FDA Granted Regulation of Synthetic Nicotine: What You Need to Know

US Government is Redefining “Tobacco Products”

On March 15th, 2022 President Biden signed the omnibus spending bill to fund aid to Ukraine and other US government programs until September of this year. Included in the bill is an amendment to the Federal Food, Drug, and Cosmetic Act, redefining the definition of tobacco products as any products “derived from tobacco or containing nicotine from any source”, granting FDA power to regulate synthetic nicotine products the same way tobacco derived nicotine products are currently regulated. This amendment closes a critical regulatory loophole that allowed vapor and other ENDS product companies to side-step regulation by switching their regulated tobacco-derived nicotine products to an unregulated synthetic nicotine formulation.

When This Goes into Effect:

This amendment goes into effect April 14th, 30 days after the bill enactment date. All modified synthetic nicotine products (see clarification on this definition below)

are considered misbranded as of this date and must be removed from the market or risk enforcement by the agency.

The PMTA submission deadline for new synthetic nicotine products is May 14th, 60 days after the bill enactment date.

The final deadline is July 13th. On this date all unauthorized synthetic nicotine products become deemed misbranded and are at risk of enforcement by the agency.

What This Means for the Industry:

For companies who currently have synthetic nicotine products on the market, many will have 90-days following the passing of the omnibus bill where the products will not yet be deemed misbranded and may continue to be sold. This includes the 30-days until this legislation is enacted and an additional 60-day submission period given for qualifying products currently on the market. However, if a company had previously submitted a PMTA application and that application had been denied, and the company then re-marketed the same products as synthetic nicotine, those products are NOT eligible for continued marketing under this legislation and will be deemed misbranded immediately upon law enactment (30 days following the passing of this bill). If companies with qualifying products intend to market their synthetic nicotine products after the 90–day window, they will need to submit a new tobacco product application (PMTA) for those products within that 60-day submission period.

New vs. Modified Products:

A critical piece of the new legislation is the distinction between a “new” and a “modified” synthetic nicotine product. If a company that had previously submitted a PMTA for tobacco-derived nicotine products, received a Refuse to Accept (RTA) or a Refuse to File (RTF) ruling for that application, and then remarketed those same products under a synthetic nicotine formulation, those products are considered modified products. Under this legislation, modified products will not be eligible to submit a PMTA application within the 60-day submission period and will be considered misbranded as of April 14th.  

New synthetic nicotine products are new to the market and have not received RTA or RFT rulings under the PMTA pathway. New products must have been on the market prior to the April 14th deadline and have until May 14th to submit a PMTA to the agency for review.

Next Steps:

Companies with qualifying synthetic nicotine products who are prepared to invest in keeping those products on the market will need to act immediately to complete the work needed to submit an application within the 90-day window. Any delay in beginning that process further restricts the ability to submit an application in time. Companies who partner with reputable regulatory firms familiar with the PMTA process and with pre-designed application development and publishing programs and established relationships with the labs needed to do the product testing will have the best chance of meeting this application deadline.

If your company is looking for a regulatory partner for your Synthetic Nicotine PMTA, click here to view our services and speak with a member of our team and begin work on your application today.

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