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What the TGA Knew — And What It Didn't Tell Australians
FOI Document Release: TGA Sunscreen Ingredient Safety Review
These documents were obtained by Joseph Mizikovsky, Chief Advisor for Industry at the Australian Sunscreen Council, under the Freedom of Information Act 1982 (Cth).
FOI 26-2459 reveals the Therapeutic Goods Administration's internal deliberations on sunscreen ingredient safety between December 2024 and July 2025 — including safety recommendations that were never communicated to the public, deliberate deletion of safety language from public communications, and internal discussions about withholding information from consumers.
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The US Food and Drug Administration concluded in 2019 that only two sunscreen active ingredients — zinc oxide and titanium dioxide — have sufficient safety data to be classified as "Generally Recognized as Safe and Effective" (GRASE). The documents below show that the TGA's own internal reviews raised similar concerns about chemical UV filters, but the agency's public messaging framed the choice as "sunscreen vs. no protection" rather than informing Australians that mineral sunscreen alternatives exist.
Key Findings
The following documents reveal what the TGA knew about sunscreen ingredient safety — and what it chose not to tell the Australian public. Each finding includes direct quotes from TGA internal documents.
The "Adult Use Only" Recommendation
Finding 1 - FOI 26-2459
TGA Draft Safety Review Recommended Restrictions Never Communicated to Public
The TGA's draft safety review of oxybenzone concluded that it could only be "deemed low-risk and appropriate for use in therapeutic sunscreens for daily use when: Used by adults only" and "Limited to face and hand application, not to the whole body" at reduced concentrations. These recommendations do not appear in the TGA's public communications, which state only that "All sunscreens available in Australia are safe." The draft review is 81 pages and dated 2024.
Embolden Anti-Sunscreen Fear Merchants
Finding 2 - FOI 26-2459
Internal Email Shows Deliberate Removal of Safety Language
An internal TGA email dated 6 March 2025 reveals that safety language about "theoretical risks" was deliberately removed from the draft media release. The author states: "My main query is to ensure (if possible) we aren't saying there are 'theoretical risks' in sunscreen use, as I fear that will embolden anti-sunscreen fear merchants to drive down sunscreen use. I've removed this from the media release and queried its inclusion on the webpage." The email also notes that Cancer Council Australia could not be briefed on the announcement because "they are also sunscreen manufacturers (through a third party)."
Expert Roundtable — Summary of Discussion
Finding 3 - FOI 26-2459
Media Release Draft With Visible Deletions
A draft media release with tracked changes shows specific safety language that was struck through and deleted before publication. Deleted text includes: "The benefits of sunscreen in preventing sunburn and skin cancers are well established and sun protection should remain a priority." The document shows the evolution from more cautious language to the final messaging that "All sunscreens available in Australia are safe."
Do Not Provide Public All Details
Finding 4 - FOI 26-2459
Internal Discussion on Withholding Information from Consumers
Internal correspondence from February 2025 shows TGA staff discussing whether to withhold information from the public. One email states: "Taking this all into account, we wondered if the current 'landing page' is providing too much content/information ahead of the public consultation where much of the detail still needs to be worked through and finalised. While it's important that we are clear and transparent, providing too much detail before things are settled may add to the confusion and lead to unintended consequences (such as people stopping using sunscreen)." The same document records Professor Robyn Langham's concerns that "the language in the media report is too complex for the community" and that "the time pressured approach [compromises] the ability to provide a robust regulatory approach that has the interests of community safety at heart."
Deletion of "Theoretical Risks" Paragraph
Finding 5 - FOI 26-2459
Evidence of Last-Minute Content Removal
Additional documentation showing the removal of content relating to "theoretical risks" from TGA public communications. This document should be read alongside Document 20 (the internal email explaining the rationale for removal) and the tracked changes version of the media release.
2022 TGA Literature Review — Safety Risk Uncertain for Children
Finding 6 - FOI 25-0104
TGA Knew About Safety Concerns Three Years Before Public Announcement
A June 2022 TGA Literature Review of seven sunscreen ingredients — including homosalate and oxybenzone — obtained under a separate FOI request (FOI 25-0104). This document shows the TGA was aware of safety concerns years before the July 2025 public announcement. The review covers: butyl methoxydibenzoylmethane (avobenzone), ethylhexyl triazone, homosalate, octocrylene, octyl methoxycinnamate (octinoxate), oxybenzone, and phenylbenzimidazole sulfonic acid.
Professor Langham's Media Release Approval
Finding 7 - FOI 26-2459
​Final Sign-Off on Public Communications
Correspondence showing Professor Robyn Langham AM's approval of the media release prior to publication on 8 July 2025. The email notes the media release "has been approved by Robyn and is currently with the MO [Minister's Office]" who are "reaching out to them this morning to ensure they are happy with it prior to distribution."
Phase 1 of Documents
Establishing the Evidence Base
(December 2024)
Expert Roundtable — Meeting Papers
Document 1
Technical Documentation for TGA's Risk Assessment of Sunscreen Ingredients
Invitation and preparatory materials for the expert stakeholder roundtable held on 18 December 2024. Distributed via GovTeams, the papers included: the meeting agenda, the TGA risk assessment discussion paper, the Australian Sunscreen Exposure Model (ASEM), the Draft Risk Assessment of Seven Active Sunscreen Ingredients (Working Copy), and the Benzophenone Risk Assessment (Working Copy). Participants were required to submit Declaration of Interest paperwork prior to attendance.
Expert Roundtable — Stakeholder Correspondence
Document 2
Logistics, Access Arrangements and Supporting Research
Pre- and post-meeting correspondence relating to the 18 December 2024 expert roundtable. Includes participant communications regarding GovTeams access and distribution of meeting papers. Post-meeting correspondence includes Professor Michael Roberts' presentation on percutaneous absorption of sunscreens, delivered at the Rutgers Center for Dermal Research Conference. Professor Roberts (Emeritus Professor, University of Queensland) has collaborated with the FDA on sunscreen assessments.
Expert Roundtable — Summary of Discussion
Document 3
Clinical Advice on Sunscreen Ingredient Safety
Official record of the expert roundtable chaired by Professor Robyn Langham AM on 18 December 2024. Twenty-two participants attended for 2 hours and 14 minutes. The summary records that "the advice from the group was that there was no clear evidence to bring about a change in practice at this time" and that "supporting the use of sunscreens to prevent skin cancers should be front and centre of any campaign." The document notes that "any messaging that advises reduction or avoidance would result in the risk of shunning sunscreen." The roundtable did not appear to consider whether recommending mineral sunscreen alternatives would address both safety concerns and skin cancer prevention.
Phase 2 of Documents
Developing the Communications Strategy
(February – March 2025)
Sunscreen Communications Reference Group — Internal Correspondence
Document 4
Messaging Development and Stakeholder Coordination
Email chain from February 2025 showing development of public messaging strategy. Professor Langham raised concerns that "the language in the media report is too complex for the community" and that "the time pressured approach the ability to provide a robust regulatory approach that has the interests of community safety at heart." Internal discussions reference avoiding language that could embolden "anti-sunscreen fear merchants." The correspondence shows the development of key messaging: "Clinical advice remains unchanged — the benefits of sunscreen continue to outweigh any theoretical risks posed by some sunscreen chemicals." This framing does not distinguish between chemical UV filters under review and mineral alternatives not subject to safety concerns.
SCRG Review Request — Communications Materials
Document 5
Draft Documents for Stakeholder Feedback
Request to the Sunscreen Communications Reference Group for review of draft materials. Documents circulated included the draft media release (D24-4445890), draft landing page (D25-932651), and talking points (D25-846157). Reference materials provided included the ministerial brief, communication strategy, Dear Healthcare Professional letter, and summary of the roundtable discussion. Feedback was requested by COB 6 March 2025 to meet Executive approval timelines.
SCRG Feedback — Stakeholder Input
Document 6
Communications Materials Review by COB 6 March 2025
Stakeholder feedback on draft communications materials. The correspondence notes that Cancer Council Australia could not be briefed pre-publication due to sunscreen manufacturing interests — a potential conflict of interest given Cancer Council markets sunscreens containing the chemical ingredients under review. The short turnaround was noted as necessary for Executive approval and a ministerial brief due the following week.
Phase 3 of Documents
Pre-Publication Planning
(June 2025)
Pre-Meeting Notice Briefing — Publication Planning
Document 7
Regulatory Publication Sequence and Scheduling Proposals
Internal briefing setting out the regulatory publication sequence for the sunscreen ingredients project. Details the simultaneous publication strategy targeting the week of 30 June 2025. The briefing notes that scheduling proposals for homosalate and oxybenzone follow "the approach for the paracetamol scheduling proposals in 2022 — presenting options which could be implemented separately or in combination." The Joint ACCS-ACMS scheduling meeting was planned for September 2025. Embargoed materials were to be provided to select stakeholders including Accord, the chemical industry body.
Media Planning — Sunscreens Announcement
Document 8
Embargo Strategy and Spokesperson Arrangements
Media planning correspondence dated 30 June 2025. Key elements include: embargoed materials to CHP Australia and Accord (the chemical industry body) on Tuesday prior to public release; Professor Robyn Langham designated as TGA spokesperson; and distribution via iSentia platform. The correspondence asks for views on "what types of questions we can anticipate from journos, so that we can start to prepare our responses." Publication was approved by Professor Lawler and the Minister's Office had been advised.
Media Planning — Stakeholder Communications
Document 9
Embargo and Distribution Arrangements
Related correspondence on media planning, confirming embargo arrangements for key industry stakeholders (CHP Australia and Accord) prior to public release. Notes that the Dear Healthcare Professional letter and Consumer Leaflet were "Not for publication" — raising questions about why information prepared for healthcare professionals was not made publicly available.
Publication Schedule — Coordination Updates
Document 10
Web Publication Sequencing and Date Changes
Email chain documenting web publication coordination from late June through early July 2025. The initial target of 3 July shifted to 8 July 2025 due to senior executive review. Critical sequencing was specified: safety reviews published first, then pre-meeting notice, then media release and landing page. One email requests: "PLEASE PUT A HOLD ON THE BELOW PUBLICATIONS AS THE SENIOR EXECs DISCUSS A POTENITAL CHANGE IN THE OVERALL PROCESS." Publication time was confirmed as 10:00 AM AEST.
Phase 4 of Documents
Media Release Development and Finalisation
(7 July 2025)
TGA Media Release — Early Draft
Document 11
Initial Drafting with Placeholder Text
Early draft of the TGA media release titled "TGA to consult on additional controls for some sunscreen ingredients." Contains placeholder text and early formatting. This draft was subsequently refined through multiple review cycles on 7 July 2025.
Media Release — Editorial Review Request
Document 12
Edits Requested by Media Team
Request from Corporate Communication Branch (Media and Events) for editorial input on the media release, sent 7 July 2025 at 1:09 PM. The subject line "Media release - edits" and request for a phone call indicates substantive changes were being discussed.
Media Release — Quick Review Request
Document 13
Internal Review Prior to Final Clearance
Urgent request from Media and Events team at 3:08 PM on 7 July 2025. The subject line "CAn yuotake a quick read and than call me" and attached draft file titled "EDIT - Day Month 2025.docx" reflect the time-pressured nature of the review process.
Media Release — Cleared Version
Document 14
Forwarded with Clearance Confirmation
Cleared media release forwarded at 12:17 PM on 7 July 2025. Confirms the media release titled "TGA to consult on additional controls for some sunscreen ingredients" has received clearance. TRIM reference D24-4445890 provided for document management tracking. This version was subsequently further amended through the afternoon.
Media Release — Final Version Email
Document 15
Near-Final Draft for Link Insertion
Email from Media and Events at 5:06 PM on 7 July 2025 with "Hopefully, final version" — indicating near-completion of the review cycle. Notes that not all links are included in the attached document and requests the recipient add them. Attached file "TGA media release- Sunscreen MR Media.docx" represents the publication-ready draft pending link insertion.
Media Release — Cleared Version
Document 16
With Tracked Amendments
Final amended and cleared media release forwarded at 7:53 PM on 7 July 2025, with thanks to the media team for their input. TRIM link D25-1144490 provided. This version incorporated all amendments from the day's review cycle and was marked as cleared for sunscreen ingredient safety. Subsequently subject to further amendment on publication day.
Media Release — Cleared Version
Document 17
Publication-Ready Document
Forwarded media release at 5:28 PM on 7 July 2025 with attached "TGA media release- Sunscreen MR Media.docx". This version was distributed as the final approved document following the day's clearance process. The attached document represents the media release as it stood at close of business on 7 July, prior to the publication-day amendment removing the third paragraph.
Phase 5 of Documents
Publication Day Coordination
(8 July 2025)
Media Release — Publication Day Amendment
Document 18
Third Paragraph Removed per Senior Executive Decision
​Critical publication-day correspondence documenting the last-minute amendment to the media release. At 10:03 AM on 8 July 2025, confirmation was sent that "Gaelene, Sharon and Kartik have agreed to remove the 3rd paragraph of the media release. This has now been updated in TRIM and can proceed." The decision followed an internal review of social media messaging that identified changes in the media release requiring additional discussion. Publication had been paused at 9:53 AM pending this resolution.
Publication Coordination — Supporting Correspondence
Documents 19-25
Web Publishing and Distribution Coordination
Collection of supporting correspondence from 8 July 2025 relating to the final publication process. Includes coordination between the Acting Assistant Secretary (Regulatory Engagement Branch), Web Experience Section, and multiple TGA branches to ensure synchronised publication. Documents the sequencing requirement that the media release be published only after all other sunscreen pages had been published. Web Experience Developer confirmed update of media release draft in TRIM following the removal of the third paragraph.