Certain Regulated Tobacco Products Found to be Not Substantially Equivalent

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 02/13/2023 updates the reason for alert, guidance section including agency contacts, charge code language, and product description. Changes to the import alert are bracketed by asterisks (***). In June 2009, the Family Smoking Prevention and Tobacco Control Act provided FDA with authority to regulate tobacco products by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products. According to the FD&C Act, a new tobacco product is any product that was not commercially marketed in the United States as of February 15, 2007. This includes tobacco products that were modified and sold or distributed after February 15, 2007. To legally market a new FDA-regulated tobacco product in the United States, generally FDA must first issue a written order permitting the sale

Quoted from the “Reason for Alert” section of the FDA page for 98-04, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.