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FDA issues guidance on use of 'latex-free' medical products labeling

March 18, 2013

By Jean Williams, ADA News staff

Silver Spring, Md.—The U.S. Food and Drug Administration has issued new draft guidance for manufacturers of FDA-regulated medical products recommending that they stop labeling products as “latex-free” or “does not contain latex.”

The FDA has concluded that the use of such language on labels is misleading as the agency is unaware of any tests that can show a medical product to be completely free of natural rubber latex proteins that can cause allergic reactions.

Announced March 8 in the Federal Register, the draft guidance suggests that manufacturers wanting to indicate that natural rubber latex was not used as a material should instead use the more scientifically accurate language “not made with natural rubber latex.” The FDA says it wants to promote the more scientifically accurate labeling.

Repeated exposure to natural rubber latex proteins in medical products can result in the development of sensitivity to the substance, which may cause symptoms ranging from skin redness, rash, hives or itching to difficulty breathing and wheezing and, rarely, shock and death.

The ADA plans to provide updates as more information becomes available.

For more information, visit Call 888.INFO.FDA for consumer inquiries.