Exclusive Q&A: New FDA sunscreen filter to transform market & standards

Sponsored Content

In this exclusive conversation, we caught up with Brian Ecclefield from Validated Claim Support. For the first time in over two decades, a new sunscreen filter is nearing FDA approval, marking a pivotal moment for the US market. From improved formulations and inclusivity to heightened scrutiny around SPF claims and testing integrity, this development signals major change. Here, Brian discusses regulatory progress, consumer trust, and how AI is reshaping clinical validation.

This has been a long time coming!  At the time of responding to this question, we still don’t have a final approval, and I certainly don’t want to jinx anything.  

That said, FDA is deep in final review and Health Canada has already approved Bemotrizinol up to 6%, so major changes in North America are inbound.  This will lead to a greater harmonization of international sunscreens, since North America has a severely limited pool of Active Ingredients when compared to Europe, Asia, and Australia as the major sunscreen markets.

For consumers, this will lead to better formulations that blend mineral and chemical filters, which will particularly help people of darker skin types and complexions who may struggle with the “whitening effects” of high concentrations of zinc and titanium filters.  

There has always been a lot of debate on these topics! It’s more in the public eye at the moment as a result of some major multinational laboratory fraud.

In the past 10 years there have been 2 major labs who have been called into question for their SPF data, and the industry has learned that label claims are only as good as the laboratory that certified them.  This has led to a lot of skepticism in the global markets, resulting in class action lawsuits and dozens of recalls.  

As a result of the new ingredient being added to the monograph, it’s a great time for companies to phase out some of their older product lines if they may have been knowingly impacted by such testing.  There is no better time to “quietly” remove products from shelves and replace them with newer formulations without the need for recalls.

We are being asked all the time whether AI is going to reduce the costs/prices of our clinical studies - there are definitely some areas where cost efficiencies are going to be realized.

One major space for development is in photographic analysis, which has always heavily relied on algorithms and backend calculations to determine changes across different timepoints.  AI is streamlining these processes on almost a daily basis - there are entities out there that charge 10’s of thousands of dollars just to assess the images that have already been captured.

I believe we will see AI significantly level the playing field in this “visual claims” field first.  The biggest variable in clinical testing is human skin - and I don’t know if the models will ever be good enough to completely rule out the benefits of consumer in use testing.

Most clinical studies and claim support packages now involve a combination of sensory or subjective outputs as well as measured or defined objective endpoints.  The simplest way to describe the difference is that sensory equates to the look, smell, and feel of products and how they impact daily life. Claims like “93% of women agreed that their skin felt smoother and more supple” would lean on sensory feedback (feel/felt).

On the objective side, an instrument or a third-party evaluator would be assessing the skin or the hair of an individual over defined timepoints. This is where claims like “Improves the skin barrier” or “Increases hydration by up to 128% in as little as one use” stem from - there is no “sensory modifier word” like “felt, saw, or noticed.”  The claims are stated as an objective fact.  Both techniques are important and commonly used, it’s really important not to misconstrue one for the other.

Validated Claim Support will be exhibiting at in-cosmetics Global this year.

Validated specializes in 4 main types of clinical testing to support claims:

• Expert Objective Clinical Grading
• Subjective User Perception
• Biophysical Instrumentation
• Clinical Before and After Photography

Onto the product/service we provide:

Validated Claim Support is a Skincare Clinical Testing Laboratory that conducts in-vivo (consumer/human) studies to determine how well products work.  We are decidedly “clinically” focused – we don’t do stand alone at home consumer perception studies, and our expertise is measurable endpoints – think clinical studies where participants, not @ home user consumer perception.

We conduct Expert Grading of visible changes in the skin and hair, biophysical instrumentation for things like hydration via electroconductivity, skin firmness and elasticity, surface sebum content, skin colour, skin texture, fine lines and wrinkles, and a wide range of other endpoint as well.

We test skincare, medical devices, OTC level ingredients, and a wide range of cosmetics (we also get into nutraceuticals but that’s less directly relevant). We’re FDA Registered and Inspected, and we ran over 70 completely custom clinical studies last year – many of which were for brands who you’ve already hosted. 

I founded VCS in 2018 as an “Alternative to the CRO (Clinical Research Organization) Status Quo” after having left two different laboratories over what I’ll call “unreconcilable ethical differences,” which proved to be extremely well founded.

The owners of both companies have been in international news for fraud, and from my perspective, there is a very good reason.  I can tell you this, with 100% certainty. . . Skincare claims data that looks too good to be true is most definitely too good to be true!  That’s not to say that there aren’t highly effective products out there, but nothing is 100% effective 100% of the time.  This is a whole exciting topic in upon itself, and I’d be happy to chat more about it at a later time. 

Find out more about Validated Claim Support here

Looking for something else?