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FDA revises product registration guidance

18 Sep 2017. The Food and Drug Administration issued a revised final guidance to manufacturers of tobacco products on who must register with the regulatory body and what information they must supply about their products.

“The updated guidance includes a compliance policy that aims to reduce the product labeling submissions by a manufacturer, and provides more transparency and predictability to this process. In particular, the guidance outlines how a registrant could provide information and labeling for a selected line of products as a single submission,” FDA said. The information must be updated annually and, since the FDA expanded its tobacco regulatory powers in 2016, also applies to makers of vaping products, cigars, pipe and hookah tobacco.

The revised guidance can be accessed at: