I thought that all accessories for any product that wasn't on the market before Feb 15, 2007 was considered tobacco product, but on the
FDA warning letter for Vape Dudes it says...
"Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the FD&C Act."
Am I misunderstanding this?
I believe the FDA is just making a Distinction between a Tobacco "
Accessory" and a "
Tobacco Product".
And No... all Accessories after the Predicate Date are Not "Tobacco Products".
III. DEFINITIONS
For the purposes of this guidance, FDA intends to use the following definitions:
Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following:
(1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or
(2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but
(i) Solely controls moisture and/or temperature of a stored tobacco product; or
(ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product.
(21 CFR 1100.3)
“Composition,” as used in this definition, means the manner in which the materials, including, for example, ingredients, additives, and biological organisms (e.g., micro-organisms added for fermentation in smokeless products), are arranged and integrated.
Examples of objects used with ENDS (including e-cigarettes) that would likely be considered accessories include screwdrivers and lanyards.
https://www.fda.gov/media/102420/download
