As we laud the FDA’s recently-announced roadmap to phase out animal testing for human drugs, a critical test case has already taken shape – one that will show us whether the FDA’s promises mean real change or just more of the same.
The case? Sunscreen ingredients.
As we reported last year, the FDA treats sunscreen as a “drug” and has intended to demand new animal testing for sunscreen ingredients that have already been sold to and used by humans for nearly 50 years – ingredients that, across all those decades, have raised no “significant or notable safety issues” in humans.
Shortly before the new FDA Commissioner Makary’s appointment and the FDA’s announcement of its roadmap, industry sources reported that – in ignorance of “decades of real-world evidence” and in conflict with “international scientific consensus” – the FDA had “privately informed companies . . . that animal studies will be required to demonstrate safety” of these very ingredients.
Think about that: Decades of real-world, human evidence. International scientific consensus. And, still, the FDA pushes forward with plans to torture and kill animals.
The FDA has yet to provide a “clear reason” for this backwardness, though a FDA representative weakly asserted that non-animal tests “cannot [yet] reliably predict effects that may occur through complex interactions between the drug and the human body.”
But, here’s the thing: neither can animal tests.
At least, human-relevant, non-animal tests are based on human biology – making them immediately more relevant for predicting human outcomes – a fact that should sway the FDA if, of course, the FDA’s real goal is protecting humans and not protecting an industry.
Further raising the question of the FDA’s true interest here is this glaring truth: no additional testing of any kind is needed.
Millions of humans have used these sunscreen ingredients for half a century, generating decades of direct, clinical observations: one of “the most important methods for true discovery” and the most reliable and relevant evidence medical science can offer. The problem is that vivisectionists have been successful in sidelining the use of clinical observations in protection of their own self-interest:
Medical science . . . has run two irreconcilable courses, one being to observe humankind and the other being the attempt to use the animal as a model for humans. The second method has overwhelmed the first and led it astray. Its influence has been powerful, because it gives the illusion of being a short-cut to clinical and anatomical-pathological observation.
– Croce, Vivisection or Science?
Even FDA Commissioner Makary recently condemned this corrupt inertia, stating: “For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally”.
The sunscreen controversy puts this inertia – and its grotesque consequences – on full display . . . and even has industry pleading for sanity.
The Personal Care Products Council (PCPC), representing hundreds of beauty and personal care companies, is urging the FDA to extend its roadmap to sunscreen ingredients, rightly condemning animal testing as “outdated”, “unnecessary”, and “ineffective”.
To this end, private industry has offered up real-world human data to the FDA.
It has presented the FDA with a modern, internationally-accepted plan for evaluating human safety risks that avoids animal exploitation.
It has offered an ethical and effective way forward.
Yet, according to sources, the FDA hasn’t changed course.
Now, some companies are even refusing to engage in new animal testing in the hope that new FDA leadership will finally break from the past – and that’s really the issue, isn’t it?
Because this isn’t a scientific problem. It’s a political one.
As one commentator laid out plainly: “‘This is a political problem, and political problems have political solutions . . . All of this testing can stop tomorrow, if the FDA will just listen to reason and modernize.’”
The FDA has signaled that it’s ready to do just that. The question: will it?
Your call to action: Support the FDA Modernization Act 3.0, a bill that aims to revise FDA regulations and remove requirements for animal research.