In an email sent to the FDA’s mailing list yesterday, the Angency announced that FDA ingredients listing deadlines would be moved for those companies struggling to cope with the effects of natural disasters.
In a statement on its website, the Angecy said:
“The FDA is aware that tobacco manufacturers and importers in the affected areas are dealing with extraordinary circumstances and may need additional time to meet certain requirements. As a result, the FDA is extending the compliance deadlines for the ingredient listing and health document submission requirements by an additional six months for manufacturers and importers of deemed products in the areas affected by these recent natural disasters.”
FDA has listed the areas where manufacturers will be given extra time to complete FDA ingredients listing. This includes Caribbean Islands and large parts of Texas and Florida that were hit by tropical storms; along with parts of California that were hit by wildfires. We have reproduced this list below for reference (last updated 19th October 2017). Should FEMA decide that other areas have been significantly affected by these disasters, FDA will do likewise.
It’s not yet known whether those companies not in these areas but who have significant suppliers who were affected will also be granted exemptions. The Agency have provided a telephone number (1.877.287.1373) and email address (SmallBiz.Tobacco@fda.hhs.gov) for those who would like further clarity. If you’re not in one of the areas listed, you should assume that the original deadline still applies to you unless you are told otherwise.
For those who will receive an extension for their FDA ingredients listing, the new deadlines are:
Large scale manufacturers: May 8 2018
Small scale manufacturers: November 8 2018