The cigar industry’s desire to delay the upcoming substantial equivalence deadline will have to find a new approach.
U.S. District Court Judge Amit P. Mehta ruled against a motion for declaratory relief that would have invalidated a ruling by a different federal court in Maryland that changed the date substantial equivalence is due from August 2021 to May 12, 2020.
A group of doctors and health groups sued the U.S. Food & Drug Administration (FDA) in Maryland arguing that the agency did not have the authority to delay the implementation of certain regulations.
The FDA lost the lawsuit and the Maryland court asked the two sides to present alternatives timelines for regulation, specifically product approval.
Substantial equivalence is expected to be the main approval process for cigars once FDA’s regulations are fully into effect. In short, a manufacturer would argue that its product is substantially equivalent to an already approved or grandfathered product, and as such poses no additional health risks and does not market towards children.
While the cigar industry had filed a motion to have this decision thrown out, it seemed like the industry’s strategy to fighting substantial equivalence had already moved on before today.
“As we told the Court at the October 1 hearing, we are moving ahead with our substantive attack on the substantial equivalence system’s application to cigars and pipe tobacco,” said Michael Edney, the lead attorney for the cigar industry in its lawsuit, to halfwheel. “Today’s ruling only underscores the importance and urgency of those substantive challenges.
Mehta ruled against the cigar industry, arguing that the groups were unable to show their standing.