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FDA Issues Not Substantially Equivalent Orders for 28 Cigarette Products

April 23, 2026

Today, FDA posted Not Substantially Equivalent (NSE) orders for 28 cigarette products manufactured by Seneca Manufacturing Company.

Under the 2009 Tobacco Control Act, these Provisional Substantial Equivalence (SE) tobacco products were allowed to be legally sold by retailers unless FDA’s review of the applications resulted in an NSE order. With the posting of these final NSE decisions, these tobacco products can no longer be distributed, imported, sold, or marketed in the United States. Retailers with remaining inventory of these products should work with the product manufacturer or supplier to discuss options for disposal. 

The Provisional SE tobacco products issued NSE orders are:
 

1. SE0001362 – Heron Red 100s Box 
2. SE0001363 – Heron Red 100s Soft Pack 
3. SE0001364 – Heron Red Kings Box 
4. SE0001365 – Heron Gold 100s Box 
5. SE0001366 – Heron Gold 100s Soft Pack 
6. SE0001367 – Heron Gold Kings Box 
7. SE0001368 – Heron Gold Kings Soft Pack 
8. SE0001369 – Heron Menthol 100s Box 
9. SE0001370 – Heron Menthol 100s Soft Pack 
10. SE0001371 – Heron Menthol Kings Box 
 

11. SE0001372 – Heron Menthol Kings Soft Pack 
12. SE0001373 – Heron Menthol Gold 100s Box 
13. SE0001374 – Heron Menthol Gold 100s Soft Pack 
14. SE0001375 – Heron Menthol Gold Kings Box 
15. SE0001382 – Heron Crimson 100s Box 
16. SE0001409 – Sands Red 100s Box
17. SE0001410 – Sands Red 100s Soft Pack
18. SE0001411 – Sands Red Kings Box
19. SE0001412 – Sands Red Kings Soft Pack

20. SE0001413 – Sands Gold 100s Box
21. SE0001414 – Sands Gold 100s Soft Pack
22. SE0001415 – Sands Gold Kings Box
23. SE0001416 – Sands Gold Kings Soft Pack
24. SE0001417 – Sands Menthol 100s Box
25. SE0001418 – Sands Menthol 100s Soft Pack
26. SE0001419 – Sands Menthol Kings Box
27. SE0001420 – Sands Menthol Kings Soft Pack
28. SE0001421 – Sands Menthol Blue 100s Box

For Provisional SE tobacco products that receive an NSE order, FDA does not intend to take enforcement action against a retailer for at least 30 days from the date the NSE order is posted on FDA’s website. Therefore, FDA does not intend to take enforcement action regarding the products listed above until May 23, 2026. After that, retailers selling these cigarettes may be the subject of compliance and enforcement actions. These actions may include, but are not limited to, warning letters, civil money penalties, seizures, and/or injunctions.

To help retailers comply with the law, FDA regularly updates its Searchable Tobacco Products Database. The database lists over 17,400 tobacco products and is the most comprehensive listing of tobacco products that may be legally sold in the United States. FDA also maintains lists of authorized e-cigarettes and authorized nicotine pouch products. Retailers can also order free educational materials through the Tobacco Education Resource Library that support voluntary compliance with the law, including a wall calendar, posters, stickers, and flyers.

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