FDA issues warning against 'latex free' claims

WASHINGTON—The U.S. Food and Drug Administration has issued a consumer advisory titled, “Don’t be Misled by ‘Latex Free’ Claims.”

The advisory, the FDA said, is in support of a guidance document it issued in December in the Federal Register recommending that manufacturers of gloves, condoms, catheters and other medical devices stop using labels such as “latex free,” “does not contain natural rubber latex,” or “does not contain latex.”

“The agency is not aware of any tests that can show a product contains no natural rubber latex proteins that can cause allergic reactions,” the FDA said in its March 26 consumer advisory.

“Without a way to verify that a product is completely free of those proteins, a claim that it is ‘latex free’ is scientifically inaccurate and may be misleading,” the agency said.

The FDA estimates that 1 to 6 percent of the general population may be sensitive to natural rubber latex, and it quotes the U.S. Occupational Safety and Health Administration as saying that percentage rises to 8 to 12 percent among health care workers.

“It is not possible to predict in advance just how much exposure to natural rubber latex might cause reaction in any specific person,” the FDA said.

In addition, the “latex free” label is confusing because polyvinyl chloride and nitrile gloves contain synthetic latex, the FDA said. Also, the label can’t warn users of accidental contamination by natural rubber latex allergens during processing, it said.

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