THE UNTOLD STORY.
In 2017, AMA Laboratories in New York was raided by the FBI for falsifying test results and providing misleading declarations to cosmetic companies. They are the largest tester of SPF Sunscreens in the Asia-Pacific. It is a fact, that many sunscreens being sold in Australia (including those being manufactured in Australia) are tested in the United States of America and Europe to provide documentation for submission to the TGA
(Therapeutic Goods Administration) for registration.
Scores of people in Australia have reported severe burns and skin irritation despite using the Cancer Council’s Peppa Pig-branded product and Banana Boat’s SPF 50+ while out in the sun. It is also a fact, that many registered SPF 50 sunscreens on the market, when tested in vivo (on human skin, in natural conditions), come back with a far lesser SPF rating than what is being claimed.
It’s a troubling topic – after all, this is the stuff designed to protect us against skin cancer, a life threatening disease that one thousand Australians are treated for every day. Of course, the importance of wearing a sunscreen or modern environmental protector is not being questioned here.
What we need to consider is:
1. The individual user’s comprehension of what SPF use means for their sun exposure time
2. The validity of the SPF claims being made and the subsequent ‘false-hope’ marketing that factor provides about protection from harmful sun exposure.
WHAT IS AN SPF?
Sun Protection Factor is best described as a ‘Delay’ Factor i.e. how long you can spend out in the sun, before your skin cells go into trauma. This will vary for each individual but, on average, skin cells without protection go into trauma in 3-4 mins, in the middle of the day.
A consumer must understand that if they can spend 3 minutes in the sun before their cells go into trauma, the application of an SPF50 will protect for 150 minutes before their skin reaches the same point of trauma.
Further, the most common misconception is that by reapplying sunscreen throughout the day, protection time can be extended past the SPF rating calculation. THIS IS A FALLACY.
Once your cells are ‘cooked’ for the day – they’re cooked. Once you’ve experienced your daily dosage, regardless of how much more sunscreen you apply, the cellular functions become impaired and mutation can occur.
Once this is understood, the issue becomes the question of whether the SPF you’re applying is in fact providing the SPF being claimed.
It should be noted that SPF does not relate to protection against reactive oxygen species, pollution, accelerated cell turnover, increased dehydration, infrared radiation or high energy visible light.
HOW IS AN SPF TESTED HERE IN AUSTRALIA?
In Europe, SPF registration is governed by the EU Cosmetics Directive and administered by the EU Health Commission. The standard requires both in-vivo (live human response) and in-vitro (chemical analysis) testing to ensure product reliability. All products produced and imported must provide validated in vivo certification before sale. In Australia, however, SPF ratings are licensed by the TGA, based on an analytical composition of the formula and an undertaking by the ‘sponsor’ (manufacturer or marketer) that an in vivo SPF test has been conducted.
Professor Sanchia Aranda, Cancer Council Australia, spoke with the ABC explaining the TGA’s involvement in testing, “While the TGA don’t specifically audit the laboratories for formulas, they do audit the goods manufacturing process that’s laid down for those things to be done”. The question must be asked – How does auditing the manufacturing process validate a claimed SPF? In this same ABC article it was reported, “The TGA Spokeswoman said the TGA does require ‘sponsors’ to undertake SPF testing for sunscreens. All testing is done under an international ISO standard”.
But what if the testing was conducted by the major global testing facility under investigation for falsifying documents?
John Staton runs Dermatest, the number one analytics and in vivo testing company in Australia and the only independent laboratory testing sunscreens in Australia. Staton says that his company conducts tests for about half of the sunscreens on the market, whilst the remaining half would be tested overseas.
“Nowhere in the world are there audits of the labs that do the testing” Staton told the ABC in 2017. “The TGA, as far as I know, doesn’t test anything, they actually rely on submissions that are put to them and they can do analytical testings but that’s different to actually testing if the product really works in the marketplace as used by consumers”.
Published in the DERMATEST Newsletter in July 2015 “Earlier this year, the Consumer Reports.org published a list of 34 US SPF tests, reported from an independent US Test lab. Of these, when compared with label claim, 14 were found to be deficient according to the SPF measured in vivo.” A troubling revelation!
BANANA BOAT AND PEPPA PIG
As increasing cases of adverse reactions and severe skin burns are reported, there is a growing consumer concern surrounding SPF reliability and safety. Michael Moore, Chief Executive of the Public Health Association told the ABC, “We can see there are problems, it does point to an inadequate system with the TGA and I think it requires the TGA themselves to look at what they’re doing”.
The respective regulatory bodies around the world e.g. TGA, FDA, require submissions of clinical data by the manufacturer (sponsor) to substantiate the claims being marketed to the public. But as consumers, we have no way of verifying the validity, nor is there any information published on product packaging or marketing material that identifies the testing conditions or types of individuals on the testing panel.
mydadthechemist.com published an article in April 2018 that explained what happened when the author phoned ‘Australian Gold’, sun care and sun protection company, and asked them to share their lab results – the answer was disappointing; “The ingredients and [SPF] levels have been tested by a third party company, which we pay them to do. We do not have the test results for consumers to review.”
If tests have been conducted, paid for, and the results are positive, why wouldn’t you share them as part of your marketing strategy to instil even more confidence in the consumer’s perception of your product?
Hopefully, one day, there will be uniformity in validation, certification and consumer education explaining the practical limitations of an ‘SPF’ product. Hopefully, one day, we will see product companies and manufacturers held accountable for the claims they are making, with public declarations of their scientific data to substantiate their ‘SPF’ rating. How difficult is it to add a page with this information on their website? Sun protection should be held in high esteem by consumers, manufacturers and testing facilities alike, given its critical role in the prevention of skin cancer.
The next generation of skin protection starting to appear around the world includes the use of peptides to add layers of defence beyond simply reflection and refraction of UV rays. At present, these new formulas have no common certification developed to allow comparison in the ultimate pursuit of protecting DNA from mutations – but I’m sure that will come.