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.

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

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

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

2.2.2.4 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 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.

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

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

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

3.3.9 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.

Dear Mr Stevens,

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”:

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