Today (March 23), the U.S. Food and Drug Administration issued Not Substantially Equivalent (NSE) orders for 28 cigarette products manufactured by Seneca Manufacturing Company, determining they do not meet the legal standard to remain on the market. As a result, these products, sold under the Heron and Sands brands, can no longer be distributed, imported, marketed, or sold in the United States.
The affected products were previously allowed to remain on the market under provisional substantial equivalence status while under FDA review. With the final NSE determinations now posted, retailers have been instructed to coordinate with manufacturers or suppliers to remove remaining inventory.
The agency said it will exercise enforcement discretion until May 23, after which non-compliant sales could face penalties. FDA noted that enforcement actions may include warning letters, fines, product seizures, or injunctions. The agency also pointed retailers to its searchable tobacco products database, which lists authorized products eligible for legal sale, as part of ongoing efforts to support compliance with federal tobacco regulations.
Seneca Manufacturing Company is a tobacco manufacturer founded in 2006 after obtaining its federal TTB license, initially operating with a small team and focusing distribution within Seneca Nation territory in the New York area before expanding to multiple U.S. states and other Indigenous markets.