Wednesday, December 28, 2011

Regulation Stifles Technology Innovation

This oped in the Washington Times is centered on a different technology issue, but it applies quite nicely to the issue of regulation of electronic cigarettes, IMHO.

SWINDLE: Technological innovation is its own antitrust policy - Washington Times

Government regulation can stifle innovation and improvements when it is applied to rapidly-moving technologies.

I am afraid that many portions of the FSPTCA are inappropriate for regulation of a high-tech product such as e-cigarettes. Read the bill: Read The Bill: H.R. 1256 [111th] -

For example, the FDA could apply item j of Section 905 to justify banning all e-cigarettes that were not being sold prior to Feb. 15, 2007.

We have seen many product improvements during the past four years. Even if the FDA were to be generous enough to grandfather in all devices being sold on the day that their regulation of e-cigarettes goes into effect, it would still bring innovation and product improvements to a screeching halt.

The first model that I used back in late 2008 produced very little vapor. I couldn't tell whether my cartridge was empty or not. Cartridges that held less than 0.5 mL of liquid cost $2 a piece. The batteries went dead within hours, so I needed to carry charged-up spares. The "high" level of nicotine topped out at 18 mg, (1.8%) leaving me still wanting to smoke a tobacco cigarette.

It was models like these that Prof. Tom Eissengberg of VCU employed with novice users and found that blood levels of nicotine didn't go up very much. When he tested experienced consumers using their own devices and choice of nicotine strength, he measured nicotine blood levels close to that seen in tobacco cigarette smokers.

While it is true that even no-nic e-cigs can be effective for some smokers, there is a certain portion of the smoking population that is dependent on the beneficial effects of nicotine. These folks, like me, will not be able to stop smoking unless we can supply them with adequate replacement levels of nicotine.

It would be a crying shame if the government takes a product line that might be made effective for up to 80% of smokers and regulates it down to being effective for 10 or 20% of smokers. That's a lot better than the effectiveness of most government-approved smoking-cessation products; but it still represents millions and millions of cases of COPD, other lung diseases, various cancers, heart attacks, and strokes that might have been prevented. That's buying a lot of misery for the sake of an unwarranted level of caution.


  1. You make some valid points, but what is your solution, just leave them unregulated? A lot of people have a problem with the current status of e-cigarettes

  2. No. Currently the FDA is getting input from organizations that want to ban the products, and from the larger vendors whose business model is to sell tobacco-flavored pre-filled cartridges and models that look as much like cigarettes as possible. Would it be too much to ask for FDA to meet with representatives of consumers to find out what's worked and not worked to make these an acceptable alternative to smoking? FDA scientific advisory groups are supposed to have a seat designated for a representative of consumers. On the Tobacco Products Scientific Advisory Committee (TPSAC) that seat is called Representative of the Public, and they gave the seat to a tobacco control proponent whose idea of smoking cessation is that nicotine abstinence is required. I was told that consumers need to wait until 2014, when that seat is open before they can be considered to serve on TPSAC.

  3. Some regulation is probably warranted for most if not all industries, however, I think the trouble comes when government over regulates.