The U.S. Food and Drug Administration (FDA) has extended the period to comment on the agency’s draft guidance around Substantial Equivalence (SE) by 30 days. The deadline to submit comments around the Substantial Equivalence Rules is now July 17, 2019.
Substantial Equivalence marks a pathway where many cigar companies can keep products introduced after February 15th, 2017 on the market without going through a more costly pre-market approval process. It involves demonstrating a product is substantially equivalent to a product commercially marketed before February 15th, 2017. Products commercially marketed before that date are exempt from FDA regulation. It is is considered to be one of the more costly rules facing premium cigar makers.
Under the original guidelines, cigars that were not grandfathered were to demonstrate substantial equivalence by August 8, 2018. In 2017, the FDA extended the deadline to demonstrate substantial equivalence to August 8, 2021. However, a recent court ruled against the FDA being allowed to extend the date and now the FDA must come back with a new date.
The full text of the draft guidance can be found here.
For more details on the Draft Guidance around Substantial Equivalence, refer to our story this past March: