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FDA issues 6-month ‘ingredients’ extension for vape shops affected by natural disasters

In a press release today, the U.S. Food and Drug Administration (FDA) announces the granting of a 6-month extension to manufacturers and importers of tobacco products located in areas affected by the many recent natural disasters.  The devastation caused by the wildfires in California as well as Hurricanes Irma, Harvey, and Maria is the basis for the compliance extension regarding the listing of ingredients and health document submission requirements. 

The new deadlines will only affect companies located in Puerto Rico, the U.S. Virgin Islands, significant portions of the Caribbean, and specific counties of California, Texas, and Florida.  Should additional counties be declared disaster areas by the Federal Emergency Management Agency (FEMA) in the future, the FDA will update their list accordingly.  The complete list of regional manufacturers and importers is provided in the FDA press release.

6-month extension date varies, according to ‘scale’ of business

The original compliance dates were based on whether the manufacturer or importer is a non-small-scale or a small-scale enterprise.  Therefore, the 6-month extensions will differ, as well.  The FDA generally considers small-scale vendors to be those consisting of 150 employees or less and whose yearly revenues are lower than $5 million.  The majority of American vape shop owners will likely fall into this category.  

However, according to the FDA press release, the agency is happy to assist retailers in answering any questions or concerns by contacting agency officials directly at SmallBiz.Tobacco@fda.hhs.gov or by calling 1.877.287.1373. Below is a brief overview of the new compliance dates as per the FDA press release.

“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 vendors choosing to email their questions, the FDA recommends including one of two very specific subject lines to receive a timely response.  Since there are two different areas in which the new deadlines apply, the subject lines should either state “Ingredient Listing Extension Questions” or “Health Document Extension Questions.”   For more information on either category, manufacturers and importers should visit the FDA website regarding Listing of Ingredients in Tobacco Products and Health Document Submission Requirements for Tobacco Products

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