Title 21 CFR reference

For purposes of this part: Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or (2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) Solely controls moisture and/or temperature of a stored tobacco product; or (ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product Cigar means a tobacco product that: (1) Is not a cigarette and (2) Is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco. Cigarette tobacco means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this chapter also apply to cigarette tobacco. Componentpart or means any software or assembly of…

The provisions of this part do not apply to a manufacturer or distributor of tobacco products that does not manufacture, package, or import tobacco products for sale or distribution within the United States.

(a) Except as stated in paragraph (b) of this section, this part will take effect 24 months after May 10, 2016. The effective date will be with respect to the date of manufacture, provided that, in any case, beginning 30 days after the effective date, a manufacturer may not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with this part. (b) The requirement to submit a warning plan to FDA under § 1143.5(c)(3) will take effect 12 months after May 10, 2016.

Packages.(a) (1) For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States such product unless the tobacco product package bears the following required warning statement on the package label: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” (2) The required warning statement must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows: (i) Be located in a conspicuous and prominent place on the two principal display panels of the package and the warning area must comprise at least 30 percent of each of the principal display panels; (ii) Be printed in at least 12-point font size and ensures that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text; (iii) Be printed in conspicuous and legible Helvetica bold or Arial bold type (or other sans serif fonts) and in black text on a white background or white text on a black background in a…

Packages.(a) (1) It is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigar product unless the product package bears one of the following required warning statements on the package label: (i) WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale. (ii) WARNING: Cigar smoking can cause lung cancer and heart disease. (iii) WARNING: Cigars are not a safe alternative to cigarettes. (iv) WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers. (v)(A) WARNING: Cigar use while pregnant can harm you and your baby.; or (B) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight. (vi) WARNING: This product contains nicotine. Nicotine is an addictive chemical. (2) Each required warning statement must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows: (i) Be located in a conspicuous and prominent place on the two principal display panels of the package and the warning area must comprise at least…

The text in each warning statement required in § 1143.3 or § 1143.5 must be in the English language, except as follows: (a) In the case of an advertisement that appears in a non-English medium, the text in the required warning statement must appear in the predominant language of the medium whether or not the advertisement is in English, and; (b) In the case of an advertisement that appears in an English language medium but that is not in English, the text in the required warning statement must appear in the same language as that principally used in the advertisement.

The warning statements required by this section must be indelibly printed on or permanently affixed to the package or advertisement. These warnings, for example, must not be printed or placed on a product label affixed to a clear outer wrapper that is likely to be removed to access the product within the package.