FDA Versus NJOY/Smoking Everywhere
Here we summarise the Memorandum Opinion of the US District Court of Columbia Jan 14th 2010 ("Memorandum") handed down against the FDA by Judge Leon (Civil Case Np. 09771 (RJL)) in an appeal for a preliminary injunction against the FDA's blocking of electronic cigarette imports.
We also look at the implications for the UK position and the MHRA.
The action was brought about by Smoking Everywhere after the FDA ordered a "hold" on two shipments in September 2008.
The hold was ordered on the basis that the devices were drug delivery devices and were intended to be used to treat nicotine withdrawal symptoms, with the FDA stating that "this product is clearly intended for 'drug' use." (Memorandum p.5/6)
After a shipment of NJOY electronic cigarettes were stopped on the same grounds, NJOY joined the proceedings.
Electronic Cigarette are tobacco products, not a drug device solution
The judge stated that because the devices have the same effect on the body as cigarettes, they could not be reclassified as drug devices.
Classifying the devices as drug devices would essentially mean cigarettes could be classified as drug devices, which would "effectively dismantle the existing regulatory wall Congress erected between tobacco products and drug devices combinations." (Memorandum p.15) This would effectively mean that cigarettes could be treated as drug delivery devices, in which case they would be banned because they were unsafe.
The judge also dealt with the possibility that the claims of the electronic cigarette to be a healthier alternative to cigarette meant it could be treated as a drug delivery device.
As the judge pointed out, such a position would be absurd as it would mean devices such as low tar cigarettes and e-cigarettes would be exposed to "more onerous regulatory burdens for drugs and devices merely because they claim to be healthier alternatives."
E Cigarettes as a Threat to Health
The judge maintained that the FDA had exaggerated the health risks of electronic cigarettes.
"I am not convinced that the threat to the public interest in general or to third parties in particular is as great as the FDA suggests. 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."
(Source: Memorandum p.30)
Criticism of the FDA
In his conclusion, the Judge criticised the FDA maintaining that:
"The case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices..."
"It's tenacious drive to maximise its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable."
Relevance for the UK
Sadly, the UK via the MHRA has given credence to the FDA's opinion and position on the electronic cigarette. In particular, they quote an FDA press release on the electronic cigarette (which mentioned the toxins found without mentioning the quantity, which was comparable to those found in many NRT's and even in some well known brands of food) as a reason for their desire to regulate the electronic cigarette as a medicine.
In the MHRA's consultation document the MHRA stated:
"We know, from work done by the Food and Drug Administration in the United States, that laboratory analysis of e-cigarette samples were found to contain carcinogens and toxic chemicals, against which general product safety legislation could not protect. "
(Source: Consultation Document MLX: p.21)
The fact that the FDA's position has been defeated in court ought therefore to have a bearing on whether the MHRA regulate the device as a medicine.
Reactions to the FDA Ruling
Professor Michael Siegel states that if the judgement is upheld electronic cigarettes will be counted as tobacco products and given the government's blessing,
"which would be a good thing, since the deadly tobacco products which kill hundreds of thousands of people every year are given the government's blessing."
Source: Tobacco Analysis Blog
He also believes that e-cigarette companies who brand their products as reduced risk would then have to meet very stringent criteria. This is against our reading of the judgement, as the Judge said it would be an "absurd position" for safer products to have to meet more stringent criteria.
Professor Rodu, writing on his Tobacco Truth blog, interpreted the decision as opening the market up to the deregulation of nicotine.
"... Judge Leon’s decision removes nicotine from FDA jurisdiction as a medicine as long as no therapeutic claims are made. If this ruling stands, it will allow pharmaceutical companies to reposition nicotine gum, patches and lozenges as recreational devices with higher doses that satisfy smokers, and sell them at prices competitive with cigarettes. This would liberate nicotine from the onerous and unnecessary restrictions and warnings currently mandated by the FDA."
Source: Tobacco Truth Blog