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U.S. Department of Health and Human Services

Tobacco Products

Misbranded and Adulterated NSE Tobacco Products

 

According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), a new tobacco product is any product that was not commercially marketed in the United States as of February 15, 2007.  This includes tobacco products that were modified and sold or distributed after February 15, 2007.

To legally sell a new FDA-regulated tobacco product in the United States, you must receive a written order from FDA permitting the sale of a new tobacco product under one of three pathways.  (Read more about each of these pathways.)
 

When a tobacco product is misbranded or adulterated, it is illegal to sell or distribute the product in interstate commerce or import the product into the United States.

Under the substantial equivalence pathway, a new tobacco product may continue to be sold or distributed if:

  1. the tobacco product was sold or distributed after February 15, 2007 but before March 22, 2011; and
  2. a Substantial Equivalence (SE) Report was submitted by March 22, 2011,

unless FDA issues an order that the new product is “not substantially equivalent” (NSE) to the predicate product that the applicant identified in its submission.  

 

When does FDA Issue a “Not Substantially Equivalent” Order?

FDA issues a “Not Substantially Equivalent” (NSE) order when an applicant’s SE Report does not contain sufficient information to demonstrate that a new tobacco product is substantially equivalent to a predicate tobacco product.  When an NSE order is issued, a tobacco product is misbranded under section 903(a)(6) and adulterated under section 902(6)(A)of the FD&C Act.  This means that, effective immediately, among other things, it is illegal to sell or distribute the product in interstate commerce and to import the product into the United States.  Doing so may result in FDA initiating regulatory action (e.g., seizures, injunctions) without further notice. 

However, FDA recognizes that retailers may have limited options for disposing of products found NSE that are in their current inventories.  FDA has published a draft guidance titled, “Enforcement Policy for Certain (“Provisional”) Tobacco Products that FDA Finds Not Substantially Equivalent .”  In this draft guidance,  FDA announced that it does not intend to take enforcement action for 30 calendar days from the date the NSE order issues for those products that are in the retailer’s current inventory at a specific retail location on the date FDA issues the NSE order.  This policy extends only to tobacco products that are already in a retail store that offers the products for sale directly to consumers.  During this time, FDA encourages retailers to contact their supplier or manufacturer to discuss possible options for the misbranded and adulterated product that they may have in their current inventory.

 

What Tobacco Products are Misbranded and Adulterated due to a “Not Substantially Equivalent” Order?

FDA has found some tobacco products submitted under the pathway described above to be NSE.  Please note that, upon the issuance of an NSE order, all products that are the subject of that NSE order become adulterated and misbranded, regardless of when they were manufactured.  Manufacturers, importers, distributors, retailers, and consumers may consult the list below to determine whether they have any misbranded and adulterated tobacco products due to an NSE order in their possession.  Information, such as lot numbers or manufacturing codes, is included to help you distinguish these products from legally sold products which may have the same name. 


Date NSE Order IssuedName of Misbranded and Adulterated Product Due to NSE OrderResponsible FirmIdentifying Information Provided by Firm
(lot numbers, manufacturing codes/dates, etc.)
8/28/14Ariva CinnamonStar Scientific, Inc.-
8/28/14Ariva WintergreenStar Scientific, Inc.-
8/28/14Ariva MintStar Scientific, Inc.-
8/28/14Ariva JavaStar Scientific, Inc.-
8/28/14Ariva CitrusStar Scientific, Inc.-
8/28/14Stonewall NaturalStar Scientific, Inc.-
8/28/14Stonewall JavaStar Scientific, Inc.-
 2/21/14Sutra Bidis Red Jash International, Inc.-
2/21/14Sutra Bidis MentholJash International, Inc.-
2/21/14Sutra Bidis Red ConeJash International, Inc.-
2/21/14Sutra Bidis Menthol ConeJash International, Inc.-


Notifications of NSE Tobacco Products Found at Retail Stores
 
During tobacco retailer compliance check inspections, FDA commissioned inspectors check whether the retailer has products subject to an NSE order in the store.  If observed, the retailer will receive a notification from FDA about the legal status of these products.

 

 Date Notification Issued Product(s) Retailer Name and Address
12/4/2014Stonewall JavaHall’s Food Mart #8
2002 Bird Avenue
Joplin, MO 64804
12/4/2014Ariva Cinnamon, Ariva Mint, Stonewall NaturalTobacco Outlet Depot Plus
2501 University Avenue Northeast
Minneapolis, MN 55418
12/4/2014Stonewall NaturalUW Smoke Shop
4140 University Way Northeast
Seattle, WA 98105
 11/18/2014 Stonewall JavaAll Mart Smoke Shop & Liquor
302 East Main Street
Mascoutah, IL 62258
 11/18/2014 Stonewall JavaBlaine Tobacco
12523 Central Avenue Northeast
Blaine, MN  55434
11/18/2014  Ariva MintCashua Ferry Convenience Store
2547 Cashua Ferry Road
Darlington, SC 29532
 11/18/2014 Ariva Mint, Stonewall Natural, Stonewall JavaDon Johnson’s Tobacco World
1420 South Glenstone Avenue
Springfield, MO  65804
 11/18/2014 Ariva Mint, Ariva CitrusDowntown Smoke Shop
115 E 6th Street
Concordia, KS 66901
 11/18/2014 Stonewall Java, Stonewall NaturalEagan Cigars & Tobacco Store
3459 Pilot Knob Road #104
Eagan, MN 55122
  11/18/2014 Ariva Mint, Stonewall Java, Ariva WintergreenFood Lion
1130 West Cherokee Street
Blacksburg, SC  29702
 11/18/2014 Ariva Mint, Ariva Wintergreen, Ariva JavaL&W Citgo
4160 Jamestown Road
Camden, SC  29020
  11/18/2014 Stonewall NaturalMonti Smoke Shop
1220 Highway 25 South, Suite 116
Monticello, MN  55362
  11/18/2014 Ariva Wintergreen, Ariva MintRich’s Smoke & Gift
1713 South Canyon Road
Ellensburg, WA  98926
  11/18/2014 Stonewall NaturalTNT Gas Mart Inc.
102 South Main Street
Smithboro, IL  62284
  11/18/2014 Stonewall Java, Stonewall NaturalTobacco
963 Oak Street
North Aurora, IL  60542
  11/18/2014 Stonewall JavaTobacco
1008 County Road 42 East
Burnsville, MN  55337
11/18/2014Stonewall JavaAbingdon, MD 21009
  11/18/2014 Ariva WintergreenWalgreens #6423
6432 State Highway 303
Bremerton, WA  98311
  11/18/2014 Ariva WintergreenWalgreens #7506
1290 Chestnut Street
Orangeburg, SC  29116

 


 

How Can I Report Potential Violations to the FDA?

You can report potential tobacco-related violations of the FD&C Act including the sale, distribution, or importation of misbranded and adulterated products.  This information will be reviewed by FDA’s Center for Tobacco Products, Office of Compliance and Enforcement.

You can also contact the Center for Tobacco Products by email at AskCTP@fda.hhs.gov, by phone at 1-877-287-1373, or by mail at:

 

Center for Tobacco Products
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850-3229