FDA Proposes Quicker ‘SE’ Application Pathway

New substantial equivalence guidance addresses changes to product labels or quantities

By 
Melissa Vonder Haar, Freelance Writer

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WASHINGTON -- The U.S. Food and Drug Administration (FDA) addressed the need for a quicker review path for manufacturers to introduce new labeling or quantities for products that keep the same ingredient characteristics. Last week the agency released the second edition of its March 2015 Guidance "Demonstrating the Substantial Equivalence of a New Tobacco Product," included the category for a “same characteristics significant equivalent” report, according to theWinston-Salem Journal.

Under the Tobacco Control Act, any tobacco products introduced to the market after the Feb. 15, 2007, grandfather date must submit a premarket tobacco product application (PMTA) or substantial equivalence (SE) application to the FDA. According to the FDA, changes to an existing product label or quantity renders that product a new tobacco product—effectively requiring a PMTA or SE application, even if said product was already on the market in February 2007.

“The material in a same characteristics significant equivalent report is substantially more limited and less burdensome,” the FDA said. “The findings are fairly straightforward. FDA anticipates that as long as the appropriate information is included, its review time should be much less than significant equivalent review generally.”

The FDA elaborated that the same characteristics significant equivalent applications would go in a separate queue from the SE applications and would rule on the applications “within two review cycles.”

This alternative pathway addresses concerns expressed by major manufacturers about the cumbersome application process. In April 2015, Altria Group Inc., Reynolds American Inc. and Lorillard Inc. sued the FDA. The three companies claimed the new packaging guidance would be too restrictive and sought a permanent injunction.

The lawsuit stated that “the substantial equivalent directive does not explain why FDA believes these new pre-market requirements for label changes are necessary, particularly given that Congress chose to grandfather certain underlying tobacco products in the market when the Tobacco Control Act was enacted.”

“Plaintiffs currently have label changes in various stages of development, from those that are ready to be introduced to those anticipated for release in the coming months.”

The lawsuit was dropped on June 2, shortly after the FDA issued an interim enforcement policy addressing these concerns (though lawsuit was dismissed without prejudice and can be refiled at any time). The latest guidance and alternative pathway represents a follow-up to the interim policy. 

Scott Ballin, former chairman of the Coalition on Smoking or Health, told the Winston-Salem Journal that the SE pathway has been “very contentious.”

“As I read the guidance/interim enforcement policy, it seems FDA is trying to work its way through all this and giving industry a little room,” he said. “At least for the time being.”

Click here for the full Winston-Salem Journal story