FDA Urges Manufacturers to Drop 'Latex Free' Claim

Labeling statements such as "latex free" or "does not contain latex" are not sufficiently specific, not necessarily scientifically accurate, and may be misunderstood or applied too widely, according to the agency.

FDA is urging manufacturers of medical products to stop using the labels "latex-free" or "does not contain latex" because the agency is not aware of any test 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," the agency reminded stakeholders in an article on its Consumer Updates page, which features the latest on all FDA-regulated products.

The agency issued a final guidance document on Dec. 2, 2014, advising firms that 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 adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches, blood-pressure monitoring cuffs, and some other medical products. It also is not possible to predict in advance just how much exposure to natural rubber latex might cause reaction in any specific person, according to the article, who adds that sensitivity is more likely to build up over time, so health care workers and others who frequently wear latex gloves are at highest risk.

"The Occupational Safety and Health Administration 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," it states.

The article includes this section, titled "The Danger of Inaccurate Labeling":

"FDA's medical device regulations require certain labeling statements on medical devices if the device or device packaging is made of natural rubber latex. At this time, there are no regulations requiring a company to make any labeling statements when natural rubber latex is not used as a material in the manufacturing of a medical product. However, some manufacturers have included such labeling statements as 'latex free' or 'does not contain latex' in their labeling. FDA believes that these labeling statements are not sufficiently specific, not necessarily scientifically accurate and may be misunderstood or applied too widely. Therefore, it is inappropriate to include such statements in medical product labeling. Statements such as 'latex free' are not specific about the type of latex involved and can cause confusion. Not all types of latex are from natural rubber and contain the proteins responsible for natural rubber latex allergy. For example, products containing nitrile and polyvinyl chloride are made of synthetic latex that does not contain those proteins and will not cause a latex allergy. Further, these statements do not account for the potential for accidental contamination of the medical product with natural rubber latex allergens during manufacturing or packaging."

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