David Mitchener

The Rt Hon Dame Andrea Leadsom DBE MP 
  Parliamentary Under Secretary of State for Public Health, Start for Life and Primary Care 
39 Victoria Street 
  London 
  SW1H 0EU 

Mr Jonathan Stevens 
HM Coroner’s Court 
Station Approach 
Woking 
GU22 7AP  

Dear Mr Stevens, 

26 April 2024 

Thank you for your Regulation 28 report to prevent future deaths (PFD) dated 19/01/24 
about the death of David Mitchener.  I am replying as the Minister with responsibility 
for Public Health, Start for Life and Primary Care. 

Firstly,  I  would  like  to  say  how  saddened  I  was  to  read  of  the  circumstances  of  Mr 
Mitchener’s death and I offer my sincere condolences to his family and loved ones. 
The circumstances your report describes are concerning and I am grateful to you for 
bringing these matters to my attention. Thank you for the additional time provided to 
my Department to provide a response. 
The report raises concerns that: 

•  Vitamin supplements can have potentially very serious risks and side effects 

when taken in excess. 

•  Current food labelling requirements do not require these risks and side effects 

to be written on the labels of products. 

•  Absence of appropriate warnings and guidance about dosage. 

We  have  noted these  issues  and  in preparing  this response,  Departmental officials 
have made enquiries with the Food Standards Agency (FSA). 

Cases of toxicity are rare.  I note that there is evidence to suggest that Mr Mitchener 
exceeded the recommended dose for the supplement, and that it is unclear whether 
Mr Mitchener had an underlying medical condition that would have made him more 
susceptible, or whether Mr Mitchener was consuming other supplements containing 
vitamin D concurrently. 

 
 
 
 
 
  
 
 
 
 
 
 The Department has responsibility for the legislation governing food supplements in 
England,  which  is  the Food  Supplements  (England) Regulations 2003,  with parallel 
policy resting with the Welsh Government in Wales, Food Standards Scotland (FSS) 
in  Scotland  and  the  FSA  in  Northern  Ireland.  We  work  collaboratively with the  FSA 
which  has  responsibility  for  food  safety  and  Trading  Standards  and  Environmental 
Health in local authorities who lead on enforcement of the regulations.   

Food  supplements  legislation  requires  manufacturers  to  include  the  recommended 
dose and include a warning not to exceed the stated dose on the label. It does not set 
maximum levels for vitamins and minerals or require specific risks and side effects to 
be written on the label, although additional information may be provided on labels to 
inform consumers on a voluntary basis.  

The NHS website that advises on the benefits of vitamin D also clearly highlights the 
dangers of taking too many vitamin D supplements and states that adults should “not 
take more than 100 micrograms (4,000 IU) of vitamin D a day as it could be harmful”: 
https://www.nhs.uk/conditions/vitamins-and-minerals/vitamin-d/  

In light of the concerns you raised, the issues in the PFD report were discussed at the 
Cross-Government Food Supplements Working Group meeting in April, which agreed 
to set up a sub-group to look at the issues raised in your report. We have also made 
relevant trade associations relating to food supplements aware of the incident and will 
meet with them in due course. 

We  note  that  a  response  has  been  published  on  behalf  of  the  manufacturer  of  the 
supplement consumed by Mr Mitchener that indicates that their product is compliant 
with the legislation and included a warning not to exceed the recommended dose. We 
would be grateful if any available packaging for the vitamin D supplements in question 
could be shared, to enable us to confirm this compliance, as the supplement dose in 
question is not currently available on the manufacturer’s website. 

I hope this response is helpful. Thank you for bringing these concerns to my attention.  

THE RT HON DAME ANDREA LEADSOM DBE MP

Chief Executive 

Floors 6 and 7, Clive House 
70 Petty France 
London 
SW1H 9EX 

14 March 2024 

Jonathan Stevens, Coroner  

Dear Jonathan, 

Thank you for providing the Food Standards Agency (FSA) with the opportunity to 
respond to your Prevention of Future Deaths Report, concerning the death of Mr. David 
Mitchener. 

I would like to offer both my own and the FSA’s sincere condolences to the family of 
Mr. Mitchener, following his death in May 2023.  

The FSA works to protect public health and consumers’ wider interests in relation to 
food in England, Wales and Northern Ireland. The FSA has a key role as the central 
competent authority in overseeing official feed and food controls undertaken by local 
authorities. We seek to work in partnership with local authorities to help them to 
deliver official food and feed controls, to ensure that this activity is effective, risk 
based, proportionate and consistent.  

The composition and labelling of supplements is devolved and policy advice to 
Ministers on it rests with a number of different bodies which includes the Department 
for Health and Social Care (DHSC) in England, Welsh Government, the FSA in Wales and 
Northern Ireland, and with Food Standards Scotland in Scotland. As your report is in 

Read the FSA’s Privacy Policy and Privacy notice Private Office Correspondence for 
more information about how we handle your personal data. 

 
 
 
 
 
 
 
  
 
 
 
 
 
 relation to England, we understand that DHSC is providing a response in respect to 
their policy. Powers to amend the key legislation in this area sits with Ministers in the 
respective nations. Co-ordination of policy takes place through a number of groups 
including the Food Supplements Working Group, which the FSA chairs. 

It is a requirement under existing rules for food supplement labels to include the 
recommended dose and a warning not to exceed that dose. Enforcement of these 
regulations is by Local Authorities (local authority Environmental Health and Trading 
Standards departments). However, current food supplements rules do not require 
specific risks and side effects to be written on the label.  

The FSA will raise your report at the next cross-government Food Supplements 
Working Group, which will take place in April, and we will ensure full consideration will 
be given to the matters of concern you have highlighted. We intend to contact the 
relevant local authorities to ascertain whether the product is in compliance with food 
supplements requirements. We would be grateful if you could share any product 
details or packaging that you have, which will inform and aid our interactions with the 
relevant local authorities.  

Yours sincerely,  

Chief Executive  

Let’s keep connected: 

    food.gov.uk/facebook 
  @foodgov 

  @foodgov 

Read the FSA’s Privacy Policy and Privacy notice Private Office Correspondence for 
more information about how we handle your personal data.

Mr Jonathan Stevens 
Assistant Coroner for Surrey 

One Central Square  
Cardiff CF10 1FS 

29 March 2024 

Dear Sir 

Response by Save on Supplements Ltd to HM Coroner’s Report to Prevent Future Deaths dated 28 
March 2024. 

We are instructed by Save on Supplements Ltd (“the Company”) to provide a response to your Report to 
Prevent  Future  Deaths  (hereafter  “the  Report”)  dated  19  January  2024,  concerning  the  death  of  David 
Charles  Mitchener  on  20th  May  2023.  In  advance  of  responding  to  the  specific  concerns  raised  in  your 
Report, our client would like to express their deep condolences to Mr Mitchener’s family and loved ones. 
The Company is keen to assure HM Coroner and the family that the concerns have been listened to and 
reflected upon.  

In your Report, you raised three Matters of Concern. We respectfully suggest that some of the Matters of 
Concern relating to the overarching regulation of vitamin supplements are better addressed by the Food 
Standards Agency and the Department of Health and Social Care. We note that you have also addressed 
the Report to these organisations who no doubt will respond directly.   

1. 

The Company 

The Company sells food supplement products, including those containing Vitamin D, via an online business 
platform. In the conduct of its business, the Company is compliant with the applicable law and available 
guidance.  

When selling  Vitamin D supplements, the Company provides  information to the  customer  on its website 
prior to, and at the point of sale, and also on its packaging, to enable its product to be safely consumed. All 
packaging is labelled in compliance with all relevant legislation currently applicable and is industry standard.  

2. 

Vitamin D toxicity 

The Company respectfully makes the following observations as to the evidence that available to the Inquest 
and upon which the Report is based: 

2.1 

The Inquest did not have the benefit of any evidence from an expert Toxicologist, and/or 
any  other  witness  with  clinical  expertise  concerning  Vitamin  D  toxicity.  Indeed,  the 
Pathologist  who  gave  evidence  at  the  inquest,  fairly  acknowledged  that  she  was  not  an 
expert  on  this  issue  and  when  providing  her  evidence  had  regard  to  her  internet-based 
research (the source of which was unclear), as opposed to her experience and professional 
expertise.  In  her  evidence,  the  Pathologist  fairly  acknowledged  there  to  be  a  range  of 
opinion as to safe Vitamin D dosage.  

2.2 

Evidence was given at the inquest that: 

2.2.1 

The  Vitamin  D  supplement  supplied  to  Mr  Mitchener  by  the  Company  (“the 
Vitamin D supplement”) included warnings on the Company’s website and on 

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 the  product’s  labelling,  not  to  consume  more  than  one  softgel  per  day  but 
notwithstanding  these  warnings,  Mr  Mitchener  had  consumed  more  than  one 
softgel per day, for an unknown number of days.  

2.2.2 

At  the  material  time,  Mr  Mitchener  was  consuming  calcium  supplements  (not 
sourced from the Company) alongside the Vitamin D supplements (“the calcium 
supplements”) but no evidence was available to the Inquest concerning: 

2.2.2.1 

2.2.2.2 

2.2.2.3 

2.2.2.4 

The dose of calcium within the calcium supplements (and, indeed, 
their chemical components generally). 

The dose of calcium supplements consumed by Mr Mitchener, the 
frequency  of  consumption  and  timeframe  over  which  the  calcium 
supplements were so consumed. 

How the calcium supplements were supplied to Mr Mitchener, and 
by whom; and 

Any  interplay  between  the  calcium  supplement  and  the  Vitamin  D 
supplement. Indeed, the Pathologist fairly accepted in her evidence 
that  if  there  had  been  a  high  level  of  calcium  consumption  by  Mr 
Mitchener,  that  would  have  “complicated”  the  hypercalcaemia  that 
he sustained.  

It is, therefore, submitted that the evidence concerning Vitamin D toxicity in the context of this particular 
inquest, was unclear.  

3. 

The Matters of Concerns 

3.1 

3.2 

The  Company  acknowledges  the  need  for  a  seller  of  Vitamin  supplements  to  provide 
consumers of its products with information concerning safe dosage. However, the Company 
is not aware of any mandatory legal requirements regarding the provision of information to 
a consumer in the context of Vitamin D supplements. 

The  Company  is  aware  of,  and  compliant  with,  its  wider  legal  duties  and  adheres  to 
guidance issued by the FSA, regarding the sale of food supplements to consumers. The 
Company provides information to its consumers, including dosage, to enable them to safely 
consume the Company’s products.  

3.3 

Specifically, in respect of the Vitamin D supplement, the Company provides its consumers 
with the following information on its website and on the product labelling (added emphasis): 

3.3.1 

A warning not to exceed the recommended daily intake (or ‘dose’), of one 
softgel per day. 

3.3.2 

Name of the food, and a list of ingredients. 

3.3.3 

3.3.4 

An  indication  of  the  categories  of  nutrients  or  substances  that  characterise  the 
product or an indication of the nature of the nutrients/substances. 

An indication of allergenic ingredients or processing aids, or those derived from 
allergens. 

3.3.5 

The net quantity of the food. 

3.3.6 

3.3.7 

The  date  of  minimum  durability,  and  any  special  storage  conditions  and/or 
conditions of use. 

Name  or  business  name  and  address  of  the  food  business  operator,  and  the 
country of origin / place of provenance. 

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 3.3.8 

3.3.9 

Instructions for use where it would be difficult to make appropriate use of the food 
in the absence of such instructions; and 

A statement to the effect that food supplements should not be used as a substitute 
for a varied diet, and that the product should be stored out of the reach of young 
children. 

The Company hopes that the above information provides reassurance to HM Coroner and Mr Mitchener’s 
family that  it operates in a  safe and compliant manner and has at  its heart, the  safety of its consumers. 
Indeed, following the Inquest, the Company reviewed its operations including the labelling of its products 
generally and remains confident that it continues to comply with the applicable law and guidance, and is 
industry standard. 

In the event any changes are made to the regulatory landscape concerning the sale or distribution of 
Vitamin D supplements, the Company will, of course, consider and take the necessary steps to implement 
the same with a view to ensuring its ongoing compliance with the law. 

Yours faithfully 

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