Synthetic Nicotine Loophole Getting Shut Down By The Congress

Congress will close the synthetic nicotine loophole this week when it passes an omnibus spending bill.

What Is in the Current Bill?

Subtitle B of the omnibus clarifies that FDA has the authority to regulate synthetic nicotine products by amending the definition of “tobacco product” in the Federal Food, Drug, and Cosmetic Act. It provides FDA with authority over tobacco products containing nicotine from any source, including such products containing nicotine that is not made or derived from tobacco. 

The provision takes effect 30 days after the date of enactment and provides a transition period for certain tobacco products that contain nicotine from any source other than tobacco that is marketed in the United States within 30 days after the date of enactment. 

The bill also requires FDA to prepare and submit an annual report to Congress for the fiscal year 2022 and each subsequent fiscal year with information on its tobacco regulation activities.

When Will the Bill Pass?

The legislation, which is more than 2,700 pages, is the culmination of months of bicameral and bipartisan negotiations between top Democratic and Republican appropriators. It is scheduled for a vote in the House today (March 9, 2022) and the Senate must pass the legislation by March 15. Funding for the federal government expires on March 15 placing a great deal of pressure on the passage of this legislation.

How Likely is Closing the Loophole?

At this stage, it seems very likely for several reasons. First, since the passage of the amendment to the PACT Act, where Congress expanded the definition of a tobacco product, it seemed increasingly likely that the FDCA would also be amended. Second, this is part of a must-pass piece of legislation. Third, this amendment to the omnibus bill does not require any type of funding, which makes it less likely to become a target for removal.

What Happens After Passage?

What this means in practice is that a PMTA submission just like the one required since 2020 will now be required for synthetic nicotine starting within 90-days of the law’s passing. It is unclear what type of data the FDA will require but they’re obviously many lessons learned from the previous PMTA experience.

Given the complexity of a PMTA submission, it would not be possible to complete all the testing required within 60 days (such as HPHC, stability testing, etc.). However, there is a strategy in developing a course admission that we pass acceptance review where the data could be submitted later. This is likely the best approach to comply with the new law.

Also, there is a provision placing synthetic tobacco products that are identical to tobacco products previously denied a marketing order on a different timeline. This provision is likely to be challenged if included in the final legislation.

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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