Senator demands edible sunscreen be taken off shelves

Senator demands edible sunscreen be taken off shelves

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Sunsafe RX is a product that promises “to help protect you from both UVA and UVB rays”. On its website, there are glowing user testimonials and photos of young, attractive people enjoying the weather. It’s the kind of marketing you might expect from a sunscreen brand, except that Sunsafe RX isn’t a cream or a spray – it’s a pill.

It’s one of a number of products to be taken orally that make claims about protection from the sun – potentially heralding a new era when, instead of slathering yourself in lotion, you could swallow a pill and head to the beach.

It sounds too good to be true. According to the Federal Drug Administration (FDA), as well as Chuck Schumer, that’s because it probably is.

Last month, the FDA explicitly warned the public that these pills were “misleading consumers and putting people at risk” and named four companies, including Sunsafe RX, Advanced Skin Brightening Formula, Solaricare and Sunergetic, which “make unproven drug claims about protecting consumers from the harms that come from sun exposure without meeting the FDA’s standards for safety and effectiveness”. The FDA sent letters to each of the companies asking them to rethink the way the products are being marketed.

The Democratic senator has demanded the FDA go further, asking that the products be pulled from shelves and online retailers. At a speech on Sunday, he said: “Sunscreen pills are a fraud … right now thousands and thousands of Americans are taking these pills and not putting on sunscreen. And they are endangering themselves.”

The SunsafeRX homepage



The Sunsafe RX homepage. Photograph: SunsafeRX

Those worried about the ability of Sunsafe Rx to prevent sunburn or skin cancer might head to the FAQ page on its website. There they would be assured that “Sunsafe Rx is not only effective but also completely safe” and that “all the ingredients in Sunsafe Rx are recognized as safe and approved by the FDA for sale in the United States”. The site does not mention that the FDA has explicitly said the pills are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn”.

In a statement to the Guardian, the company said “Sunsafe Rx is made with ingredients that published clinical studies show protect skin from sun damage” but that Sunsafe isn’t marketed “as a sunscreen, and we certainly don’t tell consumers that they don’t need any other protection from the sun or that they don’t also need to use a topical sunscreen”.

On Sunsafe’s website, however, the company strikes a different tone. The site has a specific page about traditional sunscreen suggesting that sunscreen is ineffective and damaging compared with the oral products it is marketing. The site claims: “Most sunscreen lotions are unstable, toxic and only moderately effective against UVA rays. Sunsafe Rx is healthy and safe.” It does not explicitly tell people not to use sunscreen but uses such language as “if you have to use a sunscreen lotion” and “potentially, sunscreen could actually be contributing to the damage of the very skin it was intended to protect!”

When asked about the traditional sunscreen page on the site, a company spokesperson said: “The sunscreen page has recommendations toward the end of it on the best ingredients for sunscreen lotions. You will also notice a disclaimer on every page of the website that says the product is not intended to replace topical sunscreen. But in addition to this, we are currently already working with the FDA to figure out the best messaging for the product, and those updates will be incorporated into the product messaging to best educate consumers about how the science shows the ingredients in the product help them.”

About 90% of non-melanoma skin cancers and 86% of melanoma skin cancers are associated with exposure to ultraviolet radiation from the sun. More people are diagnosed with skin cancer each year in the US than all other cancers combined.

There have been numerous claims over the years from inventors who say they’ve found a way to ingest protection from the sun. In 2011, researchers who had been examining the ways in which coral protects itself from UV rays said that algae inside the coral produced a compound that could be synthetically re-created and given to humans to protect the skin. In 2016, a new beverage called UVO was touted by its inventors as drinkable sunscreen, but since then its marketing has pivoted to emphasizing overall positive effects on skin rather than specifically focusing on sun protection. No currently available product taken orally is FDA-approved as an alternative to sunscreen.



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