Today, the FDA released recommendations for labeling medical products to avoid giving a false sense of security to people who are allergic to natural rubber latex. The Food and Drug Administration (FDA) is recommending that manufacturers of FDA-regulated medical products stop using statements on labels such as "latex-free" or "does not contain latex."
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. 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.
Those at highest risk for developing a latex allergy are those who frequently wear latex gloves, including health care workers, since sensitivity is more likely to build up over time. "It is not possible to predict in advance just how much exposure to natural rubber latex might be needed to sensitize any specific person," said Sheila A. Murphey, M.D., a medical officer in FDA's Center for Devices and Radiologic Health (CDRH).
The FDA requires manufacturers to label certain regulated products stating that they are made of natural rubber latex, including medical gloves and condoms. However, when natural rubber latex is not used as a material, medical product manufacturers are not required to state this in the product labeling. In these cases, some manufacturers use statements on the label like "latex-free. The problem with that language is that FDA is aware of no tests that can show a medical product is completely without the natural rubber latex proteins that can cause allergic reactions. Without a way to verify that a product is free of these proteins, claims that a product is "latex free" may be misleading. FDA wants to promote scientifically accurate labeling. In addition, statements such as "latex free" that are not specific about the type of latex being referred to can cause confusion. Not all types of latex contain the proteins responsible for natural rubber latex allergy. For example, products containing nitrile and polyvinyl chloride are made of synthetic latex that does not contain those proteins.
As a result, FDA is recommending in a draft guidance document announced in the Federal Register today, that manufacturers who want to indicate that natural rubber latex was not used as a material instead use the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.