Illusione, Cuban Stock Receive FDA Grandfather Status

Illusione and Cuban Stock have become the third and fourth premium cigar brands to receive approval as a grandfathered product by the U.S. Food & Drug Administration.

Both companies received approval for seven different cigars, a small part of each company’s portfolio:

• Illusione 4/2g
• Illusione ~2~
• Illusione ~68~
• Illusione ~88~
• Illusione ~888~
• Illusione cg:4
• Illusione f9

 

• Chubbys Long Dark
• Chubbys Short Dark
• Cuban Stock Classic Corona
• Cuban Stock Classic Presidente
• Cuban Stock Classic Robusto
• Cuban Stock Classic Toro
• Exquisito Doble Capa Toro

They become the latest cigars to receive explicit grandfather status in FDA’s Standalone Grandfathered Determinations database following five SKUs from Altadis U.S.A. and eight from Ortega Premium Cigars, Inc.

Grandfather status means the brands have gotten approval from FDA to remain on the market because they were sold prior to Feb. 15, 2007. This means the brands will not be subject to substantial equivalence, a process most manufacturers estimate will cost thousands of dollars due to a testing component that is still yet to be finalized.

A halfwheel survey of 34 cigar companies found that nearly half said they had submitted cigars for FDA approval either in the form of grandfather status or substantial equivalence.

So far, that approval process has taken a minimum of five months for premium cigar companies to nearly nine months for Cuban Stock.

Dion Giolito of Illusione told halfwheel that FDA officials did contact him and his attorney throughout the process.

The amount of FDA submissions is unknown. FDA’s database only shows products for which a decision has been made. In 2014, the agency estimated there were around 10,000 SKUs on the market, though by 2016 it retracted that estimate and stated the true number was uncertain.

At one point, the agency argued that as much as 60 percent of the cigars on the market would be grandfathered.