FDA says “latex free” label carries hidden danger

NEWS IN BRIEF — Posted March 18, 2013

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The Food and Drug Administration is urging manufacturers to stop using the “latex free” label on medical products to convey more accurate information about materials in rubber gloves, containers and other goods.

The FDA instead wants companies to use the statement “not made with natural rubber latex” when stating that products do not contain the milky fluid found in rubber trees and other plant sources, the agency stated in draft recommendations. Exposure to natural rubber latex can cause mild allergic reactions in some individuals, such as skin redness and hives, or more severe reactions, such as difficulty breathing and anaphylactic shock.

Medical products that are not made with natural rubber latex can be contaminated with NRL allergens during manufacturing and packaging processes, the FDA stated in a March 8 notice. Furthermore, no test exists to determine that a product is free of the allergens. The label “does not contain natural rubber latex” also should not be used, officials said.

The phrase “latex free” can be confusing because it does not distinguish a difference between natural and synthetic latex, the FDA said. Synthetic latex made of nitrile and polyvinyl chloride does not contain NRL allergies.

“Consumers rely on and expect accurate labeling and product information, especially when they are concerned about allergic reactions,” said William Maisel, MD, MPH, deputy director for science in the FDA Center for Devices and Radiological Health. “Our recommendations regarding natural rubber latex provide consistent, scientifically accurate language for health care providers, patients and consumers who want to avoid this material due to possible sensitivity or allergy.”

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