David Mitchener

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.