Changeflow GovPing Healthcare & Life Sciences Veganic SKN Directed to Cease Supply and Relabe...
Priority review Enforcement Amended Final

Veganic SKN Directed to Cease Supply and Relabel or Destroy Unapproved Sunscreens

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Summary

TGA has issued an enforceable direction to Veganic SKN Limited (ACN 142 515 437) requiring the company to cease supply of sunscreen products marketed under names different from those recorded in the Australian Register of Therapeutic Goods (ARTG). The investigation found that Veganic SKN manufactured and supplied sunscreens under a single ARTG listing (AUST number) but marketed them under different product names, rendering those products not entered in the ARTG. The direction requires Veganic SKN to quarantine all affected products for relabelling or repackaging to correspond with the ARTG entry, or destroy the goods if they cannot be relabelled. Non-compliance may result in civil or criminal penalties.

“The TGA's investigation found that Veganic SKN manufactured and supplied sunscreen products under a single ARTG listing (AUST number), but that those products were marketed under different product names to that recorded in the respective ARTG entry.”

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GovPing monitors TGA Australia Media Releases for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 11 changes logged to date.

What changed

TGA has issued an enforceable direction to Veganic SKN Limited under section 42YT of the Therapeutic Goods Act 1989, requiring the company to immediately cease supply of sunscreen products that are marketed under names different from those recorded in the ARTG. The direction also requires the quarantine of all affected stock for either relabelling to match the ARTG entry or destruction. Under the Act, therapeutic goods including sunscreens must be entered in the ARTG before lawful manufacture and supply in Australia, and product labels must accurately reflect the ARTG entry details.\n\nAffected parties manufacturing or supplying therapeutic goods in Australia should review their product naming and labelling practices to ensure consistency with ARTG entries. Any mismatch between marketed product names and registered names creates a compliance risk, as TGA has demonstrated willingness to pursue enforcement action in this area. Sponsors with multiple branded product variants should verify that each variant is separately and correctly entered in the ARTG.

What to do next

  1. Cease the supply of sunscreen products that are taken to not be entered in the ARTG
  2. Quarantine all affected products for relabelling or repackaging so that they correspond with an ARTG entry
  3. Destroy the goods if the products are not relabelled or repackaged to comply with the Act

Penalties

Failure to comply with an enforceable direction may result in further regulatory action by the TGA, including civil or criminal penalties.

Archived snapshot

Apr 24, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Veganic SKN directed to cease supply and relabel or destroy unapproved sunscreens

Published

23 April 2026

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    • Email The Therapeutic Goods Administration (TGA) has issued an enforceable direction to Veganic SKN Limited (ACN 142 515 437) (Veganic SKN) on the basis that a delegate of the Secretary believes, on reasonable grounds, that Veganic SKN is not complying with the Therapeutic Goods Act 1989 (the Act), by unlawfully manufacturing and supplying therapeutic goods that are not entered in the Australian Register of Therapeutic Goods (ARTG).

A copy of the enforceable direction, outlining the reasons that direction was given to Veganic SKN, is available at Enforceable direction: Veganic SKN Limited.

The TGA’s investigation found that Veganic SKN manufactured and supplied sunscreen products under a single ARTG listing (AUST number), but that those products were marketed under different product names to that recorded in the respective ARTG entry. These products are taken to not be included in the ARTG.

Under the Act, therapeutic goods, including sunscreens, must be entered in the ARTG before they can be lawfully manufactured and supplied in Australia, except in limited circumstances that do not apply here. Information on product labels, including the product name, must accurately reflect the details included in the ARTG entry for that product. This requirement exists for several reasons:

  • it ensures consumers and businesses can properly identify the entry in the ARTG associated with a product if needed
  • it facilitates adverse event reporting and post-market actions such as recalls, and
  • it gives the TGA visibility of the names under which therapeutic goods are being supplied. This assists the TGA in identifying instances where the name of a therapeutic good claims that it is suitable for an indication (or purpose) that is not accepted in relation to the good in the ARTG, or where the name otherwise makes the presentation of the good unacceptable. This requirement is an important part of the regulatory framework established under the Act, and helps to ensure the safety, quality and efficacy of therapeutic goods available to Australian consumers.

The enforceable direction requires Veganic SKN to cease the supply of sunscreen products that are taken to not be entered in the ARTG, and to quarantine all affected products for relabelling or repackaging so that they correspond with an ARTG entry. If the products are not relabelled or repackaged to comply with the Act, the direction requires the goods to be destroyed.

Failure to comply with an enforceable direction may result in further regulatory action by the TGA, including civil or criminal penalties.

The TGA has recently published information for industry and consumers about sunscreen labelling, which is available on the TGA website at TGA statement on sunscreen labelling practices.

Topics
- Compliance and enforcement
- Sunscreens
- Advertising

Related content

23 April 2026

Regulatory decision notices The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Veganic SKN Limited directions under section 42YT of the Therapeutic Goods Act 1989.
- ### TGA statement on sunscreen labelling practices

23 January 2026

Media releases This statement provides guidance to industry about how the Therapeutic Goods Act 1989 applies in relation to sunscreen labelling.
- ### TGA issues warning about unlawful advertising of listed medicines

27 May 2021

Media releases The TGA is warning sponsors not to advertise listed medicines that are not included in the ARTG with permitted indications

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Last updated

Classification

Agency
TGA
Filed
April 23rd, 2026
Instrument
Enforcement
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Enforceable direction: Veganic SKN Limited

Who this affects

Applies to
Manufacturers Retailers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Therapeutic goods compliance Sunscreen supply ARTG registration
Geographic scope
Australia AU

Taxonomy

Primary area
Consumer Protection
Operational domain
Compliance
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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