Eight sunscreens that failed their SPF claims tested by same lab, Princeton Consumer Research

Australia Broadcast Center

2 days ago

At least half the sunscreens that failed to meet their SPF claims in recent testing had their original SPF certification conducted at an overseas laboratory whose test results are now being called into question by senior industry experts.
An ABC investigation can reveal that the lab, Princeton Consumer Research (PCR), is used by a wide range of sunscreen makers to verify their SPF claims before they are allowed on the Australian market.
Consumer group Choice released test results from an Australian lab for 20 popular sunscreens last month and found that 16 of them did not meet their SPF 50 label claim, including one that returned an SPF result of just four.
In response to the findings, the brands said they had their own original testing showing their SPF was compliant.
The ABC can reveal that at least eight of those tests were performed by Princeton Consumer Research, which returned significantly higher SPF results than the Choice testing.
A number of senior industry experts have raised concerns about PCR's testing methodology and calculations.
Mathias Rohr, one of the world's top sunscreen testing experts, said he had never seen results like PCR's in his entire career, while another senior sunscreen scientist told the ABC the results warranted investigation.
The ABC has confirmed that the underperforming sunscreens which used PCR for their initial SPF validation include three Cancer Council products, one Woolworths sunscreen, one Coles sunscreen, one Ultra Violette sunscreen, one Bondi Sands sunscreen and a Sun Bum product.
Another two sunscreens that met their SPF 50 label in the Choice testing — a MECCA sunscreen and a Cancer Council Kids sunscreen — used PCR, with the PCR lab returning much higher SPF results.
Ultra Violette's Lean Screen SPF50+ Mineral Mattifying Zinc Skinscreen returned the worst result in the Choice testing, with an SPF of just four.
Ultra Violette rejected the Choice result and published two of its own tests conducted by PCR — one commissioned immediately after the Choice investigation, as well as its original testing.
Both returned an SPF value above 60.
But industry experts have raised serious concerns about the reliability of PCR's testing for Ultra Violette.
In SPF testing, a panel of ten volunteers is exposed to UV rays with and without sunscreen applied. The readings are then used to calculate an SPF result for each volunteer. The mean of those results is the final SPF.
Mathias Rohr, chief operating officer of the Germany-based Normec Schrader Institute, described the SPF results in PCR's original report as "quite surprising".
In an email, Dr Rohr said there was very little variation in the SPF number recorded for each test subject.
He said his lab had conducted SPF testing for decades, spanning more than 1,000 products a year, and that "a table of results including only two different numbers is quite surprising for me".
"In my entire career, we have not [had] such homogeneous results in an in vivo [human] SPF test," Dr Rohr said.
The institute was engaged by Choice to conduct a specific "validation" test on Ultra Violette's product, because the SPF results were so low compared to the other sunscreens.
The validation test returned an SPF result of five, in line with Choice's original result of four.
Ultra Violette criticised the validation test as it was performed on a smaller panel of people than the original.
Two other experts not involved in Choice's testing agreed that the lack of variation in individual SPF test results was a red flag.
One industry scientist who looked over a number of PCR's test results told the ABC it was "unusual to see this kind of spread of SPF results" and it "would never happen in real life".
"All I could do would be to suggest, recommend that they investigate that data because it doesn't look realistic."
While he said there may be a valid explanation for the uniformity of data, "I don't have any explanation for why that has happened like that".
An expert scientific statistician who looked over the same PCR results agreed.
He said this type of test procedure could generate identical values "more often than one might suspect" but he said, "it does seem odd that they're lining up that cleanly".
"There is no obvious data manipulation as far as I can tell, however it is odd how frequently the same numbers appear for different individuals and in different tests," he said.
"It seems unusual, and I would ask the lab people about why they're getting that."
PCR technical director Barrie Drewitt, who is also one of the lab's principal investigators, defended the results.
While conceding the uniformity of SPF values was "uncommon", he insisted it was "not inherently implausible, particularly with high-performing products and consistent application across a controlled test environment".
A spokesperson for Ultra Violette said it had now "engaged another [separate] lab to re-test the SPF of the product".
"That testing is currently underway."
The spokesperson added that because PCR is an internationally accredited lab, "we've never had reason to doubt the accuracy of the lab's results".
The Cancer Council's PCR reports released to the ABC display a similar lack of variability in their individual test subject results.
Of the four Cancer Council products tested by Choice, three didn't meet their SPF label claims and one did.
In one test, nine of the ten volunteers received exactly the same results, while in three other tests, the results of eight volunteers were identical.
Another PCR technical director, Jack Donnelly, conceded that the lack of variability was not as common as more variation between subjects.
"However, it is not rare to see. It just so happens the test results you are observing have a consistent SPF value between each subject," he said.
In a statement, the Cancer Council said it was committed to providing high quality, reliable sunscreens.
"The Choice findings have raised questions about the accuracy of SPF test results, and we are investigating the matter thoroughly."
It said the organisation had already submitted all four products tested by Choice to a different independent international laboratory.
"Princeton Consumer Research is a commonly used facility for SPF testing across the industry," it said.
The Cancer Council spokesperson said that even sunscreens that scored lower than their SPF label claim still provided protection.
"It is important to keep using sunscreen … What matters most is using any broad-spectrum sunscreen correctly and consistently."
The ABC investigation has also discovered that in 2010, Mr Drewitt was disqualified from being a company director in the UK for eight years, for financial mismanagement at a previous testing firm.
Euroderm Research went into liquidation in 2008, owing creditors more than 500,000 British pounds ($1,037,307).
Mr Drewitt was also accused of fabricating clinical trial data in 2006 and 2007 at Euroderm Research.
According to media reports, Mr Drewitt and others at the company were charged with contravening the Medicines for Human Use (Clinical Trials) Regulations in 2011.
However, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) presented no evidence for these charges at the trial, and the charges were withdrawn.
The judge ordered the jury to find Mr Drewitt and his co-defendants not guilty.
The ABC is not suggesting any wrongdoing by Mr Drewitt in relation to the historical charges that were dismissed.
Mr Drewitt did not comment on his directorship disqualification, but said in a statement that the clinical trial charges were laid over a decade ago and "thrown out of court".
"It is also worth noting that I was not an owner nor a director of that company. I was an employee.
"The claims were not only dismissed but effectively proven to be without merit.
"It is deeply misleading to suggest otherwise or to infer wrongdoing from a matter that was legally resolved in our favour."
He added that the historical accusation had "no bearing on the company I currently am employed by [Princeton Consumer Research]".
"Our methodologies, data integrity, and quality control processes are robust and verifiable," Mr Drewitt said.
The Therapeutic Goods Administration (TGA), which regulates sunscreens in Australia, told the ABC it was recently made aware of Mr Drewitt's previous business record.
However, the TGA told the ABC it did not directly regulate SPF testing by third-party labs such as PCR.
Instead, it relied on self-certification by sunscreen manufacturers that their products met all regulatory requirements.
"As such, the TGA does not hold information regarding whether PCR is engaged by a majority of sunscreen sponsors," a spokesperson said.
"The TGA is investigating the Choice findings and will take regulatory action as required," the spokesperson said.
The Cancer Council told the ABC it was committed to working closely with the TGA as they progressed their investigation.
Campbell Richards, CEO of Baxter Laboratories, one of Australia's largest sunscreen manufacturers, which engages laboratories including PCR for testing, said the company took questions around the integrity of sunscreen testing seriously.
"Confidence in SPF testing is a priority for us and for our partners. We recognise the significance of this moment for the category and are committed to contributing to clarity and trust across the sector," Mr Richards said.
"We are monitoring developments closely and remain focused on ensuring that the products we are responsible for meet the expected standards of safety, efficacy, and regulatory compliance," he said.
A TGA spokesperson also reiterated that sunscreen was "an important measure to prevent harmful effects of ultraviolet radiation, in addition to seeking shade, wearing a wide-brimmed hat, wearing protective clothing and using sunglasses".
The ABC approached all the other companies that had products which underperformed in the Choice review and used PCR for their original SPF certification.
A spokesperson for Woolworths said all its own brand sunscreens were regularly tested as per Australian regulations.
A spokesperson for Coles said as soon as it became aware of Choice's query it conducted a review, and its product met the necessary requirements.
The ABC has confirmed Bondi Sands's underperforming sunscreen in Choice's review, its SPF 50+ Fragrance Free Sunscreen, also used PCR for its original testing.
A spokesperson for Bondi Sands did not respond to specific questions about PCR's testing but said "we choose our manufacturing partners and testing laboratories carefully based on our high quality and safety standards".
Sun Bum didn't reply to a series of questions, but the ABC has confirmed its product, which received an SPF rating of 39.5 in the Choice review, also had its validation SPF testing conducted by PCR.
Aldi, Banana Boat, and Nivea also returned SPF results lower than their advertised claims in Choice's investigation, but would not disclose which labs conducted their testing.
Neutrogena had one product that didn't meet its label claim, and told the ABC it didn't use PCR for its SPF testing for that product.
In a statement from Invisible Zinc, which also didn't meet its label claim, said its testing was performed at an Australian lab, and not PCR.
The MECCA sunscreen met its SPF claim according to the Choice review.
A spokesperson for the company said it used PCR.
"We are incredibly passionate about SPF and we take the formulation and testing of our sunscreen protection products extremely seriously," the MECCA spokesperson said.
La Roche Posay's product also met its label claim but the company did not respond to the ABC's questions about which sunscreen lab it used.