FDA Extends Commenting Period For Substantial Equivalence

FDA Extends Commenting Period For Substantial Equivalence

The U.S. Food and Drug Administration is giving the public 30 more days to comment on a proposed rule that concerns how tobacco product manufacturers, including cigarmakers, will bring new products to market in the future.

When the FDA proposed the new rule back in March, it established a commenting period deadline of June 17. That deadline has now been extended until July 17.

The new rule proposal attempts to clarify Substantial Equivalence, one of the three pathways to product approval that the FDA established when it published its Final Deeming Rule in May 2016.

A cigar manufacturer, according to the FDA, is required to file a Substantial Equivalence report to prove that a new tobacco product has similar characteristics to a grandfathered (predicate) tobacco product, or has different characteristics, but doesn't raise any new questions of public health. A predicate tobacco product is one that was on the market on February 15, 2007.

For the companies that make handmade cigars, this is a controversial topic, as the FDA guidelines on the process of submitting acceptable reports has never been clear. Many in the industry point out that the natural variation of tobacco crops used for making premium cigars makes it difficult to develop a standard testing method.

Furthermore, cigarmakers are also concerned with how expensive testing cigars can be, as well as the slow turnaround times of the FDA to approve a new product.

If you wish to comment on the rule proposal, follow this link.