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FDA Extends Public Commenting Period for Substantial Equivalence
June 25th, 2019New Deadline Has Been Moved to July 17, 2019
The U.S. Food and Drug Administration has extended the public commenting period on Substantial Equivalence an additional 30 days with regard to a proposed rule concerning how all makers of tobacco products will introduce their products to the consumer market going forward. Originally slated for June 17, 2019, the new commenting period deadline will now be July 17, 2019.
Under Substantial Equivalence (SE) guidelines, tobacco manufacturers, which includes makers of premium handmade cigars, can continue to market products introduced after February 15, 2007, which allows them to avoid the additional cost of obtaining pre-market approval by the FDA. However, when filing a Substantial Equivalence report, the manufacturer has to show that these products are substantially equivalent to the products that entered the market prior to February 15, 2007, thereby exempting them from FDA regulation. Moreover, the new product may have different characteristics, but it cannot raise further questions regarding public health.
Tobacco manufacturers were originally required to demonstrate SE by August 8, 2018, but the FDA extended that deadline to August 8, 2021. However, a recent court decision prevented the FDA from extending the date, which means they must now set a new date.
So, how does this apply to manufacturers of imported handmade premium cigars? According to premium cigar makers, the natural differences in tobacco crop harvests make it virtually impossible to establish a standard method of testing, not to mention the high cost of testing and the FDA’s sluggish response times for approving new cigars.
The extension of the public commenting period gives manufacturers of tobacco products some wiggle room as they wait for the FDA to decide on a new deadline for making a substantial equivalence determination.