Don't Be Misled by "Latex-Free" Claims

If you’re allergic to natural rubber latex, the federal Food and Drug Administration (FDA) has good news for you: in the future, you are less likely to be misinformed about the absence of this allergen in such products as medical devices. To avoid false assurances about this hazard to your health, FDA is recommending to manufacturers to stop using the labels “latex-free” or “does not contain latex”.

The reason for this recommendation is that the agency is not aware of any tests that can show a product contains no natural rubber latex proteins that can cause allergic reactions. Without a way to verify that a product is completely free of these proteins, a claim that it is “latex free” is scientifically inaccurate and may be misleading.

FDA’s final guidance document, issued on December 2, 2014, advises firms who want to indicate that natural rubber latex was not used in the manufacturing of their product, to state on the label that it was “not made with natural rubber latex.”

Natural rubber latex is made from plant sources such as the sap of the Brazilian rubber tree. It is used in numerous medical products, including adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches and blood-pressure monitoring cuffs. 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.

It is not possible to predict in advance just how much exposure to natural rubber latex might cause reaction in any specific person.

Who is at Risk?

Since sensitivity is more likely to build up over time, health care workers and others who frequently wear latex gloves are at highest risk.

The Occupational Safety and Health Administration (OSHA) estimates that 8 to 12 percent of health care workers are latex-sensitive. Workers in plants that produce natural rubber latex or that manufacture products containing natural rubber latex might also be at greater risk. FDA estimates that 1 to 6 percent of the general population may also be sensitive to natural rubber latex.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention and OSHA recommend anyone with ongoing exposure to natural rubber latex to take the following steps for protection from allergic reactions:

Use nonlatex gloves for activities that involve contact with biological materials including blood and bodily fluids whenever possible.

In addition, use nonlatex gloves for activities that are not likely to involve contact with blood and bodily fluids, such as house cleaning, yard work, wall painting, etc.