30-Day Countdown for Synthetic Vape PMTAs Begins

On May 14, premarket tobacco product applications (PMTAs) are due for all non-tobacco nicotine products. The legislation enacted on March 15 makes clear that U.S. Food and Drug Administration can regulate tobacco products containing nicotine from any source, according to an FDA statement.

Additionally, no new non-tobacco nicotine, such as synthetic nicotine products, can be entered into the market beginning today, as some portions of the law take effect. Electronic nicotine-delivery system (ENDS) products must ensure compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) resulting from this law, such as:

• Not selling these products to persons under 21 years of age (both in-person and online);
• Not marketing these products as modified risk tobacco products without FDA’s authorization; and
• Not distributing free samples of these products.
• Additionally, the owners and operators of establishments engaged in the manufacture, preparation, compounding, or processing of NTN products must register with the FDA and list all these tobacco products that they manufacture, prepare, compound, or process for commercial distribution.

The May 14 PMTA is the deadline for only those using the recommended FDA’s electronic submission process. An application submitted in hard copy must be received by FDA no later than 4:00 p.m. EDT on Friday, May 13, according to the agency.