SILVER SPRING, MD. – The widespread and long-term use of sunscreens demands that manufacturers provide more long-term safety data and information on how the active ingredients affect the health of special populations including infants, children, the elderly, and those with skin conditions, according to an expert panel called by the Food and Drug Administration.
Sunscreen safety has become an increasingly more important concern, especially since they are intended to be applied over the entire body, multiple times a day, and for a lifetime, Dr. Theresa Michele, director of the FDA’s division of nonprescription clinical evaluation, said Sept. 5 at a meeting of the agency’s Nonprescription Drugs Advisory Committee. "We’re essentially talking about a cradle-to-grave product."
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The widespread use of sunscreens demands that manufacturers provide more long-term safety data on how the active ingredients affect the health of infants, children, the elderly, and those with skin conditions.
FDA has been under pressure from physicians, consumers, manufacturers, and Congress to approve a backlog of eight ingredients that are generally available outside of the United States and to improve the process for reviewing new ingredients. The agency proposes to add carcinogenicity and developmental and reproductive toxicity to the required safety testing prior to approval.
Speaking at the meeting, a coalition of sunscreen manufacturers said that most of what was being requested by the FDA is redundant or not necessary. "Today’s sunscreen ingredients have a wealth of data to support their safety," said the Personal Care Products Council (PCPC) in a statement. The group also said that many of the ingredients had been used for decades, without any indication that they caused cancer or led to any significant safety issues.
Advisory committee members, however, said that their concerns were not allayed.
"If you don’t look for a signal you’re not going to find a signal," said Dr. David J. Margolis, professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Margolis said he was concerned about safety over the long term, and about perhaps too much reliance on rodent models.
"The penetration through rodent skin is different than the penetration through human skin," he said.
Dr. Geoffrey L. Rosenthal, professor of pediatrics at the University of Maryland, Baltimore, said that he was bothered by the lack of specific studies in children. "Unless you study them in kids, you just don’t know," he said.
Dr. Marissa J. Perman, a pediatric dermatologist at the Children’s Hospital of Philadelphia, agreed and said that the agency should also consider requiring studies in pregnant and lactating women.
Dr. Perman, who spoke on behalf of the American Academy of Pediatrics during the public section of the meeting, said that AAP also would like to see studies based on actual – not directed – sunscreen use and investigations of the effects of spray sunscreens and of nanoparticles on children.
Several panel members also said that they were concerned about the disconnect between real-world use of sunscreens and the amounts studied during trials. The PCPC said in its background materials that market data indicate that many people use sunscreen only once a week, and that among users, only about 22% reapply as often as directed on the label.
Some committee members said that they viewed sunscreens as drugs that should always be subject to the same review and approval process.
"It’s really shocking to me that these are not being regulated through the process by which drugs are regulated," said Lorraine Gudas, Ph.D., chairman of pharmacology at Cornell University, New York. She noted that little was known about the potential systemic effects of sunscreen ingredients.
The FDA is not required to follow the panel’s advice. Any change to how sunscreens are regulated would require issuing a new rule and going through a public comment period. An FDA official declined to say when that process might occur.
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