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Jash International, Inc., a domestic importer of cigarettes, cigars, and pipe tobacco products, failed to remit required user fee assessments to the FDA by the statutory deadline, rendering all regulated tobacco products it imported adulterated under the Federal Food, Drug, and Cosmetic Act. The company had been assessed user fees by FDA's Office of Financial Management for multiple fiscal quarters but failed to make payment on any of the invoices issued. This noncompliance with Section 919 of the FD&C Act triggered FDA enforcement action under the Family Smoking Prevention and Tobacco Control Act.