The TPD was introduced for a number of reasons, most of which revolve around raising awareness of the potential dangers associated with tobacco products, particularly for children.
The FDA has been working to reduce unauthorised electronic nicotine delivery systems (ENDS) and other tobacco products being sold to children and teenagers. Here’s what you need to know about the new FDA regulations for vape products and how to ensure that your business is marketing responsibly.
Any person or company can submit a PMTA if they have a new tobacco product they wish to bring to the market. The PMTA process was put in place to ensure all tobacco-related products meet a certain standard.
The Deeming Regulations that deemed nicotine-containing products as tobacco products created a number of pathways for products on the US market to be granted Market Orders (MOs) by the FDA. The most common pathway for approval for electronic nicotine delivery systems or ENDS is that of the Premarket Tobacco Application (PMTA) pathway. Under this pathway, ENDS manufacturers or importers must submit an application to FDA which contains a broad array of information related to the product in order to determine the appropriateness of the product for the protection of public health (APPH).
Stability studies or shelf-life studies are studies conducted on products to evaluate their shelf-life. These studies are important in ensuing products are both safe and also that they meet their label claim over the course of their life.
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