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Sunscreen testing by AMA laboratories - Condition of Listing
The TGA has taken action to ensure the effectiveness of some sunscreens on the Australian market that may be affected by potentially fraudulent laboratory testing that has been reported in the United States of America (USA). The TGA's action will ensure there is minimal impact on the availability of sunscreens to Australians while maintaining confidence in their performance.
All sunscreens on the Australian Register of Therapeutic Goods (ARTG) must be tested to verify the claimed sun protection factor (SPF) rating prior to marketing. The sponsors of some sunscreens on the ARTG have in the past engaged AMA Laboratories, a company based in the USA that conducts testing for skincare, haircare, cosmetics and drug products, including sunscreens, to conduct SPF testing for their products.
In August 2019, the United States Department of Justice announced that an investigation by the United States Food and Drug Administration (FDA) led to several executives and supervising laboratory technicians of AMA Laboratories pleading guilty to wire fraud resulting from alleged fraudulent laboratory testing. The potential that fraudulent SPF testing data may have been relied upon to support the SPF claims of some sunscreens on the ARTG and supplied into the Australian market is of concern.
In view of this concern, in late 2019, the TGA commenced post-market compliance reviews of sunscreens that may potentially be affected by fraudulent testing by AMA Laboratories as well as actively engaging with the sunscreens sponsors to assess the impacts on their products. On 15 June 2020, the TGA published a web statement advising of its concerns regarding the reliability of test data provided by AMA Laboratories in light of these investigations in the US and that additional regulatory measures were being considered to address these concerns.
On 7 September 2020, the TGA wrote to all sponsors of Australian sunscreens notifying them of the TGA's proposed interim regulatory measures to safeguard the continued access of Australian consumers to reliable sunscreens. The TGA has now implemented these measures as part of its post-market compliance monitoring of sunscreens. The measures require that sponsors provide adequate justification for ongoing supply of their products that have been tested by AMA Laboratories, such as additional supportive testing data conducted by an independent testing laboratory.
Information for consumers
The TGA has taken action to ensure the effectiveness of some sunscreens on the Australian market that may be affected by potentially fraudulent laboratory testing that has been reported in the United States of America (USA). The TGA's actions will ensure there is minimal impact on the availability of sunscreens to Australians during the coming summer while maintaining confidence in their performance.
At the present time, the TGA does not have any direct evidence that those sunscreens that have been tested by AMA Laboratories are less effective than claimed. However, consumers and health professionals are encouraged to report any problems with sunscreens to the TGA, as these will contribute to the TGA's ongoing monitoring of these products.
Information for sponsors
The TGA has imposed a condition on the listing of all sunscreens on the ARTG that requires testing results from AMA Laboratories are supplemented with additional justification by the sponsor in support of the efficacy of their sunscreen. The condition makes it clear that it is the responsibility of the sponsor to ensure they can substantiate the efficacy of their sunscreen where testing results from AMA Laboratories are held to demonstrate compliance with the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products-Evaluation and classification (the Sunscreen Standard).
Sponsors should ensure that they:
- hold evidence to confirm the validity and accuracy of the SPF, broad spectrum and water resistance claims for the product; and
- Provide this evidence to the TGA for evaluation and approval, when requested (within 10 working days of the request, unless otherwise agreed by the TGA, upon request by the sponsor).
Rather than holding additional evidence or justification, sponsors may instead consider having their sunscreens tested by an approved testing facility other than AMA Laboratories Inc. Testing conducted by an alternative facility will be considered acceptable where it meets the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products-Evaluation and classification (the Sunscreen Standard) without any additional evidence or justification needing to be provided to the TGA under the condition of listing.
Further technical advice for sponsors to comply with the Condition of Listing
Where testing conducted by AMA Laboratories Inc. has been relied upon, then supplementary data must be held. The following factors should be considered:
- The test methodology used should adhere to best practice according to contemporary scientific literature.
- For any in-vitro testing in support of SPF, broad spectrum or water resistance claims, the method must be validated.
Testing data held for a comparable formulation from an approved facility, may be considered acceptable where the active ingredients and their quantities are the same. The sponsor is expected to provide adequate scientific justification to demonstrate how these two products with slightly different formulation, are expected to perform the same in SPF, broad spectrum and/or water resistance claims.
If sponsors propose to rely on a justification other than in-vitro testing data or testing on a comparable formulation, they should contact the TGA to confirm whether their proposed other justification is adequate.