I recently suggested to Paul Bergen from the TobaccoHarmReduction.org programme that he and other scientists write an open letter to the UK government currently considering making e-cigarettes a medicine.
I got this reply:
Am going to give it a shot but wonder about an agency that uncritically puts in the FDA nonsense and disregards its own ASH … have the feeling that they have already made up their minds but will speak up…
The FDA and the Electronic Cigarette
The FDA tested the electronic cigarette last year.
They tested the ingredients of the electronic cigarette and found traces of four tobacco specific nitrosamines at ‘very low levels.’
‘Very low levels’ – that’s what the scientists said, but that’s a quote that was omitted in the FDA press release.
In fact, they didn’t report any levels, which was surprising as they measured them in parts per trillion.
Here are some interesting points about the levels of tobacco specific nitrosamines found:
The levels found were the same as the levels found in the nicotine cessation aids approved by the FDA. (Source: Siegel)
The levels found were 1400 times lower than those in Marlborough cigarettes. (Source: Siegel)
If we banned electronic cigarettes based on the levels of carcinogens found in them, we would also have to ban many food stuffs. (Source: Carl Phillips)
The Vapour not the Ingredients
The FDA couldn’t be bothered to test the vapour of the cigarettes. They left that to us.
Despite the fact that the FDA study proved beyond a doubt that the NJOY electronic cigarette was far safer than regular cigarettes, press misinterpretation of the FDA study (which included one newspaper stating that the e-cigarette contained 40 times as much nicotine as regular cigarettes!)* lead to over 100,000 dollars being spent on independent lab tests of the electronic cigarette.
The tests proved that the NJOY e-cg va pour has one tobacco specific nitrosamine in its vapour – and that one is non-toxic.
The FDA Has Been Discredited
Bear in mind that the FDA conducted this study and released the press release while being sued by two e-cigarette companies.
And they lost the case!
The judge strongly criticised the FDA’s action, stating:
‘This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices.’
The judge also slammed the FDA’s argument that the e-cigarette was dangerous:
Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.
The MHRA and the FDA
Despite admitting that the electronic cigarette can save lives, the MHRA quotes the FDA report as a reason for regulating the electronic cigarette as a medicine (handing over control to big pharm?)
We know from work done by the Food and Drug Administration (FDA) in the United States that laboratory analyses of e-cigarette samples were found to contain carcinogens and toxic chemicals, against which general product safety legislation could not protect.
Source: Consumer Letter MLX p.4
Handing Over Control to Big Pharm?
Can scientists and bloggers be blamed for being suspicious?
After all, pharmaceutical companies already bankroll the organisations that have been campaigning against the electronic cigarette.
And the amount the MHRA wants from manufacturers is suspiciously large – a cool 1.4 million to be precise.
Enough to put off a few e-cigarette companies, but not enough to give a seconds thought to big pharm.
Are we being too suspicious? I hope so!
*When we pointed this out in an open letter, ASH US released a press release urging newspaper to continue to lie.
Check it out for yourself: If you haven’t already guessed, we retail the Njoy electronic cigarette tested by the FDA!