The FDA has not reached a decision about the safety and efficacy of spray-on sunscreens, but continues to accumulate information to base an eventual verdict, a skin specialist said here. After manufacturers stated their case, the agency concluded that available information about spray-on sunscreens is insufficient to rule on its safety or whether it works as advertised. With respect to safety, the principal issues relate to the inhalation potential of spray-on sunscreens, according to Henry Lim, MD, of Henry Ford Health System in Detroit, who presented an update on the status of sunscreens during the summer meeting of the American Academy of Dermatology.
“Anyone potentially could inhale the product, children or adults,” Lim told MedPage Today. “It is not yet clear what the potential is or how great a risk it might pose.”
The FDA has been monitoring the situation since June 2011, when the agency issued rules for manufacturer testing to establish the safety and effectiveness and rules that tightened labeling requirements for sunscreens. At the same time, the FDA requested more data from manufacturers and comments from consumers and other interested parties. The rules went into effect in 2012. The FDA has continued to accumulate and review information on sunscreen safety, Lim said, but maintains that information is still insufficient to make definitive decisions on safety and effectiveness. A year ago the agency did issue a consumer safety notice, warning against use of spray-on sunscreens near an open flame. According to the FDA, at least five cases of serious burns had been reported at that time.
Earlier this year, Consumer Reports urged parents not to expose children to spray-on sunscreens until the FDA reaches a decision about the products’ safety. With regard to effectiveness, manufacturers of spray-on sunscreens have yet to demonstrate that the products provide coverage equivalent to that of other formulations, such as oils and lotions. Lim pointed out that spray-on sunscreen coats the skin with small droplets that have equally small spaces in between. Whether that affects the products’ protection against ultraviolet (UV) radiation remains unclear.
During his presentation at the AAD, Lim also addressed alternative formulations of sunscreens in various stages of development. Some of the products have been available without prescription for years, including vitamins C and E. Technically, the oral products are not “sunscreens” but antioxidants, said Lim, who has participated in studies of some of the products. In theory, the products work inside the body to counter the effects of exposure to UV radiation.
One of the most widely studied oral compounds is polypodium leucotomos, an extract of a fern plant indigenous to parts of Central America. Laboratory studies have demonstrated potential antioxidant and anti-inflammatory properties, Lim said.
Small clinical studies dating back almost 20 years have produced evidence suggesting the substance affords protection against phototoxicity, solar urticaria, and polymorphous light eruption. Besides vitamins C and E, other substances evaluated as potential oral photoprotectants include lutein and alpha-melanocyte stimulating hormone (alpha-MSH) analogs. Studies of oral lutein have demonstrated protoprotective potential in humans, and alpha-MSH analogs have been found helpful in management of erythropoietic protoporphyria and solar urticaria, associated with increased tolerance to artificial light and increased melanin content.
As for the long-term potential of oral photoprotection candidates, Lim remained cautious. “The results have been encouraging, but these products are still in early stages of development,” he said. Regardless of the outcome for oral photoprotectants, none of them should be considered a replacement for conventional sunscreens and the longstanding advice regarding limitations on UV exposure and use of protective clothing, broad-brimmed hats, and sunglasses, he added.
Source: MedPage Today
We include skin cancer screening in the Center’s executive physicals.