Description
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.
Scope & Applicability
Product Classes
6Class of tobacco product subject to user fees; includes hookah or water pipe tobacco for user fee purposes
Newly deemed products include cigars.; Warning requirements currently enjoined by court order.; Specific tobacco product category mentioned in court stays
Class of tobacco product subject to user fees
Class of tobacco product subject to user fees
Class of tobacco product subject to user fees
Tobacco product subject to 21 CFR Part 1140
Stakeholders
2Must comply with registration if meeting facility/responsible person definitions
Entity required to submit data for user fee calculation; Entity responsible for user fee submission
Regulatory Context
Attributes
2Used to calculate percentage shares for classes
Basis for individual user fee assessment within a product class
Related CFR Sections (7)
- 21CFR1150.17§ 1150.17 Penalties.
(a) Under section 902(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387b ), a tobacco product is deemed adulterated if the domestic manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer by the later of the date the assessment iRead full regulation →
- 21CFR1150.15§ 1150.15 Disputes.
(a) A domestic tobacco manufacturer or importer may dispute an FDA assessment. The dispute must include the basis for the dispute, and the dispute must be:Read full regulation →
- 21CFR1150.13§ 1150.13 Payment of assessments.
(a) Payment of an assessment must be received by FDA no later than the last day of each fiscal year quarter.Read full regulation →
- 21CFR1150.11§ 1150.11 Notification of assessments.
(a) Notification. No later than 30 calendar days before the end of each fiscal year quarter, FDA will notify each domestic manufacturer and importer of the amount of the quarterly assessment imposed on the domestic manufacturer or importer.Read full regulation →
- 21CFR1150.9§ 1150.9 Domestic manufacturer or importer assessment.
Each quarter, FDA will calculate the assessment owed by each domestic manufacturer or importer for that quarter.Read full regulation →
- 21CFR1150.7§ 1150.7 Yearly class allocation.
For each fiscal year, FDA will allocate the total assessment among the classes of tobacco products.Read full regulation →
- 21CFR1150.5§ 1150.5 Required information.
(a) General. Each domestic manufacturer and importer of tobacco products that are part of a class of tobacco products must submit the information described in this section for such products each month, and the information must be received by FDA no later than the 20th day of each month. The informatRead full regulation →