All Products Must Have A PreMarket Tobacco Application Authorization

Be prepared for paperwork. The Family Smoking Prevention and Tobacco Control Act has required all products must have a PreMarket Tobacco Application (PMTA) authorization. The deadline for these products was initially set for May 12th, but the FDA pushed the deadline back as the pandemic caused many companies a delay.

According to recent postings, “To this effect, on March 30th the agency filed a request for a 120-day extension on the deadline, and on April 3rd, Judge Paul Grimm of the United States District Court for the District of Maryland agreed to the request, moving the deadline to September 9th, 2020.” As of last week, all applications must have been turned in to the FDA to become approved, or else all their items not registered will be withdrawn from the United States market.

Unfortunately, the PMTA process is enforced for those product manufacturers who are able to afford the cost that comes with the headache. Over 10,000 vape businesses are going to be forced to close, and leave over 150,000 Americans unemployed. It is suspicious that this was their intentional doing to close more vape shops and prolong users from having access like the youth community.

The PMTA website is created with additional information including how to fill out an application, order status, brands that applied, brands that didn't, and much more. According to the PMTA website, “A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health.” The purpose of all this is to ensure safety on all products and for FDA officials to be aware of who is selling what in the U.S.

The PMTA creators are working very closely with all participants in the vaping industry to gather all accurate information and data on every vendor who is in their status.

According to the PMTA, “In order to reach such a decision and to authorize marketing, FDA considers, among other things…”

  • “Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;”
  • “Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;”
  • “Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and”
  • “The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.”

These are the determining factors that will inform users on these tobacco products to keep the people informed on all the information they will be consuming. It is important to have all this information available because it is a safety issue since past vendors or companies did not have their tobacco products approved by the PMTA, and it caused many devices to have defects or an uncertain concentration of nicotine and tobacco. These PMTAs will help users have a better understanding of their product and will be approved by the U.S. to legally sell these items.


Works Cited

Products, C. (n.d.). Premarket Tobacco Product Applications. Retrieved September 18, 2020, from Premarket Tobacco Product Applications

-, D., By, -, Diane Caruana In-house journalist covering international vaping news., Caruana, D., & In-house journalist covering international vaping news. (2020, September 14). VAPE PMTA: A Pre-Market Tobacco Application Database. Retrieved September 18, 2020, from VAPE PMTA: A Pre-Market Tobacco Application Database/