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.)
Under the substantial equivalence pathway, a new tobacco product may continue to be sold or distributed if:
- the tobacco product was sold or distributed after February 15, 2007 but before March 22, 2011; and
- 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 FDA has published a draft guidance titled, “Enforcement Policy for Certain (“Provisional”) Tobacco Products that FDA Finds Not Substantially Equivalent .” In this draft guidance, FDA announced that it does not intend to take enforcement action for 30 calendar days from the date the NSE order issues for those products that are in the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.)
|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.
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