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Pipe, Cigar, and Vape Shops that Are Regulated as Both Retailers and Manufacturers

Pipe, Cigar, and Vape Shops that Are Regulated as Both Retailers and Manufacturers

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.

Guidance: Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal FD&C Act Requirements to Vape Shops

Actions on Flavored Tobacco Products

FDA unveiled steps preventing youth access to flavored tobacco products and announced plans to ban menthol in cigarettes and cigars.

Manufacturer Requirements

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:

You must comply by these deadlines:

2016

  • 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

2017

2018

2019 - 2022

Retailer Requirements

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:

  • Do NOT sell, distribute, or display advertisements for any tobacco product without a health warning statement on the package. 6, 7, 8 

Download the “FDA Age Calculator,” a voluntary smartphone application to help retailers comply with federal, state, and local age restrictions for selling tobacco products.

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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 .


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