With summer coming up, health agencies, doctors and magazine articles all try to remind you that sunscreen can save your life. Sunscreen formulations available in the US, though, use only chemicals that are considered obsolete over the rest of the world. Apart from zinc oxide, US consumers have access o no product that offers reliable protection against UVA. What should you do then — illegally import sunscreen from elsewhere?
Buying Sunscreen: Do You Want To Respect the Law or Care for Your Health?
If you’ve ever shopped for sunscreen in Europe, Asia or Latin America, you’re likely to have come across modem formulations that advertise UVA filtering ingredients such as Tinosorb M, Tinosorb S and E capsule on the bottle that you never saw on a US drugstore shelf. If you have extremely light skin or have skin cancer in the family, these products can save your life. However, these formulations haven’t been cleared for sale in the US yet.
If you live in the US, you have no choice but to make do with inferior and obsolete sunscreen formulations. They don’t offer effective protection from UVA rays — rays that penetrate the skin more deeply than UVB and increased cancer risk.
In the US, sunscreens with UVA protection usually use ingredients such as oxybenzone and avobenzone. Both chemicals are problematic. Not only do they offer narrow spectrum UVA protection, they quickly lose effectiveness after they’ve been on the skin a few minutes. If you want long-lasting protection, sunscreen based on zinc oxide is your only choice. While it’s effective, it makes you look terrible by leaving an opaque white film on your skin. No one who likes to look good on the beach uses it. In other words, the US market doesn’t get UVA protection.
If you would like a chance to use the modem products available elsewhere in the world, there’s only one easy way open to you — importing them through an Internet pharmacy. The problem with this plan, though, is that it’s illegal to import anything classified by the FDA as an over-the-counter drug if it contains ingredients that aren’t FDA-approved (if you want to look at the law, here it is: law.cornell.edu/uscode/text/21/331). While the FDA rarely prosecutes things like sunscreen imports, there’s always a chance of having it happen. If you try to be law-abiding, though, you end up not being able to protect your health with a superior product.
Why aren’t these sunscreen products available in the US?
The last time the FDA approved a new sunscreen product for the US market was the year 1999. Eight new sunscreen formulations that have been approved and made available in the rest of the world since then languish in the FDA’s approvals pipeline.
What happens at the FDA?
The FDA is an underfunded and overstretched organization that isn’t equipped to handle the avalanche of new products that are submitted by manufacturers each month. They also have the highest standards in the world when it comes to approving new products for the general public. If European governments quickly approve sunscreens, it’s because they apply lower safety standards. To them, sunscreens are simple cosmetics. To the FDA, though, sunscreens are over-the-counter drugs that require extreme levels of scrutiny.
European governments don’t demand that drug manufacturers provide them with complex and expensive-to-prepare test data. For this reason, manufacturers don’t tend to have this information ready when the FDA demands it. For instance, for one sunscreen ingredient in the FDA pipeline, the manufacturer only had animal safety test data. The FDA requires actual human studies, though. Compliance with these kinds of demands takes time.
The FDA also has the responsibility of formulating guidelines for marketers to follow. Current guidelines, for example, define how terms such as broad-spectrum or water-resistant are to be used.
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