Aussie sunscreen recalled over SPF fail was already under scrutiny in US
An Aussie sunscreen maker at the centre of a sunscreen scandal had their shipments placed on a “red list” by US authorities after repeated failures during inspections.
An Australian manufacturer at the centre of the sunscreen scandal repeatedly failed to follow manufacturing standards during inspections and had their shipments placed on a “red list” by US authorities.
Records seen by the Herald Sun reveal Wild Child laboratories – which produced more than 20 sunscreens for various brands using a base formula that had a lower than intended SPF level – has previously come under scrutiny in the US.
The US’s Food and Drug Administration inspected the laboratory’s drug manufacturing processes against US standards last year, and issued an “official actions indicated” – meaning an “unacceptable state of compliance” – for the third time in a row.
FDA auditors – who inspect overseas manufacturers who wish to sell goods to the US – had also found the laboratory failed to follow “good manufacturing practice” (GMP) in multiple areas in 2022 and 2019.
The inspections were all carried out before consumer group CHOICE tested multiple sunscreens’ SPF levels, sparking a chain reaction that ultimately led to Ultra Violette’s Lean Screen and several other similar products, all Wild-Child made, being recalled.
The Herald Sun is not suggesting that Wild Child is to blame for their products’ lower SPF results, and the Australian regulator – whose investigation is ongoing – did not identify any manufacturing issues in a recent inspection.
The FDA records show auditors found issues across several areas, including a failure to “fully follow” procedures for quality control during their inspections.
Some citations were fixed by the next inspection, but some – such as a citation for their “failure to thoroughly review any unexplained discrepancy” – were issued all three times.
The laboratory has also been listed on a public FDA “red list” – which gives US authorities greater rights to seize shipments – of “firms which have not met drug GMP” (Good manufacturing practices) for several years.
The Herald Sun can also reveal the FDA issued a warning letter to Wild Child in 2019, stating there were “significant violations” – against U.S. standards – found during an inspection.
“Your firm does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality,” the letter said.
“Our inspection also found instances where batches of (redacted) were manufactured using significantly different (redacted) parameters.”
Wild Child has switched locations since the letter was issued, and in its response to the FDA’s letter, said some of the issues raised would not be considered breaches under Australian practices.
A TGA spokesman said they were aware of the FDA’s findings over the years but refused to say whether they had taken any action as a result.
“The identification of deficiencies does not necessarily suggest a problem with product quality,” he said.
“It is not uncommon for deficiencies to be identified during GMP inspections.
“The TGA does not comment on any ongoing manufacturing inspections or investigations, or other agency’s inspection findings.”
Wild Child has been contacted for comment.
The FDA documents are the latest development in a lengthy saga that kicked off when SPF testing, commissioned by CHOICE and released in June, cast doubt on multiple sunscreens SPF50+ claims.
Australia’s Therapeutic Goods administration has publicly acknowledged there are reliability concerns with an overseas SPF testing laboratory but is otherwise tight-lipped on the ongoing investigation.
Experts are unanimous in urging the public to continue to use sunscreen, pointing out that – bar the no longer available Lean Screen – the products tested by CHOICE all had an SPF of at least 24.
Cancer Council, whose own products were called out by CHOICE, said while they always recommend choosing the highest possible SPF, “the difference between SPF ratings is often misunderstood”.
“When applied correctly, SPF 20 filters about 95 per cent of UVB rays, allowing 5 per cent to penetrate, compared with SPF 50, which filters 98% allowing 2% of UVB to get through.”
Australia sunscreen regulation expert John Staton said – with the exception of Lean Screen – none of the products tested by CHOICE had an SPF that was low enough “to say the products don’t work”.
The TGA has repeatedly urged consumers to continue to wear sunscreen as well.
