SUORIN has received the acceptance letter for the first round of PMTA applications from the Food and Drug Administration (FDA). With its PMTA submission, SUORIN has provided a scientific foundation for the FDA to evaluate whether these products are “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole.
What is PMTA
PMTA is abbreviation for “Premarket Tobacco Product Applications for Electronic Nicotine Delivery System”, which initiated by FDA on June of 2019. Essentially a PMTA involves compiling and submitting a detailed product dossier of information to the US Food and Drug Administration (FDA). In doing so, companies are required to demonstrate that marketing of a particular tobacco-containing product is appropriate for the protection of public health (APPH). As ENDS products are tobacco-derived, the requirement for a PMTA applies to this sector.
Applicable Scope of PMTA
Simply speaking, PMTA is applicable to the company who manufacture the ENDS products.
PMTA requirement not only relate to new products being brought onto the market, but also applicable to the existing product which modified after market.
Companies who involves in any one of the categories are required to submit a PMTA:
- Companies producing e-liquids
- Companies producing e-cigarettes
- Companies producing combined ENDS products
- Retailers that modify products, or that are engaged in the manufacture, preparation, compounding or processing of products.
Meaning of PMTA
FDA require details of well-controlled investigations and valid scientific evidence to evaluate the products and determine whether or not to issue a marketing order. For meeting the requirement of PMTA, the ENDS company must make a through consideration from the beginning of designing, which make a high requirement on product’s concept. Also, the company shall take environmental impact into consideration, which will be reflected from the marketing plan, on which FDA will determine whether the product is APPH or not. PMTA also have requirement on the whole production process, for which the quality and safety be assured.