The Food and Drug Administration on Thursday ordered 28 cigarette products manufactured by Seneca Manufacturing Co. to be removed from the U.S. market after determining they do not meet federal requirements for continued sale.
The agency issued “not substantially equivalent” (NSE) orders, which means the products can no longer be distributed, imported, sold or marketed in the United States.
The cigarettes had previously been allowed to remain on the market while the FDA reviewed their applications under the 2009 Family Smoking Prevention and Tobacco Control Act.
The decision affects a range of brands, including Heron and Sands cigarettes in multiple varieties. The FDA did not provide specific details about why each product failed the review.
They include, according to the FDA:
- Heron Red 100s Box
- Heron Red 100s Soft Pack
- Heron Red Kings Box
- Heron Gold 100s Box
- Heron Gold 100s Soft Pack
- Heron Gold Kings Box
- Heron Gold Kings Soft Pack
- Heron Menthol 100s Box
- Heron Menthol 100s Soft Pack
- Heron Menthol Kings Box
- Heron Menthol Kings Soft Pack
- Heron Menthol Gold 100s Box
- Heron Menthol Gold 100s Soft Pack
- Heron Menthol Gold Kings Box
- Heron Crimson 100s Box
- Sands Red 100s Box
- Sands Red 100s Soft Pack
- Sands Red Kings Box
- Sands Red Kings Soft Pack
- Sands Gold 100s Box
- Sands Gold 100s Soft Pack
- Sands Gold Kings Box
- Sands Gold Kings Soft Pack
- Sands Menthol 100s Box
- Sands Menthol 100s Soft Pack
- Sands Menthol Kings Box
- Sands Menthol Kings Soft Pack
- Sands Menthol Blue 100s Box
For these types of products, the FDA said it does not intend to take enforcement action against a retailer for at least 30 days, with May 23 as the compliance deadline.
Following that date, the FDA said retailers selling these cigarettes may be the subject of compliance and enforcement actions, which include, but are not limited to, warning letters, civil money penalties, seizures and/or injunctions.
Retailers with remaining inventory of these products should work with the product manufacturer or supplier to discuss options for disposal, the agency said.
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