CSP: FDA Guidance on Flavored Vape

[LoveVanilla]

FDA Guidance on Flavored Vape
What retailers need to know about selling electronic nicotine products

The FDA will begin enforcement of its guidance document “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” on Feb. 6. Retailers need to know how that guidance will affect their business practices.

Beginning that day, flavored cartridge- and pod-based ENDS products (other than tobacco-flavored and menthol-flavored cartridge or pod-based ENDS products) may be manufactured, distributed or sold only if the FDA has issued a premarket tobacco authorization (PMTA) approval order for the specific product. A cartridge or pod is separate from the electronic cigarette device and must be fit into or be attached to the device, in contrast to self-contained, sealed, disposable electronic cigarette products, non-cartridge-based or “open system” ENDS products and bottles of nicotine e-liquids used in open-system ENDS products.

If an application has been filed but the FDA’s decision is pending, it has not been approved and must be removed from the market as of Feb. 6 until the FDA approves the PMTA application.

Flavored ENDS products that can continue to be sold by any retailer up until May 12, 2020, are disposable, sealed electronic cigarettes; open-system ENDS products; and bottles of nicotine e-liquids intended for use in open-system ENDS products, whether flavored or not. Manufacturers need to file a PMTA for each ENDS product with the FDA by May 12, 2020, to keep their products on the market after May 12

Beginning Feb. 6, the FDA also intends to prioritize enforcement against cartridge- or pod-based tobacco-flavored, menthol-flavored or nonflavored electronic nicotine products if the manufacturer has not taken or is not taking adequate measures to prevent underage access to these products. The FDA will also take enforcement action against open-system electronic nicotine products or small manufacturers such as vape shops that mix e-liquids on-site and primarily sell non-cartridge-based open-system electronic nicotine products, if they market to youth or do not take adequate measures to prevent youth access.

FDA enforcement actions can include warning letters, import alerts to refuse admission of specific tobacco products into the United States, seizure actions, civil court actions and criminal prosecutions.

For a list of the FDA’s approved PMTA applications, click here. A list of pending PMTA applications will not be available from the FDA. Retailers will need to obtain information about pending applications from distributors and manufacturers so they can satisfy themselves that an application was filed on time and has not been denied.

Note above list of approved PMTA application currently shows "page not found".

 

[Rossum]

If an application has been filed but the FDA’s decision is pending, it has not been approved and must be removed from the market as of Feb. 6 until the FDA approves the PMTA application.

In other words, they're reversing what they said in the original Deeming Regs, which quite clearly stated that manufacturers would have an additional year on the market after the PMTA deadline, provided they had filed a PMTA by the deadline. In fact, they're forcing stuff off the market prior to the actual deadline.

 

[zoiDman]

In other words, they're reversing what they said in the original Deeming Regs, which quite clearly stated that manufacturers would have an additional year on the market after the PMTA deadline, provided they had filed a PMTA by the deadline. In fact, they're forcing stuff off the market prior to the actual deadline.

Does the Deeming Rule Set specifically say that there would be a 1 Year period to continue to sell products while under PMTA review?

 

[puffon]

Confusing...it also says this:
"Manufacturers need to file a PMTA for each ENDS product with the FDA by May 12, 2020, to keep their products on the market after May 12"

 

[Rossum]

Does the Deeming Rule Set specifically say that there would be a 1 Year period to continue to sell products while under PMTA review?

I'm not really inclined to re-read the whole depressing 499 pages again. My guess is it was couched in some words make it a matter of the FDA's "discretion".

 

[zoiDman]

I'm not really inclined to re-read the whole depressing 499 pages again. My guess is it was couched in some words make it a matter of the FDA's "discretion".

I'm with you on the Not Re-Reading part. It kinda makes me want to Spit on my Monitor every time that I do.

But if I recall correctly, it said that a PMTA-ed product could remain on the market while under FDA Review. And or if the FDA requested Additional information or Data regarding the PMTA.

I Don't recall any Statuary Time Limits as to how long a PMTA-ed product under review could remain on the Market. And the 1 Year time frame I believe came from FDA Statements regarding How Long a successful PMTA would take to be Reviewed. Be that as it may.

There were also Statements by the FDA say'n that they predict that a Substantial Percentage of PMTA would be Summarily Dismissed due to "Incompleteness".

But that Isn't surprising. Seeing that the FDA has NEVER disclosed exactly what a "Complete PMTA" would look like.

 

[Rossum]

Seeing that the FDA has NEVER disclosed exactly what a "Complete PMTA" would look like.

I don't think they know themselves what one should look like.

I believe to date, three have been approved:
* The one for some Swedish Match snus.
* The one for IQOS
* The one for 21st Century's ultra-low nicotine cigs.

All three of these are totally different products, and of course, none are vapor products.

 

[zoiDman]

I don't think they know themselves what one should look like.

...

Yeah... If it Wasn't True, it would almost be Funny.

That the FDA alone can define what is a successful PMTA. But they are Unwilling or Unable to define what Exactly that is.

"You got to stem the evil tide
And keep it all on the inside
Mary you're nearly a treat
Mary you're nearly a treat
But you're Really a Cry"