(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;
(2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;
(3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(4) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;
(5) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 387g of this title unless such tobacco product is in all respects in conformity with such standard;
(6)(A) it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or
(B) it is in violation of an order under section 387j(c)(1)(A) of this title;
(7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or
(8) it is in violation of section 387k of this title.
Structure US Code
CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX— TOBACCO PRODUCTS
§ 387a. FDA authority over tobacco products
§ 387b. Adulterated tobacco products
§ 387c. Misbranded tobacco products
§ 387d. Submission of health information to the Secretary
§ 387f. General provisions respecting control of tobacco products
§ 387f–1. Enforcement action plan for advertising and promotion restrictions
§ 387g. Tobacco product standards
§ 387h. Notification and other remedies
§ 387i. Records and reports on tobacco products
§ 387j. Application for review of certain tobacco products
§ 387k. Modified risk tobacco products
§ 387m. Equal treatment of retail outlets
§ 387n. Jurisdiction of and coordination with the Federal Trade Commission
§ 387o. Regulation requirement
§ 387p. Preservation of State and local authority
§ 387q. Tobacco Products Scientific Advisory Committee
§ 387r. Drug products used to treat tobacco dependence
§ 387t. Labeling, recordkeeping, records inspection