PMTA Updates

[Hooked]

PMTA Included in White House Rules Freeze
https://tobaccoreporter.com/2021/01/27/pmta-rules-included-in-white-house-rules-freeze/
27 Jan. 2021

"The new U.S. administration has frozen all new and pending rules introduced in the last days of the Trump administration. Included in the freeze are the new finalized rules for premarket tobacco product applications (PMTA) and substantial equivalence (SE) that were announced on Jan. 19, the last full day of the Trump administration.

The Food and Drug Administration’s CBD enforcement policy draft guidance, which had been under review at White House Office of Management and Budget (OMB) since July, was also withdrawn...

Previous administrations, including those of Trump and Barack Obama, issued similar memos to stop last-minute actions by the outgoing administration.

What this means for the nicotine business is unclear. It does not change the rules concerning the Sept. 9 deadline to submit a PMTA to be eligible to stay on the market for year. Because the rule was not formally published in the Federal Register by the U.S. FDA before the end of Trump’s presidency, the Biden administration could move forward with the rule as is, make changes to the rule or scrap the rules entirely.

An note on the Federal Register website reads,” The Food and Drug Administration withdrew this document while it was on public inspection. It will remain on public inspection until the close of business on January 27, 2021. A copy of the withdrawal request is available at the Office of the Federal Register.” ... "

 

[Hooked]

FDA Threatens More Small Vape Companies
https://vaping360.com/vape-news/108326/fda-threatens-more-small-vape-companies
12 Feb. 2021

"The FDA Center for Tobacco Products today issued 11 warning letters to vape manufacturers that have continued to sell products registered with the FDA without having filed Premarket Tobacco Applications (PMTAs). This is the third round of warnings since Jan. 15...

All three batches of warning letters have gone to small e-liquid manufacturers that primarily sell to online or vape shop customers. Because they registered products with the FDA, as mandated by the agency’s Deeming Rule, the FDA is able to cross-reference their registered products with PMTA submissions and build a list of enforcement targets.

With hundreds or maybe over a thousand small manufacturers that didn’t attempt to file PMTAs, the FDA will be able to issue small batches of warning letters weekly for a long time while it decides how to proceed handling the thousands of PMTAs submitted by small manufacturers who attempted to participate in the process..."

 

[CMMACKEM]

Stash eliquid who made arguably the best and cleanest eliquid on the planet closed down in September. SMAX who make Grimm Green's favorite eliquid Pony on Acid will be closing from the 15th of March. Seriously fck them!

 

[zadiac]

If only all vapers could learn to DIY, then **** the FDA

 

[Hooked]

Remember the PMTA List FDA Promised? It's Still Not Done
https://vaping360.com/vape-news/108414/remember-the-pmta-list-fda-promised-its-still-not-done
16 Feb. 2021

"Before last September’s PMTA deadline, the FDA promised it would issue a list of products that have been submitted for consideration and are legal to remain on the market until further action. Today, instead of a list, FDA Center for Tobacco Products Director Mitch Zeller issued a statement explaining why there is still no list.

The short answer: small vaping companies submitted a lot of Premarket Tobacco Applications. One company submitted applications for four million products.

“For PMTAs, as of mid-January 2021, the agency has completed the Processing step of applications for more than 4.8 million products from over 230 companies,” wrote the shocked and awed CTP boss.

"During Processing,” Zeller added, “FDA found that the PMTAs posed additional challenges due to the size, complexity and diversity of the submissions; for example, some firms provided separate submissions for each section of the tobacco product application, such as submitting the clinical information separately from product identification and manufacturing information, while others included up to tens of thousands of products within a submission.”

The bottom line is that the agency is still slogging through the first stage of processing applications. Zeller’s statement doesn’t explain how many are left to be vetted before they’re rejected (“Refuse to Accept”) or accepted for substantive review.

The fact that the FDA has completed processing for almost five million applications—and still isn’t done—says a lot. Presumably if the agency was almost finished checking for basic issues, Zeller would have waited and issued the list, instead of an explanation for why he couldn’t. That suggests that the poor regulators still have a long way to go.

It’s not clear how the agency will handle it if the one-year grace period passes without the whole pile of PMTAs having even been preliminarily vetted. But that’s a possibility, considering that it’s already been five months since the Sept. 9 deadline.

Another question is how such a list would even be useful for compliance cops. Would they visit a vape shop and check each bottle of e-liquid on the shelves against a list of 15 or 20 million products? ... "

 

[CMMACKEM]

Add Cloud Alchemist to the list, one of the best damn Blueberry dominant vape ever made. The small guys are getting hit and unfortunately they have the best eliquid.

 

[Hooked]

Will Puff Bar Force FDA to Regulate Synthetic Nicotine?
https://vaping360.com/vape-news/108752/will-puff-bar-force-fda-to-regulate-synthetic-nicotine
9 March 2021

"Puff Bar is back, and its new synthetic nicotine-based e-liquid could push Congress or the FDA to address the long-festering issue of vaping products made with nicotine not derived from tobacco.

The gray market Puff Bar device and its shadowy owners have succeeded in the retail market by ignoring FDA regulations ...

The new Puff products are reinvigorating those tobacco control groups’ long campaign to pressure the FDA to regulate synthetic nicotine...

“The FDA is aware that Puff Bar’s web site says that they are offering products for sale with claims they contain ‘tobacco-free nicotine,’” an FDA spokesperson told The Hill...

The Tobacco Control Act and tobacco-derived nicotine
The 2009 Tobacco Control Act gave the FDA regulatory authority over cigarettes and smokeless tobacco, and also the ability to “deem” additional consumer products that contain nicotine derived from tobacco. In 2016, the agency issued its Deeming Rule, which defined several other classes of product, including e-cigarettes and all of their components and parts, as tobacco products.

The FDA carefully crafted its regulations to capture any device capable of being used with tobacco-derived nicotine—including components and parts like batteries and nicotine-free vape juice—even if they didn’t contain nicotine at the point of sale. Any open-system (refillable) vaping product is automatically included, because it is capable of being used with tobacco-derived nicotine or altered to do so.

However, the existing rules don’t appear to apply to a sealed device prefilled with synthetic nicotine, like the Puff Bar sellers claim of their new device. Because a disposable isn’t intended to be refilled with tobacco-derived nicotine, the device would probably skirt existing FDA rules (although not necessarily state rules, some of which define tobacco products to include any nicotine, no matter its source).

Tobacco control activists have long advocated for the FDA to regulate synthetic nicotine, to avoid this very situation. The prospect of unregulated products made with synthetic nicotine creating a new vaping “wild west” right when anti-vaping groups finally have the vaping industry on the ropes is maddening to those organizations.

There are essentially three ways synthetic nicotine could be captured by the government (with a lot of potential variations):

• Congress could amend the Tobacco Control Act to include synthetic nicotine
• FDA could claim synthetic nicotine is a drug and attempt to regulate it as one
• FDA could attempt to deem synthetic nicotine to be a tobacco product

All three strategies could be challenged in court, but in the long run, it is difficult to believe that this loophole would survive determined efforts to close it..."

 

[Hooked]

FDA PMTA Carnage Begins As 3 Vape Companies Are Thrown Under the Bus
https://www.ecigclick.co.uk/fda-pmta-carnage-begins/
27 August 2021

"... Many fear this could spell the beginning of the end for vaping in the USA as we know it, especially with the deadline for decisions on PMTAs looming on September 9th this year...

JD Nova Group LLC, Great American Vapes and VaporSalon are named by the FDA as:
Failing to Provide Evidence They Appropriately Protect Public Health...

The three companies involved do have the option of applying again – one wonders if they will given the cost.
And of course, it goes without saying, our hearts go out to all of the company’s staff who are now staring at job losses and all the misery that entails.

Read the full FDA decision.

 

[Hooked]

4.5 Million Vape Products Denied
https://www.planetofthevapes.co.uk/news/vaping-news/2021-08-27_45-million-vape-products-denied.html
27 August 2021

"...America’s Food and Drug Administration (FDA) has denied PMTAs for 4.5 million vape products. The kicker? Every single product is from one single company - JD Nova Group LLC.

JD Nova Group LLC hold the trademarks for Vapolocity electronic cigarettes, De-Ja e-liquid, Ideal Elixirs e-liquid, Stronghold Vapery (assorted vape goods and services), and Wicked Coils.

The company has been issued with a Refuse to File (RTF) letter by the FDA notifying the owners that its PMTA’s failed to meet the requirements for new tobacco products seeking a marketing order. The positive news is that other PMTAs submitted by the company have not been included and are still moving through the review process.

The FDA said: “As a result of this RTF action, the company must remove approximately 4.5 million products from the market or risk enforcement action by FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.” ...

The FDA explained that the company was issued with the RTF letter because the product applications lacked an adequate Environmental Assessment. Under FDA’s regulations implementing the National Environmental Policy Act, an assessment must be prepared for each proposed authorisation – all 4.5 million of them..."