• Deanna Clark-Esposito

FDA Tobacco Health Documents Due For Most on Nov. 8th

Last week the US Food and Drug Administration (FDA) extended the deadline for the submission of the required Tobacco Health Documents for those in regions affected by recent natural disasters.

Specifically, the FDA announced it recognizes that:

“...[R]ecent natural disasters have affected several areas. Multiple hurricanes have devastated parts of the Caribbean, including Puerto Rico and the U.S. Virgin Islands, and hurricanes and wildfires have affected parts of the continental United States. FDA is announcing several actions regarding industry in the affected areas.

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. If you have questions about these new compliance deadlines, please contact the FDA at SmallBiz.Tobacco@fda.hhs.gov or 1.877.287.1373.

Areas Affected by Recent Natural Disasters

Caribbean Islands — This extension will apply to manufacturers and importers of deemed products in all areas of:

· Puerto Rico

· U.S. Virgin Islands

· Caribbean islands:

· Anguilla

· Antigua and Barbuda

· Barbados

· Bonaire

· Sint Eustatius and Saba

· British Virgin Islands

· Cuba, Dominica

· Dominican Republic

· Guadeloupe

· Martinique

· Montserrat

· Saint Barthélemy

· Saint Kitts and Nevis

· Saint Lucia

· Saint Vincent and the Grenadines

· Saint Martin/Sint Maarten

· Turks and Caicos Islands

In the continental United States, this extension will apply to manufacturers and importers of deemed products in the following counties designated by the Federal Emergency Management Agency (FEMA) as disaster areas:

· California —

· Butte

· Lake

· Mendocino

· Napa

· Nevada

· Orange

· Sonoma

· Yuba

· Florida

· Alachua

· Baker

· Bradford

· Brevard

· Broward

· Charlotte

· Citrus

· Clay Collier

· Columbia

· DeSoto

· Dixie

· Duval

· Flagler

· Gilchrist

· Glades

· Hardee

· Hendry

· Hernando

· Highlands

· Hillsborough

· Indian River

· Lafayette

· Lake

· Lee

· Levy

· Manatee

· Marion

· Martin

· Miami Dade

· Monroe

· Nassau

· Okeechobee

· Orange

· Osceola

· Palm Beach

· Pasco

· Pinellas

· Polk

· Putnam

· Sarasota

· Seminole

· St. Johns

· St. Lucie

· Sumter

· Suwannee

· Union

· Volusia

· Texas —

· Aransas

· Austin

· Bastrop

· Bee

· Brazoria

· Caldwell

· Calhoun

· Chambers

· Colorado

· DeWitt

· Fayette

· Fort Bend

· Galveston

· Goliad

· Gonzales

· Grimes

· Hardin

· Harris

· Jackson

· Jasper

· Jefferson

· Karnes

· Kleberg

· Lavaca

· Lee

· Liberty

· Matagorda

· Montgomery

· Newton

· Nueces

· Orange

· Polk

· Refugio

· Sabine

· San Jacinto

· San Patricio

· Tyler

· Victoria

· Walker

· Waller

· Wharton

If FEMA declares additional counties as disaster areas, the FDA will continue to update this list.

For non-small-scale tobacco product manufacturers and importers with deemed tobacco products on the market as of Aug. 8, 2016, in the areas specified above, the extended compliance deadline to submit a listing of all ingredients in each tobacco product to the FDA is May 8, 2018. The extended deadline for small-scale tobacco product manufacturers in the specified areas is Nov. 8, 2018.

For small-scale tobacco product manufacturers with deemed tobacco products on the market as of Aug. 8, 2016, in the specified areas, the extended compliance deadline to submit certain tobacco health documents to the FDA is May 8, 2018. Please note that the deadline for submission of tobacco health documents by non-small-scale tobacco product manufacturers and importers was Feb. 8, 2017, and is not included in this extension.”

For more information on this, head over to the FDA’s website here.

Have questions about this process? Connect with us using the Contact form.











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