FDA’s deadline for receipt of first documentation

The U.S. Food and Drug Administration, (FDA), is demanding to receive the first health related documentation by the 8th of February 2017, from manufacturers of e-cigarettes who released their products on the market between the 23rd of June 2009 and the 31st December of the same year.

Diane Caruana

October 27, 2016

Companies who fall under this time bracket are expected to first fill out and send an online Tobacco Health Document “including all documents developed after such date of enactment that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives”.

Failure to provide the requested documents would be considered as a law violation.

After submission of the above they will need to provide their documents up to the aforementioned date, which falls at exactly six months from when the infamous deeming rule was implemented.

Smaller companies will have an additional six months to submit the requested documents whilst manufacturers who do not fall within the 22/09/09 – 31/12/09 time bracket are not required to submit any documents as yet.

Note to all manufacturers to have required docs prepared

Since very few e-cigarette companies were operative in 2009, the above is not expected to create much havoc within the vaping industry. However the FDA did point out that it is imperative that any companies that launched their products in the following years do obtain and hold on to their documents as these will be required at a later date, and failure to provide them would be considered as a law violation.