If you mix e-liquids, make or modify vaporizers, or mix loose tobacco, and you also sell these products, you will 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 are considered a tobacco product manufacturer.
If you manufacture "finished tobacco products", 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 or
- August 8, 2017 for “small scale tobacco product manufacturers”
- Submit cigar warning plans by May 10, 2017.
- Register your establishment and submit list of products, including labeling and advertisements, by June 30, 2017 (extended from December 31, 2016).5
- Submit ingredient listing by:
- August 8, 2017 (extended from February 8, 2017)
- February 8, 2018 (extended from August 8, 2017) for "small scale tobacco product manufacturers"
- Submit a premarket application for “new” tobacco products to stay on the via market:3,6
- Exemption from Substantial Equivalence by August 8, 2017
- 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 September 8, 2017.
- For "small scale tobacco product manufacturers", submit ingredient listing by February 8, 2018 (extended from August 8, 2017).
- Submit a premarket application for “new” tobacco products to stay on the market via:3,6
- Include Required Warning Statements on Packages and Advertisements on “covered” tobacco products by May 10, 2018.7
- Submit quantities of Harmful and Potentially Harmful Constituents by August 8, 2019.
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 May 10, 2018::
- Do NOT sell, distribute, or display advertisements for any tobacco product without a health warning statement on the package.6
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.