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/ Source: Reuters
The US Food and Drug Administration on Thursday released a much-anticipated update of the rules on sunscreens to strengthen the regulation of sunscreen over-the-counter.
According to the FDA, two of the 16 major chemical ingredients currently used in over-the-counter sun protection products are considered safe, as part of a proposal to improve the safety and quality of sunscreen products sold without prescription in the United States.
The agency said that the use of two ingredients – PABA and trolamine salicylate – in sunscreen products without a prescription was banned, adding that she was asking the industry to additional data on 12 other ingredients.
The health regulator said the proposed rule had been issued to define the conditions under which certain sunscreen medicines can be sold without FDA-approved marketing applications.
The agency has proposed that of the 16 ingredients currently used, only two – zinc oxide and titanium dioxide – are considered safe and effective based on the available data.
"This action is an important step in the FDA's efforts to take into account modern science to ensure the safety and effectiveness of sunscreens," said FDA Commissioner Scott Gottlieb on Thursday. , MD.
"The proposed rule we released today would update the regulatory requirements for most sunscreen products in the United States, to better ensure consumers access to effective sun protection options." and secure with the latest science, "Gottlieb added.
In November 2016, the FDA had published guidelines detailing the data that over-the-counter sunscreen manufacturers had to produce to prove that the ingredients contained in the products were safe and effective.
"Broad-spectrum sunscreens with SPF values of at least 15 are essential to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by Sun rays. Yet some of the essential requirements of these preventive tools have not been updated. decades, "said FDA Commissioner Scott Gottlieb.
Among other measures, the agency also plans to raise the sun protection factor or the maximum SPF value proposed on SPF 50+ SPF 60+ sun protection labels.
The SPF is a measure of the extent of protection offered by a product against ultraviolet radiation from the sun's rays, generally considered harmful.
SPF 15 blocks 93% of UVB rays, while SPF 30 and 50 respectively block 97% and 98% of UVB rays, thus contributing to the prevention of skin cancer. As a result, the FDA continues to encourage sunscreen users to continue using skin protection products as the regulatory process continues.
"It is important that, as this regulatory effort progresses and the FDA gathers additional scientific information, given the recognized benefits of using sunscreen for public health, consumers continue to use sunscreen in conjunction with other sun protection measures, "said Dr. Janet Woodcock. , director of the FDA's Center for Drug Evaluation and Research in a statement.
Although sunscreen has been around since the 1940s, it's only been regulated by the FDA since 1978. In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy on over-the-counter sun protection products marketed without authorization. application, the first revision of the policy since 2011.
Environmental Working Group (EWG), a non-profit health and environmental advocacy group, described the proposal as "a major step toward cleaning up a largely unregulated industry."
"We expect many companies to reformulate their formulas to avoid ingredients that the FDA considers unsafe or for which there is not enough data to prove safety," EWG's Scott Faber said. a call to the press after the announcement of the FDA.
Dr. Shamard Charles from NBC News contributed to this report.