Synthetic Nicotine Regulations: Your Questions Answered

Questions and answers about new FDA regulation of tobacco products with synthetic nicotine

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If a manufacturer of a synthetic nicotine vapor product does not file a Pre-Market Tobacco Application (PMTA) with the FDA by the filing deadline of May 14, 2022, is that product no longer legal to sell?
An electronic vapor product with synthetic nicotine becomes what the FDA calls “misbranded and adulterated” if a PMTA is not filed with the FDA by May 14, 2022 and then becomes illegal to sell as of May 15, 2022. Also, at this time, there is no sell through period for electronic vapor products with synthetic nicotine if the manufacturer does not file a PMTA with the FDA by May 14, 2022.

Does the new requirement to file a PMTA with the FDA by May 14, 2022 for electronic vapor products with synthetic nicotine apply regardless of the flavor profile of the product?  For example, if a retailer is carrying a tobacco flavored electronic vapor product with synthetic nicotine that does not have a PMTA filed by May 14, 2022, would that product also become illegal to sell as of May 15, 2022?
Yes, both flavored and tobacco-flavored electronic vapor products with synthetic nicotine are required to have PMTAs filed with the FDA by May 14, 2022 and either kind of synthetic nicotine product is illegal to sell as of May 15, 2022 if a PMTA is not timely filed with the FDA.

What can a retailer or wholesaler do to ensure that they comply with these new FDA regulations on electronic vapor products with synthetic nicotine?
To comply with FDA regulations, retailers and also wholesalers should be in contact with the manufacturers of electronic vapor products containing synthetic nicotine to determine whether the manufacturer plans to file a PMTA with the FDA by May 14, 2022 for each of its electronic vapor product containing synthetic nicotine. In addition, retailers and wholesalers should be prepared to remove from their store shelves or no longer distribute any electronic nicotine vapor products with synthetic nicotine as of May 15, 2022 if PMTAs for those products are not submitted to the FDA by the May 14, 2022 filing deadline.

For all the latest news from the National Association of Tobacco Outlets (NATO), visit natocentral.org.