On 21 February 2019, the US Food and Drug Administration (FDA) issued a proposed rule (the tentative final Sunscreen Monograph) with updated regulatory requirements for over-the-counter sunscreen products in the United States, describing the conditions under which products are generally recognized as safe and effective (GRASE).
This government pronouncement leaves only two of sixteen UV filter active ingredients that are currently used in sunscreen products within the United States defined as GRASE, also triggering consumer uncertainty around sunscreen safety.
For twelve of the remaining UV filters, additional safety data are needed to support GRASE status, requested by the FDA in the face of changing conditions such as increasing sunscreen usage and evolving information around potential risks associated with sunscreen products since their initial evaluation. Importantly, the FDA has clearly indicated that this request for more data “does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens”.
In response, the Personal Care Products Council (PCPC) Sunscreen Consortium was formed to support and defend the GRASE status previously held by seven commonly used UV filters, with the aim of ensuring that adequate UV filters remain available to protect the US population from the dangers of UV exposure.
Here we provide an overview of the challenges presented by the proposed FDA Sunscreen Monograph Administrative Order, and introduce the PCPC Sunscreen Consortium and its ongoing work within the UV industry.
Under the FDA’s Proposed Tentative Final Sunscreen Monograph, zinc oxide and titanium oxide are the only two of sixteen active ingredients currently used in sunscreen products that are now recognized as GRASE. Aminobenzoic acid (PABA) and trolamine salicylate have been deemed as not GRASE due to safety issues, and the remaining twelve UV filters require further efficacy and safety data to attain GRASE status.
While the industry as a whole supports efforts to see that all of the available UV filters attain GRASE status, the timeline to fully meet the testing requirements proposed by the FDA is extensive and complex. Significantly more data are now required, presenting the need for time- and cost-intensive tiered studies (approximately $10-$12 million per filter) (Fig. 1).
With only a handful of UV filters available, defending the status of each active ingredient at risk is essential to ensure that we have the means to develop an adequate range of safe and effective sunscreen products that consumers can be confident in – particularly as skin cancer rates continue to climb globally. An estimated 2-3 million non-melanoma and 132,000 melanoma skin cancer cases are recorded each year, with 1 in every 3 cancers diagnosed being a type of skin cancer (source: World Health Organization).
In response to the FDA’s Sunscreen Monograph, and with support from an array of suncare experts and UV ingredient and product developers from across the industry, the PCPC Sunscreen Consortium was formed.
Chaired by Carl D’Ruiz of DSM, the PCPC Sunscreen Consortium is working in close exchange with the FDA to defend and support the previous GRASE status of UV filters under the FDA’s Sunscreen Monograph, and to establish a suitable FDA approach for alternative testing.
The PCPC Sunscreen Consortium is formed of four key working groups (Fig. 2):
Lead: C. D’Ruiz, Senior Manager, Regulatory, Scientific and Government Affairs, DSM
Responsible for developing comprehensive strategy for coordinating, communicating, and aligning technical group activities with FDA and other government entities.
Chair: J. Nash, Director, Procter & Gamble
Responsible for evaluating toxicological data and generating risk assessments for each UV filter.
Acting Chair: A. Kowcz, Chief Scientist, EVP Science, Personal Care Products Council
Responsible for ID labs and developing test protocols for proposed IVPT and clinical MusT studies; and for collecting and summarizing existing company data for dermal safety.
Chair: A. Kowcz, Chief Scientist, PCPC
Responsible for developing and testing appropriate formulations and dosage forms for MusT studies.
The PCPC Sunscreen Consortium is currently defending and supporting the GRASE status of seven UV filter active ingredients:
The FDA has indicated that if a satisfactory indication of timely and diligent progress on the necessary studies for a specific ingredient is received, then it would be prepared to initially defer issuance of a revised final order regarding the status of sunscreens containing that ingredient annually.
The PCPC Sunscreen Consortium intends to provide further detailed clinical and non-clinical information regarding the progress being made to support the safety of the ingredients being sponsored and its intention to work with the FDA to find ways to avoid unnecessary testing in this process. More specifically, for the UV filters now in question, the PCPC Consortium is committed to addressing the toxicological endpoints identified by the FDA in the 2021 Proposed Final Order for Sunscreen products and will propose a path to address these endpoints and establish GRASE for the seven UV filters, including data which already exists together with supplemental data that utilize non-animal approaches and human data from clinical studies (e.g. required MUsT).
The PCPC Sunscreen Consortium will also propose that new alternative methods and validated scientific approaches are established to confirm the safety of the ingredients. As well as aiming to reduce time and cost and increase regulatory efficiency, this includes a proposed non-animal safety testing approach that uses alternative methods for evaluation of carcinogenic potential, the developmental and reproductive toxicity (DART) and endocrine hazards/risks of the seven UV filters to supplement existing data.
At DSM, like most other developers within the sunscreen and cosmetics industry, we are committed to do all we can to avoid and limit the use of animal testing by using proven alternative methods accepted by authorities wherever possible. We are therefore working towards the validation of alternatives to animal testing as proposed and supported by the PCPC Sunscreen Consortium – such as those envisioned in the National Research Council report ‘Toxicity Testing in the 21st Century: A Vision and a Strategy’ (Tox 21) (2007), the FDA’s ‘Predictive Toxicology Roadmap’ (2017) and the National Academies of Sciences, Engineering and Medicine report ‘Using 21st Century Science to Improve Risk-Related Evaluations’ (2017).
Skin cancer is a significant and largely preventable public health concern, and every day that consumers actively avoid sunscreens due to misplaced concerns regarding their safety puts them further at risk.
The focus of the PCPC Sunscreen Consortium, as well as DSM and the Sun-Safe Society, will therefore remain on ensuring the availability of safe and effective sunscreen ingredients and products with adequate SPF. To this end, we as an industry will continue to work alongside the FDA to prove the safety and attain GRASE status for a broad range of UV filter active ingredients.
The PCPC Sunscreen Consortium already has a long and growing list of achievements to date – a list of which is available at the end of this article. In terms of priorities for the coming weeks, the Strategic Advisory Team has laid out next steps and recommendations to support discussions with the FDA, all of which will help us achieve a final set of requirements that does not entail UV filters being regulated as drugs with the same amount of supporting data.
This includes, for example, outreach to the FDA to gain further clarity on administrative procedures and to advance the next phase of IVPT studies for proposed formulations using the active ingredients.
As we continue our work, further updates will be shared in the Shining a Light on Regulation section – stay tuned.