Manufacturers will now no longer be able to use the labels “latex-free” and “does not contain latex” due to a recommendation by FDA.
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.” FDA’s medical device regulations require certain labelling 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 labelling statements when natural rubber latex is not used as a material in the manufacturing of a medical product. However, some manufacturers have included such labelling statements as “latex-free” or “does not contain latex” in their labelling. FDA believes that these labelling 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 labelling. 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.