PMTA Super Sale

By September 1, 2020Promotions

We are clearing inventory for items that will no longer be available after 9/9. You have the opportunity to get items at prices that will not be there for long, so we strongly encourage you to check those now and stock up for your favorite products.

Prices are marked down on the website and are final. There is no need for any coupon in the checkout.

Overview of PMTA

A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. 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;
  • The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.

Products Affected

  • Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007.
  • Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
  • However, as most people will know, there weren’t any vaping products on the market at this point.  Vaping products are so new that 99% of all vaping products will have to go through the whole process.

Deadline of PMTA

The current deadline for PMTAs is Sept. 9, 2020. This date has changed multiple times since the initial publication of the deeming regulations.
For companies which submit applications, the product can remain on the market for up to one year or until a decision is made.

 

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