You are here > Knowledge Base > Current Awareness > Article View

SAFENANO News

Public interest groups criticise FDA's sunscreen rules over nanotechnology
Created by assoceditor on 24/06/2011 15:05:27

Public interest groups say that the new FDA sunscreen rules called blind to nanotechnology.


On the 14th June, the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens currently sold over-the-counter (OTC) (i.e. non-prescription).

The new measures include the following:
  • Final regulations that establish standards for testing the effectiveness of sunscreen products and require labeling that accurately reflects test results
  • A proposed regulation that would limit the maximum SPF value on sunscreen labeling to “SPF 50+”
  • A data request for safety and effectiveness information for sunscreen products formulated in certain dosage forms (e.g., sprays)
  • A draft guidance for sunscreen manufacturers on how to test and label their products in light of these new measures.
In a press release announced this week, public interest groups including Friends of the Earth and The International Center for Technology Assessment and Consumers Union (ICTA) are calling out that the newly released sunscreen rules fail to meaningfully consider the risks posed by nanoscale ingredients.

"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."

Nanoscale ingredients are widely used in sunscreens to make the sun-blocking ingredients titanium dioxide (TiO2) and zinc oxide (ZnO) rub on clear instead of white. These materials have been shown to exhibit different fundamental physical, biological, and chemical properties than their larger counterparts and there is therefore concern that they may also demonstrate different toxicological profiles.

"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," said Ian Illuminato, Health and Environment campaigner at Friends of the Earth. "Why is it that the FDA continues to falter in protecting Americans' health?"

In 2006, ICTA filed a legal petition on behalf of consumer and environmental groups with the FDA insisting the agency issue specific regulations for nanotechnology and properly regulate the use of nanoscale ingredients in sunscreens. FDA has broad authority under the Federal Food, Drug and Cosmetic Act (FFDCA) over many nanomaterial products, including nanoscale ingredients in sunscreens and cosmetics. 

"Despite a separately released Guidance to Industry on nanotech products last week, FDA failed to connect the dots in its rule for over-the-counter sunscreens," said Colin O'Neil Regulatory Policy Analyst for ICTA.

"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 Michael Hansen, Senior Scientist at Consumers Union.

Click here to read the full press release. 

Source: Adapted from materials provided by Friends of the Earth and FDA.

print
rating
  Comments

Terms Of Use | Privacy Statement
Copyright 2011 by SAFENANO @ IOM