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.  


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  FDA has published a draft guidance titled, “Enforcement Policy for Certain (“Provisional”) Tobacco Products that FDA Finds Not Substantially Equivalent .”  In this draft guidance,  FDA announced that it does not intend to take enforcement action for 30 calendar days from the date the NSE order issues for those products that are in the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 Issued Name of Misbranded and Adulterated Product Due to NSE Order Responsible Firm Identifying Information Provided by Firm
(lot numbers, manufacturing codes/dates, etc.)
5/21/15 North Red 84 mm Eagle River Importers, Inc. -
5/21/15 North Red 100 mm Eagle River Importers, Inc. -
5/21/15 North Blue 84 mm Eagle River Importers, Inc. -
5/21/15 North Blue 100 mm Eagle River Importers, Inc. -
5/21/15 North Green 84 mm Eagle River Importers, Inc. -
5/21/15 North Green 100 mm Eagle River Importers, Inc. -
5/21/15 North Cool Green 84 mm Eagle River Importers, Inc. -
5/21/15 North Cool Green 100 mm Eagle River Importers, Inc. -
5/21/15 North Silver 84 mm Eagle River Importers, Inc. -
5/21/15 North Silver 100 mm Eagle River Importers, Inc. -
8/28/14 Ariva Cinnamon Star Scientific, Inc.   -
8/28/14 Ariva Wintergreen Star Scientific, Inc.   -
8/28/14 Ariva Mint Star Scientific, Inc.   -
8/28/14 Ariva Java Star Scientific, Inc.   -
8/28/14 Ariva Citrus Star Scientific, Inc.   -
8/28/14 Stonewall Natural Star Scientific, Inc.   -
8/28/14 Stonewall Java Star Scientific, Inc.   -
2/21/14 Sutra Bidis Red Jash International, Inc.  -
2/21/14 Sutra Bidis Menthol Jash International, Inc.   -
2/21/14 Sutra Bidis Red Cone Jash International, Inc.   -
2/21/14 Sutra Bidis Menthol Cone Jash 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
5/11/2015  Stonewall Java Discount Tobacco
1392 Highway 96 S
Lumberton, TX 77657
5/11/2015  Stonewall Natural Nothin’ Butt Smokes #4
904 Slide Rd.
Lubbock, TX 79416
5/11/2015  Ariva Cinnamon, Ariva Java, Ariva Wintergreen, Stonewall Java, Stonewall Natural Discount Tobacco Beverages & More
696 South Willow Avenue, Suite 8
Cookeville, TN 38501
4/01/2015 Stonewall Natural Deerfield Amoco
13721 Hull Street Road
Midlothian, VA  23112
3/25/2015 Stonewall Natural, Stonewall Java Lake Elmo Smoke Shop
11227 Stillwater Blvd. N
Lake Elmo, MN 55042
3/25/2015 Stonewall Natural, Stonewall Java, Ariva Wintergreen, Ariva Java Lucky’s of Brandermill
13636 Genito Road
Midlothian, VA 23112
3/25/2015 Ariva Wintergreen Al’s Marketplace
3440 Anderson Highway
Powhatan, VA 23139
3/25/2015 Stonewall Natural, Stonewall Java Dinwiddie’s Convenience Store
2895 Anderson Highway
Powhatan, VA 23139
3/10/2015 Stonewall Natural, Stonewall Java Cigar Land Issaquah
6130 East Lake Sammamish Pkwy SE, Suite F
Issaquah, WA  98029
3/10/2015 Stonewall Natural In N Out Mart
336 Huffman Mill Road
Burlington, NC  27215
3/10/2015 Stonewall Natural, Ariva Wintergreen The Market Place #3
4501 Nine Mile Road
Richmond, VA  23223
3/10/2015 Stonewall Natural, Stonewall Java Choice Tobacco
603 Broadway East
Seattle, WA  98102
3/10/2015 Stonewall Natural, Ariva Mint Puff N Stuff Smoke Shop
1038 South Lincoln Avenue
Jerome, ID  83338
3/10/2015 Stonewall Natural, Stonewall Java Cigarettes & Gifts
11870 Washington Street, Unit C
Northglenn, CO  80233
2/11/2015 Stonewall Natural Discount Tobacco
1419 West Main Street, Suite C
Salem, IL 62881
2/11/2015 Stonewall Java Cigar Land of Kent
25451 104th Ave SE #106
Kent, WA 98031
2/11/2015 Stonewall Natural Fairway Grocery
2501 Sumner Avenue
Hoquiam, WA 98550
2/11/2015 Stonewall Java, Ariva Wintergreen, and Stonewall Natural Inver Grove Tobacco, Inc.
6570 Cahill Avenue
Inver Grove Heights, MN 55076
1/28/2015 Stonewall Java and Stonewall Natural
1/5/2015 Stonewall Java Smoke 4 Less
1104 West Harmony Lane
Neosho, MO  64850
1/5/2015 Stonewall Java Coeur D’Alene Pipe & Cigar
416 ½ East Sherman Avenue
Coeur D’Alene, ID  83814
1/5/2015 Stonewall Java and Stonewall Natural Choice Deli & Grocery
6415 8th Avenue Northwest
Seattle, WA  98107
12/4/2014 Stonewall Java Hall’s Food Mart #8
2002 Bird Avenue
Joplin, MO 64804
12/4/2014 Ariva Cinnamon, Ariva Mint, Stonewall Natural Tobacco Outlet Depot Plus
2501 University Avenue Northeast
Minneapolis, MN 55418
12/4/2014 Stonewall Natural UW Smoke Shop
4140 University Way Northeast
Seattle, WA 98105
 11/18/2014 Stonewall Java All Mart Smoke Shop & Liquor
302 East Main Street
Mascoutah, IL 62258
11/18/2014 Stonewall Java Blaine Tobacco
12523 Central Avenue Northeast
Blaine, MN  55434
11/18/2014  Ariva Mint Cashua Ferry Convenience Store
2547 Cashua Ferry Road
Darlington, SC 29532
 11/18/2014 Ariva Mint, Stonewall Natural, Stonewall Java Don Johnson’s Tobacco World
1420 South Glenstone Avenue
Springfield, MO  65804
 11/18/2014 Ariva Mint, Ariva Citrus Downtown Smoke Shop
115 E 6th Street
Concordia, KS 66901
 11/18/2014 Stonewall Java, Stonewall Natural Eagan Cigars & Tobacco Store
3459 Pilot Knob Road #104
Eagan, MN 55122
11/18/2014 Ariva Mint, Stonewall Java, Ariva Wintergreen Food Lion
1130 West Cherokee Street
Blacksburg, SC  29702
 11/18/2014 Ariva Mint, Ariva Wintergreen, Ariva Java L&W Citgo
4160 Jamestown Road
Camden, SC  29020
11/18/2014 Stonewall Natural Monti Smoke Shop
1220 Highway 25 South, Suite 116
Monticello, MN  55362
11/18/2014 Ariva Wintergreen, Ariva Mint Rich’s Smoke & Gift
1713 South Canyon Road
Ellensburg, WA  98926
11/18/2014 Stonewall Natural TNT Gas Mart Inc.
102 South Main Street
Smithboro, IL  62284
11/18/2014 Stonewall Java, Stonewall Natural Tobacco
963 Oak Street
North Aurora, IL  60542
11/18/2014 Stonewall Java Tobacco
1008 County Road 42 East
Burnsville, MN  55337
11/18/2014 Stonewall Java Abingdon, MD 21009
 11/18/2014 Ariva Wintergreen Walgreens #6423
6432 State Highway 303
Bremerton, WA  98311
 11/18/2014 Ariva Wintergreen Walgreens #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
10903 New Hampshire Ave
Silver Spring, MD 20993

 

Page Last Updated: 05/21/2015
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