Dear Ministry of Health and Medsafe,

OIA request, October 1, 2024.
Regarding: Hardy Nutritionals Daily Essential Nutrients (DEN).
A September 22, 2024 release by Hardy Nutritionals stated ‘Pending further review, Medsafe has classified the original DEN (which contains lithium - this is the most researched formula) as a prescription medicine.’

Under the OIA, please supply the following information:

1. What year did the Hardys DEN formulation first become recognised by Medsafe.

2. Number of adverse events reported to Medsafe annually over the time period identified in question, and what each adverse event comprised (1).

3. Minutes from any Medsafe and/or Ministry of Health consultations seeking advice for (a) removing DEN’s status as a dietary supplement, and/or
(b) recategorizing the original DEN a prescription medicine.

4. Terms of reference used throughout this consultation and decision-making process, including all the relevant legislation and/or regulatory protocols and/or guidelines which guide officials in the Ministry of Health and Medsafe concerning this matter.

5. Ministry of Health and Medsafe information concerning actions by foreign medicines regulators to reclassify the DEN product as a prescription medicine, particularly in Canada, Australia, the UK, South Africa and the United States.

6. All information which considered by officials pertaining to the risk profile of this dietary supplement, including:
(a) The dose/dosage; and/or
(b) The risk profile of specific ingredients; and/or
(c) The concentrations (levels) of each ingredient; and/or
(d) References used by Medsafe which inform and guide officials on the safety profile of each of the ingredients of concern, and the concentrations/dose of each ingredient.

7. All published literature held by Medsafe on the safety and efficacy profile of DEN or equivalent formulations.

8. Any information received by Medsafe officials concerning the expected rise in cost of the DEN product as a consequence of Hardys Nutritionals complying with the Medsafe directive and moving to process the product (which cannot be patented) as a pharmaceutical.

It is to be expected that this information, by its nature, will be limited and contained within a reasonable span of time, and can be found and identified using the 'Daily Essential Nutrients' and/or 'DEN' and/or 'Hardys' search terms and that this OIA request is practicable and cannot be refused based on their being too much information.

As a large proportion of DEN users appear to be young children and younger people, and that these nutrients may substitute medications with unpleasant side effects, I very much hope that Medsafe will expediate this OIA request as a public interest request, and that it will not be delayed.

Thank you.

Yours faithfully,

Jodie Bruning