Some manufacturers label or promote their products as “latex free” or “does not contain latex” to inform users that natural rubber latex in any of its forms was not used in their product. In a guidance document titled “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex Guidance for Industry and Food and Drug Administration Staff,” published on December 2, 2014, FDA strongly recommends that these statements not be used in medical product labeling.
First, according to FDA, the term “latex” in those labeling statements could refer to different forms of latex. These labeling statements are not sufficiently specific.
Second, no currently available analytical method can identify all components in natural rubber latex that may cause an allergic reaction. Additionally, the limits of current analytical methods cannot assure that a product is completely “free” of natural rubber latex allergens.
Finally, the threshold allergen levels for the many distinct natural rubber latex allergens vary among individuals and groups of individuals and likely depend on the route of exposure. Therefore, FDA believes there is no one threshold level of exposure that can be considered safe.
No current regulation requires a manufacturer to state that natural rubber latex was not used as a material in their medical product, its container and/or its packaging. If a manufacturer elects to include such a statement, FDA recommends the use of the statement “Not made with natural rubber latex.” If this statement is made without any qualification, it would apply to the medical product, its container, and any packaging. Where the lack of natural rubber latex applies only to a component of a medical product, FDA recommends the statement “The <component> is not made with natural rubber latex.”
Labeling continues to be one of the “sticky wickets” of device compliance and FDAImports.com can provide the way through device labeling traps.
