Public Interest Disclosure: TGA Internal Records and NACC Submission
Following a multi-year inquiry into sunscreen safety standards, VeganicSKN is releasing internal records obtained via Freedom of Information (FOI 25-0169). This archive includes our formal referral to the National Anti-Corruption Commission (NACC). We believe that public health policy must be transparent and based on independent science; these documents are shared to provide the public with the primary data used in regulatory decision-making.
Key Findings from the Released Records
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Establishment of Safe Limits: Internal TGA toxicology reviews from 2022 and 2021 detail the challenges in establishing a "Margin of Safety" for the chemical 4-MBC at current permissible concentrations.
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Revision of Safety Findings: The documents show discrepancies between internal draft safety assessments and the final public versions, with several scientific warnings regarding common chemical filters being omitted prior to public release.
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Industry Consultation: Records document a high level of coordination between TGA leadership and chemical industry stakeholders regarding the timing and implementation of safety restrictions.
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Enforcement Protocols: Internal correspondence captures admissions from TGA staff regarding the lack of a legislative basis for specific enforcement actions taken against VeganicSKN in 2022.
Executive Summary
DOCUMENT GALLERY
Document 1: Formal Referral to the National Anti-Corruption Commission
Submission Requesting a Preliminary Investigation into Sunscreen Regulation and TGA Enforcement Protocols.
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This 30-page document constitutes the formal complaint lodged by VeganicSKN with the National Anti-Corruption Commission (NACC). It requests that the Commission investigate specific regulatory processes within the Therapeutic Goods Administration (TGA) to determine if they meet the standards required under the National Anti-Corruption Commission Act 2022.
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The submission outlines VeganicSKN’s concerns regarding perceived discrepancies in regulatory enforcement. It details the timeline of enforcement notices issued against VeganicSKN and contrasts this with the regulator's approach to chemical UV filters that internal TGA reviews had flagged for safety concerns.
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The document requests that the NACC examine the decision-making processes involving key industry stakeholders. It questions whether the prioritization of market supply over updated safety restrictions aligns with the TGA's statutory mandate to ensure the safety of therapeutic goods.
Document 2: FOI 25-0169: Internal TGA Literature Review of Listed Sunscreen Active Ingredients (June 2022)
Internal toxicology assessment regarding Margin of Safety (MoS) calculations and potential endocrine disruption risks for common chemical UV filters.
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This technical literature review, released under Freedom of Information, outlines the TGA’s internal assessment of safety data for several chemical filters, including Homosalate, Octocrylene, and Oxybenzone.
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The document details the TGA's internal calculations regarding the "Margin of Safety" (MoS) for these ingredients. It documents specific instances where, based on the exposure models used, the calculated MoS for certain ingredients did not meet the internationally accepted threshold of 100.
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Furthermore, the review evaluates available international data regarding the potential endocrine-disrupting properties of these ingredients. This document provides the specific toxicological data and safety calculations held by the regulator as of June 2022.
Document 3: FOI 25-0169: Official Minutes of the Complementary and OTC Medicines Regulatory and Technical Forum (ComTech) – 18 October 2023
Record of outcomes detailing the TGA’s timeline for establishing Benzophenone safety limits and the maintenance of the "low-risk" regulatory category.
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This document records the proceedings of the ComTech meeting held on 18 October 2023, specifically Item 4.3 regarding the "Update on Benzophenone safe limit in sunscreens."
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The minutes detail the TGA’s position following a consultation on proposed safety limits. The official record explicitly states the TGA's view that "there is no rush to set a safety limit and the aim is to keep sunscreens within the low-risk category."
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Furthermore, the document outlines the regulator's intention to hold further discussions with industry members before a legislated safe limit for Benzophenone is established, noting that the outcome of the risk consultation may need to be deferred.
Document 4: FOI 25-0169: Official Minutes of the Complementary and OTC Medicines Regulatory and Technical Forum (ComTech) – 3 May 2023
Official record detailing the TGA’s response to US FDA safety reclassifications and the status of the Australian internal toxicology review.
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This document provides the official record of the TGA's update to industry stakeholders regarding the US FDA’s proposal to remove certain sunscreen ingredients from the "Generally Recognized As Safe and Effective" (GRASE) list due to safety concerns.
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The minutes confirm that the TGA was conducting its own internal safety review of these ingredients at the time. However, the record explicitly states that the TGA "does not have a timeframe of when the review will be finalised."
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The document further outlines that while a "TGA exposure model is being refined internally," the regulator continued to maintain existing market settings for these ingredients pending the outcome of their review.
Document 5: FOI 25-0169: Official Record of the TGA-Industry Sunscreen Working Group (12 February 2025)
Strategic Coordination to Mitigate Supply Chain Disruption Regarding the Re-Scheduling of Safety-Compromised Chemical Ingredients.
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This "Meeting Outcome Note" records the proceedings of the Sunscreen Working Group session held on 12 February 2025, attended by senior TGA officials (including Branch Head Avinash Clarke) and industry representatives from Accord and CHPA.
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The document outlines discussions regarding the potential scheduling of sunscreen ingredients. Specifically, it records that the agenda included planning for "transition allowances" and giving consideration to "market impacts" and "downstream effects on sunscreen supply" resulting from potential regulatory safety changes.
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Action items listed in the document confirm that industry bodies were tasked with providing "sunscreen market data" to inform these considerations. The record documents the regulator's engagement with industry on implementation planning prior to the finalization of scheduling decisions.
Document 6: FOI 25-0169: Industry Submission of Market Data to Inform Regulatory Impact Analysis
Correspondence between the TGA and industry body Accord regarding the provision of sales and market share data for specific sunscreen ingredients.
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This email correspondence documents the exchange of information between the TGA and the industry lobby group, Accord, in late 2024 and early 2025.
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The records show that following a request from TGA executives, including Branch Head Avinash Clarke, Accord provided commercial data, including sales volumes and market share estimates, for sunscreen products containing specific chemical filters.
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The correspondence confirms that this economic data was solicited to assist the regulator in understanding the potential market impact of proposed regulatory changes. It demonstrates that commercial considerations were being evaluated alongside the scheduling process for these ingredients.
Document 7: FOI 25-0169: TGA Invitation for Industry Agenda-Setting
Official Correspondence Demonstrating the Formal Process for Industry Influence on the TGA’s Regulatory Priorities.
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This document is an official 'Call for agenda nominations' issued by the TGA’s ComTech Secretariat for the meeting scheduled in May 2025.
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The correspondence invites industry representatives to nominate topics for inclusion in the upcoming meeting agenda. It was sent in March 2025, during the same period the regulator was reviewing internal toxicological data regarding sunscreen ingredients such as Homosalate and Oxybenzone.
Document 8: FOI 25-0169: Analysis of TGA's Pre-Decisional Consultation on Sunscreen Ingredient Scheduling
Direct Evidence of TGA Branch Head Avinash Clarke Ceding Influence Over Regulatory Process Design to Accord and the Broader Chemical Lobby.
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This "Proposed Project Plan," released under FOI 25-0169, outlines the TGA's administrative roadmap for the potential scheduling of sunscreen ingredients.
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The document was disseminated by TGA Branch Head Avinash Clarke to industry bodies, including Accord, in March 2025, with a request for their "comments/suggestions" on the proposed approach.
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The plan details a strategy involving the "stratification" of ingredient application categories and sets out a timeline for public consultation and the consideration of regulatory impacts. It serves as a record of the pre-decisional consultation process undertaken by the regulator with industry stakeholders.
Document 9: FOI 25-0169: Industry Inquiry Regarding the Integration of Commercial Impact Data (March 2025)
Correspondence from the Accord industry body regarding the sequence of regulatory impact analysis in the sunscreen scheduling process.
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This document is an email sent by the Accord industry body in response to the TGA’s "Proposed project plan" for the scheduling of sunscreen ingredients.
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In the correspondence, the industry representative seeks clarification on the TGA's decision-making process, specifically questioning if "regulation impact consideration will only occur after the decision is already made."
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The email records a request that decision-makers have access to commercial information—including the "number of products impacted" and the "impact of different transition times"—to "inform them before they make their decision" regarding the scheduling of specific ingredients.
Document 10: FOI 25-0169: Confidential Draft TGA Safety Review (June 2021)
An earlier internal toxicology assessment drafted one year prior to the final 2022 review.
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This document is a "Confidential" draft of the TGA's literature review, dated June 2021.
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It confirms that the TGA had collated data regarding the safety profile and "Margin of Safety" calculations for chemical UV filters a full year before the 2022 internal review was completed.
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This draft establishes the timeline of the regulator's internal knowledge regarding ingredient safety signals, demonstrating that the evaluation of these substances was ongoing within the TGA for a significant period while the ingredients remained available on the market.
Document 11: Freedom of Information (FOI) Decision 25-0169: Official Authentication of the Evidentiary Record
The Formal Government Response, Compelled by Joseph Mizikovsky's Application, Confirming the Provenance and Authenticity of All Documents in This Archive.
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This is the official Notice of Decision issued by the Therapeutic Goods Administration (TGA) for Freedom of Information request FOI 25-0169.
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It provides the definitive schedule of the documents released to VeganicSKN, confirming that the meeting minutes, internal emails, and project plans regarding sunscreen regulation are authentic government records held by the Department of Health and Aged Care.
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The notice outlines the scope of the release, verifying that these documents specifically relate to interactions between the TGA and the industry body Accord during the period where safety standards for chemical UV filters were being reviewed.
