Public interest groups raise concerns over FDA sunscreen monograph

By Andrew McDougall

- Last updated on GMT

Related tags Fda Sunscreen

The U.S. Food and Drug Administration's newly released sunscreen rules do not sufficiently consider the risks posed by nanoscale ingredients according to some public interest groups, leading them to label the latest announcement 'disappointing.

Last week the FDA announced the new rules for sunscreen labelling and the safety measures surrounding sunscreen and were backed by several organizations including the Personal Care Products Council, who had supported the FDA and agreed that it had 'evaluated available scientific literature, tested sunscreen nanoscale ingredients and concluded they do not penetrate the skin'.

However Friends of the Earth, and The International Center for Technology Assessment and Consumers Union say that the FDA are missing the key health threat that nanotechnology poses.

"The FDA's new rule fails to address any of the concerns we raised five years ago in our legal petition,"​ said George Kimbrell Senior Attorney at ICTA. "FDA's continuing failure to address these pressing health and environmental risks is extremely disappointing and unlawful."

"The FDA's new sunscreen standards miss the boat by ignoring this key health threat. The FDA has known about the threats posed by nanotech sunscreens for years, yet it refuses to regulate or require labelling for these products,"​ added Ian Illuminato, health and environment campaigner at Friends of the Earth. "Why is it that the FDA continues to falter in protecting Americans' health?"

Support for FDA monograph

However when the announcement was made the FDA had actually given a positive endorsement of the safety of nanoscale inorganic sunscreens, which the PCPC had supported.

Nanoscale ingredients are widely used in sunscreens where particle size and design are utilized to optimize the performance of the sun-blocking ingredients titanium dioxide (TiO2) and zinc oxide (ZnO) rub on clear instead of white.

ICTA says that these materials have been shown to exhibit different fundamental physical, biological, and chemical properties than their larger counterparts, however this does not seem to be the case, as global ingredients provider Croda told USA that a weight of research indicates there is no biological properties and no fundamental differences in other properties.

Michael Hansen, PhD, senior scientist at Consumers Union is fully behind further research to get to the bottom of nanotechnology use in consumer products.

"Our government must promote research focused on the health and safety of nanomaterials and in the meantime protect the public from these ingredients. We are far from getting 'full-spectrum' protection from our regulators when it comes to sunscreens, the FDA rules will also allow other potentially toxic ingredients such as oxybenzone to remain in sunscreens,"​ said Hansen.

However, studies have been carried out by the FDA that show these materials to be safe, with indications from the industry that these ingredients actually go a long way to protect against skin cancer.

Related topics Regulation & Safety

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