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FDA Warns Manufacturers Against 'Latex Free' Custom Product Labels

FDA Issues New Policy On Latex Custom Product Labels

Crafting custom product labels that caution customers against potential allergy-triggering substances is a priority for all manufacturers. However, businesses may have to change their labeling practices regarding latex, as the U.S. Food and Drug Administration (FDA) issued new guidance on the matter.

In it, the FDA cautioned manufacturers to stop labeling medical products as "latex-free" or "does not contain latex," because it is not truly indicative of a product's exposure to latex in its naturally occurring form, which can still prompt an allergic reactions.

Product Label Printing Not Supported By Science
If medical products need product label printing that denotes latex content, the FDA recommended manufacturers use "not made with natural rubber latex" labels.

"The problem with [latex-free labeling] 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," the agency said in a press release. "Without a way to verify that a product is free of these proteins, claims that a product is 'latex free' may be misleading."