An Update on FDA Pre-Market Tobacco Applications


Besides these PMTA refusal and denials, the FDA has issued orders authorizing the sale of 23 electronic cigarette devices and nicotine e-liquids sold by R.J. Reynolds Vapor Company, NJOY, and Logic. However, of the 23 products authorized, the only flavor allowed is tobacco flavored nicotine e-liquids. To date, the FDA has not authorized any flavor other than tobacco flavor for electronic cigarette and nicotine liquid products.

Synthetic Nicotine PMTA Update
The FDA received PMTAs for almost one million synthetic nicotine products, the vast majority being vapor products. As of September 6, 2022, the FDA has refused to accept PMTAs for more than 800,00 products containing synthetic nicotine. At the same time, the agency has accepted PMTAs covering 350 synthetic nicotine products for agency review and is still processing more PMTAs for products with synthetic nicotine.

The new law passed by Congress provides that a product with synthetic nicotine can remain on the market if the FDA issued a Marketing Granted Order (MGO) by July 13, 2022. If a MGO was not issued by July 13th, then the product is illegal to market. At this point in time, the FDA has not issued any MGOs for products that contain synthetic nicotine.

The FDA issued an announcement in early August 2022 which states that manufacturers, distributors and retailers may be subject to FDA enforcement if products continue to be sold without first receiving a MGO.

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