Tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Under section 801 of the FD&C Act, imported tobacco products, as with most Food and Drug Administration (FDA) regulated products, are subject to refusal of admission if, among other reasons, they are, or appear to be, adulterated or misbranded.
The Food and Drug Administration has issued a final rule requiring domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act. This information is currently collected by the U.S. Department of Agriculture (USDA) and provided to FDA, but beginning October 2014, when the USDA program sunsets, manufacturers and importers will have to submit this information to FDA instead. FDA will use a similar submission process and the method of assessing user fees currently used by the USDA. The final rule applies to domestic manufacturers and importers of four classes of tobacco products – cigarettes, snuff, chewing tobacco, and roll-your-own tobacco.
Tobacco health documents – Sec. 904 FD&C Act
Under section 904(a)(4) of the FD&C Act, a manufacturer or importer, or their agents, must submit all documents developed after June 22, 2009 “that relate to health, toxicological, behavioral, or physiological effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components and additives.” Health documents developed between June 23, 2009 and December 31, 2009 should have been submitted to FDA by April 30, 2010. FDA does intend to collect tobacco health documents developed after December 31, 2009, but before doing so will publish additional guidance specifying the timing of subsequent submissions. Note that you are to preserve tobacco health documents developed after December 31, 2009 for future submissions to FDA. Failure to comply with the above requirements is a prohibited act and also causes a tobacco product to be misbranded. For more information, please see Guidance for Industry: Tobacco Health Document Submission, issued April 2010.
Under section 904(c) of the FD&C Act, at least 90 days prior to delivery for introduction into interstate commerce of a tobacco product not on the market as of June 22, 2009, a manufacturer or importer, or their agents, must submit a listing of all ingredients of each tobacco product. That provision also requires the manufacturer or importer, or their agents, to submit information whenever any additive, or the quantity of any additive, is changed. Failure to comply is a prohibited act and also causes a tobacco product to be misbranded. For more information, please see Final Guidance for Industry: Listing of Ingredients in Tobacco Products, issued November 2009.
Ban on cigarettes that contain certain characterizing flavors – Sec. 907 FD&C Act
Section 907(a)(1)(A) of the FD&C Act bans the use of certain characterizing flavors in cigarettes, stating, in part:
“…a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.”
Market authorization – Sec. 910 FD&C Act
Sections 910(a)(1)(A) and (B) of the FD&C Act define a new tobacco product as “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007, or any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.” Under section 910(c)(1)(A)(i) of the FD&C Act, a premarket order for a new tobacco product is required prior to its introduction and distribution in the United States, unless, (1) the manufacturer submits a report under section 905(j) and FDA determines the tobacco product to be substantially equivalent to an appropriate predicate tobacco product; or (2) FDA determines that the product is exempt under 905(j)(3) from the requirements demonstrating substantial equivalence. It should be noted that under 910(a)(2)(B) of the FD&C Act, manufacturers of tobacco products first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007 and prior to March 22, 2011, who submitted a 905(j) report not later than March 22, 2011, may continue to market those tobacco products unless and until FDA issues an order that the tobacco product is not substantially equivalent to the predicate tobacco product. Failure to obtain appropriate authorization to introduce a new tobacco product causes a tobacco product to be adulterated or misbranded and is a prohibited act. For more information, please see Guidance for Industry and FDA Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products, issued January 2011.
Modified risk tobacco products – Sec. 911 FD&C Act
Section 911 of the FD&C Act addresses modified risk tobacco products. The term “modified risk tobacco product” means “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” A modified risk tobacco product may not be introduced or delivered for introduction into interstate commerce unless FDA issues an order that it may be commercially marketed. As of July 22, 2010, manufacturers, including importers of finished tobacco products, may not introduce into the domestic commerce of the United States any tobacco product for which the label, labeling, or advertising contains the descriptors “low, ” “mild,” or “light,” or any similar descriptor without an FDA order in effect. Failure to comply is a prohibited act and also causes a tobacco product to be adulterated. For more information, please see Guidance for Industry and FDA Staff: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products, issued June 2010
Smokeless tobacco labels and advertising warnings – Sec. 3 of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA)
Section 204 of the Tobacco Control Act amended section 3 of the Comprehensive Smokeless Tobacco Health Education Actof 1986, 15 U.S.C. 4402, to prohibit (1) any person from manufacturing, packaging, selling, offering to sell, distributing, or importing for sale or distribution within the United States any smokeless tobacco product unless the product packaging bears one of the four textual warning statements that must appear on smokeless tobacco product packages; and (2) any smokeless tobacco product manufacturer, packager, importer, distributor, or retailer to advertise or cause to be advertised within the United States unless the advertising bears one of the four textual warning statements that must appear on smokeless tobacco advertising. Additionally, in accordance with an FDA-approved warning plan, the tobacco product manufacturer, importer, distributor, or retailer must (1) randomly display the required warning statements in as equal a number of times as possible on each brand of smokeless tobacco packaging and randomly distribute in all areas of the U.S. where the smokeless tobacco product is marketed; and (2) rotate quarterly in alternating sequence the required warning statements on smokeless tobacco product advertising. Failure to comply is a prohibited act and also causes a tobacco product to be misbranded.
If you have further questions, please contact the Center for Tobacco Products at AskCTP@fda.hhs.gov
Updated January 2012