Many users of electronic cigarettes, as well as suppliers and health advocates who support the technology, are scratching their heads about why the FDA is so determined to make the electronic cigarette a new drug and drug delivery device rather than attempting to regulate it as a tobacco product. We too have pondered this question, so we did a bit of research. Below is what we found and is our opinion, not necessarily fact.
The FDA has regulations in place for new drugs and drug delivery devices. They get paid to receive applications for each of these categories. We noted this in our blog response to the American Legacy Foundation Panel on Electronic Cigarettes who didn’t seem to understand the costs associated with gaining FDA approval of a new drug and drug delivery device. The FDA fees associated with a new drug approval and the device approval fee would put many small e-cigarette suppliers out of business, while funneling a bunch of money from those who could afford it, to the FDA. This also means that not only the e-liquid (or cartridges filled with e-liquid) would be generating revenue for the FDA, but the batteries, atomizers, and chargers would also have fees as medical devices.
This isn’t to say that the FDA’s only goal is to make money. We don’t believe that. But since the FDA obviously believes that the product needs to be regulated (as do we), they appear to see it as “why not regulate it in a manner that produces the most money for us?”. I make this speculation because if this were about public health, then they would not have so blatantly misled the public about the potential dangers of electronic cigarettes.
So won’t regulating the electronic cigarette as a tobacco product generate funds for the FDA? It appears very little. In the recently passed Family Smoking Prevention and Tobacco Control Act it states:
(A) In general.–The total user fees assessed and
collected under subsection (a) each fiscal year with respect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year. ``(B) Applicable percentage.-- ``(i) In general.--For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accordance with clause (ii): ``(I) Cigarettes. ``(II) Cigars, including small cigars and cigars other than small cigars. ``(III) Snuff. ``(IV) Chewing tobacco. ``(V) Pipe tobacco. ``(VI) Roll-your-own tobacco. ``(ii) Allocations.--The applicable percentage of each class of tobacco product described in clause (i) for a fiscal year shall be the percentage determined under section 625(c) of Public Law 108-357 for each such class of product for such fiscal year.
As you can see, there is no category for the electronic cigarette. And even if they created a category for the electronic cigarette, we assume it would be at the end or near the end of the list. When we look up Section 625(c) of Public Law 108-357, we find:
(c) Assessments for Classes of Tobacco Products.-- (1) Initial allocation.--The percentage of the total amount required by subsection (b) to be assessed against, and paid by, the manufacturers and importers of each class of tobacco product in fiscal year 2005 shall be as follows: (A) For cigarette manufacturers and importers, 96.331 percent. (B) For cigar manufacturers and importers, 2.783 percent. (C) For snuff manufacturers and importers, 0.539 percent. (D) For roll-your-own tobacco manufacturers and importers, 0.171 percent. (E) For chewing tobacco manufacturers and importers, 0.111 percent. (F) For pipe tobacco manufacturers and importers, 0.066 percent.
Of course placing the electronic cigarette cigarette into this FDA fee schedule is not that simple. First, it would need to be determined that the nicotine in the e-liquid is indeed a tobacco product. Even if it is a tobacco product, a 15 ml bottle of e-liquid of high (24mg/ml) can replace 300 tobacco cigarettes and would only contain 360 mg of actual “tobacco product”. A cigarette contains about 800 mg of tobacco. So, 300 cigarettes would contain 240,000 mg of tobacco product in comparison to 360 mg for the equivalent amount of e-liquid.
On top of that, nowhere in the Family Smoking Prevention and Tobacco Control Act does it state that the FDA can regulate paraphernalia associated with the tobacco product. Assuming the batteries, atomizers, and chargers for electronic cigarettes fall under this new Tobacco Bill would also be asserting that all rolling paper, pipes, and tobacco vaporizers also fall under this Bill. And let’s not forget that e-liquid can be used with no nicotine at all. No nicotine means no tobacco product.
So, that is our speculation about why the FDA continues to assert that the electronic cigarette is a new drug and drug delivery device, even after a Federal Judge indicated that the FDA should be regulating the electronic cigarette as a tobacco product.