The Food and Drug Administration (Fda) has issued a plan – long overdue – to update product regulations for the protection sunscreen marketed in the United States. The move could mean major changes to widely used sunscreens, many of which contain chemicals that the regulatory agency says have not been proven safe.
“Since the initial evaluation of these products was done, we have accumulated a great deal of new knowledge about the effects of the sun and how sunscreens are absorbed through the skin,” Fda Commissioner Scott Gottlieb said in a note.
Over-the-counter sunscreen products are regulated by the Fda under the Sunscreen Innovation Act, a process put in place in 2014, but some ingredients can be marketed without going through this screening because they are generally considered safe.
The new regulation proposes to maintain free distribution, without the need for further approvals, of certain ingredients and formulations, such as zinc oxide and titanium dioxide, but two substances have disappeared from the list: PABA and trolamine salicylate, now deemed “unsafe,” and, for 12 other ingredients, the Fda has asked manufacturers for new data confirming their safety.
Labels will also have to change: active ingredients will have to appear prominently, and there will be informative claims about the consequences of excessive sun exposure for aging skin and melanoma risk.
The maximum sun protection factor (Spf) value will be allowed to increase from +50 to +60; “we believe there is no data to support additional benefits by a factor of more than 60.”, said Theresa Michele, director of the Fda’s OTC Products Division, but the agency is proposing to allow products with Spf up to 80, to give manufacturers more flexibility. In any case, sunscreens with protection of at least 15 should also provide broad-spectrum protection; then, as the Spf increases, protection against Uva rays should also increase. As usual, the Fda solicits participation in decisions from insiders and ordinary citizens, who are given three months to submit comments and proposals.
