Views:9 Author:Site Editor Publish Time: 2020-09-08 Origin:Site
In August 2020, YOUME subsidiary vape brand Suorin has submitted a PMTA application to FDA.
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.
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.
The PMTA deadline has been brought forward to September 9, 2020
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.
DO NOT USE THIS PRODUCT IN THE FOLLOWING SITUATIONS:
• Are under the legal age of purchase
• Are pregnant or breastfeeding
• Have heart disease, stomach or duodenal ulcers, liver or kidney problems, throat disease, or difficulty breathing due to bronchitis, emphysema, or asthma
• Have an overactive thyroid or pheochromocytoma a tumor of the adrenal gland that can affect blood pressure)
• Are taking certain medications, such as theophylline, ropinirole, or clozapine .