U.S. FDA Promotes Labeling Change for Products that May Contain Latex, Repeated Exposure Can Cause Rash or Difficulty Breathing

Recent reports from the U.S. Food and Drug Administration suggest that changing the labeling on products could help consumers determine if they're goods are really "latex-free."

In order to avoid giving a false sense of security, the FDA recommends that medical products stop using statements on labels such as "does not contain latex." Researchers note that the problem stems from the inability to provide a medical assessment that can indicate whether the products, do in fact, not contain latex. With an appropriate labeling that has been scientifically tested, the FDA hopes to provide accurate information for products and those that may be allergic to latex.

Hence, the FDA is recommending in a draft guidance document that was announced in the Federal Register on March 8, 2013 that manufacturers who want to indicate that natural rubber latex was not used as a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 Details on how to submit comments are provided in the draft guidance document and Federal Register notice.

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.