April 23, 2020
FDA COMPLICANCE UPDATE AND SHOW CIGARS PRODUCTS
MAY 12, 2020 FDA DEADLINE EXTENDED TO SEPTEMBER 9, 2020
Show Cigars Valued Customers:
On April 22, 2020, the U.S. District Court for the District of Maryland issued an Order which formally changed the upcoming May 12, 2020 FDA deadline and extended it to September 9, 2020. This is the new deadline with the FDA requiring manufacturers to file one of the required tobacco market pathway applications for the product to legally remain on the market after that date. Show Cigars has been working diligently with our manufacturers and attorneys to make sure all our products will have a legal market pathway filed by the September 9, 2020 deadline.
In light of the COVID-19 pandemic, several manufacturers and laboratories closed, thus making it impossible to comply with the FDA requirements. The FDA and the Court has acknowledged this crisis and granted an extension to September 9, 2020. We plan on having a legal market pathway for each of our products and having several Substantial Equivalence (SE) applications filed. After the filing, the FDA will assign a Submission Tracking Number (STN) for each filing. Once the STN is provide to us, we will provide all our customers with this information to maintain for their records. We anticipate the filings to be submitted well in advance of the current deadline.
As always, Show Cigars stands behind all our products.
