Substantial Moves

Are Zeller’s announcements on substantial equivalence and menthol historic—or more of the same from the FDA?

By  Melissa Vonder Haar, Tobacco Editor

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And with no official notice or ANPRM on deeming regulations, the industry may have to wait even longer to learn whether or not the FDA will exert its authority over products such as cigars, pipe tobacco or electronic cigarettes. All of which has led many to question whether or not Zeller’s actions signify a faster, more efficient rulemaking process by the CTP or more of the same waiting game.

Substantial Work to Be Done

The issue of substantial equivalence came about as part of a special provision included in the 2009 Family Smoking Prevention & Tobacco Control Act regarding new tobacco products introduced into the market between Feb. 15, 2007, and March 22, 2011, though it can also be applied to existing tobacco products that were changed during that time period.

“If you want to sell a product that didn’t make it to market by February 2007, you must first either qualify the product as a new product or demonstrate that the product is substantially equivalent to one of those earlier products,” explains Seth Gold, legal counsel for Glenview, Ill.-based Republic Tobacco. “If you apply as a new product, you have to persuade the FDA that there are no additional health risks in this product. The statute implies that this is a difficult task, but the FDA must act within 180 days. Substantial equivalence is supposed to be less difficult for the manufacturer.”

However, with no clear guidelines on what is needed to convince the FDA that a new product is substantially equivalent to an existing product, and a seemingly never-ending review period, manufacturers have found the process far from easy. In fact, Gold describes Republic’s experience with substantial equivalence as a “Kafka-esque nightmare.”

Yet the complicated process has paid off for at least one manufacturer: On July 25, the FDA granted Lorillard Inc., Greensboro, N.C., permission to market two Newport Non-Menthol Gold products.

“We are very pleased that the FDA has found that Lorillard’s Newport Non-Menthol Gold products are substantially equivalent to existing tobacco products currently marketed,” Lorillard chairman, president and CEO Murray Kessler said after the FDA’s announcement. “As such, we are proud to be the first company in the industry to receive authorization to begin marketing these new products in the U.S. through the FDA’s substantial-equivalence pathway. We believe that the FDA has carried out its evaluation process in a deliberate manner reflecting sound science.”

Zeller also focused on the scientific rationale behind the agency’s first SE announcement in an FDA-issued press release.

“The FDA is committed to making science-based decisions on all product applications and providing the agency’s scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties, according to the law,” he said. “Today’s decisions are just the first of many forthcoming product review actions to be issued.”

Others, such as Republic’s Gold, are more skeptical about these initial SE approvals.

“It has been two and a half years and there are roughly 3,500 products (waiting for a ruling on SE): six have been ruled on,” he says. “We’re in the bakery line; we hold No. 3,500 and have been waiting in line for two and a half years. The sign at the counter says, ‘Now serving No. 7.’ ”

Does the June SE announcement represent a new era in which the FDA will issue decisions (both on SE application and other important issues) in a more timely, transparent fashion, as suggested by Zeller? Or did the literal handful of decisions only further highlight how much more work the agency has to do on substantial equivalence? The truth probably lies between these two extremes.

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