PMTA
What is a PMTA?
“A PMTA” is “a Premarket Tobacco Product Application” that companies have to file to FDA to continue marketing their tobacco products in the U.S. after the regulation came into effect. US FDA can approve or deny a product based on risk assessment data and whether the product meets Appropriate for the Protection of the Public Health (APPH).
What is ALD doing for PMTA?
As a responsible enterprise, ALD is always striving for full regulatory compliance. ALD has set up a professional PMTA team of more than 50 staffs, who come from different professional fields, including Chemistry, Toxicology, Engineering Science and Epidemiology, and so on.
Up to now, ALD has submitted three Premarket Tobacco Product Applications for seven series of ENDS products, and details are listed below:
| Product | Submission Date | STN |
|---|---|---|
| AH1804-B (B2 Plus Series, Upone Series) | January 24, 2022 | PM0005168 |
| AH2503 & AH2504 (CUBE CHARACTER Series, CUBE NUMBER Series, UpBar CUBE Series) | April 19, 2022 | PM0005248 |
| AH3001 & AH3001-A (BOOM MAX Series, UpBar Bottle Series) | July 4, 2022 | PM0006588 |
FDA accepted ALD's PMTA submissions
