Food and drug administration

The FDA Misses Deadline to Rule on PMTA’s

Last updated on September 7th, 2023 at 12:44 am

In the vaping world, Pre-Market Tobacco Applications (PMTAs) are becoming increasingly important. 

These applications must be submitted to the FDA before any vaping product can be sold in the United States, with each application taking up to 18 months to process. 

Recently, the FDA missed its deadline to make a ruling on PMTAs, leaving many vape companies in limbo as they await their fate. 

In this blog post, we will discuss why the FDA missed its deadline and what it means for both established and new vape businesses in the US.

MDO’s: The Steady Roll of ‘Significant Progress’?

The FDA has missed its self-imposed deadline to issue a ruling on PMTA’s, or premarket tobacco product applications. 

This leaves the e-cigarette industry in a state of limbo, as manufacturers don’t know if they will be able to continue to sell their products or not.

The FDA has been reviewing PMTA’s for over two years now, and was supposed to issue a ruling by May 2020. 

However, the agency has pushed back its decision multiple times, most recently to October 2020. Now, with just a few weeks to go until the new deadline, it seems unlikely that the FDA will be able to make a decision.

This is bad news for e-cigarette manufacturers, who are already struggling to comply with the FDA’s stringent regulations. 

If the agency does not issue a ruling soon, it is possible that many companies will go out of business.

It is also unclear what the FDA will do if it does not issue a ruling by October 2020. The agency could extend the deadline again, or it could start enforcement actions against companies that are selling e-cigarettes without approval. 

Either way, the e-cigarette industry is in for a long wait before it knows what its future holds.


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The FDA Misses Deadline to Rule on PMTA’s 5
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A woman vaping

PMTA’s and the ‘Big Five’

As the FDA’s deadline to issue final guidance on PMTA’s looms, the so-called “Big Five” tobacco companies are watching and waiting. 

These companies, who control the vast majority of the U.S. tobacco market, have already submitted their own versions of PMTA’s for review.

The FDA has said that it will take a “risk-based approach” to reviewing these applications, but it is still unclear what that means in practice. 

Some public health advocates worry that the FDA will go easy on the Big Five in order to avoid disrupting the status quo.

There is also concern that even if the FDA does issue strict guidelines for PMTA’s, the tobacco companies will simply ignore them. 

After all, these companies have a long history of flouting regulations and manipulating the marketplace to their own advantage.

Only time will tell how this all plays out, but one thing is certain: The future of vaping in the United States hangs in the balance.

Machine making vape
Machine Making Vape

What Happens Next?

The FDA was originally supposed to rule on PMTA’s by September 30th, 2020 but they have failed to do so. This delays the possible implementation of PMTA’s until 2022. 

Many vape companies are upset by this news as it will likely put them out of business. The FDA has said that they need more time to review the over 10,000 submissions they have received.

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Final Thoughts

As the FDA deadline to rule on PMTA’s looms, many in the vaping industry are feeling anxious. 

The FDA has said that they will not issue any rulings until they have fully evaluated all of the submitted data, but with over 700 products already submitted for review, it’s unclear how long that process will take.

In the meantime, many small businesses are struggling to keep up with the costs of compliance and some have even closed their doors for good. 

It’s a difficult time for the industry, but there is still hope that the FDA will rule in favor of vape products and allow them to remain on the market.


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