The Report, I must confess, rather impressed me, with its balanced and ostensibly unbiased reporting of the responses received. Electronic cigarettes are barely mentioned, which is probably a good sign, since classification as a tobacco product would be enormously problematic for the industry in Europe. There did not seem to be any indication in the Report that the European Commission has any intention at this time to consider including electronic cigarettes in any classification as a medicinal product, but we have our legal arguments prepared if they were to make this move.

The full text of the Report can be found here, but the points of significance for the vaping community are as follows:

“Those who were in favour of extending the scope of the Directive to all tobacco and nicotine products argued that these products present hazards to public health. Some respondents suggested nicotine products should be regulated under pharmaceutical legislation. Others arguing against the extension of the scope raised concerns about the lack of scientific evidence and claimed that the use of many novel forms of tobacco and nicotine products are healthier than cigarette use.”

“Overall, the public consultation generated over 85,000 responses via the online form. DG SANCO also received around 300 letters and pieces of background material sent to the functional mailbox created for the consultation. Moreover, a large number of letters were sent to Commissioner John Dalli, as well as to other Commissioners and their services.

In addition, the Commission also received 10 petitions from citizens, retailers, traders, wholesalers, gas station owners and trade unions. In total these petitions counted for around 18, 650 signatures. Four of the petitions collected more than 1,000 signatures each.”

This would seem to indicate that our petition was one of the largest the Commission received, and it is gratifying to note that they paid some attention to the petitions as part of the process.

The Report continues:

“It should be noted that no previous public consultation launched by the European Commission had ever registered such significant participation. The amount of participation clearly underlines the great interest of both stakeholders and the general public in the policy making process.”

That’s right, policy-makers: we are watching your every move!

In discussing the sub-divisions of responses by ‘type’, there are some rather interesting comments in the Report about responses from putative ‘Governmental Representatives’:

“Many of the responses that classified themselves as ‘government’ appeared to be from private persons working for government bodies which made the process of sub-classifying these responses quite challenging. While hand-processing the responses, it was found that most of them should not have been classified as governments. In many cases, respondents who classified themselves as government representatives were either citizens or represented non-governmental organisations.

Among the responses in this group five main types of sub-categories could be identified:

• National Government/Ministry level Representatives, presenting the views of the government in question or of a specific Ministry;
• Regional/Local Authorities, presenting the views of a broad range of public authorities from local municipalities, to larger, more regional representation. The vast majority of them were sent from Poland, Italy and Greece;
• Members of the European Parliament and National Parliaments. The number of MEP responses represented approximately 6% of the total size of the European Parliament. Responses by Members of National Parliaments represented less than 1% of the total number of Parliamentarians across the EU-27;
• Private persons who could be part of a Member State Government. These contributions were submitted by citizens working in assorted government offices, agencies, parliaments or ex-politicians;
• Others (NGOs, citizens, industry, etc.). This broad category includes the responses self-identified as government representatives, but in fact they do not represent government. The group consists of citizens representing NGOs (a substantial amount of these were from the UK), citizens who improperly classified themselves, and a small selection of unusable responses” (footnote: “Which included insulting responses”).

Hmm… can you say ‘power-hungry, self-aggrandising, trumped-up megalomaniacs’?

I can’t help but remember our last meeting with the MHRA, when Jeremy Mean, a deputy in the Vigilance and Risk Management section, told us that, for the purposes of that meeting, he represented the UK Government. Strangely, I don’t remember his name being on the ballot papers at election time.

At section 6, under the heading ‘Responses’, we find the first mention of electronic cigarettes, although (of course!) they have been given their snazzy EU title of ‘Electronic Nicotine Delivery Systems. Well, we can’t have them sounding like anything fun or appealing, now can we?

The Report states:

“6.1 Scope of the Directive

The public consultation’s questions about the scope of the Directive presented information about the changing market of tobacco and nicotine products and a need to implement reforms based on an evolving market. Respondents were asked if they agreed with the problem definition, and then offered two options for policy change: status quo or extension of the scope of the current Tobacco Products Directive.

6.1.1 Governmental Representatives

A significant majority of Member States who submitted contributions to the public consultation were either in favour of extending the scope of the Directive or did not refer to the question in a detailed manner. Two EFTA States were also in favour of extending the scope of the Directive. A small number of respondents were in favour of either maintaining the status quo or extending the directive to all tobacco products, but not to tobacco-free nicotine products, ENDS (Electronic Nicotine Delivery Systems), or herbal cigarettes.

Those Member States in favour of extending the scope of the Directive argued that all tobacco and nicotine products presented hazards to public health, both directly and indirectly. They argued that the most desirable option would be to include all products containing tobacco or nicotine in the Tobacco Products Directive, with the exception of those products exclusively and purposefully designed to assist in smoking and nicotine cessation. While the present Tobacco Products Directive has the objectives of facilitating the functioning of the internal market while ensuring a high level of health protection, it was also argued that the Directive is not functioning satisfactorily in this respect.

As regards the future regulation of ‘electronic cigarettes’ in tobacco legislation, Member States seemed to be more divided, with some presenting arguments for regulating the product as a pharmaceutical or medical device, and others arguing for the inclusion of electronic cigarettes in the Tobacco Products Directive.

Reactions from MEPs, National Parliamentarians, and local/regional authority respondents were mixed. Those in favour of extending the scope suggested that the current market of novel products should be regulated, but product bans should only be implemented based on significant scientific evidence. [our emphasis.] Those against extending the scope of the directive suggested that the EU should develop a concrete scientific assessment process to test the health impacts of new products before making a decision about their availability inside the EU.”

This theme of a reliance upon robust scientific evidence has been given a certain amount of prominence in the Report, and was clearly a point raised by many of the respondents, particularly the Citizens groups, but also from Governmental and Public Health groups, too. We can but hope that the Commission will pay sufficient attention to this point, and insist on a reliance upon genuine, fact-based scientific evidence, and not the junk science favoured by the FDA and others.

“6.1.2 Non Governmental Organisations

Among the many different sub-categories of stakeholders within this group a wide range of opinions appeared. The key arguments can be categorised as follows:

Public health organisations universally supported regulating tobacco and nicotine products, on the grounds of the potential health dangers of these products. Many argued for the strict limitation of novel forms of nicotine delivery systems, whereby these nicotine systems should only be sold as smoking cessation aids, subject to the regulatory framework on pharmaceutical products. [‘It’s not fair that electronic cigarettes are stealing such a significant market share from our very lucrative, if largely ineffective pharmaceutical NRT products!’] They also argued for the inclusion of herbal cigarettes into this framework, citing that the most harm from these products has to do with the combustion and inhalation of smoke, which is identical to cigarette usage. Some of the respondents within this category also expressed concern regarding the current differential treatment between NRTs (Nicotine Replacement Therapies) and novel forms of nicotine products freely available on the market.

On the other hand, arguments against changing the current scope of the Directive explained that the problem definition was framed inaccurately and incorrectly. Respondents within this sub-category argued that any proposed new regulation should be based solely on strong and precise scientific evidence. For example, smokers’ rights groups generally found the scope of the Directive to be fundamentally flawed, citing the fact that electronic nicotine delivery systems and nicotine drinks feature no tobacco, and should be regulated in a separate framework.[*] They also claim that the European Commission’s consultation not only ignores the issue of consumer choice, but “is also looking for problems that do not exist.” They argue, based on this reasoning, for no change to the current scope of the Directive.”

* As far as ‘a separate framework’ is concerned, we are fortunate in now having such a separate framework set up, established, and fully operational. ECITA has introduced its Industry Standard of Excellence programme, and ECITA members are now being regularly audited to its standards. Much more information will be published soon about this programme, and we shall be presenting it to the UK government and the European Commission in the coming months. Trading Standards have described the ECITA ISE as ‘a Code any industry would be proud to have’. The notion of electronic cigarettes’ being ‘unregulated’ is now completely dead in the water!

“6.1.3 Industry Representatives

The industry representatives almost universally disagreed with the problem definition. They argued that a fundamental difference exists between products which use tobacco to deliver nicotine and those that do not. They claim that the Directive is aimed at regulating tobacco products, and no further regulation is needed for other products. Additionally, they advocated that many of these products are considerably healthier, when compared to their ‘combustible’ counterparts, and should not be subject to an outright ban until scientific evidence suggests otherwise.

Retailers and growers commonly raised concerns about the lack of scientific evidence used to categorise these ‘novel’ forms of tobacco- and nicotine products, citing that many of these products were fundamentally different from one another. This prompted retailers and growers to reason that large, ‘blanket’ policies for these types of products might not be in the best interests of manufacturers or consumers.

The Pharmaceutical industry favoured extending the current regulation of tobacco and nicotine products [did anyone NOT spot that one coming?], claiming that the Tobacco Products Directive has brought significant progress to the regulation of tobacco products, but that it is not well or evenly applied across the whole of Europe. [What? You mean pharma profits are not high enough in certain areas? Clearly, greater restrictions on tobacco products are needed, so that medicinal nicotine products become the only option. Naturally, this will need consumer products such as electronic cigarettes to be brought into Tobacco classification, and massively restricted, or brought into medicinal classification and banned. After all, we can’t have pharma profits being negatively affected by better alternative products becoming widely available!] They argue for a comprehensive approach to tobacco control policies and are in favour of including tobacco-free nicotine products in the scope of the Tobacco Products Directive insofar as they are not otherwise regulated by EU food or pharmaceutical legislation – because of the significant linked history that tobacco and nicotine have had for decades. Additionally, the pharmaceutical industry is concerned about addiction transference between tobacco and non-tobacco based products.”

What utter rubbish! The pharmaceutical industry cannot claim to be ‘concerned about addiction transference between tobacco and non-tobacco based products’ when they themselves manufacture and sell nicotine replacement therapies, which are, by definition, ‘non-tobacco based products’. Clearly, they won’t be wanting to have anything more to do with Nicoventures, then. It is all too obvious that what they are really concerned about is a genuine and very real threat to their profit margins from an infinitely superior product: the electronic cigarette!

The last of the respondent groups in this category was the ‘Citizens’, and their comments are also interesting:

“6.1.4 Citizens

A significant majority of respondents were against extending the scope of the Directive. While many presented that the problem definition was incorrect, vague, or unclear, the group as a whole demanded more scientific inquiry about the relative safety of novel forms of tobacco and other nicotine products. These respondents also argued about the consumer’s freedom of choice, so long as they are properly informed with the risks involved, and they criticised the tendency to over-regulate and prohibit products in this area.”

In conclusion, the Report ends with:

“The opinions and information received in reply to the consultation will continue to be considered within the Impact Assessment and the formulation of the proposal for the revised Tobacco Products Directive.”

It seems that the policy makers are now aware that the world of voting citizens is watching their every move, so we trust that the European Commission will give the necessary care and due consideration to all the responses it received during this consultation, and particularly to the need for robust scientific evidence to support whatever decisions it makes. Provided this is the case, then electronic cigarettes should remain free to benefit everyone who wants to exercise their freedom to choose to use nicotine in whatever way they wish: by smoking, by using medicinal NRT products, or by switching to electronic cigarettes.

Ultimately, it has to be about freedom of choice!

They began by telling us about some of the problems they had been finding, and explained that electronic cigarettes are very high on their agenda at the moment. The NMO are examining ecigs with regard to batteries and RoHS as they do not consider that they are medicinal products and therefore do not qualify for exemption from these regulations.

In products they tested recently from an online vendor (not an ECITA member), the NMO found unacceptably high levels of lead in the solder used to connect the battery to the switching circuitry. Unfortunately, despite the best intentions of the vendor in question, the NMO told us they had “recently removed from the marketplace in excess of £10k stock value”. The vendor in question was also required to pay for the disposal costs of these items.

They told us that their superiors had instructed them to examine ecig traders with a view to taking legal action against non-compliant and potentially dangerous electrical products. They announced that since ECITA members were demonstrably striving for compliance, they were a low priority for NMO enforcement actions. They asked us to supply them with a list of our members, which we have done.

The NMO shared some of their other concerns with us. In particular, they seemed very worried about the fact that ecig batteries (on cigarette-style ecigs) are not removable from their steel casing. We were able to point out that there is a safety exemption in the legislation, and that ecig batteries have built-in safety circuitry which must not be removed for the lifetime of the product. Therefore, to remove the battery would be to disable the safety circuitry, and this is what the safety exemption is intended to cover. They agreed to take advice from their technical experts on this point, and asked us to supply them with some examples, which we shall.

They were also concerned about the legal requirements for the correct markings to be displayed on products. We showed them a draft copy of the Industry Standard of Excellence (ISE) guidebook, which itemises all the regulatory requirements drawn from the legislation which apply to ecigs. This includes details of the markings required to cover the batteries legislation, along with everything else.

The ISE is the foundation for the internal auditing programme we are engaged in. (This is why the blog has been somewhat quiet of late!) Every ECITA member is given a copy of the ISE, and we hope to achieve Board approval within the next couple of weeks. At that point, we shall be able to print sufficient copies to be able to supply them to Trading Standards Officers across the UK. We hope to be able to present the ISE to all the regional groups of Trading Standards Officers over the coming months, and shall make copies available to all other enforcement officers as necessary.

The NMO enforcement officers were reassured on seeing the draft copy of the ISE and hearing about the audit programme ECITA has established. They offered to attend a meeting of ECITA members, to be able to advise and provide assistance directly. We hope to be able to arrange this in the near future. The NMO are happy to assist vendors who engage with them to achieve compliance with the law, and at the end of the meeting, they reiterated their support for the ecig industry.

As we refine the ECITA programme, we have been delighted to see just how supportive enforcement officers are – of the Trade Association, and of the industry as a whole.

In the Court submissions attached to this ‘thrashing out’ of whether or not Smoke Anywhere should be allowed to ‘intervene as plaintiff’, there are some very interesting documents indeed. The first is a Declaration, signed “under penalty of perjury that the foregoing is true and correct” by one Domenic J. Veneziano, the Division Director of the FDA’s Division of Import Operations and Policy (DIOP), which is a component of FDA’s Office of Regulatory Affairs (ORA).

In this declaration, Mr Veneziano states that, if called, he would testify as follows:

“3. As the Division Director of DIOP, I oversee FDA’s efforts to prevent the importation of food, drugs, medical devices and radiological health, tobacco, and cosmetics that appear to be in violation of the Federal Foods, Drug and Cosmetic Act (‘FDCA’) or that otherwise are subject to refusal of admission under the FDCA. …

5. Until recently, FDA has detained and/or refused shipments of e-cigarettes, e-cigars, and other high-tech electronic smoking articles and their components at the border on the ground that the products were unapproved drugs or unapproved drug/device combination products. However, since at least December 8, 2010, FDA directed its field operations not to detain or refuse shipments of e-cigarettes without therapeutic claims. And on January 24, 2011, FDA reissued its directive that e-cigarettes should not be detained or refused unless they are accompanied by labelling that makes therapeutic claims, including electronic cigarettes imported specifically by Sottera, Inc. d/b/a NJOY.” (our emphasis.)

So we have this Declaration – effectively made under oath to the Court, and with the threat of perjury hanging over any untruths issued or stated within it– made by the FDA employee responsible for ensuring that all FDA field officers are given accurate information about products they should and should not detain. And according to this sworn Declaration, the FDA is not detaining any shipments of ecigarette products anymore unless they bear therapeutic claims. This has been the case, Mr Veneziano assures us, since “at least” December 8th, 2010, the day after the Court ruling of December 7th, 2010.

On the basis of his statement, there should not be any detained shipments at all unless they bear labelling with therapeutic claims. Mr Veneziano’s wording very clearly states that only electronic cigarette products bearing labels making therapeutic claims will be detained. This would seem to indicate that any and all electronic cigarette products not bearing labels making therapeutic claims will be granted free passage into the United States.

And since Mr Veneziano has been so exact in the timing of this – in linking it to the Court ruling of 7th December 2010 – clearly there should be no shipments detained, or remaining in detention, after 8th December 2010. Naturally, we would also expect to see an update to the all-important Import Alert which guides the behaviour of US Customs officials at the borders. Unfortunately, as we shall see, this does not appear to be the case.

The FDA’s suggesting that the labelling claim of an ‘experience like smoking’ may be regarded as a therapeutic claim was ‘debunked’ in the ruling for NJOY, when Judge Leon concluded:

“In sum, absent substantial evidence of the manufacturer’s objective intent that its electronic cigarettes affect the structure or function of the body in a way distinguishable from “customarily marketed” tobacco products or that its electronic cigarettes have the therapeutic purpose of treating nicotine withdrawal, there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette. Thus, the plaintiffs are substantially likely to succeed on their claim that FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.”

So let’s be very clear about this: labelling claims of a ‘smoking-like experience’, or anything short of a distinct medicinal claim, i.e. that the product can be used as a smoking cessation device, are not sufficient for the FDA to detain shipments of electronic cigarette products at US borders. Therefore, the question we have to ask is: are there any shipments being detained as drug/device combinations – or, indeed, for any other reason than labelling of an express smoking cessation claim – after the ruling date/now? If so, Domenic J Veneziano has perjured himself.

Evidence of perjury on the part of Domenic J Veneziano

From import alert 66-41:

Desonic Industrial Date Published : 09/30/2009
11 Bl Shiao 2nd In , Shenzhen, CHINA
66 B – - 44 Nicotine Delivery System
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
66 B – - 99 Stimulant N.E.C.
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
77 E – - PN Pump, Nebulizer, Manual
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
77 K – - CO Inhaler, Nasal
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
89 M – - ZX Stimulator, Electrical for smoking cessation
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
91 D – - LC Atomizer, Tlc
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
Date Published:
Loongtotem Science And Technology Co., Ltd. 09/30/2009
2f Pingan Bldg Gangkou Road 1 , Guangdong, CHINA
66 B – - 44 Nicotine Delivery System
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
66 B – - 99 Stimulant N.E.C.
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
77 E – - PN Pump, Nebulizer, Manual
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
77 K – - CO Inhaler, Nasal
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
89 M – - ZX Stimulator, Electrical for smoking cessation
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
91 D – - LC Atomizer, Tlc
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
Date Published:
Loongtotem Science And Technology Co., Ltd. 09/30/2009
2f Pingan Bldg Gangkou Road 1 , Guangdong, CHINA
66 B – - 44 Nicotine Delivery System
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
66 B – - 99 Stimulant N.E.C.
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
77 E – - PN Pump, Nebulizer, Manual
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
77 K – - CO Inhaler, Nasal
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
89 M – - ZX Stimulator, Electrical for smoking cessation
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
91 D – - LD Thin Layer Chromatography, Codeine
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
Shenzhen Kanger Technology Co Lt Date Published : 09/30/2009
4th Bldg, 3rd Industrial Zone , Shajing Town Shenzhen, CHINA
66 B – - 44 Nicotine Delivery System
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:3/30/09
66 B – - 99 Stimulant N.E.C.
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:3/30/09
77 E – - PN Pump, Nebulizer, Manual
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:3/30/09
77 K – - CO Inhaler, Nasal
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:3/30/09
89 M – - ZX Stimulator, Electrical for smoking cessation
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:3/30/09
91 D – - LC Atomizer, Tlc
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:3/30/09

All of the above were fine, as of the dates of inception marked herein. However, once you realise that the same document lists other items from as late as February 2011:

Laboratorios Lopez S.A. de C.V. Date Published : 02/07/2011
Km 5.5 Blvd del ejercito nacional , Soyapango, SV-SS EL SALVADOR
66 V – - 99 Miscellaneous Patent Medicines, Etc.

…suddenly, Mr Veneziano’s sworn testimony begins to ring a little hollow. Apparently, the FDA is not particularly adept at keeping up to date anyway. It seems that when the tide of the US legal system began to turn against the FDA, they stopped updating their website on the subject of electronic cigarettes – it has not been updated since September 13th 2010. Considering the remarkable news and indeed court rulings which have emerged since this date, this seems to be an irreconcilable oversight.

Evidence of FDA’s Contempt of Court

Totally Wicked have recently engaged in legal proceedings against the FDA over a consignment of their products which was detained in October 2010. Since this consignment is still in detention – and we have reports of several others before and since 8th December 2010 – it would appear that the FDA is in Contempt of Court.

The FDA’s justification for detaining Totally Wicked’s consignment was that its test centre for drugs evaluation found:

“The labeling claims… for the ‘totally wicked’ products indicate that they are intended to affect the structure or function of the body and to mitigate, treat, or prevent disease. They suggest that ‘totally wicked’ products are substitutes for traditional cigarettes and that they are capable of delivering nicotine, which is recognized by the scientific community as a pharmacological agent and is understood by consumers to have drug-like effects. It is well understood that people smoke for the pharmacologically rewarding effects of nicotine, such as alleviation of stress and negative mood, enhancement of thinking, and increased alertness. For an addicted smoker, the body has adapted to nicotine, and abstinence produces withdrawal and craving. As a result, people also smoke to avoid the negative effects of nicotine withdrawal, such as anxiety, difficulty concentrating, negative mood, increased appetite, insomnia and irritability. The inclusion of labeling claims stating that the ‘totally wicked’ products will deliver a vapor or mist for inhalation by the user, which may or may not include nicotine; that these articles replicate the physical pleasures of smoking; and satisfy cravings for nicotine establish that the articles are intended to affect the structure or function of the body [really? Even with no nicotine???] and to mitigate, treat, or prevent disease. Moreover, the marketing of these articles targets the knowledge and expectations of conventional tobacco users that these articles are suitable for these uses when one cannot, or chooses not to, smoke. The scientific and medical communities have determined that nicotine addiction is a disease and that nicotine withdrawal is itself a recognized medical condition. Thus, these labeling claims fit within the ‘drug’ and ‘device’ definitions in the Act.”

Thus the FDA appears to be suggesting that anything which behaves like a cigarette is actually a medicine (bizarrely, including cigarettes!) or ‘drug’ as they prefer to call them in America. However, as we have seen above, the judgement upheld that similarity to a cigarette was not a therapeutic claim. Therefore, any and all detentions using justifications such as this would appear to be in direct contempt of court.

Unfortunately, this does not appear to be an isolated case either. According to anecdotal evidence, many other suppliers and consumers are still having their shipments detained:

“Crown 7 e-cigarette company in Phoenix, informed me today that Customs just seized 20 boxes of his e-cigarettes (valued at $100,000).”
12th January 2011

Cherry Vape shipment seized by customs at JFK 12th January 2011

VapnNow: “I have had a package from Royal Smokers that was sent EMI that has shown it has been inbound into Chicago Customs since Nov 26th. I have tried everyway possible to find out where this package is what is going on. Today after numerous phone calls and talking to various unhelpful people I finally found one who referred me to a FDA number in Chicago. I got a recording, I left my package info and a call back number. I figured what the heck I want to find out what’s going on and that info is already on the package. The FDA did call back and yes my little package is being held by them. The FDA Agent said that they are holding any and all e cigarette shipments that they find. They still can legally hold them since after the verdict on Dec 7th they have so many days to appeal and try to get a stay and during this time they can still seize packages. He thought it was 50 days after the verdict but wasn’t sure. They are waiting for the decision to be made by the FDA. If they appeal they will be able to stop shipments and all these shipments will be sent back to China. If they don’t appeal then all these shipments will be released and sent to everyone in the U.S. They will wait for a directive from the FDA before anything is done with these packages. He said at this time they are trying to stop everything that is coming through Chicago. He didn’t know if the other ports were being as diligent, but the directive was sent to all Customs, but they were and that they were holding big or small packages, it didn’t matter. My package has 100 empty CE2′s and 3 510 batteries in it. He said it didn’t matter whether they had juice or not anything associated with the e cig.” 12th January 2011

Dee74: “I had ordered on 10-16, got to NY and was sent back to China then sent back here and has so far per PO never arrived.” 12th January 2011

Notcigs.com: “BIG BROTHER has struck again ! , I have a package stuck in LA customs , no word no reply nothing ,…”. 12th January 2011

TrueVapor.com: “I currently have a shipment of e-cigs being held by DHL well really the FDA at LAX. I have never had a package held for so long and I have been getting shipment for about 2 years. It has now been over 2 weeks. After calling DHL everyday I finally had a import supervisor tell me that they is nothing I can do and They can’t do anything either. It sounds like I will get a letter in the mail or that DHL will get a letter. I’m not really sure anymore.

I believe I was told that they have about 100 orders being held just at LAX, It seems this has started because of the last court decision.” 15th January 2011

Pure Cigs: “Oh yea, those asking about any other vendors getting seized.. +1

out ~$60,000 of product.” 22nd January 2011

TrueVapor.com: “I finally got my packages. It only took about 40 days….
They even sent me a letter still claiming they are medical devices and that other shipments may be detained.” 12th February 2011

VapnNow: “My order was from Royal Smokers (e-liquid Web Shop). It contains 100 CE2′s and 3 batteries. No nic liquid nothing else. Still no word. If I hadn’t called I wouldn’t have known that they even detained it. I really don’t expect to ever see it. Hard to get any money back since it still shows the package is at customs. If they would have sent it back I could have done something. Right now I’m just out the money.” 25th February 2011

Madvapes.com: “My last customs letter had a phone # to call and although the phone was never answered, in one voicemail, I stated something short and sweet about the ruling. A week or two later I got another form letter from Customs stating something along the lines of ‘customer comments noted.. US Customs and border protection has not received any directive from the FDA to change the current position‘” 26th February 2011

And in March 2011, the Ashtray Blog reported as follows:

“one e-cigarette vendor, Arno Lamb, has posted this FDA notice on Facebook:

I think we should give the last word on this issue to Elaine Keller of CASAA, who appears to have summed up the situation pretty accurately in this letter of 24th January 2011:

Dear Sen. Kohl:

Again I thank you for your offer to be of further assistance. I look forward to your spearheading the investigation into the behavior of FDA officials in this matter.

Let’s hope that Senator Kohl and others in the US Administration are well on their way with this very necessary investigation into the conduct of the FDA. We await updates and indeed indictments – against Domenic J Veneziano for perjury, and against the FDA for Contempt of Court.

We have already successfully demonstrated that electronic cigarettes are not medicinal products, and the Courts in the US have concurred in 3 separate Judgements. Also, the EU is considering electronic cigarettes’ status as potential ‘tobacco products’, so clearly this will be the time for the MHRA to bow out and allow us to proceed with our program, working closely with the wider Department of Health, Trading Standards, and any other interested parties.

Ultimately, the associated documents published alongside the MHRA’s announcement of the outcome of their consultation on 9th March tell us all we need to know: the MHRA is simply too conflicted to have any useful role to play in the regulation of electronic cigarettes.

I’ve said it before, and I’ll say it again: until the MHRA is prepared to take on the regulation of ALL nicotine containing products – including tobacco cigarettes, and indeed, pesticides (and even potentially, some seriously dangerous vegetables!) – they simply have no right to interfere in the lawful trade of ecigs, as regulated under the appropriate legal statutes, internally-audited, and regulated by Trading Standards.

We look forward to presenting our case to them in May.

Interestingly, we were told that the current political will – set against the climate of inevitable cuts, the vast majority of which are hitting the public sector hardest – is very likely to support our desire to provide self-regulation for the ecig industry. Trading Standards told us that this is precisely what this government wants to see, in terms of providing a robust, appropriate regulatory framework, based on the relevant legal statutes. (With the added bonus, of course, of costing the government coffers virtually nothing!)

Trading Standards continue to offer their support for our program, and we are delighted to have the opportunity to work closely with them as we put the finishing touches to the Industry Standard of Excellence documentation and protocols. This will comprise all the compliance issues required of ecig vendors, together with a few more specifically customer services orientated items for ECITA members, and will ultimately form the basis for the program of internal audits we shall be rolling out towards the end of this month. It will, of course, include requirements for eliquid testing, and disclosure about ingredients for the prevention of allergic reactions.

There will be opportunities for vendors to earn Outstanding Achievement Awards if they are able to achieve a completely ‘clean bill of health’ on two consequential audits. In this way, we hope to help drive up the standards and give consumers a far better idea about the vendors they choose to buy from.

In due course, we hope to be able to make the full document available via our website, and look forward to hearing from consumers as well as vendors if there is anything further you would like to see added.

We live in exciting times, my friends, and I truly believe that the common sense of our approach is increasingly undeniable. Trading Standards have recognised it; let’s just hope the government can see it too….

Yesterday saw the appearance of a very alarming and saddening news story on the BBC.

The man who unfortunately lost his life was apparently a long term smoker, who had used ecigs for a period of around 6 or 8 months, before stopping due to problems with his breathing. His death at the age of merely 57 cannot be viewed as anything other than a tragedy.

The coroner who examined Mr Miller recorded an open verdict on the cause of death, which was given as “severe lipoid pneumonia”. It has been suggested by Dr Rob Allcock (who, according to available information, is a consultant in respiratory medicine) that this was linked to the use of electronic cigarettes.

These are about all the independently-verifiable details currently available.

I am not a doctor (like I am sure, most of you), and this was the first time I had heard of lipoid pneumonia, necessitating some research. On the plus side, I do have a fairly good knowledge of electronic cigarettes, and this seemed like rather a leap of logic to me.

Here’s a brief summary of what I found out about lipoid pneumonia.

There are 2 forms of lipoid pneumonia, and it is unclear at this point which led to Mr Miller’s untimely demise.

Exogenous lipoid pneumonia is caused by the inhalation of lipids (fats and oils) from outside of the body. It’s most commonly seen in elderly patients (in their 60′s and 70′s), and is more likely in people with an impaired swallowing ability and “the consistent use of the various kinds of oils – mineral, animal, and less commonly, the vegetable oils found in laxatives, nasal drops, mouth spray, oral lubricants, insecticides or traditional folk remedies” (and perhaps not surprisingly, fire eaters, for whom it is an occupational hazard). It tends to be associated with long exposure to oils (one study had a mean of 9.5 years, but brief exposures of as little as a month have been known (with liquid paraffin).

Endogenous lipoid pneumonia is caused by a build-up of the body’s natural fats (it is also known as cholesterol pneumonitis) in the lung. It’s most commonly seen in people with chronic bronchial obstruction (often tumours or foreign bodies). In fact it has a very large association with cancers of the lung (and to a lesser extent with Hodgkin’s lymphoma):

“In one research conducted, endogenous lipoid pneumonia was diagnosed in the resected lungs of 33 of 147 patients with lung cancer. It was found in 16 out of 89 (18%) of patients with adenocarcinoma and in 17 of 55 (31%) patients with squamous cell carcinoma. In 23 cases, it was observed that endogenous lipoid pneumonia was localized to lung parenchyma distal to the airway obstructed by the tumour, and of these 16 were patients with squamous cell carcinoma. Out of 5 patients with adenocarcinoma, 4 had endogenous lipoid pneumonia present distal to the tumour and having spread to isolated segments.”

Smoking (perhaps not surprisingly) also has an effect on levels of fat within lung tissue “When normal lung tissue is chemically analysed, it shows a total fat content of 8.63 per 100 g of dry tissue, of which 19% is cholesterol; although this percentage shows a marked increase in smokers. When the breakdown of these cells takes place, it results in the lipid gaining access to lung parenchyma and it is phagocytosed by the pulmonary macrophages”.

(For those without a medical dictionary to hand, lung parenchyma indicates the functional parts of the lung, and phagocytosed is the body’s attempt to remove dead cells and foreign bodies at the cellular level using white blood cells.)

So that’s the medical research, but how does this relate to ecigs? Certainly mineral oil and animal fats should never be found in an eliquid, but natural flavourings may contain essential oils. It’s worth bearing in mind that essential oils are used in aromatherapy, and the NHS seems happy with inhalation of essential oils in this context.

Dose is clearly a key element, so how much oil might we find in an eliquid? A great many will not contain any at all, but a natural fruit flavouring (i.e. one based on actual fruit extracts) may have up to 2% in the concentrate (as estimated by Peter Cole at Decadent Vapours), so based on a heavy vaper using about 5ml a day of eliquid with 20% flavouring, this would equate to 0.02ml of volatile oils.

This would seem unlikely to carry a significantly higher risk factor than aromatherapy, and considerably less than the ingestion of liquid paraffin as a laxative which seems fairly typical of exogenous lipoid pneumonia cases.

Is this death a tragedy? Yes, it certainly is.

Is it an electronic cigarette related tragedy? It seems very unlikely.

Without a more detailed diagnosis (with regard to endogenous or exogenous lipoid pneumonia) and without sight of any analysis of the ‘oily residue’ found in Mr Miller’s lungs, it’s impossible to be sure, but this could easily be yet another smoking-related tragedy.

He told me that the coroner had found an ‘oily residue’ in the man’s lungs, and that the man’s doctor had some concerns about his use of the ecig, since so little is known about these devices.

He asked me for a statement, and I explained some of the basics about the fact that we don’t use oils in eliquid, that the base liquids are PG, VG or PEG, which are all GRAS (Generally Regarded As Safe) and that there are between 4,000 and 10,000 chemicals in cigarettes – many of which have yet to be identified – which we know can leave oily residues in the lungs.

The journalist told me that the coroner had not mentioned a specific brand of ecig, but that he believed the doctor had mentioned Intellicig. I said that they were not members of ECITA, but that there was no reason to believe that their eliquid would be materially different from any other, and that it was incredibly unlikely to have been the cause of this gentleman’s lung problems.

I explained that I would need to know how long the gentleman had been smoking for, and how long he had used an ecig before I could provide an accurate statement on behalf of ECITA Ltd. He said that he would make some enquiries and get back to me.

After a few minutes, a reporter called me to provide more information. She told me that the deceased gentleman had been using an ecig between October 2009 and June/July 2010. He stopped using the ecig after having respiratory problems, she said. He passed away in August last year.

The reporter confirmed that the deceased had been a heavy smoker for decades previously. He was 57 when he died.

I asked her if the coroner had performed any analysis on this ‘oily residue’ in the lung, and if so, what did it turn out to be? The reporter was unaware of any such analysis being undertaken.

The reporter told me that interstitial lung disease was the official cause of death. In the normal run of things, this would be recorded as ‘natural causes’ and would be put down to the deceased’s having been a heavy smoker. He also had ongoing emphysema and thickening of the arteries. These are all conditions which we see all too frequently in heavy smokers.

Oddly, however, the gentleman’s doctor felt that ‘smoking’ an ecig may have been associated with the lung condition. He had an enlarged heart, which, together with the interstitial lung disease, would have been recorded as natural causes, but according to the coroner, ‘because the jury is still out about ecigs and their safety’ he recorded an open verdict.

I made enquiries with ECITA’s resident expert on all things eliquid, Peter Cole of Decadent Vapours, who confirmed the following: if the residue is a non-volatile oil, it must have come from cigs, not ecigs.

Essential oils readily evaporate at ambient temperatures and wouldn’t leave any oily residue in the lungs.

If you put non-volatile oils into an eliquid, they don’t make it into the vapour because they will just burn on the coil rather than vaporise.

The real shame in all this is that once again, the truth is being lost amongst the ill-informed scare-mongering! Here is the full statement I provided to the reporter (which was heavily edited for the broadcast):

Electronic cigarettes have been tested vigorously in various scientific studies around the world. It is incorrect to suggest that these products are currently unregulated, since in the UK, electronic cigarettes fall within the General Product Safety Regulations and are regulated by Trading Standards. Since there has been some confusion over the correct regulation, ECITA Ltd is working closely with the UK government and our regulators, Trading Standards, to put together an appropriate regulatory framework, as well as creating an Industry Standard of Excellence.

The thing you have to remember is that ecig users are almost 100% former smokers, and therefore have all the attendant health problems. The kind of health issues faced by this poor gentleman are what we see all too often as the result of decades of heavy smoking. It is essential that smokers are fully and truthfully informed about their options, rather than just being told to quit or die. The NRT products offered by the NHS fail over 93% of smokers attempting to quit this way, and carry their own risks. NRT gum nearly killed a 14yr old school boy in July 2007, after it was handed out in his school, without the parents’ knowledge.

Electronic cigarettes offer a harm reduction, pleasant alternative to traditional smoking, with massively reduced risk since there is no combustion. It is the combustion of tobacco cigarettes – the burning process – which causes all the carcinogenic by-products to be taken into the body. Electronic cigarettes merely vaporise a liquid, with no combustion at all. It does not take a rocket scientist to see that this is orders of magnitude safer than smoking, and would certainly not result in lung disease such as was seen in this unfortunate former smoker.

We hope that the UK government and policy makers around the world will begin to be more honest in the information they provide to smokers, so that smokers can have the freedom to make informed choices for themselves – either to continue to smoke; to give up using willpower alone; to give up using medicinal NRT (if they are able to); or to switch to a reduced-harm alternative, such as smokeless tobacco or electronic cigarettes.

Unfortunately, it seems that this is NOT what was conveyed by this broadcast.

Come on BBC! Get your act together!

“The Government is committed to fair excise duties on tobacco and alcohol which contribute to deficit reduction whilst supporting health objectives. In addition to the duty increases that the Government inherited, it is restructuring cigarette duty and increasing duty on hand-rolling tobacco by a further 10 per cent.”

What a pity that the coalition government appears to be continuing the misguided efforts to subsidise the national economy through unfair and punitive tobacco and alcohol taxation. This flies in the face of common sense rational approaches, particularly to tobacco ‘control’ issues, since the more dependent the national economy is upon tobacco taxation, the less incentive there is to efficiently tackle such issues.

The notion of tobacco (and alcohol) taxation ‘contributing to deficit reduction’ demonstrates the inherent fallacy of such an approach. If tobacco taxation is designed to contribute in any significant way to deficit reduction, then our economy is necessarily overly reliant upon such taxation. Since the taxation policies have taken tobacco excise duties to an almost unreachable level for the vast majority of smokers these days, there can only be one outcome to such a policy decision: a growing, uncontrollable, criminal black market, supplying the market demand for cheaper tobacco products, bypassing any and all contributions to the economy by way of excise duties, and with no quality controls in place whatsoever. This is a lose-lose situation for everyone but the criminals, for whom it is a win-win, with them laughing all the way to the bank.

More detail on the budget changes concerning tobacco:

Tobacco

“As announced in the March Budget 2010, tobacco duty rates will increase by 2 per cent above the RPI. Duty on hand rolling tobacco will increase by an additional 10 per cent. These changes will come into effect from 6pm on 23 March 2011.”

Changes to the tobacco duty regime

“The government is also restructuring cigarette duty to support health objectives. As a result, ‘ad valorem’ duty on cigarettes will decrease to 16.5 per cent, and specific duty will increase by 25 per cent above the RPI.

This will target the duty increase on cheaper cigarettes, adding 50 pence to a packet of economy cigarettes and 33 pence to a packet of premium cigarettes. These changes will come into effect from 6pm on 23 March 2011.”

As outlined above, this kind of punitive taxation, which is overtly designed to affect the majority of smokers who come from poorer economic circumstances, cannot succeed in achieving anything other than an increase in the already profligate illicit trade in counterfeit cigarettes.

Tobacco: tackling fraud

“The government is fully committed to tackling the illicit trade in tobacco to protect public finances and support health objectives. HMRC and the UK Border Agency will be introducing a renewed strategy to tackle this fraud from April 2011.

Presumably, the tobacco excise duty increases announced in this budget are intended to form part of this ‘commitment to tackling the illicit trade in tobacco’. What a pity that it can only achieve precisely the opposite.

Surely now is the time for the UK government to undertake a critical examination of the realities surrounding tobacco harm reduction, with a detailed, scientific analysis of the evidence on all the available options. If this could be done by government agencies without conflicting vested interests, then perhaps smokers could finally be told the truth about their options.

If smokers are told honestly that their options are:

1. Continue to smoke, notwithstanding the known risks;
2. Stop smoking – the most effective method being cold turkey;
3. Use pharmaceutical NRT products in combination with NHS counselling services to quit smoking, but with the foreknowledge that this only works for a very small minority of smokers attempting to quit using this method (approximately 7% over the longer term);
4. Switch to a reduced-harm alternative, such as the range of smokeless tobacco products offered by the tobacco industry; or
5. Switch to using electronic cigarettes, which public health experts suggest may be up to 99% safer than traditional tobacco smoking

then maybe some real progress can be made in tackling the Tobacco Control problems faced by the UK government (and most other governments around the world).

The fundamental problem remains, however: for as long as the UK economy relies heavily upon tobacco excise duty and punitive taxation, there is no incentive for real progress to be made, and UK smokers will continue to die unnecessarily, for want of truthful information being provided which would have allowed them the freedom to make informed choices for themselves.

My goodness, I hope not! But just for safety’s sake, and since our emphasis is on scientific, fact-based evidence, let’s just make absolutely sure, shall we?

So, the Center for Regulatory Effectiveness. What’s that then?

There is a somewhat troubling indication on the CRE website that US home-grown tobacco stock trading up or down is significant to the CRE! Hmm… time to investigate, methinks.

Jim Tozzi, the architect of the CRE, and indeed of the Data Quality Act – both of which have been criticised for attempting to robustly defend industry from regulatory attack – does indeed have some conflicts of interest which ought to be made known.

In 1972, he began working at the US Office of Management and Budget while Reagan was in power. According to SourceWatch:

“Under his directorship, the OMB’s Office of Information and Regulatory Affairs was the gatekeeper for virtually all proposed regulations dealing with public health and safety.

Tozzi was at the OMB when evidence arose in the 1980s that giving aspirin to children with flu symptoms increased the risk of Reye’s syndrome, a potentially fatal complication. A federal health agency recommended that aspirin containers bear warnings, but Tozzi said he was not satisfied the evidence was good enough. It took years for activists and Congress to force the labeling issue — years in which almost 200 children died of Reye’s. Today, with labeling, the syndrome is extremely rare.”

It occurs to me that there are a number of potentially nasty side-effects with paracetamol-based medications, too, which have been used as an alternative for children since aspirin was deemed ‘too risky’. With medication comes risk, but surely a proper analysis of the evidence is necessary?

In any case, if we want to take SourceWatch as a source of information, we need to understand its inherent bias, which is to expose people who are funded by industry. Either we are going to investigate through layers and layers of possible conflict, or we are going to look for the common sense and follow that.

In 1986, Dr Tozzi founded Federal Focus, a Philip Morris-funded non-profit organisation. He went on to become a significant lobbyist for Phillip Morris, and fought hard to prevent the FDA from gaining regulatory power over tobacco products. He is still involved with political efforts to push for the legalisation of marijuana.

Dr Tozzi (who holds a doctorate in Economics and Business Administration, not in medicine or other science) has some history of helping businesses achieve proportionate regulation, based on sound and secure scientific evidence, rather than opposition-funded potentially questionable science. This may be a good thing or a bad, depending on one’s viewpoint on any given issue. The real problem is that one can scientifically ‘prove’ just about anything – given sufficient funding from whatever quarter. Anyone who is insisting on checks and balances, rather than bald acceptance of so-called ‘scientific fact’, seems to me to be on the right lines – generally speaking.

In 2004, the Data Quality Act was criticised by the Washington Post:

“Things were not looking good a few years ago for the makers of atrazine, America’s second-leading weedkiller. The company was seeking approval from the Environmental Protection Agency to keep the highly profitable product on the market. But scientists were finding it was disrupting hormones in wildlife — in some cases turning frogs into bizarre creatures bearing both male and female sex organs.

But many consumers, conservationists and worker advocates say the act is inherently biased in favor of industry. By demanding that government use only data that have achieved a rare level of certainty, these critics maintain, the act dismisses scientific information that in the past would have triggered tighter regulation.”

Judge for yourselves, my friends, whether the Data Quality Act is a good thing or a bad, but bear in mind that it will also be applied to the consideration of electronic cigarettes and eliquid….

Jim Tozzi will be handing over to a successor at the CRE in the coming year, I understand.

And what of the Regulatory Policy Committee in the UK? Its website describes it as ‘Providing independent advice to Government on the quality of analysis supporting new regulations.’ This sounds good, providing it is accurate.

In ‘About the committee‘ it says:

“The Committee consists of a mix of independent experts with a wide range of experience and current knowledge of business, employee and consumer issues. The Committee is supported by a secretariat of civil servants.

Michael Gibbons was appointed the first Chair of the Regulatory Policy Committee with effect from October 2009. Michael has a strong interest and background in better regulation both at domestic and EU level.

Working with Michael are the five members of the Regulatory Policy Committee:

• Dr David Parker – Emeritus Economics Professor of Cranfield School of Management;
• Dr Ian Peters – Chief Executive of the Institute of Internal Auditors;
• Philip Cullum – Deputy Chief Executive of Consumer Focus;
• Mark Boleat – Consultant on regulation and public policy;
• Sarah Veale – Head of the Equality and Employment Rights Department at the TUC.”

Owing to the wide range of backgrounds and ‘special interests’ covered in this list, this seems to me to represent a reasonably independent group, who could reach reasonably independent conclusions, irrespective of whether some or all of them held shares in a particular high-profile pharmaceutical company, for example, or had worked for the tobacco industry in the past. I have not looked for such conflicts, so do not know whether or not they exist. My point is that it is not necessary to do so, since the overall ‘blend’ is clearly a suitable vehicle for producing independent opinions.

Is it possible to avoid conflicts of interest completely? Not really. Is it necessary, for everyone connected with regulatory policy-making to be entirely unconflicted? No.

What matters is that there are sufficient checks and balances in place to ensure that no one group’s or individual’s personal agenda can skew a particular outcome. This, unfortunately, is what is entirely lacking at the MHRA. The two most significant conflicts of interest which mean that the MHRA is in no sense a suitable agency to regulate electronic cigarettes are these: their funding is largely drawn from the pharmaceutical industry whom they are tasked with regulating (and who are in direct market competition with the electronic cigarette industry); and there are too many pharma shareholders in the MHRA’s ranks who have a vested interest in helping them market their products, even if those products are unsafe, and ineffective.

Conflicts of interest are inevitable. After all, everyone has to make a living. However, it does seem that some are more acceptable than others.

Even I have conflicts of interest, although I have declared these whenever opportunities to do so have arisen. For the record, I shall do so again now.

I am a paid consultant for ECITA Ltd; I am also a shareholder in that company; my brother, Peter Cole, owns and operates the only (current) UK business manufacturing eliquid to USP/EP grade standard, Decadent Vapours; I operated a small retail business, FreeGenie Ecigs, for a short time, but this is now closed; and I lost my husband to cancer when we were both aged 31.

I have an agenda, folks. Sorry if that is a disappointment. I would just like to clarify what my agenda is, though, for anyone who doesn’t know:

I have made it my mission to assist the Electronic Cigarette Industry in getting the truth about smokers’ options out there in the public view;

to achieve credibility for this industry in the global market-place;

to ensure that my colleagues in this industry are operating legally, and to the Industry Standard of Excellence ECITA is leading;

to assist regulators in formulating appropriate, proportionate and sensible regulatory frameworks for these innovative products;

to do everything in my power to make sure that no more children have to watch their parents waste away and die before their very eyes from smoking-induced cancer, as mine did.

If smokers can be told the whole truth about their options, they can make genuinely informed decisions. For some, that may be to continue to smoke; for some, it may be to choose a medicalised quitting method; and for some, it may be to choose an alternative means of taking nicotine which has massively-reduced risks, such as smokeless tobacco, and/or electronic cigarettes.

The ‘quit-or-die’ lie has to be tempered with the truth.

Regulatory Policy Committee

9 June 2010

OPINION
Consultation on regulation of nicotine containing products

Introduction
1. The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health (DH), is consulting on introducing new regulations on nicotine containing products (NCPs) (excluding tobacco). At present any nicotine containing product that claims or implies that it can help with the cessation of smoking is considered a medicinal product by presentation and is regulated by MHRA (“regulation by claims”). These products are widely referred to as Nicotine Replacement Therapy (NRT). However, there are a number of NCPs, such as electronic cigarettes, which do not currently make such claims and hence are not regulated by MHRA.

MHRA are seeking to change how medicinal products are classified. The use of the word ‘hence’ here seems to imply that the normal mechanism for deciding whether products should be regulated by MHRA as medicines, or by another regulator as general consumer products, relies solely upon whether or not claims or implications of health benefits are being made for a product.

In reality, this is unworkable, since there are many products making health claims which are not (nor ever will be) regulated as medicines by the MHRA, e.g. Red Bull, life-jackets, running shoes, seat belts, Yakult, hard hats, Lucozade, etc., etc.

2. MHRA believes that the regulation of all NCPs will “protect public health from products that have not been assessed for safety, quality and efficacy”. Any requirement for NCPs to be brought within medicine licensing would apply throughout the UK₁.

3. The RPC has looked at the quality of evidence and analysis provided in the consultation letter₂ and accompanying impact assessment (IA) and, following a meeting with MHRA and DH, would like to make the following comments.

Summary Opinion

4. The RPC is of the opinion that the IA and consultation letter do not provide sufficient evidence to suggest that there is a significant risk to public health from currently unlicensed NCPs which would justify the future regulation of these products.

It is entirely possible that the RPC is ill-informed enough to believe that this is merely an oversight on the part of the MHRA, and that (now that they have been prompted) the MHRA will go away and find the evidence which suggests that “there is a significant risk to public health from currently unlicensed NCPs” which would justify the MHRA’s behaviour. We know that this evidence does not exist, and if any proof of this were needed, it seems obvious that if such evidence were to be found anywhere in the world, the FDA in the States would have found it by now, and taken it to the Appeal Court as part of its legal case (which returns to Court 23rd September 2010). In the absence of any such evidence, the FDA will be returning to Court with no new evidence at all, and is highly likely to obtain a very similar verdict to that given in January by Judge Richard Leon.

MHRA should have made clearer what evidence is available to suggest there are safety and public health concerns about these products and considered a wider range of policy options before consulting on the introduction of a mandatory licensing requirement for all NCPs. In addition, the data and assumptions used in the IA for estimating the costs and benefits of the new regulations do not appear to be robust.

This paragraph appears to represent a resounding rap across the knuckles of the MHRA, but more importantly, the RPC appears to emphasise the fact that the MHRA should have undertaken much more thorough research and evidence gathering before entering into the consultation process. This is likely to become significant if legal action is pursued subsequently for punitive damages to the many small to medium enterprises which make up the UK ecig industry. The wording ‘mandatory licensing requirement’ smacks of disapproval in this context, too. Finally, to suggest that ‘the data and assumptions used… do not appear to be robust’ may well qualify as the understatement of the century, but at least the RPC return to this later on.

Detailed Opinion

Policy background and rationale

5. Following a recent review of its current policy on the application of the definition of a medicinal product in the context of nicotine and, after obtaining legal advice, MHRA has concluded that nicotine may potentially fall within medicines legislation because it affects human metabolism.

MHRA has refused to disclose any details concerning this purported ‘legal advice’, claiming confidentiality privileges, despite numerous Freedom of Information requests. We simply do not believe that a legal mechanism has been found which exempts tobacco cigarettes while leaving ecigs affected. The MHRA acknowledges this challenge in MLX364 and the RPC Opinion seems to have a similar leaning. At the stakeholder meeting on 4th June, the MHRA were repeatedly pressed to quantify the precise level at which nicotine is determined to have an “appreciable effect on human metabolism”. To date, they have been unable to provide this information. Also, consider how many non-medicinal products/substances appreciably affect human metabolism, but are not being dragged kicking and screaming into requiring a Marketing Authorisation: the air we breathe, all foods and drinks, pollution, caffeine, chocolate, glucose, vigorous exercise – all these things affect metabolism significantly, and yet none are regulated as medicines. It seems unlikely that reliance upon an effect upon human metabolism can provide a legally sound basis for requiring all nicotine containing products – except tobacco products, potatoes, aubergines, tomatoes and many other vegetables which naturally contain nicotine – to be regulated as medicines, or arbitrarily removed from sale.

MHRA is therefore proposing to regulate all NCPs (“regulation by function”), which means that all currently unlicensed products containing nicotine (excluding tobacco products) will either need to be removed from the market or licensed by a specific date. However, if MHRA considers changing its practice from regulating “based on claim” to a “regulation by function” principle, then it is not clear from the consultation letter how this will affect tobacco products (e.g. cigarettes), which also contain nicotine and hence will be within scope for these new regulations.

I think it is significant that the RPC points out that the consultation proposals actually represent the MHRA’s considering “changing its practice” on determining how products should be classified for regulation. The MHRA is clearly aware that it cannot ever expect to have regulatory control over tobacco cigarettes, hence its desire to exempt them from this consultation, and yet their preferred option appears to leave little wriggle room for such an exemption!

MHRA has told the RPC that the tobacco products are excluded from this consultation as they have a separate regulatory regime and have no medicinal function.

I believe there is a case to be made here: if tobacco products are excluded “as they have a separate regulatory regime and have no medicinal function” then so are ecigs. Our separate regulatory regime is the General Product Safety Regulations, CHIP and any and all other regulations monitored and policed by Trading Standards (having nothing whatsoever to do with the MHRA unless health claims are made or implied), and there is no medicinal function in switching from obtaining nicotine from tobacco cigarettes to maintaining one’s nicotine addiction by using an ecig. Job done, thank you very much RPC!

6. It is not clear from the consultation letter or IA what specific policy problem MHRA is trying to address through the proposed new regulations. MHRA claims that the licensing of all NCPs is needed “in order to ensure there is no risk to public health from these products” (paragraph 18 of consultation letter). However, the evidence provided in the IA and consultation letter is not sufficient to conclude that there are serious risks to public safety and health to warrant regulatory intervention. In fact, the consultation letter itself acknowledges that the risk to the public health from NCPs is “unknown” (paragraph 17 of the consultation letter). MHRA has informed the RPC that there is potentially a legal obligation to licence these products. However, this issue is not clearly discussed and presented in the IA. The RPC also understands there is some limited evidence of potential harm from testing carried out by the US Food and Drug Administration.

The MHRA, together with the FDA, has been unable to find evidence “that there are serious risks to public safety and health to warrant regulatory intervention” because such evidence does not exist. On the contrary, the existing regulatory framework is a very comfortable ‘fit’ for ecigs, with regulation by Trading Standards.

“MHRA has informed the RPC that there is potentially a legal obligation to licence these products.” What can this mean? Can they believe that Competition Law requires that we have to license our products because NRT has to be licensed? No, that can’t be the case, since we make no health claims, treat no disease and are not medicinal products, whereas NRT claims to be a medicine (albeit a largely ineffective one!). I cannot see how there could be a “legal obligation to licence” these products which would be capable of excluding tobacco products and caffeine products. (It is rather interesting to see that this is what the MHRA believes, however ill-informed it may be!)

“Limited evidence of potential harm” is loose and woolly, and simply doesn’t stack up, particularly when one considers the truly robust scientific evidence which has been brought forward to negate the FDA’s initial report. The so-called toxins which were found were at levels similar to, or below those found in existing licensed NRT products. Even the dreaded di-ethylene glycol – a long-term approved additive in tobacco cigarettes – was found in only one out of 16 cartridges and at a level which would not cause harm. The UK government’s ongoing reliance upon debunked junk science (for which read ‘propaganda’) from the FDA is baffling in the extreme! However, I do not believe that we can successfully challenge this consultation (or its reliance upon junk science) until after the MHRA deigns to release its decision. Then, heaven help them!

Options

7. The IA considers two options in addition to the “do nothing” option. These two options both propose the regulation of all currently unlicensed NCPs, and the only difference between them is the proposed timeline for implementation of licensing requirements. It appears that Option 1, which provides a much shorter transition period (21 days) than Option 2 (implementation by June 2011), is preferred by MHRA on the grounds of being consistent with their current practice. In addition, the “do nothing” option is not developed because MHRA believes that “it is neither in the public health interest nor commercial interest to leave the current regulation of NCP/NRTs untouched” (paragraph 10 of the IA).

8. Subsequent to this the RPC believes that the range of options considered is too limited and the selection of the preferred option is not based on a robust appraisal of alternative options and their costs and benefits.

Hear, hear!

Costs and benefits

9. The data and assumptions used in the cost and benefit analysis of the IA do not seem to be robust. In the consultation letter MHRA acknowledges that the number of manufacturers of unlicensed NCPs and the number of products on the UK market are unknown. However, the IA estimates of costs and benefits are based on the assumption that there are 24 manufacturers and 50 products available on the UK market currently. However, the origin of these numbers is not provided and this raises concerns about the subsequent quality of cost estimates. MHRA has told the RPC that these estimates were based on the number of importers contacting the agency about licensing requirements. This needs to be clearly explained and presented in the IA.

It will be enormously difficult for the MHRA to ‘clearly explain’ and present accurate information in a rehashed IA since they appear to be entirely clueless as to the extent of the UK ecig industry, or the numerous types of product ranges available. Despite the fact that the MHRA appears to have realised that they have insufficient knowledge about this, they do not seem to be attempting to find out any information which they could effectively use to create a realistic IA. Therefore, I believe it is unlikely that one will be forthcoming. I think that the fundamental problem faced by the MHRA concerning the IA is that it will not be possible for them to produce an IA which demonstrates the point the MHRA is trying to prove: that ecigs can be simply removed from sale with no negative impact and lots of positives. This is a fallacy, so creates an insurmountable challenge for the MHRA.

10. MHRA estimates that there will be 1,312 additional permanent quitters of tobacco product users as a result of licensing of all NCPs. However, the assumptions and analysis behind this estimate do not appear to be supported by strong evidence. For example, the assumption that the proposed new regulations will bring a further 5% reduction in the number of individuals who permanently quit smoking using licensed NCPs per year is not based on a robust evidence and analysis.

We know that existing licensed NRT products fail at best 93% of smokers attempting to quit using these methods. Plucking figures from the air about the numbers who may or may not quit if ecigs were licensed as medicines, or removed from sale, indicates the MHRA’s entrance into the realms of fantasy, and is a total waste of time.

11. Also, it is assumed that 50% of producers of currently unlicensed NCPs will obtain licences. It is not clear on what basis this assumption is made, nor is it clear why the cost of the remaining manufacturers and importers (for not being able to sell their products in the UK market) is not included in the cost estimates.

The MHRA can’t have it both ways: they have not accurately reflected the costs of obtaining a licence, and yet assume that 50% will follow this course. This is highly unlikely, since it is exponentially cheaper simply to operate in a black market, which would be the logical conclusion of most businesses in this sector. Due to the high prevalence of internet sales in this industry, simply moving off-shore will guarantee that these products continue to be sold, resulting in any and all regulatory safeguards being lost.

Impact on competition

12. The IA does not provide an appropriate assessment of the impact of the proposed regulations on competition. For example, the IA claims that all businesses will be equally affected by the regulations, while at the same time it assumes that at least 50% of manufacturers will be required to remove their products from the market as a consequence of the regulations.

The RPC neatly side-steps the cross-industry competition issues (as does the MHRA’s consultation letter) by avoiding any acknowledgement of the competition issues between our industry, and the pharmaceutical and tobacco industries. It is entirely unrealistic to expect that any products would actually be removed from the market: prohibition didn’t work in the 1920s with alcohol in the US, and it won’t work with ecigs today. Our industry and customer base is just too big to be halted now.

13. The regulations are likely to create additional barriers for entry for new producers and importers of NCPs, which is not fully discussed in the IA. According to MHRA the European Commission has said that nicotine could fall within the medicines licensing regime. It is however not clear how consistent the proposed new regulations are with European Internal Market rules and how effectively they would be enforced to achieve their aims in this context.

Since other Member States have made relatively sensible decisions regarding ecigs, e.g. Germany has offered 10 years to licence, Malta and Italy appear to have no problem with ecigs remaining on sale, it is hard to see how the MHRA can rely on the European Commission for support. It would be literally impossible to enforce or police restrictions on sales of ecigs across Europe and/or the rest of the world, and therefore it becomes even more important that the correct regulatory framework (under Trading Standards) be applied. The alternative is a completely unregulated – and ‘unregulatable’ – black market.

14. The RPC is pleased to note that MHRA acknowledges the deficiencies in the existing analysis and evidence base, and the way the available evidence is presented in the consultation letter and the IA. The RPC hopes that these shortcomings will be addressed in the next version of the IA.

Is it optimism, hope, or fantasy to suggest that there will be a ‘next version of the IA’? As indicated above, no matter how hard the MHRA tries, it cannot produce an IA which shows what they are trying to show. (They can claim the sky is green until they’re blue in the face, but we all know the truth….)

Michael J S Gibbons OBE
Chair

1 To the extent that this RPC opinion refers to a devolved matter it relates only to England.
2 There is a consultation letter sent to all interested organisations, and not a full consultation document. RPC Reference: RPC10-MHRA-0374