FDA Issues Guidance on Latex-Free Claims in Medical Product Labeling
The Food and Drug Administration posted new guidance on the labeling of products that do not contain natural latex (here). FDA says some companies are labeling their drugs, devices and biologics as “latex free” or “does not contain latex.” However,…
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there is currently no test that can back up a claim that a product is completely latex-free, said the agency. Instead, companies should label their products as “not made with natural rubber latex.” If a company wants to say a specific product or part isn’t made with natural latex, it should say “the [product] is not made with natural rubber latex,” said FDA. Although FDA said the guidance is not binding, the agency told manufacturers that currently include statements like “latex-free” or “does not contain latex” to update their labeling to show FDA’s recommended labeling statement, or consider removing any such statements altogether.