No Reliable Test for 'Latex-Free' Claims: FDA

The agency has issued a draft guidance document urging manufacturers that want to indicate natural rubber latex was not used as a material instead use the statement on the product label, "not made with natural rubber latex."

"Latex-free" and "does not contain latex" claims on product labels may give people who are allergic to natural rubber latex a false sense of security, the Food and Drug Administration reported March 8, as it issued a draft guidance document recommending different claims by manufacturers of FDA-regulated medical products.

"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," the agency’s news release stated.

The guidance document says manufacturers should instead use "the more scientifically accurate labeling statement 'not made with natural rubber latex.' " Natural rubber latex can be used in medical products such as adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches, and blood-pressure monitoring cuffs, according to the agency. Sensitivity is likely to build up over time, and people who frequently wear latex gloves are generally at highest risk. According to OSHA, 8-12 percent of health care workers are latex-sensitive.

"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 Dr. Sheila A. Murphey, a medical officer in FDA's Center for Devices and Radiologic Health.M

OSHA and CDC recommend these steps to prevent allergic reactions:

  • Avoid using gloves with natural rubber latex for activities that are unlikely to involve contact with infectious materials.
  • If you need such gloves, use powder-free gloves labeled with reduced protein content. When wearing them, do not use oil-based lotions. Natural rubber latex proteins can become attached to powder used to lubricate gloves, and when the gloves are removed, the particles become airborne and can be inhaled, which is another form of exposure. Oil-based lotions can cause deterioration of the gloves.
  • After use, wash your hands with a mild soap and dry thoroughly.
  • Learn to recognize the symptoms of a natural rubber latex allergy and take training offered by your employer.

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