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Compliance Timeline

Retailers – Regulatory Compliance Timeline

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August 8, 2016

Prohibition on Free Samples

“FDA wishes to clarify that allowing prospective adult buyers to smell or handle a cigar is not considered the distribution of a “free sample” as long as the product is not actually consumed in the retail facility and the prospective buyer does not leave the facility with a free tobacco product (whole or part). . . . However, if the prospective buyer lights and draws or puffs on the cigar to keep the cigar lit, or otherwise uses the free cigar or leaves the retail establishment with a free cigar, this would constitute a “free sample” in violation of” FDA regulation. 

 

Minimum Age and Identification Requirements

  • Must not sell to any person younger than 18 years of age;
  • Must verify by means of photographic identification containing the bearer’s date of birth that the person is 18 or over;
  • No such verification is required for any person over the age of 26; and
  • Can not sell cigars with the assistance of any electronic or mechanical device (such as a vending machine), except in facilities where the retailer ensures that no person younger than 18 years of age is present, or permitted to enter, at any time.
  • Note: A tobacco product “accessory” (e.g., humidors, lighters, cutters, ashtrays) is not regulated as a tobacco product.  “Components” and “parts” of a tobacco product are deemed subject to regulation (e.g., pipes, flavors, tobacco pouches).

 

Can not 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.

 

Enforcement action against products determined to be adulterated or misbranded

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).

August 10, 2017

Submission of Cigar 'Warning Plan' to FDA

Retailers who are responsible for or direct their own cigar advertising must submit a “warning plan” to FDA for those advertisements.

September 30, 2017

Manufacturers are Required to Register and List Products

According to the final rule, “retail establishments that blend pipe tobacco, are subject to and must comply with all applicable statutory and regulatory requirements for tobacco product manufacturers” (see below).

August 10, 2018

Point-of-sale warnings

For cigars sold individually and not in a product package, all of the cigar warnings must be placed on a sign a minimum of 8.5 x 11 inches posted on or within 3 inches of each cash register.

Manufacturers and Importers – Regulatory Compliance Timeline

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August 8, 2016

First day for domestic manufacturers to register and list products. Registration is required by December 31, 2016. Foreign manufacturers will be required to register and list too, but this will require a separate registration with its own effective date.

Registration:

  • The name and full address of each establishment engaged in manufacturing the registrant owns or operates, as of the date of registration.
  • The name and places of business of the owner or operator. In the case of a partnership, include the name of each partner. In the case of a corporation, include the name of each corporate officer and director, and the State of incorporation.
  • Optional but recommended by FDA:
    • An email address.
    • A Data Universal Numbering System (D-U-N-S®) Number or other unique identifier (codes) for the place of business of the owner, the place of business of the operator, and the location of the establishment.

 

Listing:

  • Each product manufactured is to be clearly and uniquely identified by the product category and unique name (i.e., brand/sub-brand or other commercial name used in commercial distribution).
  • Must include product identification numbers (e.g., SKU, catalog number, UPC) as needed to uniquely identify the product.
  • All labeling for that product and “a representative sampling of advertisements” for the product.
  • These changes must be reported twice a year:
    • Any new tobacco products not included in a previous product listing;
    • Notice of discontinued manufacturing for any product listed; and
    • Notice of resumed manufacturer for any product listed as discontinued.

 

Can not 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.

 

Enforcement action against products determined to be adulterated or misbranded

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).

By August 20, 2016 and Monthly After That

First report due for user fees

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.

August 10, 2017

Submission of cigar Warning Plan to FDA.

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.

November 8, 2017

Prohibition against the use of light, low, and mild descriptors.

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.

Last day to submit SE exemption requests for products marketed before August 8, 2016 but not “grandfathered.”

Submission of Health Documents by domestic manufacturers and importers (or the foreign manufacturer)

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.

Domestic manufacturers and importers or the foreign manufacturer must submit ingredient lists but not HPHCs²

 

Small-scale tobacco product manufacturers have 12 months from the effective date of the final rule. [2]

  • Each product for which an ingredient list is submitted is to be clearly and uniquely identified by its brand and subbrand, 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:
      • the type (e.g., burley, bright, oriental)
      • the variety
      • the cure method (e.g., flue, fire, sun, steam, air) and heat source (e.g., propane, wood)
      • a 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.

May 8, 2018

Last day to submit SE reports for products marketed before August 8, 2016 but not “grandfathered.”

August 10, 2018

Required health warnings and other required labeling statements.

  • Name and place of business of manufacturer, packer, or distributor.
  • Quantity of contents.
  • % tobacco that is domestic and % that is foreign.
  • “Sale only allowed in the United States.”
  • One 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.

  • One 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.

November 8, 2018

Last Day to submit PMTA for products marketed before August 8, 2016 but not “grandfathered.”

November 8, 2019

HPHC reporting for all constituents including smoke constituents under 904(a)(3).  Required HPHC reporting under 915 will require a separate regulation.

Premarket Review Compliance Periods - See Details

Premarket Review Compliance Periods

For newly deemed products that are on the market on the effective date of the final rule and were not on the market on February 15, 2007:

August 8, 2016 to August 8, 2017

 

Manufacturer may submit an SE exemption request (however, FDA can “refuse-to-accept” an incomplete SE exemption request, and then it is not considered submitted).

August 8, 2016 to February 8, 2018

 

Manufacturer may submit an SE report (however, FDA can “refuse-to-accept” an incomplete SE report, and then it is not considered submitted).

August 8, 2016 to August 8, 2018

 

Manufacturer may submit a PMTA (however, FDA can “refuse-to-accept” an incomplete PMTA, and then it is not considered submitted).

If the manufacturer submits and FDA accepts one of the submissions by the deadline stated above, FDA will not take enforcement action against that product for one year.  However, at the end of that period, even if FDA has not completed its review, the product will be subject to enforcement action unless FDA determines that “substantial progress” is being made towards completion.

Blending changes to address the natural variation of tobacco in order to maintain a consistent product do not require preauthorization, but the ingredients must be listed.  Blending changes intended to alter the chemical or perception of the product (e.g., nicotine level, pH, smoothness, or harshness, etc.), including seasonal and limited release products, do require premarket authorization.

[1]  A “small-scale tobacco product manufacturer” employs 150 or fewer full-time equivalent employees and has annual total revenues of $5,000,000 or less.  FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with.

 

[2] Required reporting of HPHCs is by August 9, 2019.  However, some SE or PMTAs may be required to contain HPHC information.

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