October 18, 2019 Charlie Minato FDA/Deeming Regulations,  Regulations

D.C. Court Rules Against Cigar Industry’s Petition to Delay Substantial Equivalence Deadline

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.

Overall Score

American Academy of Pediatrics American Academy of Pediatrics — Maryland American Cancer Society Cancer Action Network American Heart Association American Lung Association Amit P. Mehta Campaign for Tobacco-Free Kids Cigar Association of America Cigar Rights of America Cynthia Fishman David Myles Deeming Regulations El Cubano Cigars En Fuego Tobacco Shop FDA International Premium Cigar & Pipe Retailers Association Leah Brasch Linda Goldstein Public Health Intervenors Steven Hirsch Texas Cigar Merchants Association Truth Initiative U.S. Food & Drug Administration
Avatar photo

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.

Related Posts