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FDA action on sunscreen too little, too late
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FDA misses the mark on new sunscreen requirements

By Rita R. Robison, Consumer Specialist

My last post described the U.S. Food and Drug Administration’s proposal to require the testing of sunscreens and to standardize how information about sunscreen protection is presented to consumers.

Sunscreen-1 While the new labeling will be helpful to consumers, the FDA isn’t addressing possible health hazards caused by sunscreen ingredients. Consumer groups – the Environmental Working Group, Consumers Reports, and the Organic Consumers Association – have expressed concerns about the ingredients in sunscreen.

FDA response to the safety issues raised by consumer groups

I asked the FDA about the recommendations of these consumer groups.

FDA spokeswoman Shelly Burgess said the agency considers sunscreens to be safe.

“This includes nanoparticles which do not penetrate beyond the outer layer of the skin,” Burgess said in an e-mail. “FDA is working to help design studies to look further at the safety of retinyl palmitate. At this time there's no data to indicate that retinyl palmitate in sunscreens poses a concern. If we determine that any of the active ingredients, including nanoparticles, do not meet required safety standards, the agency will notify the public and work to remove that ingredient from the market promptly.”

Woman-sunscreen I asked Burgess to respond to comments made in a Consumer Reports article about the possible harm to consumers of Oxybenzone and other endocrine disruptors and the possibility that nanoscale zinc oxide and titanium oxide are linked to potential reproductive and development effects? 

“Zinc oxide and oxybenzone are included in the 1999 final monograph for sunscreen ingredients which means that they are generally recognized as safe and effective,” Burgess said. 

But she added:

However, the FDA is constantly evaluating new information relating to the safety and effectiveness of all drugs as new data emerge. In addition, the agency may call for additional studies when new research is required to gain a more comprehensive view of potential risks and may adapt its recommendations based on new information when that is warranted. For example, oxybenzone has been sent to the National Toxicology Program by FDA for further evaluation of its safety profile.

I also asked Burgess about retinyl palmitate.

She said here's what FDA knows about the research:

The National Toxicology Program conducted a study that tested products that did not contain sunscreens. The results of the NTP study showed an increase in tumors regardless of whether the animals were exposed to retinyl palmitate so it is not clear what the effects of retinyl palmitate were. That's why we can't reach a final conclusion on the safety of Retinyl Palmitate based on that study.

FDA is working to help design studies to look further at the safety of retinyl palmitate. At this time, the data do not tell us that we need to be concerned about retinyl palmitate.

I asked Burgess about sunscreen with nano particles and why they aren’t labeled so consumers who wish to do so can avoid them.

She replied: 

We are not aware of data that suggest that any sunscreen active ingredient is unsafe. FDA has created a cross-agency Nanotechnology Task Force to further evaluate issues involving nanomaterials, including sunscreen active ingredients processed as nanoparticles. FDA will be developing a draft guidance that will identify those FDA-regulated products that may involve application of nanotechnology or use of nanomaterials. 

FDA considers sunscreens safe

I also asked Burgess why the FDS isn’t warning consumers about these chemicals or banning them.

Sunscreen3 She said: “FDA will always take the necessary action to ensure consumers have access only to safe cosmetic and sunscreen products.”

In addition, I wanted to know why the FDA is working only on new labeling and not on ingredients that may be harmful to consumers. Shouldn't the FDA ban the dangerous ingredients in sunscreen instead of merely requiring new labels? 

The response from Burgess:

If any data [in the development of testing and labeling requirements] had demonstrated that a sunscreen product put consumers at serious risk, FDA would have taken measures to remove that product from the market. FDA is not aware of any such data. The pace of developing requirements for OTC sunscreen products has been largely dictated by the availability of adequate data to support those requirements. 

In light of the warnings from consumer groups from about sunscreen, I haven’t worn much over the years. However, several members of my family have had skin cancer. Since there’s conflicting information about the safety of sunscreen ingredients, I asked Burgess what the FDA recommends consumers do about using it.

She said: “Spending time in the sun increases the risk of skin cancer and early skin aging. To reduce this risk, consumers should regularly use sun protection measures including”:

  • Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed.
  • Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense.
  • Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants, sunglasses, and broad-brimmed hats.
  • Reapply sunscreen at least every two hours, more often if you’re sweating or jumping in and out of the water.

I think the FDA is unnecessarily dragging its feet on adequately regulating sunscreen, to the detriment of consumers.

Copyright 2011, Rita R. Robison, Consumer Specialist


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I am particulary concerned about sunscreen as myself and my 2 year old are freckled red heads. I have had several pre-cancerous lesions removed. I had no idea until recently that I should be looking for sunscreens that specifically sy "Broad Spectrum"


Yes, it's quite difficult to try to decide what to do. Skin cancer runs in my family, and I had physicians assistant tell me I had pre-cancerous areas on my nose.

It's troubling that consumer groups are warning about possible harmful chemicals in sunscreen. Then, the FDA says the chemicals in sunscreen are generally recognized as safe, but studies are going on.


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