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Monday, July 25, 2016

FDA Espouses False Labeling...

[The] FDA says this: "Regarding your fourth question, if the product does not contain nicotine and you have submitted a statement to FDA certifying so, according to the regulatory requirement, then you would not have to include the mandatory warning regarding the contents of nicotine in the product."  (from

(This post is interesting in and of itself...)

But on to the business at hand...

SO if I have e-liquid that contains no nicotine AND I register it with them then I don't have to label it as a nicotine product if I register it?

Now if you look at page #8 of the deeming regs ( it clearly says that e-liquids ARE tobacco products through the "components and parts" logical nonsense espoused on that page.

This is the nonsense: "Components and parts of the newly deemed tobacco products, but not their related accessories, are included in the scope of this final rule. The following is a nonexhaustive list of examples of components and parts used with electronic nicotine delivery systems (ENDS) (including ecigarettes): e-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software."

And here we find "e-liquid..." - really anything else that does not contain nicotine: mods, ENDS, software, whatever.

So it would seem that, according to this FDA correspondence, if your e-liquid (or software) does "not contain nicotine" AND you have "submitted a statement to the FDA certifying so" you would not have to include a mandatory warning label that it contained nicotine.

Hmmm.....  this is new - recall my blog posts about the FDA making software a "tobacco product."

Now it would seem that, if we register it with the FDA, at least it won't be labeled as such...

So if its not LABELED as nicotine (because it isn't) and it does not contain nicotine (because it doesn't) it's apparently still regulated as if it were nicotine because...?

Could it be an "accessory:"

(page #8 and #9 of the deeming regs): "FDA is defining "accessory" to mean "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 product or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product."

 No, probably not...

 So I guess e-liquid that contains no nicotine and is properly registered with the FDA as having none is an unlabeled tobacco product.

 But we have this: "... this rule authorizes FDA to take enforcement action against manufacturers who sell ... or false or misleading claims on their labeling or advertising, ..."

 The result of all this is that we have an unlabeled tobacco product which is a clear violation of  the FDA regs - this being exactly what the FDA tells us to do.

So to be unclear it would seem that if we certify something with no tobacco content has no tobacco content with the FDA and our product contains no nicotine then what, its a regulated tobacco product?

At least from my point of view there is certainly nothing lost in registering anything without nicotine with the FDA...!?!??

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