FDA officials said there are no tests showing a medical product is completely without the natural rubber latex proteins that can cause allergic reactions and the agency wanted to promote scientifically accurate labeling.
Without a way to verify that a product is free of these proteins, claims that a product was "latex-free" might be misleading. FDA wants to promote scientifically accurate labeling, officials said.
As a result, FDA recommended in a draft guidance document published in the Federal Register Friday manufacturers who want to indicate natural rubber latex was not used as a material instead use the more scientifically accurate labeling statement "not made with natural rubber latex."
Public comments are welcome. Details on how to submit comments are provided in the draft guidance document and Federal Register notice.
Natural rubber latex made from plant sources such as the sap of the Brazilian rubber tree or its synthetic derivatives is used in numerous medical products, including adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches and blood-pressure monitoring cuffs, the FDA said.
Repeated exposure can result in sensitivity to natural rubber latex proteins, with symptoms ranging from skin redness, rash, hives or itching to difficulty breathing and wheezing. Rarely, shock and even death can occur.