Synthetic Nicotine

NEW FDA REGULATION

In March 2022, the US Congress extended the Food and Drug Administration's (FDA) authority over tobacco products to include synthetic nicotine in products such as vapes, heated products, and oral nicotine pouches.

The new regulation was passed on March 15th and came into effect immediately. This meant any synthetic nicotine NGP manufacturer that wanted to keep their products on the US market had to first prove that they were on sale as of April 14th and then file a PMTA application within 60 days of the law change, by May 14th. If a PMTA was submitted within that timeframe, products had the potential to remain on the market for an additional 60 days until July 13th.  After July 13th any synthetic nicotine product that hasn’t received authorization or extension from the FDA will be removed from sale.

If a synthetic nicotine product was modified by a manufacturer based on a tobacco-derived nicotine product that had previously been denied a marketing order by the FDA, it was effectively banned from April 13th as manufacturers of these modified products were not allowed to submit a new PMTA application.

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What can synthetic nicotine manufacturers do now?

 

Manufacturers will now need to submit a PMTA to gain a Marketing Granted Order from the FDA.  The first task is to understand how much data you already have about your synthetic nicotine ENDS product and then build additional analytical studies to fill gaps to file the best PMTA dossier possible. 

 

 

What is synthetic nicotine?
Synthetic nicotine, also called tobacco-free nicotine, is a synthesized form of nicotine produced via a chemical process instead of extraction from tobacco. Recent improvements in manufacturing processes have enabled producers to mimic the enantiomeric ratio of tobacco-derived nicotine. Synthetic nicotine is not new, with it first synthesized in 1904, but the production on a mass scale is relatively recent. Most e-cigarette manufacturers do not use synthetic nicotine because it tends to be more expensive than tobacco-derived nicotine. There is also far less infrastructure to create synthesized nicotine from scratch than the well-established facilities for harvesting nicotine from tobacco plant materials.
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Learn more about the Premarket Tobacco Product Application (PMTA) process.

Speak to a regulatory expert today.

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A Guide to PMTA for NGP Businesses

Learn more about the requirement of the PMTA process in the US market. 

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