The significance of the "90 day" period

[paulw2014]

I keep on hearing that manufacturers have 90 days to release products otherwise it will get hard. Is it because of the amendment introduced by House Representatives Tom Cole (R-Oklahoma) and Sanford Bishop (D-Georgia) to a spending bill would exempt existing products from regulation?

So basically, if the FDA rules stands, then anything after 2007 would have to go thru costly hoops. But people are betting that the bill would pass that would exempt everything up to 90 days from now, hence why some manufacturers are rushing products out?

Please correct me if I'm wrong. Thanks

 

[Mazinny]

The deemings will officially be published on May 10, 2016. The regulations will be effective 90 days later ( Aug 8, 2016 ). Any product not inn the market by that date will need prior FDA approval. If you get your product out by Aug 8 , you are basically buying yourself another 2 years ( where the product can stay on the market ). Somewhere in the two year period, you must file a PMTA. The product can then stay on the market for another year, unless the FDA denies approval within that year, in which case the product must be removed from the market. If the FDA has not ruled on your application, the product must be removed a year after PMTA filing date. If approval is granted, the product is then allowed to stay on the market indefinitely. My understanding.

Not related to the Cole Bishop amendment.

 

[paulw2014]

I appreciate the response but does making a mod and selling it to only a handful of people count as "in the market"? And how would FDA know that it was "released" prior to Aug 8, 2016 as opposed to Aug 9.

I believe I read some where that the manufacturer need to submit info to the FDA prior to Aug 8, 2016.

 

[Rule62]

I appreciate the response but does making a mod and selling it to only a handful of people count as "in the market"? And how would FDA know that it was "released" prior to Aug 8, 2016 as opposed to Aug 9.

I believe I read some where that the manufacturer need to submit info to the FDA prior to Aug 8, 2016.

Technically, yes, it's in the market.
But no, the FDA probably wouldn't know.

 

[paulw2014]

Thanks. The reason I'm asking is because I'm a modder (small timer) and I've been designing a mod for quite a bit of time and it hasn't been released. I just want to get the rules straight so I can make a decision on whether to rush or not. But it seems that I better get a few of them in other people's hand before Aug 8, wouldn't you agree?

I think I read some where that the way FDA knows when a product is "out on the market" is by manufacturers "declaring it" in the 90 days grace period, by submitting info,etc. Do you know anything about this?

 

[rice721]

I didn't read through the 499 pages. I did watch some youtube clips, read the forum threads and googled some info. There are 2 main points from what I can tell (other than the fact that all vaping related products are now considered tobacco products).

1. Age restriction (18 and above) - personally, no problem with this one

2. Lengthy and extremely expensive process to get each and every product (different flavored ejuice counts as an individual product) reviewed by the FDA and even then you're not guaranteed to pass.

So with #2 they're basically killing off ALL small businesses who cannot afford the time or resources to have their products reviewed. Thus creating an oligopoly controlled by BT and thus removing our rights to choose through the plethora of products that are available today (whether it be mods, tanks, coil heads, ejuices, wires?, wicking cotton/rayon/mesh??, batteries???, chargers????, different colored sleeves for my box mods???!?!?!?!?!?!?!. The more I think about this the more ridiculous it is.

As for your question yes if you want to take advantage of the 2 year grace period starting from 8/9 then you should get your product out before then.

 

[paulw2014]

As for your question yes if you want to take advantage of the 2 year grace period starting from 8/9 then you should get your product out before then.

What if I get an unrefined version out before 8/9 but later came out with a refined version with only minor changes, like dimensions of the firing button, height of the mod. Would it be considered a different product or no?

 

[rice721]

What if I get an unrefined version out before 8/9 but later came out with a refined version with only minor changes, like dimensions of the firing button, height of the mod. Would it be considered a different product or no?

I can't answer that as I really do not know. My guess is yes since you won't be applying (or will you) with the FDA for your product as you're only taking advantage of the 2 year grace period.

Don't quote me on this, I'm just a vaper

 

[StormFinch]

What if I get an unrefined version out before 8/9 but later came out with a refined version with only minor changes, like dimensions of the firing button, height of the mod. Would it be considered a different product or no?

Yes, with the FDA even the slightest changes are thought to make it a new product and the process starts all over again. It's stated in the front of the PMTA application like this:

When you create a new tobacco product or modify a tobacco product in any way, you must obtain an order from FDA authorizing the marketing of the product before the product may be introduced or delivered for introduction into interstate commerce (section 910(a)(2); 21 U.S.C. 387j(a)(2)). This includes "a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery, or form of nicotine, or any other additive or ingredient” (section 910(a)(1)(B)).

Here's the page with the PDF link to the guidance for PMTAs: Applications for Premarket Review of New Tobacco Products