Is Mexoryl Unapproved Due to the Lengthy FDA Approval Process?

[Mk]

Our suntan lotions are good at screening out the sun's UVB rays — the ones that cause sunburn and skin cancers — but most people don't realize their sunscreens don't offer much protection against UVA rays, the ones that put wrinkles in your skin.

"Ultraviolet A light ages your skin. And the reason it does that, it's a longer wavelength, so it can penetrate deeper into the skin, and instead of attacking the upper layers of the skin where skin cancer often forms, it attacks the layers that give your skin its tone, its elasticity, as we call it. … You get the lines, the wrinkles, all the things associated from aging," said Dr. Darrell Rigel, clinical professor of dermatology at New York University

But there's good news. Lotions that contain the ingredients Oxybenzone, Titanium Dioxide or Parsol 1789 block out some UVA rays.

Doctors say a chemical called Mexoryl offers even better protection.

"It produces a product which gives us almost perfect protection against sunshine," said Dr. Vincent DeLeo, chairman of dermatology at Columbia University.

People are happily protecting themselves with Mexoryl on the beaches of Rio de Janeiro, the streets of Paris, in Canada, Mexico and Australia.

Mexoryl "is the No. 1 individual ingredient in terms of protection from Ultraviolet A radiation," Rigel said.

But even though dermatologists say Mexoryl is the best, you cannot legally buy it in the United States. It's illegal, because the Food and Drug Administration won't approve it. They won't even say why. The FDA is charged with making sure no drug is sold unless the government is convinced it's safe and effective. Dermatologists think it's just stuck in the bureaucracy. It routinely takes 12 to 15 years for a drug to get approval. After an approved drug — Vioxx, for example — gets bad publicity as a health risk, the FDA gets particularly cautious.

Is mexoryl unapproved because of 12-15 years waiting time for drug approval??

 

[Mattara]

Yes, It appears so. The standard waiting period for drug approval in the United States are long and even longer now because of the Vioxx and others. A substance/drug (like mexoryl) can contain several thousand ingredients and every single on of them needs to be tested. Also, their conbined effect needs to be tested too.

 

[ravenprp]

It is likely that the reason for Mexoryl being unapproved is due to the lengthy and strict process of drug approval by the FDA. As mentioned in the article, it can take 12 to 15 years for a drug to get approval from the FDA. This is because the FDA has strict standards for ensuring the safety and effectiveness of drugs before they can be sold to the public. Additionally, the FDA may also be more cautious in their approval process for drugs that have received negative publicity, such as the example of Vioxx mentioned in the article. It is possible that Mexoryl is still going through the approval process and has not yet met all of the necessary requirements for FDA approval.