SE Announcement 'Historic' for FDA

Published in Tobacco E-News

Zeller touts the importance of transparency and science-based regulations

By  Melissa Vonder Haar, Tobacco Editor

WASHINGTON-- Mere months into his tenure as director of the U.S. Food & Drug Administration's Center for Tobacco Products (CTP), Mitch Zeller made good on his promise of a more efficient, effective and fair regulatory process by issuing the agency's first Substantial Equivalents (SE) approvals yesterday. (For more on the SE announcement, click here) It wasn't just good news for Lorillard, which received SE approvals for two new products. Zeller believes the move has broader implications for how tobacco regulations will be issued in the future.

"This is historic," Zeller said in a media briefing. "We went through a thorough, extensive, pre-market scientific review and the supporting material that we're putting up on the web today to further explain the rationale behind our decisions shows that the day of evidence-based tobacco product regulation is here. Today is the first day a regulatory agency anywhere in the world has made a science-based determination on a pre-market basis that a product either can or cannot be marketed."

Still, the FDA has only ruled on six applications (two were approved, four were found to be NSE--"not substantially equivalent"). There are still some 4,000 SE applications awaiting review. While Zeller noted that the majority of these applications were missing information his organization needs to complete the required review, he acknowledged the need to speed up the process.

"We recognize that the SE review process has taken time, with a learning curve both for manufacturers and the agency," he said. "As all involved parties continue to gain experience, the FDA expects the process to move much more quickly. Forthcoming decisions will be made on a periodic basis. FDA is committed to working through the remaining SE reports in a consistent, transparent and predictable manner."

Zeller added that manufacturers who have withdrawn from SE review or whose products were found to be NSE will have the option of submitting or a new tobacco product application or a new substantial equivalent report to the FDA.

As to the products that were approved--Lorillard's Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box--Zeller cautioned against reading too much into the decision, especially when it comes to the color descriptions many manufacturers have used in lieu of the light, medium and bold descriptors banned by the FDA.

"Nobody should read anything into the SE orders that we have issued today on the issue of color," he said. "SE is a rather narrow part of the law--it's supposed to be an exception to the broader, pre-market new product approval process. All it means is that we have conducted a thorough scientific review and at the end of the day concluded that the SE products are not more harmful than the predicate product that they're being compared to."