FOI release

Freedom of Information request about enquiries concerning unregulated medicines (FOI-21-068)

Published 24 March 2021

Thank you for your communication to the MHRA in relation to a Freedom of Information request for the details of :

• Are you aware of any illegal or unregulated medicines, medical devices, substances, products etc being sold by individuals or organisations that claim to boost immunity to Covid-19, cure Covid-19 or act as a replacement to the Covid-19 vaccine?

• Have you investigated any individuals or organisations that are selling or advertising illegal or unregulated medicines, medical devices, substances, products etc that claim to boost immunity to Covid-19, cure Covid-19 or act as a replacement to the Covid-19 vaccine?

• Have sanctions been taken against any individuals or organisations that are selling or advertising illegal or unregulated medicines, medical devices, substances, products etc that claim to boost immunity to Covid-19, cure Covid-19 or act as a replacement to the Covid-19 vaccine?

• Are you aware of any individuals having been harmed or injured from purchasing/taking illegal or unregulated medicines, medical devices, substances, products etc that claim to boost immunity to Covid-19, cure Covid-19 or act as a replacement to the Covid-19 vaccine? If so, please give the figures of how many individuals you are aware of, the products they have purchased/obtained, and the harms they have suffered.

• Are you aware of the product GcMAF or Magic Mineral Solution being sold/advertised as related to Covid-19 in any way? If so, please provide relevant details: eg. Where it is being sold, by whom, and the official action that has been taken to counter advertisements/sales.

MHRA investigated an incident concerning an offer to broker supplies of an unapproved vaccine and resulted in suspension of a Wholesale Dealer’s Authority.

There have also been two Yellowcard reports from members of the public in the Manchester area regarding a product called; Haim Natan Covid19 antidote.

Both referrers state that they have received a text message offering this medicine for £150

It’s claimed the medicine treats patients who are critically ill, results can be seen in 24 hours.

This seems to originate from Israel and is circulating in the Jewish community.

The Agency had raised two separate investigations after working closely with the US Food &Drug Administration (FDA).

One case involved unapproved drug exported to US from UK.

Second case involved suspected counterfeit COVID-19 test kits exported from UK to US the test kits were removed from market.

Please see below the number of complaint cases investigated and closed for products making boost immunity claims against Coronavirus/Covid-19 . To clarify, action was taken by issuing Urgent Notices under reg 165 of the HMR, determining the products to be medicinal products due to the claims made in their promotional material. Companies were instructed to either amend their promotional material to remove all medicinal claims or immediately remove the products from the UK market. Lastly, we have not received any referrals for GcMAF or Magic Mineral Solution being sold/advertised as related to Covid-19.

No of closed cases	Comments	Period
27	Products presented with claims to boost immunity against Covid-19	1 Jan 2020 to 25 Jan 2021

The MHRA has received Adverse Drug reaction (ADR) reports, via the Yellow Card scheme, in relation to Sodium hypochlorite (a substance used in many disinfectant and bleach products) however these pre-date COVID-19. Additionally, the MHRA have received reports via the Yellow Card scheme in relation to use of Dettol linked with Covid-19, however these did not report specific side effects. Please note, as report numbers are below 5 we cannot release details to protect patient/ reporter confidentiality.

Furthermore, we would like to confirm that we are not aware or any GcMAF product or Magic Mineral Solution being sold/advertised as related to Covid-19.

If you have a query about this letter, please do not hesitate to contact us at IE&[email protected]

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: [email protected]

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

After that, if you remain dissatisfied, you may write to the Information Commissioner at;

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request. Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU