FDA’s authority now extends to synthetic nicotine in products such as vapes, heated tobacco, and oral nicotine pouches. Credit: Freepik.
In March 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. This will bring these products into line with tobacco-derived nicotine next-generation nicotine delivery products (NGPs). The synthetic nicotine language changes the wording of the 2009 Tobacco Control Act to read, “The term ‘tobacco product’ means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”
The new regulation passed on March 15 and comes into effect immediately. This means any synthetic nicotine NGP manufacturer that wants to keep its products on the US market must first prove that they were on sale by April 14 and then file a PMTA application within 60 days of the law change, by May 14. If a PMTA is submitted within this timeframe, products have the potential to remain on the market for an additional 60 days until July 13. This may be sooner if FDA denies the PMTA application earlier. After July 13 any synthetic nicotine product that hasn’t received authorization or extension from FDA will be subject to enforcement and removed from sale.
If a synthetic nicotine product is modified by a manufacturer based on a tobacco-derived nicotine product that was previously denied a marketing order by FDA, it will effectively be banned from April 13. Manufacturers of these modified products will not be allowed to submit a new PMTA application. This appears to be US lawmakers’ way of closing the apparent loophole that allowed products that were refused or denied FDA authorization switching to using synthetic nicotine to get around the PMTA process.
Going forward manufacturers of synthetic nicotine products will be subject to all the rules and regulations associated with tobacco-derived nicotine products. This will include all aspects of the Tobacco Control Act such as establishment registration and product listing, ingredient listing, label compliance, and health document submissions. There is a high chance that this will further curtail the independent vape sector in the US due to the financial and regulatory expertise required for these in-depth PMTA submissions.
How easy it is for a synthetic nicotine product manufacturer to file a PMTA application within this limited timeframe depends on the amount of data they already possess about their product. Some of the larger international manufacturers probably feel they have a chance to submit a credible application, and there is still time to strengthen data with additional studies around HPHC testing and comparator product studies or environmental impact assessments. However, time is short, and companies need to act quickly to build the best dossier possible in the time left.
The cost associated with a full PMTA submission for a synthetic nicotine product is likely to be similar to that for a tobacco derived nicotine product. However, as time is so limited, the initial costs for these PMTAs won’t be nearly as large as the full-service PMTAs submitted for tobacco-derived ENDS products last year. Those submissions ran into the cost of millions of dollars and some of the studies took over two years to complete. Synthetic nicotine manufacturers will need to build the most robust dos-sier possible to have any chance of passing the first-stage FDA review and keeping their products on the market after July 13. This also offers chance for a manufacturer to add supplementary evidence to their application after the May 14 deadline.
As we’ve seen with the PMTA process for tobacco-derived nicotine ENDs products, FDA follows a clear process and if the initial submission is accepted there could be the opportunity to augment the dossier with additional data after the initial deadline or following receipt of a deficiency letter from FDA. There-fore, it will be in the manufacturer’s interests to continue to conduct research around their product after submission of the initial dossier in the hope that it passes first review. This could allow them to keep their product on the market while the more substantial FDA review process takes place, and they add more data to the application.
The industry debates how the US government will respond to regulating synthetic nicotine products for some time, so this change does not come as a complete surprise to anyone. However, it raises many questions about the future of synthetic nicotine in the NGP sector. It is still not cost-effective to manufacture, and only a few companies currently produce synthetic nicotine due to patents around the manufacturing process. It is estimated that synthetic nicotine is up to 13 times more expensive to manufacture than tobacco-derived nicotine. It will be interesting to see if ENDS manufacturers now abandon using synthetic nicotine in the US because of this regulatory change or stick with it. A large part of this may be decided by how FDA evaluates the PMTA submissions they receive and if there appears to be any difference in how synthetic nicotine and tobacco-derived nicotine PMTA applications are evaluated.