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Tuesday, May 10, 2016

FDA - All Software On Earth is a "Tobacco Product"

The "Bluetooth" Laisimo Mod
The latest FDA deeming regulations (see pages 7-8 at include the following language: 

FDA may put in place "restrictions on the sale and distribution of a tobacco product," 


This final rule has two purposes: (1) To deem all products that meet the definition of "tobacco product" under the law, except accessories of a newly deemed tobacco product, and subject them to the tobacco control authorities in chapter IX of the FD&C Act and FDA's implementing regulations; and (2) to establish specific restrictions that are appropriate for the protection of the public health for the newly deemed tobacco products. In accordance with section 5 of the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.


The final rule defines "component or part" and "accessory" to provide additional clarity as to which products are subject to FDA’s tobacco product authority.

and finally

Specifically, "Component or Part" means "any software or assembly of materials intended or reasonably expected: 1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or 2) to be used with or for the human consumption of a tobacco product. The term excludes anything that is an accessory of a tobacco product."  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. Similarly, the following is a nonexhaustive list of examples of components and parts used with waterpipe tobacco: flavor enhancers and the vials in which they are contained; hose cooling attachments; water filtration base additives (including those which are flavored); flavored waterpipe tobacco charcoals and the wrappers or boxes that contain the charcoals; and bowls, valves, hoses, and heads.

Note the underline above includes “digital displays” and “programmable software.”

How interesting - software as a “tobacco product.”

Now the PrimusZ Bluetooth controllable mod (discussed on this blog, sold during 2014 and 2015, and actually still available in limited quantities, supporting iPhone, Windows, Apple and Android) would clearly fall under this designation.  The mod is controlled via the phone or computer display (“digital display”) and uses “programmable software.”

Now the software included here would have to include iOS, Android, Windows and Linux (and I suppose BSD) as the PrimusZ requires these to operate (as in "runs on them in the canonical way as appropriate per platform").

But, as they say “Wait! There’s More…”

Additionally these are available as “free apps” in various app stores - so while not "sold" they could not be given away in an app store.  Are they "free samples" as restricted by FDA tobacco regulations?

There’s also GNU-GPL code used (which is freely available) - is this now a “tobacco product” too (and hence no longer "freely available," at least to "the children?"

These control programs are Bluetooth and/or Wifi applications (using third party software technology) not specifically designed to control a mod but instead to control general classes of electronic hardware controllers wirelessly.

Of course, there’s a web site (now dormant), which uses .NET.  This was called "" at the time - but now its owned by another unrelated party.  It logged data such that you could see how you were using your "tobacco product."

I wonder if any "data" is also included in this...

Now of course, these commercial packages are a “requirement” to operate the "tobacco product" and enable its operation.  So, at least to me, it would seem to qualify under the above FDA language.

The PrimusZ is, of course, not the only mod like this.  There is the Laisimo (shown above) as well as others made by companies such as SMOK.

So, at least from a regulatory perspective, these FDA regulations would be trumping all software licensing on earth.

UPDATE: First lawsuit:

(Software explicitly called out..._


  1. Now that you are an "investor" in a company promoting a sketchy tobacco substitute product, your common sense and decency gives way to your profit motive. You use your public forum (2 followers) to promote your sad business.


  3. UK Physicians: - Smoking should stop, everyone should vape.