On Friday, March 11, President Biden signed into law the “Consolidated Appropriations Act of 2022.” The bill funds the U.S. government through September of 2022 and also includes a section that grants the FDA the authority to regulate tobacco products which contain nicotine that is not made or derived from tobacco (e.g., synthetic nicotine).
As reported in the NATO News Bulletin over the past several days, the appropriations bill amends the definition of the term “tobacco product” under the Family Smoking Prevention and Tobacco Control Act to define a tobacco product as “any product made or derived from tobacco or containing nicotine from any source, that is intended for human consumption” (new language is italicized). In addition, the language of the section includes a new sentence that reads “This chapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco.”
The new law states that the amendments to the definition of a tobacco product would have an effective date 30 days after the day that the bill is enacted. The legislation provides that a manufacturer marketing a tobacco product which contains nicotine from a source other than tobacco (e.g., synthetic nicotine) must file a Pre-Market Tobacco Application (PMTA) with the FDA within 30 days after this effective date for the product to remain on the market. Then, within 90 days after the effective date, if the FDA issues a marketing authorization order authorizing the sale of the product, the product can remain on the market. However, if the agency does not issue a marketing authorization order or issues a marketing denial order within this 90-day period, then the manufacturer cannot continue to sell its product on the market.
The following deadline dates are now applicable under the Consolidated Appropriations Act of 2022 for any tobacco product that contains nicotine from any source, including synthetic nicotine:
- Enactment Date: March 11, 2022 (the date the legislation was signed by President Biden)
- Effective Date: April 11, 2022 (30 days after the Enactment Date)
- PMTA Deadline Filing Date: May 11, 2022 (the date by which a manufacturer must file a Pre-Market Tobacco Application with the FDA for a tobacco product that contains nicotine from any source, including synthetic nicotine in order to keep the product on the market while the FDA reviews the PMTA)
- FDA Order Deadline Date: July 11, 2022 (the date by which the FDA must issue a marketing authorization order in response to a submitted PMTA to allow a tobacco product with synthetic nicotine to continue to be sold on the market after July 11, 2022)