The U.S. Food and Drug Administration (FDA) has issued draft guidance related to accurately labeling medical products not manufactured with natural rubber latex. Titled “Draft Guidance for Industry and FDA Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex,” the guidance offers recommendations on the “appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container.”

FDA cites concerns that statements submitted for inclusion in medical product labeling such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are not accurate because “it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product.” The agency will accept comments on the draft guidance until June 10, 2013. See Federal Register, March 5, 2013.