JAMA Study Reinforces FDA’s Call to Further Test Sunscreens

Regulatory NewsRegulatory News
| 06 May 2019 | By Zachary Brennan 

A small study published in JAMA on Monday showed the need for more research into the absorption of some sunscreen ingredients.

The objective of the JAMA study with 24 healthy participants, which was run by US Food and Drug Administration (FDA) officials, was to determine the systemic exposure of active ingredients (avobenzone, oxybenzone, octocrylene and ecamsule) present in four commercially available sunscreens of different formulation types under maximal usage conditions.

Researchers found plasma concentrations that exceeded the threshold established by FDA for potentially waiving some nonclinical toxicology studies for sunscreens.

“The systemic absorption of sunscreen ingredients supports the need for further studies to determine the clinical significance of these findings. These results do not indicate that individuals should refrain from the use of sunscreen,” the researchers concluded.

FDA’s Center for Drug Evaluation and Research (CDER) Director Janet Woodcock wrote in a letter to CDER staff on Monday: “Because sunscreens are designed to work on the surface of the skin, some have proposed that sunscreens would not be absorbed in appreciable quantities, making MUsTs [maximal usage trials] unnecessary. But the pilot study showed that all four active ingredients tested were absorbed systemically in significant amounts, underscoring the need for us to require absorption studies of these widely used OTC drug products.”

The JAMA study follows a recently issued proposed rule to update regulatory requirements for most sunscreen products available in the US. As part of this rule, FDA is asking industry and other interested parties for additional safety data on 12 of the 16 active sunscreen ingredients currently available. Data on systemic human absorption in a MUsT is one of the key elements requested for all 12 ingredients, Woodcock said.

In addition to the absorption data, FDA is proposing to require sunscreens with a sun protection factor (SPF) value of 15 or higher to also provide broad spectrum protection. The agency also proposes that, for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation also increases.



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