Safety Information

Trans-Tasman Early Warning System - Alert Communication

Miracle Mineral Solution – buyer beware

19 June 2015

Information for consumers and caregivers
Information for healthcare professionals
Review Summary
What actions are Medsafe taking?
How to report adverse events
Further information

Miracle Mineral Solution products are promoted as highly effective destroyers of pathogens, fungi, disease, bacteria and viruses.  Medsafe is not aware of any scientific evidence that these products are effective against pathogens in the body when the product is consumed.

Sodium chlorite is used for textile bleaching and as a disinfectant.  Whilst it may be an effective disinfectant when used on household surfaces or for water purification, this is not the same as ingesting the product.  These products are being sold in New Zealand and are not approved medicines. 


Information for consumers and caregivers

  • Miracle Mineral Solution products are not approved medicines. The quality of the products is unknown.
  • Consumers who have bought Miracle Mineral Solution are advised to stop using the products immediately.
  • Medsafe is not aware of any research showing that Miracle Mineral Solution is effective for any illness when consumed (taken orally).
  • These products produce chlorine dioxide which is used as a bleach and can cause serious harm to health when consumed.
  • Taking Miracle Mineral Solution products can cause nausea, vomiting, diarrhoea and symptoms of severe dehydration which may be life threatening.
  • Consumers who have experienced adverse reactions to these products should consult their healthcare professional as soon as possible and are encouraged to report to the Centre for Adverse Reactions Monitoring (CARM). Reports can be submitted online at https://nzphvc.otago.ac.nz/report/. Please see below for other ways to report adverse events.

 

Information for healthcare professionals

  • Miracle Mineral Solution products contain sodium chlorite, an industrial bleach. These products are not approved medicines.
  • Medsafe is not aware of any research showing that Miracle Mineral Solution is effective for any illness when consumed (taken orally).
  • Ingesting Miracle Mineral Solution products can cause nausea, vomiting, diarrhoea and symptoms of severe dehydration.
  • Please report all suspected adverse reactions to Miracle Mineral Solution products, and any medicine, to the Centre for Adverse Reactions Monitoring (CARM).  Reports can be submitted online at https://nzphvc.otago.ac.nz/report/. Please see below for other ways to report adverse events.

Review Summary

Medsafe is not aware of any research carried out to assess the quality and efficacy of these products.  Other Medicines regulators have issued warnings about this product following reports of harm to consumers (see below).

What actions are Medsafe taking?

Medsafe investigates products that may be in breach of the Medicines Act 1981.  Medsafe is continuing to monitor these products as they are currently unregulated and may pose a high risk of harm to users.   

How to report adverse events

Phone + 64 3 479 7247 to speak to a Medical Assessor at the Centre for Adverse Reactions Monitoring (CARM)
Online Submit a report to CARM
Prescribers can submit using the online reporting tool available in patient management software
Yellow Card A completed Yellow card can be submitted to CARM via email, fax or mail (address is on the card)
Email carmnz@otago.ac.nz
Fax +64 3 479 7150


Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Further information

Medsafe issued a media publication regarding Miracle Mineral Solution in 2010.  http://www.medsafe.govt.nz/hot/media/2010/miraclemineralsolution.asp

The FDA also issued a statement in July 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220756.htm 

The TGA issued a similar statement in November 2014.
https://www.tga.gov.au/alert/miracle-mineral-solution-mms

Health Canada issued an information update in March 2015.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/52719a-eng.php