If you mix e-liquids, make or modify vaporizers, or mix loose tobacco, and you also sell these products, you may be regulated as both a retailer and a manufacturer.
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import any "tobacco product," then you may be considered a tobacco product manufacturer.
FDA intends to limit enforcement of most of the requirements described below to e-cigarettes, cigars, and other deemed "finished tobacco products" manufactured prior to August 8, 2016.
Compliance Date Updates:
- March 2019: Revised reporting compliance requirements for submission of Harmful and Potentially Harmful Constituents
November 2018: Ingredient Listing Deadline Extended for Small-Scale Manufacturers and Importers Impacted by Recent Natural Disasters
- July/August 2018: Guidance: Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
- November 2017: FDA extended the ingredient listing compliance deadlines for manufacturers and importers of newly deemed tobacco products to provide the same six month extension that previously only applied to those in certain natural disaster areas.
- August 2017: FDA published extended timelines to submit tobacco product review applications for newly-regulated tobacco products that were on the market as of August 8, 2016.
- May 2017: FDA announced it was providing a three-month extension of all future compliance deadlines for requirements under the final deeming rule.
You must comply by these deadlines:
- Stop distributing products with modified risk claims (other than “light,” “low,” or “mild”) by August 8, 2016.
- Report user fee information for cigars and pipe tobacco by August 20, 2016, and monthly thereafter.4
- Pay user fees for cigars and pipe tobacco by December 31, 2016, and quarterly thereafter.4
- Submit tobacco health documents by
- February 8, 2017 for non-"small-scale tobacco product manufacturers" or
- November 8, 2017 for “small-scale tobacco product manufacturers” not in natural disaster areas or
- May 8, 2018 for “small-scale manufacturers” and importers in certain natural disaster areas.
- Submit cigar warning plans by August 10, 2017.
- Register your establishment and submit list of products, including labeling and advertisements, by October 12, 2017.5(For products introduced after August 8, 2016, you must register and submit product listing immediately upon manufacturing.)
- Stop distributing products with modified risk claims, i.e., "light," "low," or "mild," or similar descriptors, unless you have a Modified Risk Tobacco Product order in place, by November 8, 2017.
- Submit tobacco health documents for "small scale tobacco product manufacturers" in certain natural disaster areas by May 8, 2018.7
- Submit ingredient listing by
- May 8, 2018 for non-small-scale tobacco product manufacturers
- November 8, 2018 for "small scale tobacco product manufacturers," except small-scale manufacturers and importers impacted by recent natural disasters
- May 8, 2019 for "small-scale tobacco product manufacturers" and importers impacted by recent natural disasters
(Products introduced after August 8, 2016, must submit ingredient listing 90 days before marketing.)
- Include required warning statements on packages and advertisements on "covered" tobacco products by August 10, 2018.7, 8
2019 - 2022
- Submit quantities of Harmful and Potentially Harmful Constituents
- Submit a premarket application for "new" combustible tobacco products by August 8, 2021. (Revised deadline is based on whether or not the product is combustible—regardless of the pathway chosen (SE, Exemption from SE, or PMTA)).
- Submit a premarket application for "new" non-combustible tobacco products by August 8, 2022. (Revised deadline is based on whether or not the product is combustible—regardless of the pathway chosen (SE, Exemption from SE, or PMTA)).
If you sell e-liquids, pipes or cigars, but do NOT mix or prepare e-liquids, make or modify vaporizers, or mix loose tobacco, then you are considered a tobacco retailer.
Requirements for retailers include:
Beginning August 8, 2016:
- Only sell tobacco products to customers age 18 and older.
- Check photo ID of everyone under age 27 who attempts to purchase tobacco products.
- Do NOT give away free samples, including any components or parts.
- Do NOT sell in a vending machine unless in an adult-only facility.
Beginning August 10, 2018:
1. Domestic manufacturers and importers of cigar and pipe tobacco must begin reporting on August 20 and paying user fees on December 31. Only domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco must report (monthly) and pay (quarterly) user fees.
2. Any domestic establishment engaged in manufacturing regulated tobacco products must register, and every registrant must file a list of its regulated tobacco products.
3. A “new tobacco product” is defined in in section 910(a)(1) of the Federal Food Drug & Cosmetic Act.
4. Unless FDA has issued an order denying or refusing to accept the submission, products for which timely premarket applications have been submitted by the applicable compliance date identified above will be subject to a continued compliance period for 12 months after the initial compliance period. Once the continued compliance period ends, new tobacco products on the market without authorization will be subject to enforcement. Products entering the market after August 8, 2016 are not covered by the foregoing compliance policy and will be subject to enforcement if marketed without authorization after August 8, 2016.
5 A "covered tobacco product" is defined in the final rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.
6 A retailer of any cigarette tobacco, roll-your-own tobacco or "covered tobacco product" will not be in violation of this section for packaging that: (i) Contains a health warning; (ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable, and (iii) Is not altered by the retailer in a way that is material to the requirements of this section.
7 FDA does not intend to enforce these warning statement requirements for products that were manufactured before the compliance date (August 10, 2018) of the new required warning statement for covered tobacco products, cigarette tobacco, and RYO tobacco. See “Guidance for Industry, Small Entity Compliance Guide, FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (Revised).
8 For cigars and pipe tobacco, please see our Guidance: Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco .