Tobacco Products

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.

Draft Guidance (Jan 2017): Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops

This draft guidance is intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements (such as requirements for manufacturers) of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.

Note: In May 2017, FDA announced it was providing a three-month extension of all future compliance deadlines for requirements under the final deeming rule

Manufacturer Requirements

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" prior to August 8, 2016, 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

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

 

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


References

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.

Contact FDA

1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov


Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002


Courier Deliveries

Page Last Updated: 07/13/2017
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