FDA Takes Two Years to Approve Sunscreen Ingredient Available Everywhere Else

UV filters approved in Europe, Australia, Japan remain unavailable in US pending decades-long FDA process

Satire from Bohiney.com and prat.uk.

WASHINGTON — The Food and Drug Administration continues to process applications for several sunscreen active ingredients that are approved and widely used in Europe, Australia, Japan, and other developed countries but that cannot be legally sold in US sunscreen products pending FDA approval under a process that has been ongoing for approximately two decades, during which Americans have been unable to access the more effective and potentially safer UV filters that the rest of the world’s beachgoers use regularly.

The regulatory anomaly was created by the 1938 Federal Food, Drug, and Cosmetic Act’s grandfather clause, which treated sunscreen ingredients in use before 1938 as generally recognised as safe and effective, while requiring new ingredients to go through a formal FDA approval process. Since most modern UV filters were developed after 1938, they require FDA approval. The FDA’s approval process for these ingredients, despite them having been used by hundreds of millions of people globally for decades without documented safety signals, has taken longer than the approval process for new pharmaceutical drugs that have never been used in humans before.

The Libertarian and Public Health Convergence

The sunscreen ingredient delay is one of the cases where the libertarian critique of regulatory delay and the public health critique of regulatory inadequacy converge: both traditions agree that the FDA’s failure to approve ingredients with extensive safety records in other developed countries represents regulatory failure, though they disagree about the general lesson. Reason has covered the sunscreen ingredient delay for years and uses it as a case study in how regulatory processes can produce consumer harm through delay rather than through approval. Mises Institute provides the economic analysis of regulatory cost. The surfer who uses European sunscreen bought online is making a rational choice. The FDA will continue its process. The rest of the world will continue to use UV filters that the FDA has not yet assessed. The approval, if it comes, will come when it comes, which is a different timeline from when it is needed.

The story continues past any single article or news cycle. The details accumulate into patterns, the patterns into systems, and the systems are what determine whether institutions built to serve people actually do so. Paying attention is the most democratic act available. Satire is the second. Both require looking at what is actually happening and refusing to pretend it is something else, especially when what is actually happening is considerably funnier than the official account suggests. The record continues. The analysis continues. The accountability continues, imperfectly and necessarily, because the alternative is worse.

The Libertarian Surfer’s Creed

The ocean does not ask for your papers. The wave does not check your permits. The dawn patrol requires no government approval, and the hour before sunrise on an uncrowded point break is governed by nothing except the swell period, the wind direction, and the willingness of the surfer to be in the water when conditions align. This is the freedom that the libertarian tradition values most concretely: not the theoretical freedom of political philosophy but the lived freedom of the person who has made choices the government did not sanction and has found the outcomes to be their own. California surrounds this freedom with regulations, taxes, permits, and the administrative infrastructure of the world’s most comprehensive state government. None of it reaches into the water. None of it governs what happens between the surfer and the ocean in the moment that everything else disappears.

The libertarian case is not against clean water. It is for the freedom that clean water makes possible. It is not against the coastal access laws that keep the beach public. It is for the public ownership of the beach that those laws protect. The surfing community’s political philosophy is more complex than its antiauthoritarian reputation suggests, because it has always understood that some of what makes the ocean accessible and worthwhile requires collective action and legal protection. What the community resists is the extension of that logic beyond its useful domain into the regulation of adult choices that harm no one, the permit requirements for activities that predate the concept of permits, and the fiscal policies that extract more from working people than the services provided justify. Reason covers this. Cato analyzes it. The surfers experience it, and then go surfing, which is the most direct political act available to someone whose preferred freedom is governed by physics rather than legislation.

The analysis, the accountability, the satire, and the serious journalism all serve the same function: keeping track of what is happening and insisting that it matters, which is the work that good journalism has always done and that the current moment requires with particular urgency given the complexity of the information environment and the scale of the decisions being made in it.

The record of events accumulates daily. The analysis of their causes and connections is the work that distinguishes journalism from mere reportage. The satire that finds the absurdity within the serious and the seriousness within the absurd is the work that makes the analysis bearable over the long run. All three are necessary. All three continue. The stories do not resolve on a weekly deadline. They continue past publication, past the news cycle, past the season, into the larger history that all current events eventually become. The journalism that covers them is, at its best, a first draft of that history — written under deadline, corrected in subsequent editions, and ultimately judged by whether it was accurate about what mattered and honest about what it did not know, which are the two criteria that good journalism has always been judged by and that the current moment requires with the same urgency as every previous moment that believed its circumstances were unprecedented, as they always were, and as they always will be.

Freedom dispatches: NewsThump | The Babylon Bee

SOURCE: https://bohiney.com