FDA Cracks Down on “Latex-Free” Labeling

Companies have been banned from marketing their products as “latex-free” after a judge deemed it impossible to guarantee items such as rubber gloves and condoms don’t contain the natural substance.


New guidance put out by the the U.S. Food and Drug Administration last month says the term should not be used on labeling of medical products because it’s misleading.

“FDA is aware of no test method or combination of test methods available at this time that can demonstrate the absence of proteins or components from natural rubber latex (NRL) that may cause allergic reactions in susceptible individuals,” the agency said in a release.

The FDA said there were at least 13 compounds related to natural rubber latex that have been identified. But it knows of only three tests that exist to pick up traces of latex in products, and only two of these meet FDA standards. This means many allergens are going unnoticed.

So what does this mean for manufacturers? The FDA suggests manufacturers replace the term “latex-free” with the more accurate labeling statement “not made with natural rubber 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, the FDA said.

Prolonged or repeated exposure to latex can result in sensitivity or allergy while mild reactions may include skin redness, rash, hives, or itching and severe reactions could include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, anaphylactic shock and even death may occur.

“Consumers rely on and expect accurate labeling and product information, especially when they are concerned about allergic reactions,” said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health.

So, next time, check the label before you enable!


[Source: www.fda.gov]



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