Synthetic Nicotine Regulation - Consolidated Appropriations Act 2022
The Consolidated Appropriations Act of 2022, signed by President Biden on March 15, 2022, gave the Food and Drug Administration (FDA) the authority to regulate nicotine from any source, including synthetic nicotine.
The Act gives a manufacturer of a tobacco product with synthetic nicotine (or nicotine derived from a source other than tobacco) 30 days after the effective date to file a premarket tobacco application (PMTA) with FDA. If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market.
What Products Are Affected?
Tobacco products that contain nicotine from any source, including synthetic nicotine, are subject to regulation under the Act.
Effective Date: April 14th, 2022
The Consolidated Appropriations Act of 2022 goes into effect on April 14th, 2022, 30 days after the bill was enacted (signed by President Biden).
PMTA Filing Deadline Date: May 14th, 2022
Manufacturers have 30 days after the effective date to file a premarket tobacco application (PMTA) with the FDA.
Note: May 14, 2022, is a Saturday so the FDA may extend the PMTA Deadline Filing Date to Monday, May 16, 2022, but the agency would issue a formal notice to that effect if the filing date is extended to May 16, 2022.
FDA Order Deadline Date: July 13th, 2022
The product cannot be sold if the FDA has not approved the PMTA via a marketing authorization order within 90 days of the effective date.