FDA Proposes New Guidelines for Substantial Equivalence

FDA Proposes New Guidelines for Substantial Equivalence

Yesterday, the U.S. Food and Drug Administration proposed a new rule detailing how all tobacco product manufacturers—including cigarmakers—should submit their Substantial Equivalence reports for bringing new products to market. Additionally, the agency said it will open up a public commenting period that starts April 2 and lasts through June 17 to get feedback for the new proposed rule.

Before the FDA was put in charge of the U.S. tobacco industry, new products flowed freely from cigarmakers to store shelves. Today, Substantial Equivalence is one of the three pathways to product approval that the FDA established when it published its Final Deeming Rule in May 2016. According to the FDA, a cigar manufacturer files an SE report to show that a new tobacco product has similar characteristics to a grandfathered (predicate) tobacco product, or has different characteristics, but doesn't raise any new questions of public health. A predicate tobacco product is one that was on the market on February 15, 2007.

A suitable SE report for a cigar, according to the new rule, would include basics such as a brand name, dimensions and wrapper material, along with more ambiguous information such as harmful or potentially harmful constituents (HPHCs) and characterizing flavors. 

For producers of premium, handmade cigars, product approval remains one of the most controversial aspects of the Final Deeming Rule. Lack of clear guidance, costly testing and slow turnarounds are just a few of the problems cigarmakers mention when speaking out against the FDA’s product approval plans.

Unfortunately for handmade cigarmakers, the new rule proposed yesterday doesn’t seem to clarify much, but instead may actually raise more questions as the words “premium cigar” aren’t mentioned once in the 171-page document. The FDA seems to understand this confusion, hence why it opened up a public commenting period and included the following passage in the new proposed rule: “For tobacco products not specifically identified (e.g., ENDS, cigars), FDA invites comments and information on the parameters that may be needed to support an SE Report.”

“I remain very skeptical about whether it is possible to reliably test premium cigars because making premium cigars is an inherently unscientific process,” said Drew Newman, general counsel for J.C. Newman Cigar Co., which produces premium cigar brands such as Brick House and Diamond Crown. 

The natural variation of premium cigars has made it difficult to develop a standard testing method.

“Because premium cigars are handcrafted, they are subject to great natural variation. We know that the amount of sunlight, rain and wind affects the characteristics of premium cigar tobacco just as the size of tobacco leaves and where they are grown on a plant does as well. As cigarmakers, we harness this natural variation to create unique and interesting blends,” said Newman.

A study funded by the FDA and conducted by staff at the agency’s Center for Tobacco Products and published in 2017 demonstrates the variation of premium cigars. One of the cigars studied was a Romeo y Julieta 1875 Churchill, and the researchers found “considerable within-brand variance in nicotine content and concentration between the first and second analyses.” Additionally, the “percent free nicotine differed by 16 percent to 45 percent” between the years “[d]espite consistency in physical properties.”

“We contend that there should be no substantial equivalence process for premium handmade cigars,” said Glynn Loope, executive director of the Cigar Rights of America. “When the only ingredient is all-natural, dark air-cured tobacco, water and a little vegetable gum, we’re referring to a product far more subject to the soil in which it was grown, the amount of sun and water it receives, and the length of time it was aged, coupled by the human hands that brought it together. No other tobacco product can make that contention. That’s why a one-size-fits-all approach to regulation just doesn’t work. We look forward to conveying that in our comments to the FDA during this new public comment period.”

In addition to the difficulty of testing premium cigars accurately, Newman also points to the likely enormous laboratory costs that cigarmakers will have to pay to complete an acceptable SE Report.

“A lab that proposed testing premium cigars like cigarettes recently quoted $18,000 just to test a single cigar. This huge sum works for a product like cigarettes that are mass produced but not for premium cigars that are hand rolled in small batches,” Newman said. “As there are tens of thousands of different premium cigars sold in the U.S. today, the total cost for testing them could be in the hundreds of millions of dollars.”