These(my excerpts) are not a very good synopsis of the article regarding the FDA’s interpretation of the Significant Equivalency requirements and I heartily urge those reading this to put their grown-up pants on and read it all the way through at least once.
Carl has done the hardest part: unraveling the true meaning by bureaucracy-speak and translating into a language we can understand.
FDA signals that nothing is ever “substantially equivalent” | Anti-THR Lies and related topics
We are still trying to make sense of the details as they relate to the particular products (note all the complexities below), but one implication is clear: FDA plans to use the SE process to block the introduction of THR products.
What is not complicated is that FDA is clearly using the SE process as a tool of prohibition. The only important SE approvals to date were for non-menthol versions of Lorillard’s flagship cigarettes, a transparent political maneuver. (At the time, CTP still thought they could get away with banning menthol cigarettes. By granting this permission, they would have been able to claim that they were not putting a major corporation out of business with the stroke of a pen.) According to FDA’s public statements, the new dissolvables varieties were rejected because they had higher levels of acetaldehyde and nicotine than the predicate products (which presumably means the original flavors of these products, though even that is not clear).