Sunscreen SPF testing by AMA Laboratories

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 - external site 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. Since late 2019, the TGA has been conducting post-market compliance reviews of sunscreens that may potentially be affected by fraudulent testing by AMA Laboratories. The TGA has also been actively engaging with the sunscreens sponsors to assess the impacts on their products.

At the present time, the TGA does not have any evidence that those sunscreens that have been tested by AMA Laboratories are less effective than claimed. The SPF rating of a product depends on the types and quantities of the sun protection ingredients it contains. The TGA continually reviews sunscreens on the market to ensure they meet appropriate regulatory requirements, including that they contain the claimed ingredients that provide sun protection. For example, testing of a variety of commonly used sunscreens was completed by the TGA laboratories in 2017 and showed that all products tested contained the correct levels of ingredients, as specified on their labelling, and complied with the Australian regulatory guidelines for sunscreens for content of sun protection ingredients. On the basis of continued monitoring, the TGA has confidence that sunscreens on the ARTG contain the necessary ingredients claimed to provide sun protection.

However, given the importance of consumers being able to rely on sunscreens working as claimed, the TGA is implementing additional interim regulatory measures as part of its post-marketing compliance monitoring activities. These will ensure that potentially affected products can continue to be supplied in Australia until further SPF testing can be conducted by an independent laboratory. The TGA will require that sponsors provide adequate justification for ongoing supply of their products that have been tested by AMA Laboratories. This could include additional supportive testing data on comparable products in their product line or from product development studies, or other robust scientific justification that substantiates the claimed SPF rating.

These measures will ensure there is minimal impact on the availability of sunscreens to Australians during the coming summer.

Information for consumers

On the basis of the available evidence and the steps the TGA is taking, consumers can continue to have confidence in the sunscreen products currently available on the Australian market when used as directed on the label.

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 will be contacting potentially affected sponsors of sunscreens to request information about the impacts of AMA Laboratories testing on their products. The TGA will be engaging with sponsors to ensure interim measures are in place to allow further supply of affected products into the Australian market until such time as testing by another laboratory can be performed.