Tobacco/E-Cig

Tobacco Health Document Submission

A tobacco product manufacturer or importer must submit to FDA all tobacco health documents it possesses that were created after June 22, 2009. Tobacco health documents consists of any document that relates to the “health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.” Even if a manufacturer or importer lacks health documents, it must still provide a carefully worded statement to FDA to that effect. Failing to make the appropriate submission constitutes a violation of federal law.

FDAImports.com, LLC assists tobacco manufacturers and importers prepare and submit their tobacco health documents. Contact FDAImports.com, LLC and allow us to guide you The Way Through the new tobacco regulatory process.

Tobacco Rotational Warning Plans

Cigarettes

The Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) amended the Federal Cigarette Labeling and Advertising Act (FCLAA) by changing and enhancing the warning statements that must appear on cigarette labels and advertisements. Every cigarette label or advertisement must include one of the nine newly required warnings. The warning statement must be accompanied by a color graphic depicting the negative health consequences of smoking.

One of the more comprehensive changes these amendments present to the industry relate to a rotational warning plan that details for FDA how you will ensure that each of the nine newly required warnings will be randomly displayed at an equal frequency on product packages.  In addition, the plan must detail how each warning will rotate quarterly in alternating sequences in cigarette advertising. The cigarette manufacturer, importer, distributor, and possibly retailer, are subject to this requirement and the plan must be submitted to and approved by FDA.

The new cigarette warning requirements take effect 15 months after FDA issues regulations regarding the graphic accompanying the warnings. FDA has not yet issued these regulations.  FDAImports.com, LLC is monitoring FDA’s implementation of these changes and will help you find The Way Through to lawful marketing, importation, distribution, packaging and labeling of cigarettes.

Smokeless Tobacco

The Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) amended Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) by changing the required warning statements for smokeless tobacco labels and advertisements. A label or advertisement must include one of the four required warnings.


One of the more comprehensive changes these amendments present to the industry relate to a rotational warning plan that details for FDA how you will ensure that each of the four required warnings will be randomly displayed at an equal frequency on product packages.  In addition, the plan must detail how each warning will rotate quarterly in alternating sequences in smokeless tobacco product advertising. The smokeless tobacco product manufacturer, importer, distributor, and possibly retailer, are subject to this requirement and the plan must be submitted to and approved by FDA.

The new warning statements for smokeless tobacco products have taken affect and are required by federal law, but FDA has issued meager guidance on how to implement these new requirements. FDAImports.com, LLC is monitoring FDA’s implementation of these changes and will help you find The Way Through to lawful marketing, importation, distribution, packaging and labeling of cigarettes.

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