To the FDA, Sunscreen Is a Drug That Requires Animal Testing

The Rise for Animals Team, February 28, 2024

If you didn’t know that sunscreen is considered a non-prescription drug – and, therefore, is regulated by the U.S. Food and Drug Administration (“FDA”) – you’re not alone. 

And, if you didn’t know that the FDA is requiring companies to conduct new animal tests on several sunscreen ingredients that have been used by humans for decades, you’re also not alone.

In a situation that has been unfolding for some time, the FDA is demanding that sunscreen ingredients already sold to and used by humans for nearly 50 years undergo new animal experimentation (i.e., animal experimentation additional to that undertaken on the same ingredients decades ago).  

In so doing, the FDA is effectively ignoring 50 years’ worth (!) of human-relevant data that already exists and the FDA Modernization Act 2.0’s foundational interest in prioritizing human-relevant experimental methods . . . all under the guise of protecting humans by investigating “the long-term safety of these sunscreen active ingredients”.

Grievously (yet typically), the FDA’s reference to human “safety” is nothing more than a smokescreen. 

Invoking buzz words like “safety” is one of the animal research industries primary tools for currying public favor and deflecting further inquiry. To be sure, the animal research industry relies heavily on the “ethically questionable” and “negative emotional” frame of fear – i.e., the industry engages in “fear-mongering” to “block[] sympathy towards nonhumans” and against animal experimentation. Indeed, public relations experts caution that the “use of th[is] frame[] . . . should immediately trigger an alarm regarding the sincerity and truthfulness” of the message.

And, they would certainly be right in this case. Plainly, the FDA has no legitimate basis for suggesting that the absence of animal testing (much less more animal testing!) would endanger humans:

  • The ingredients at issue have been sold to humans for use for almost five decades without  any “significant or notable safety issues”.
  • Other U.S. regulatory agencies (like the Environmental Protection Agency) “assess[] the safety of [] sunscreen ingredients without the need for animal testing”.
  • Currently available, human-relevant, non-animal approaches “offer many advantages over traditional animal testing: They provide information about product safety and efficacy that is more relevant to humans because they incorporate human biology instead of relying on the biology of other animal species, they reduce development time and costs by better guiding decision-making and saving on resource-intensive animal tests, and they help companies and federal agencies meet goals to reduce and replace animal use.”

And, most poignantly of all, animal toxicology testing is both unethical and unable to predict human response any better than a coin flip.

In truth, the FDA is serving its own interests as a leading player in the animal research industry, not the interests of the public. 

Consistent with the expected character of a “regulatory” agency that has been captured by private industry, the FDA has remained “adamant about its nonclinical study requirements, which involve animal testing” and “unwilling to embrace more modern and alternative toxicological safety and risk assessment methods that minimize or eliminate the need for animal testing.”

The FDA has continued to take this position in the face of both (1) increasing domestic support “from all stakeholders for integrating nonanimal in vitro and computational methods, which rely on human cells, tissues, and data in regulatory testing”, and (2) vastly divergent international approaches. 

With regard to the latter, most other countries classify sunscreen as a cosmetic or a personal care product (rather than a drug), and many of these countries have made far greater advancements in sunscreen development than has the U.S. Yet, the FDA continues to “firmly” decline any regulatory approach more in line with other, progressive countries, asserting that – apparently in the U.S. and nowhere else? –  “a full suite of absorption and toxicology studies, including human and animal trials, is needed to ensure that the ingredients are safe.” 

We must force the FDA to act in our interests by embracing ethical, human-relevant science.

The FDA’s conflict of interest between its assigned role as a governmental, regulatory agency and its chosen role as a facilitator and partner of the private animal research industry is on clear display; and it beckons us to take action in genuine pursuit of safety for all.

Contact your Representatives in support of the FDA Modernization Act 3.0 (H.R. 7248), a bipartisan effort seeking to force the FDA to “facilitate the development, qualification, and adoption” of human-relevant, non-animal testing methods for drugs . . . including, it turns out, our sunscreen. 

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