CSP: FDA to Make PMTA List Public

[LoveVanilla]

FDA to Make PMTA List Public

The U.S. Food and Drug Administration will make public a list of the tobacco products subject to the premarket tobacco application (PMTA) deadline of Sept. 9—something NACS and other retail associations had urged the agency to do.

The move will help convenience-store retailers identify illegal products that must be pulled from shelves following the deadline.

With the PMTA deadline quickly approaching, the FDA is preparing to receive a large volume of applications, particularly from manufacturers of e-liquids, e-cigarettes and other electronic nicotine devices (ENDS), Mitch Zeller, director of the FDA’s Center for tobacco Products (CTP) said on Aug. 31. The FDA has one year to review products that were filed on time—but it might not make that deadline.

While the FDA does not know how many applications will be submitted by Sept. 9, there are more than 400 million deemed products listed with the FDA.

Manufacturers of cigars, pipe tobacco, electronic cigarettes, vapor products, hookah, alternative nicotine products and heated tobacco products introduced after Feb. 15, 2007, were required to file substantial equivalence (SE) or PMTA marketing authorization requests by Sept. 9. The deadline was originally May 12, 2020, but the FDA asked for more time due to the COVID-19 pandemic.

The likelihood of the FDA reviewing all of the applications during the one-year review period is low, the agency said, given that this would be an unprecedented number of applications and “several orders of magnitude greater” than anything the FDA has experienced.

The FDA said, however, that it has been laying the groundwork for years to receive, process and review the applications in a timely manner. To date, the FDA has received applications for about 2,000 deemed products, of which about 40% have been resolved.

For products with timely applications, the FDA may continue to defer enforcement of the premarket requirements for up to one year through Sept. 9, 2021, unless a negative action is issued by the FDA on an application during that time.

 

[UncLeJunkLe]

"The move will help convenience-store retailers identify illegal products that must be [sold on the black market]."

 

[Vapeon4Life]

And if the FDA says a product is illegal to sell, how are they going to enforce the decision? Confiscations, fines, penalties, criminal charges? What are their supposedly legal ways to enforce their decisions?

Is it going to be like Prohibition of a hundred years ago where they get on the media and show their confiscations of bootleggers products, or Like they do with drug confiscations now?

Now that they caught El Chappo {Shorty} the drug king pin from Mexico, and now that Marijuana is mostly legal in many states, and completely legal in others - Do they need something else, like vaping products, to create a black market in???

Makes sense when you think about it - Give the government a new black market to keep the whole rotten system going.

Technically Marijuana is still a class A narcotic according to Federal law still on the books - But the Federal government is not enforcing it and many states have bipassed it and legalized it.

Vaping, unfortunately has different problem, certain big money interests {big tobacco {???} and at least one "Goldfinger" like control freak super villain with money to burn, using his money to destroy the industry.

The media is bought and paid for and most of it is working for the anti-vape group of liars and hypocrites.

Just be careful who you vote for in the coming election - If you want to keep vaping legally don't vote for a bought and paid for politician who wants to take you vapes away!