FDA Announces Database For Grandfathered Products

FDA Announces Database For Grandfathered Products

The U.S. Food and Drug Administration has launched a new database of grandfathered tobacco products meant to assist manufacturers seeking substantial equivalence, but the extent to which it will benefit cigarmakers remains unclear.

As of now, there isn't a single premium handrolled cigar in the database. This may change—the FDA says the listing will be updated periodically—but under current regulations the registration of grandfathered products is strictly optional. Manufacturers do not have to register the cigar brands if they don't want to.

"Grandfather determinations will only appear in the database if a request is submitted by a manufacturer for a particular product and the FDA has made a determination on that request," said Michael Felberbaum, press officer for the FDA. The FDA declined to comment on whether or not additional cigar manufacturers have requested to appear in the database.

When the FDA published its Deeming Rule in May of 2016, it did not require cigar manufacturers to register grandfathered products with the agency. In that ruling, the FDA stated it "does not anticipate that many manufacturers will make such submissions." 

The database contains roughly 1,000 cigarette brands, 200 smokeless tobacco products, 100 "roll-your-own" products and 58 cigars. The listing of cigars—including brands like Dean's Lil' Cigars, Prime Time Filtered Little Cigars, and Smoker's Choice Filtered Cigars—appear to be machine-made, flavored cigars.

It's also unclear how registering grandfathered blends would assist a substantial equivalence process. Drew Newman of J.C. Newman Cigar Co. says the company has no plans to register its grandfathered brands because the database doesn't include any key information that he believes would be necessary for establishing substantial equivalence.

"I don't think that the new grandfathered products database will be very helpful to cigarmakers," Newman told Cigar Aficionado. "What is not published, because it is protected as a trade secret, are the actual ingredients and blends of each predicate product ... Without knowing what was in a predicate product, cigarmakers will be unable to show that a new product is substantially equivalent to it."

Newman added that manufacturers can establish that a product was sold before the predicate date as part of the substantial equivalency application, and he doesn't see any advantage to doing it separately now.

The information listed in the database only provides the product name, category (i.e. cigar, cigarette, etc.), manufacturer, and the dates in which they were submitted and approved as an established grandfathered product.

This article first appeared in the February 21 edition of Cigar Insider.