Manufacturers and Importers Regulatory Compliance Timeline

If you fail to take any required action listed here or in future regulations, or if FDA determines that the products are contaminated by an added substance that may cause injury, then FDA can deem the products “adulterated” or “misbranded” under the law. That determination permits FDA to take enforcement action (e.g., Warning Letters, product seizure, injunction, fines).

Required warnings to be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of cigar sold in product packaging and randomly distributed in all areas of the United States. For advertisements, the warnings must be rotated quarterly in alternating sequence in each advertisement for each brand of cigar.

Domestic manufacturers and importers of cigars and pipe tobacco must submit information to FDA for purposes of calculating user fees.

“Domestic manufacturer” means a person who is required to obtain a permit from ATTTB of the Department of the Treasury for the production of tobacco products.

“Importer” means a person who is required to obtain a permit from ATTTB of the Department of the Treasury for the importation of tobacco products.

First report for cigars: Domestic manufacturers and importers of cigars must submit, for each TTB permit, the Federal excise tax paid, by class (small cigars and large cigars), for products removed for each month in the Fiscal Year. After August 20, 2016, they must submit the information monthly.

First report for pipe tobacco: Domestic manufacturers and importers of pipe tobacco must submit for each TTB permit, the Federal excise tax paid for products removed for the previous month only. After August 20, 2016, they must submit the information monthly.

Domestic manufacturers and importers of cigars and pipe tobacco will start being assessed fees at the start of the fiscal year following the effective date of the rule. User fees will then be assessed quarterly.

Cannot say or imply in labeling or advertising that a product has a lower risk of disease, is less harmful, or that it contains a reduced level or is free from any substance.

Prohibition on Free Samples.

Premarket review requirements (SE, SE exempt, and PMTA) apply to all products not on the market as of August 8, 2016 unless “grandfathered.” For products marketed before August 8, 2016 but not “grandfathered,” enforcement is delayed if submitted and/or under review by certain dates (see “Premarket Review Compliance Periods” below).

Notify FDA if adding a new additive or increasing the quantity of an existing additive 90 days before making such change.

These terms or “other unauthorized modified risk claims” are prohibited. Plus an additional 30-day period in which a manufacturer may continue to distribute existing inventory manufactured before the effective date.

Small-scale tobacco product manufacturers have an extra 6 months. [1]
FDA intends to publish guidance that specifies the scope of such health documents within three to six months of the publication date of the final rule.  Manufacturers and importers must preserve all tobacco health documents developed after June 22, 2009 for future submissions to FDA.

Each product for which an ingredient list is submitted is to be clearly and uniquely identified by its brand and sub-brand, which includes identifiers (e.g., SKU, catalog numbers or UPC) as needed.

For each product, submit a listing of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product as of the date of submission.

Ingredients that are single chemical substances (e.g., sodium chloride, ammonium hydroxide) are to be uniquely identified by using a unique scientific name or code (e.g., FDA UNII code, CAS number, or IUPAC name).

Leaf tobacco (i.e., whole leaf or parts) that has been prepared solely by mechanical processing that involves no chemical, additive or substance other than potable water is to be uniquely identified by providing the following information: (1) type (e.g., burley, bright, oriental); (2) variety; (3) cure method (e.g., flue, fire, sun, steam, air) and heat source (e.g., propane, wood); (4) description of any recombinant DNA technology used to engineer the tobacco.

Ingredients that are not single chemical substances or single types of leaf tobacco are considered complex ingredients and must be identified. Such ingredients include, for example, chocolate, flavor extracts, tobacco leaf blends, and reconstituted tobacco, as well as naturally-derived, mechanically processed ingredients (e.g., ground spice, fruit juice).

When the manufacturer knows or intends that an ingredient will be formed through a chemical reaction during tobacco product manufacturing, FDA considers the resultant material to be an ingredient that is added by the tobacco product manufacturer and these reaction products are to be included in the ingredient listing.

Must include:
• name and place of business of manufacturer, packer, or distributor
• quantity of contents
•. tobacco origin (% of domestic tobacco/% of foreign tobacco)
• “Sale only allowed in the United States”
• 1 of 7 required cigar warnings must appear on 30% of the two principal display panels of the package. It must be indelibly printed or permanently affixed to the package
• Plus an additional 30-day period in which a manufacturer may continue to introduce into interstate commerce existing inventory manufactured before the effective date that does not contain the required warning statements on packaging

Required Health Warnings in Advertising
1 of 7 required cigar warnings must appear on 20% of the advertising area

Pesticide levels in domestic or foreign tobacco can not be greater than that specified by any tolerance applicable under federal law to domestic tobacco.

Small manufacturers are defined by less than 150 employees and annual total revenues of less than $5 million

FDA Actions Regarding Tobacco Manufacturers/ Importers Affected by Recent Natural Disasters.  

Compliance date for manufacturers to submit a premarket tobacco product application (PMTA)(§905of the FD&C Act) for non-combustible tobacco products such as cigars or pipes.