The substantial equivalency (SE) process allows for tobacco companies to argue that a new product is essentially the same as an existing tobacco product. If the FDA’s investigation — which, like all things regulatory, can take a very long time — finds that claim to be accurate, then the product could be cleared for sale.
And this is how Lorillard received the okay to market two new items: Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. Meanwhile, the FDA gave the no-go on four other unspecified items (the agency is not allowed to disclose information on products that don’t make it through the SE gauntlet).
The FDA does not reveal the reasons it rejected the SE claims for those four new products, but did give the general reasons [PDF] for which this group of products was rejected. These include:
-Inadequate information on design features. The manufacturers are supposed to provide info on things like ventilation and filter efficiency. If these stats are different from the predicate product, then the FDA has to consider whether the changes raise “different questions of public health.”
-Inadequate information on the type of tobacco used. The type of tobacco in a cigarette determines the levels of harmful and potentially harmful chemicals that the user comes into contact with. So any changes to the tobacco used in the product brings up new questions about whether the product is possibly more dangerous than its predicate.
-Added chemicals. The FDA said that some proposed new products showed increased levels of specific ingredients than were found in the predicate product. Further, the agency, in a fit of double-negativity, says Lorillard failed to show that “the changes did not result in the new product not raising different questions of public health.”
While the FDA is patting itself on the back over the SE process, the agency is also taking every opportunity to point out that approval of a new cigarette does not mean it’s any less harmful than what’s already available to smokers, nor does FDA’s go-ahead mean smoking is a good idea. In fact, tobacco companies are forbidden from saying their products are “FDA approved.”