This week the FDA announced a six-month extension of the ingredient listing requirement for manufacturers and importers of newly “deemed” tobacco products (including cigars) that are on the market as of August 8, 2016. This extension pushes the submission deadline from February 8, 2017 until August 8, 2017, and provides an additional six months for small-scale manufacturers. The delay follows the FDA’s similar decision earlier this month to push back the manufacturer registration and product listing deadlines by six months to June 30th, 2017. CLICK HERE to view the revised guidance.
So, what’s new?
- The FDA does not intend to enforce the submission deadline for its ingredient listing requirement until August 8th, 2017 for businesses not considered as small-scale tobacco manufacturers. For small-scale tobacco manufacturers (less than 150 full-time employees and $5 million in annual revenues), the deadline is extended to February 8th, 2018.
- The revised deadline applies only to tobacco products introduced on or before August 8, 2016. For any products introduced after August 8, 2016, manufacturers must provide the ingredient listing 90 days prior to the product’s introduction to the market.
Similar to the manufacturer registration and product listing deadline extension, IPCPR is encouraged by the FDA’s decision to extend the deadline for the ingredient listing requirement. We will continue to seek additional clarification from the FDA on the current and pending requirements under the deeming rule. For any questions or requests for additional information, please contact Daniel Trope, Director of Federal Government Affairs at firstname.lastname@example.org.