133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
6 April 2022
Chuck Schooner
By email: [email address]
Ref:
H202201546
Tēnā koe Chuck
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 10 and 16
February 2022. On 10 March 2022, the first part of your request was responded to.
You requested:
“So just a follow up on this there was one confirmed report of poisoning and one other
Medsafe are aware of so “Two” in total.
So what is the criteria for a product to be removed?
Please provide all the reporting/documents that linked this product to being removed and
the associated recommendation by Medsafe.
I want to see the process that Medsafe went through and the evidence used to justify
stopping this product being used.
Did the person die?
If not there was one person in total that had a reaction?
What is the criteria for a medicine to stop being prescribed?
- one death?
- heart conditions?
- two deaths?
- one reaction as per Goree product being removed
- Bells Palsy?
- 13 year olds death being investigated? Would that warrant a roll out being stopped?
- miscarriages?
- auto immune disorders?
What criteria needs to be met for a product to be removed? Please provide the Goree
reporting so I can understand the criteria.
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and administers
the requirements of the Medicines Act 1981. This law requires that products intended for a
therapeutic purpose are assessed and approved by Medsafe (under delegation from the
Minister of Health) unless there is a legislative exemption. The Medicines Act can be viewed at:
www.legislation.govt.nz/act/public/1981/0118/latest/DLM53790.html. The Medicines Act permits
the classification of medicines as: ‘prescription’, ‘restricted’ (pharmacist-only) and ‘pharmacy-
only’. The Medicines Act also enables the removal of products from the market should they
pose a safety issue. Medsafe received a report about harm arising from the use of the Goree
product and found it contained both lead and mercury at above prescription medicine levels.
In this instance, the primary reason for the product being removed was patient safety. This
product was being marketed as a cosmetic, it contained high levels of mercury and lead, and a
person using the product was reported as being managed by their GP for suspected mercury
poisoning. Although marketed as a cosmetic, the mercury and lead present were at levels that
would make the product a prescription medicine. The product did not have consent for sale,
advertising or distribution as a medicine, so sale of the product was also a breach of section 20
of the Medicines Act. The presence of lead and mercury in the product was not identified on the
product labels. The dangers associated with use of the product were specified in the Alert
Communication published at
: www.medsafe.govt.nz/safety/Alerts/skin-whitening-cream.asp.
In this instance the process followed was:
• A GP reported a case of suspected mercury poisoning to the local district health board
public health unit (DHB PHU).
• The DHB PHU obtained some of the product that was suspected to have caused the
poisoning.
• The DHB PHU found an overseas alert online about the product and alerted Product
Safety at Medsafe.
• Medsafe assisted the DHB to send a sample of the product to ESR for testing.
• The patient identified the business that supplied the product.
• Medsafe staff visited the business and located this product and some other similar
products of concern.
• These products were detained, and samples of product from this location were also sent
to ESR for testing.
• The testing results identified that the products contained high levels of mercury and lead.
• Medsafe contacted the Ministry for the Environment about the mercury content in the
products as it was working to ratify the Minamata Convention, an international treaty
designed to protect human health and the environment, including reducing the release of
mercury and mercury compounds.
• Medsafe contacted the Environmental Protection Agency (EPA) as the product was
marketed as a cosmetic and the Cosmetic Product Group Standard sits with EPA.
• As it was not possible to identify who had imported and/or was selling such skin
whitening products, a Director-General’s Privileged Statement under section 98 of the
Medicines Act was published as an alert communication on the Medsafe website to warn
users of the potential dangers associated with use of the product.
Medsafe is aware of two reports of harm following use of this product.
This product was not sold as a medicine, nor was it prescribed. It was sold as a cosmetic and
self-selected by customers. Both the purpose for the product, skin whitening, and the content,
meant the product was a medicine and not a cosmetic.
The process for removal of an approved medicine from the market is different. It involves a
review of the risk-benefit of the product following reported adverse events where a signal is
identified that the product has potential for harm. A description of the process followed when
Reductil, a prescription medicine for weight loss was withdrawn from the New Zealand market in
2010, is published at:
www.medsafe.govt.nz/hot/media/2010/SibutramineOct2010.asp.
Please find attached to this letter copies of the key documents that informed the regulatory
action taken. The documents are outlined in Appendix 1 and copies are enclosed. The table in
Appendix 1 outlines my decisions on the release of each document. I have considered the
countervailing public interest in release in making this decision and consider that it does not
outweigh the need to withhold at this time.
Page 2 of 4
- Please provide any and all information that contradicts Medsafes own data that
vaccination is safe for pregnant woman because clearly there is a risk due to real world
data
Are pregnant woman being warned that they may lose there baby due to the vaccine?
If not - why not?
How many more premature deaths are required before Medsafe decide that this isn't safe
for the pregnant woman and their unborn child.”
The Ministry does not hold any information that ‘contradicts’ its own data. As you have been
advised, the Act does not support requests where an opinion, comment, argument, or
hypothetical statement is put to the Ministry for response, couched as a request for information.
These questions are therefore refused under section 18(g) of the Act on the grounds that the
information sought is not held by the Ministry.
However, the Ministry has published a range of information about pregnancy and COVID-19
vaccination. Section 5.5.4 of the
Immunisation Handbook addresses pregnancy and vaccination
with the Pfizer Comirnaty vaccine. The Handbook, which provides references to a range of
reputable peer-reviewed scientific literature, found no safety concerns for pregnant women with
the Comirnaty vaccine and recommended they be routinely vaccinated. It noted that: “The risk
of an adverse outcomes from COVID-19 infection during pregnancy is significantly higher
compared to non-pregnant adults.” It is available at:
www.health.govt.nz/our-work/immunisation-
handbook-2020/5-coronavirus-disease-covid-19#23-5. The Ministry has also published a review of scientific literature that found no link between
COVID-19 vaccination and an increased risk of miscarriage. It is available at:
www.health.govt.nz/system/files/documents/pages/csu-13-sept-2021-vaccination-in-pregnancy-
is-not-associated-with-miscarriage.pdf. Additionally, the Immunisation Advisory Centre at the
University of Auckland has published advice for health professionals that recommends COVID-
19 vaccination for pregnant women. It is available at:
https://covid.immune.org.nz/sites/default/files/2022-
02/Pregnancy_COVID19%20and%20COVID19%20vaccination_HP_2022Feb15.pdf. Comirnaty vaccine like all medicines can cause side effects in some people. It is approved
because the expected benefits outweigh the risk of side effects for the population as a whole.
Nevertheless there are some people for whom the vaccine is contraindicated (should not be
used), these are people who have a severe allergic reaction to the vaccine. The product Goree
which is referred to above has not demonstrated any benefit, therefore the balance of benefits
and risks is unfavourable, and this is the reason for the difference in regulatory actions.
I trust this fulfils your request. Under section 28(3) of the Act, you have the right to ask the
Ombudsman to review any decisions made under this request. The Ombudsman may be
contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry of Health website at:
www.health.govt.nz/about-ministry/information-releases. Nāku noa, nā
Chris James
Group Manager
Medsafe
Page 3 of 4
Appendix 1: List of documents for release
#
Date
Document details
Decision on release
1
N/A
Overseas regulator alert
Released in full.
2
2 December
Letter to store owner linked to the Some information withheld under
2021
initial complaint details
the following under section 9(2)(a) of
the Act, to protect the privacy of
natural persons, and section
9(2)(b)(ii) as its release would likely
unreasonably prejudice the
commercial position of the person
who supplied the information.
3
20 December Memo
Information deemed out of scope
2021
has been excluded
4
22 December Memo to Director-General of
Some information withheld under
2021
Health requesting approval to
section 9(2)(a).
publish Privileged Statement
under s98 of the Medicines Act
1981
Page 4 of 4
