Yeah, that is the process, I suppose. But the statement that comes closest is "Marketing orders for substantially equivalent tobacco products can be issued for new products that have the same characteristics as valid predicate tobacco products, or have different characteristics but the new products do not raise different questions of public health." is still very vague, but somewhat promising in itself, at least to me. However, the wiggle room allows the FDA to do whatever it wishes to do on the Substantial Equivalence statement.