Tobacco | Labeling

Under the Federal Cigarette Labeling and Advertising Act (FCLAA), any person manufacturing, packaging or importing cigarettes or smokeless tobacco is now required to register with FDA and to submit a list of ingredients added to cigarettes every year to the Department of Health and Human Services (HHS) and the Centers for Disease Control (CDC). This list is called the Tobacco Ingredient Report. The Tobacco Ingredient Report must include all tobacco additives and flavors. The manufacturer, packer or importer of tobacco products must also submit a Tobacco Nicotine Report, which declares the amount of nicotine contained in each tobacco product (cigarettes and smokeless tobacco products).

Failure to register or failure of a facility to list tobacco products with FDA as required causes all unlisted tobacco products and all tobacco products manufactured, packed, or distributed by an unregistered facility to be misbranded and in violation of federal law.

Before passage of the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), labeling and label warnings on tobacco products were regulated by the Federal Trade Commission under the authority of the FCLAA. The most commonly known labeled warnings are called the Surgeon General's health warnings required for cigarettes. However, after passage of the TCA, FDA has express authority to govern the words that may appear on tobacco and tobacco product labels (package text) and labeling (including written, printed or graphic matter that may accompany tobacco or tobacco products).

Since passage of the TCA, FDA has initiated restrictions on the use of words such as “Light” “Mild” and “Low” on cigarette labels and labeling. In addition, FDA has required a size increase for the Surgeon General’s health warnings.

Other required information must appear on the labels and labeling of all tobacco and tobacco products under the jurisdiction of several federal and even state regulations and statutes.

FDA now has the authority to pre-approve labeling statements for tobacco products. Although not yet implemented by FDA, the agency will eventually begin to require tobacco product manufacturers and distributors and importers to submit labeling information to FDA prior to marketing their tobacco products.

FDAImports.com, LLC is monitoring the changes that are being implemented by the various regulating agencies and will help you find The Way Through to lawful marketing, importation, distribution, packaging and labeling of tobacco and tobacco products.