Arti Lakhani

to ge From George Freeman MP
va Minister for Life Sciences

Department Freeman. MPST@bis.gsi.gov.uk
Department for Business
of Health Innovation & Skills
Mr A Walker

Senior Coroner

North London Coroner’s Court
29 Wood Street

Barnet EN5 4BE

13 August 2015
Dear Mr Walker,

Thank you for your letter of 10 June 2015 following the inquest into the death of
Arti Lakhani. I was very sorry to hear of Miss Lakhani’s death and wish to extend
my sincere condolences to her family.

You report that Miss Lakhani died after drinking a bottle of e-cigarette fluid. Your
concern is that the sale of e-cigarette fluid is not regulated or licensed.

There is no doubt that the use of e-cigarettes has increased rapidly since their
introduction. 5.5% of the adult population of England used an e-cigarette in the first
quarter of 2015, indicating a marked rise from 0.5% in 2011. This measure of use is
taken from the Smoking Toolkit Study, compiled from four survey questions and
assesses current use for any reason. A very similar estimate is obtained for Great
Britain (GB) using the 2015 Action on Smoking and Health (ASH) survey, with
5.4% of the population estimated to be current (defined as people who have tried e-
cigarettes and still use them, see Appendix B) e-cigarettes users. This translates to
about 2.6 million e-cigarette users in GB in 2015. The ASH survey also assessed
trial use and about 17% of the adult GB population was estimated to have tried e-
cigarettes.

Enquiries to the National Poisons Information Service (NPIS) about e-cigarettes
and their refill solutions have also increased over the same period. A total of 204
enquiries were received by NPIS in 2014, more than the total number of enquiries
about these products in the previous six years. 22% of the enquiries involved
children aged under five and the majority of exposures (162 of 204) were
accidental. Twenty-one enquiries concerned intentional overdoses and the
remainder of enquiries included adverse reactions to intended use, recreational
abuse and ‘therapeutic errors’. Where the individual route of exposure was
specified, ingestion was the commonest, although multiple routes of exposure also
occur.

Where the clinical features were known at the time of the enquiry, 103 patients had
no features of toxicity and 94 had features of only mild toxicity (four were
unknown). Two patients had moderate toxicity (one aged 13 months), while another
had severe toxicity and was treated in an intensive care unit. Features of toxicity
included conjunctivitis, irritation of the oral cavity, anxiety, vomiting,
hyperventilation and changes in heart rate.

Since 2011 a small number (21) of reports of harm have been submitted on e-
cigarettes through the Medicines and Healthcare Regulatory Agency (MHRA)
Yellow Card scheme. This scheme allows patients and health professionals to report
adverse events associated with medicines and medical devices. Adverse events
reported included pulmonary fibroses, cardiac problems, gastro-intestinal upset,
oropharangeal pain and swelling, headache, convulsions and allergic response.
Whilst these do not relate to licensed medicinal products, and therefore fall outside
of the MHRA’s current jurisdiction they have nevertheless been retained within the
Sentinel Adverse Drug Reactions (ADR) reporting system for tracking purposes.
No assessment of these reports has been made as to possible causal association with
the product and no action has been taken as a consequence.

Whilst e-cigarettes are a fairly new product to the mass market there are several
generic pieces of existing consumer product legislation that apply to them
including:

e The General Product Safety Regulations (2005)
http://www. legislation.gov.uk/uksi/2005/1803/
These Regulations impose requirements concerning the safety of products
intended for consumers or which are likely to be used by consumers. They
require that only safe products are placed on the market and that producers
inform customers about the risks of products and to monitor the risks their
products pose. Distributers are required to act with due care so as not to
supply unsafe products and to co-operate in monitoring the safety of
products. Both producers and distributors are required to notify an
enforcement authority if a product placed on the market poses risks that are
incompatible with the general product safety requirement.

e Regulation (EC) No 1272/2008 of the European Parliament and of the
Council on classification, labelling and packaging of substances and
mixtures;

http://eur-
lex.europa.eu/Lex UriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:

PDE

ae vs

Department
Department for Business
of Health Innovation & Skills

e The Biocidal Product and Chemicals (Appointment of Authorities and
Enforcement) Regulations 2013 (SI 2013/1506).

These Regulations require manufacturers etc. to classify, label and package
hazardous chemicals before placing them on the market so that consumers
and other users are informed of the hazards posed and the necessary
protective measures that should be taken.

e The Plugs and Sockets etc. (Safety) Regulations (1994)
http://www. legislation.gov.uk/uksi/1994/1768/contents/made

e The Batteries and Accumulators (Placing on the Market) Regulations (2008)
http://www. legislation.gov.uk/uksi/2008/2164/pdfs/uksi_20082164_en.pdf

These two sets of Regulations set out additional electrical safety
requirements.

There is also an EU wide system (RAPEX) to alert enforcement officers and the
trade to any products that do not meet existing product safety requirements and the
actions that have been taken by the manufacturers/importers to rectify the problem.

htt
h

://ec.europa.eu/consumers/safety/rapex/alerts/main/index.cfm?event=main.searc

In addition, in England, the Nicotine Inhaling Products (Age of Sale and Proxy
Purchasing) Regulations 2015 were laid at the end of the last Parliament. From 1
October 2015 these will restrict the sale of e-cigarettes and e-liquid refills to those
over the age of 18 and to prohibit their purchase by an adult on a minor’s behalf .

Further regulation of e-cigarettes and e-liquids is planned. In April 2014 the EU
published new rules, which are set out in Directive 2014/40/EC.

http://ec.europa.eu/health/tobacco/docs/dir_ 201440 en.pdf

The UK is in the process of implementing these rules. They will apply from 20 May
2016.

The new legislation will include a number of new product specific provisions on
safety, quality, ingredients, labelling and advertising of e-cigarettes sold as

consumer products and not as quitting aids (medicines), as well as refill
mechanisms (e-liquid refills).

Under the new legislation nicotine containing liquids for consumer products must
contain no more than 20mg/ml of nicotine and there will be a restriction on the refill
containers of 10 ml. Products with higher strengths will be prohibited, unless they
make a medicinal claim and are licensed as medicines. In addition refill containers
will be required to be packaged in child resistant containers, which also include
tamper evident features. These must also meet certain criteria that will reduce the
chances of spillage and contact with the nicotine liquid when refilling the tank of
any e-cigarette device. These provisions in particular are aimed at reducing
accidental contact and/or consumption.

The Directive also sets out requirements as to the information that must accompany
electronic cigarettes/refills or form part of their packaging. This includes
information on the nicotine content of the liquid, categories of consumers that are
not recommended to use the products, information on possible adverse reactions
and contraindications and a mandatory health warning: ‘This product contains
nicotine which is a highly addictive substance. It is not recommended for use by
non-smokers’.

Further the Directive will require mandatory notification to the competent authority
of a range of product information 6 months in advance of placing them on the UK
market. This will improve Government’s understanding of the market: improving
its ability to monitor, over time, the development of the market and any adverse
consequences of consumption.

Finally, the Directive provisions will introduce new restrictions on advertising and
promoting these products on TV and radio, in the press or through association by
sponsoring large sporting or music events. The aim of these restrictions is to
contribute to shaping the environment in which these products are marketed, so that
advertising is targeted only at smokers without wider spread promotion and take up
by children and non-smokers.

Products with higher strengths of nicotine than 20mg/ml and which make medicinal
claims can still be marketed but will need to take the medicinal licence route to
market. E-cigarettes licensed as medicines by the Medicines and Healthcare
products Regulatory Agency in the UK will be subject to the robust medicines
regime. Licensed medicines are subject to separate regulatory rules that cover the
safety, quality and efficacy of the products along with other aspects such as
advertising, product presentation, post-marketing surveillance, to whom medicines
can be supplied, and other aspects relating to their sale and supply.

de} ig

Department
Department for Business
of Health Innovation & Skills

There are existing controls on product safety in place which cover e-cigarettes and
refill containers. Existing legislation will be supplemented by a product specific
regime for e-cigarettes and refills, sold as consumer products, that will be
introduced from May 2016. Together, these provide a robust set of rules and should
mitigate the risks of inadvertent contact and accidental poisoning from the use of
these products. However, it should be recognised that no regulatory regime can
protect fully against misuse of products.

I hope that you find this reply helpful and I am grateful to you for bringing the
circumstances of Miss Lakhani’s death to my attention.

Yours sincerely,
CG L,
_—_—_— >
GEORGE FREEMAN