The FDA has issued more warning letters to manufacturers selling unauthorized electronic nicotine delivery systems (ENDS) and eLiquid products.
The manufacturers in question had not submitted a premarket tobacco product application (PMTA) in time, meaning their products were sold illegally in the eyes of the FDA.
Following a deficiency letter, manufacturers have 15 days to respond with a plan on how they intend to comply with the regulation. Otherwise, they will likely face further action. Additionally, a public list of products the FDA have received applications for is forthcoming. This will aid retailers to identify the products that they must pull from their shelves.
This comes off the back of the first batch of letters issued earlier in January. The crux of the story – it isn’t too late to act. Hall Analytical can partner with you to ensure that your products are as safe as possible and compliant with PMTA guidelines.
Have questions about the PMTA application? We are holding a live Q&A on the 11th of February to answer all your questions relating to the PMTA submissions. We have assembled a comprehensive panel of experts from the scientific, legal, and regulatory perspectives to answer questions and concerns from all standpoints.
Our panel includes:
- David Lawson – CEO, Inter Scientific
- Sally McGuigan – Principal Scientist, Hall Analytical
- Patricia Kovacevic – Founder and Principal, RegulationStrategy