“Latex Free” misleading according to the FDA

A “Draft Guidance for Industry and Food and Drug Administration Staff” released by the FDA (Food and Drug Administration) released today (March 11, 2013), outlines the problem with claims of “Latex Free” or “does not contain latex”. According to the FDA the problem is that “it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex” and “may give users allergic to natural rubber latex a false sense of security”

While the draft and recommendations only apply to FDA regulated medical products, the implication is clear for pretty much anything else, especially for products that are made in an area where latex is processed or used.

At this time there are no regulations requiring a company to state that natural rubber latex was not used as a material in the manufacture” of a specific product, because of the increasing awareness and widespread scope of latex allergies, many manufacturers are starting to write “Latex-Free” or “Does not contain latex” (or sometimes “natural rubber”) on the packaging of products that are made with silicone, nitrile or other non-latex items.

The FDA’s suggestion is that manufacturers change the statement to “Not made with natural rubber latex” in order not to lull users with latex allergies into a false sense of security which may adversely effect their health when even minute particles of latex protein shows up in a supposedly “latex-free” item.

Bottom line is that, if you have a latex allergy or suspect that you may have one, you need to be proactive about making sure that even items labelled as “latex-free” don’t give you a reaction.

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