufacturer to select an appropriate predicate tobacco product and provide the scientific evidence demonstrating SE. If the manufacturer provides scientific evidence and a rationale that demonstrates to FDA that the new product does not raise different questions of public health than the predicate (even though there are differences from the predicate product), FDA could issue an SE order. However, manufacturers of cigars or ENDS would have great difficulty showing that a product is substantially equivalent to a combusted
cigarette or a smokeless tobacco product. For example, if FDA received an SE Report for a new product that is an ENDS closed aerosol generating apparatus and a predicate product that is a filtered combusted cigarette, then the product characteristics between the new and predicate products would be different. Because of the differences in characteristics in this example, a significant amount of scientific evidence would be needed to demonstrate that the new product does not raise different questions of public health. Such evidence, as discussed in FDA’s 2011 Guidance titled "Section 905(j) Reports: Demonstrating Substantial Equivalence," could include but would not be limited to the following: (1) Smoke yield data from HPHCs, (2) actual use data demonstrating how smoke topography compares between the new and predicate products, (3) actual use data demonstrating how the amount of product use varies between the new and predicate products (e.g., number of puffs per day), and (4) marketing data indicating how consumer perception (product appeal) by youth differs between the new and predicate products. (e.g., number of puffs per day), and (4) marketing data indicating how consumer perception (product appeal) by youth differs between the new and predicate products. In these cases, it would be difficult to show that the differences between the product and the predicate product are such that the product "does not raise a different question of public health." In addition, the evidence required to make such a showing may be as substantial or even greater than the evidence required under the PMTA pathway (section 910(b)), and the PMTA pathway allows for different effects on public health--as long as the applicant provides a demonstration that the product is appropriate for the protection of the public health"
Mike

 

[skoony]

How do you log in to comment on Vaping.com?
Mike

 

[pennysmalls]

How do you log in to comment on Vaping.com?
Mike

I'm logged in through Facebook and I believe twitter log in will get you there. Otherwise I think if you click to comment you'll get a register option.

 

[skoony]

Some products will make it through the pre-marketing according to the FDA.
I wonder which ones/
"(Comment 21) Some comments argued that application of the February 15, 2007, date is unfair to the manufacturers of the newly deemed tobacco products (particularly e-cigarettes) because they were not on notice of pending regulation and they contended that "all newly deemed products will be forced from the market." Thus, they argue, decisions were made to invest in an industry that was presumed to be unregulated, and now the industry must bear unanticipated costs. (Response) FDA disagrees with comments stating that all newly deemed products will be forced to be removed from the market as some newly deemed products will qualify as "grandfathered" products under the statute and any that are not grandfathered will be able to apply for premarket authorization."
Mike

 

[markfm]

@skoony - Click Comments under any post, then click on the popup to login. You can create a local account, or use your Facebook account (and maybe others -- I used FB login)

 

[skoony]

I'm logged in through Facebook and I believe twitter log in will get you there. Otherwise I think if you click to comment you'll get a register option.

Can you provide the facebook link. i can't find it.
thanks
mike
@pennysmalls ,logged in with facebook.

 

[Susan~S]

How do you log in to comment on Vaping.com?

Click on comment and then you have to login.

 

[pennysmalls]

Can you provide the facebook link. i can't find it.
thanks
mike

Yes, click on comment and the facebook logo should be there, just click on that.

 

[LilWhiteClouder]

SFATA just released their statement: "WASHINGTON, D.C., May 5, 2016 — The Smoke-Free Alternatives Trade Association (SFATA), the largest trade association representing and managing the interests of the vapor industry, today issued the following statement regarding the Food & Drug Administration’s (FDA) final deeming rule on e-cig and vapor regulations:

“As the Royal College of Physicians, one of the world’s leading medical associations, recently released its historic report endorsing vaping as a harm reduction option, stating that regulations should not inhibit the development or use of vapor products, the FDA today issued its final rule classifying vapor products as tobacco, essentially banning 99 percent of all vapor products on the market as a result of the February 15, 2007 predicate date.

“Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product.

“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging. Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.

“These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.

“Since a growing body of scientific evidence confirm that vapor products are more than 95 percent less harmful than combustible cigarettes, it is essential that Congressional action be taken so vapor products can remain on the market as highly effective replacement tools for smokers. The only viable option at this time is to change the predicate with federal legislation, such as H.R. 2058 (aka Cole Bill), as well as a recent bi-partisan amendment introduced by U.S. Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) that recently passed the House Appropriations Committee, so that a more reasonable substantial equivalency pathway to market is created.”

 

[skoony]

The leaked draft guidance was right on the money.
"We also note that, elsewhere in this issue of the Federal Register, FDA has made available draft guidance, which when final will describe FDA's current thinking regarding some appropriate means of addressing the premarket authorization requirements for newly deemed ENDS products."
Mike

 

[sparkky1]

You would think non biased scientific study's would have been published to show just how addictive pure nicotine really is by now ?
And the the undisputed winner is A Perfect Puff. First Time. Every Time. | VUSE | Digital Vapor Cigarettes, notice the new warning label
At least we still have state by state sin taxes / online purchase banning to look forward to
now that nicotine and flavoring ( e juice ) will be a tobacco product

 

[skoony]

There goes your replaceable coils and small mom and pop e-liquid makers out the window.
"For example, where a manufacturer seeks authorization of a new e-liquid to be used with ENDS, the manufacturer may need to provide evidence and analysis of the product's likely 80 impact when used in the range of delivery systems available. Similarly, a manufacturer seeking authorization of a stand-alone apparatus component--such as a heating coil or cartridge--may need to provide evidence and analysis of the product's likely impact when used together with the range of other components and liquids available."
Mike

 

[skoony]

You would think non biased scientific study's would have been published to show just how addictive pure nicotine really is by now ?
And the the undisputed winner is A Perfect Puff. First Time. Every Time. | VUSE | Digital Vapor Cigarettes, notice the new warning label
At least we still have state by state sin taxes / online purchase banning to look forward to
now that nicotine and flavoring ( e juice ) will be a tobacco product

Bingo! I will be perusing my local B&M's for comments. I will wager anyone one
within a month sales reps will be all over them selling the only products likely
to pass muster with the FDA.
Mike

 

[skoony]

How forward thinking of them. Thje FDA wants to get away from animal testing
and rely more on in vitro testing and computer modeling. News Flash,"vaping
causes head lice".
"(Comment 24) A few comments expressed concern that if manufacturers would be forced to submit PMTAs rather than SE applications, they would need to conduct more animal studies to meet PMTA requirements. (Response) FDA shares an interest in reducing the reliance on animal-based studies, and the Agency is committed to the three "Rs" of reduction, refinement, and replacement in animal testing. Although we are hopeful that in vitro assays and computer models can ultimately help to replace much of the need for animal testing, there are still many areas for which non-animal testing is not yet a scientifically valid and available option. FDA is committed to addressing concerns raised regarding use of animal testing methods, while still ensuring that the Agency satisfies its public health and patient safety responsibilities and acts in accordance with its governing statutes."
Mike

 

[skoony]

Any change in composition of the ingredients in e-liquid no mater
how trivial = new product.
"(Comment 25) One comment stated that e-cigarettes have two variables--the ratio of the propylene glycol to vegetable glycerin and the level of nicotine in the product--which would result in many combinations and, therefore, require submission of numerous, very costly PMTAs for products that have very minor variations. In contrast, one comment noted that the lower number of ingredients in e-cigarettes means that less information will be required in PMTAs for e-cigarettes than for other products. (Response) The requirements and costs of a PMTA may vary based on the type and complexity of the product. Variations in the ratio of ingredients, such as propylene glycol and 82 glycerin, would indicate that products have different levels of each of these ingredients. As stated in section 910(a)(1)(B) of the FD&C Act, any change in an ingredient level, as with additions or removal of ingredients, yields a new tobacco product."
Mike

 

[Robino1]

How forward thinking of them. Thje FDA wants to get away from animal testing
and rely more on in vitro testing and computer modeling. News Flash,"vaping
causes head lice".
"(Comment 24) A few comments expressed concern that if manufacturers would be forced to submit PMTAs rather than SE applications, they would need to conduct more animal studies to meet PMTA requirements. (Response) FDA shares an interest in reducing the reliance on animal-based studies, and the Agency is committed to the three "Rs" of reduction, refinement, and replacement in animal testing. Although we are hopeful that in vitro assays and computer models can ultimately help to replace much of the need for animal testing, there are still many areas for which non-animal testing is not yet a scientifically valid and available option. FDA is committed to addressing concerns raised regarding use of animal testing methods, while still ensuring that the Agency satisfies its public health and patient safety responsibilities and acts in accordance with its governing statutes."
Mike

I think they will find the animals, that they test on, are extremely healthy after their tests.

So, when do we organize a march on the FDA?

I am so .......

 

[crxess]

So.................For all the chatter............It Regulations do as we always expected.
1) Open the Market to BT cig-a-likes
2) Destroy the Marketplace we now enjoy


Results:
1) Unemployment is about to take a Massive Jump
2) BT is about to see an increase in Adult tobacco Sales
3) Teen Tobacco use will once again increase

Well, maybe it will slow this stupidity

 

[skoony]

mispost