LEAP Testing Service

Latex Free Claims. We have had some questions from customers on how to handle latex free claims. Specifically, how can the manufacturer claim the product is latex free when you are receiving the materials from a supplier and are not sure if their formulation is latex free. The best way to handle this situation would be to ask for a signed “truth statement” from your supplier. This would be a letter signed by the CEO or some other authorized representative of the supplier, that the product contains no natural rubber latex (NRL) in its formulation or manufacture. Any additional documentation such as latex protein test results that are consistent with this claim can also be submitted as supporting information with your application.

Occasionally in telling a customer that their samples tests below the detectable limit of the assay, we sometimes get the response, “That means that I can say that the test item is latex free right?” NO! A latex free claim CAN NOT be placed on an item if any amount of NRL is used in its production, even if it tests below the detectable limits of ANY or all protein determination methods.

If you are still not sure on how to proceed or have more questions about latex free claims, then please contact the FDA directly.

Another frequent question we receive is the following. Our product has no standard specification for allowable latex protein levels. How do we find out what the standards are regarding latex protein levels and our product? With regards to latex proteins there are only a few directives that we are aware of for latex products. The first one from the US FDA CFR title 21 part 801 Labeling, is that products that contain NRL that contact humans MUST carry the statement “This product contains Natural Rubber Latex which may cause allergic reactions”. Again this means that if you are aware of Any NRL used in the manufacture or formulation of the product you cannot make a latex free claim.

See the following FDA attachments for labeling claims. attachment 1, attachment 2

The other directive is for the labeling claims of latex gloves. At present the minimum protein claim on gloves is “This product contains less than 50ug/gm NRL”. This is based on the ASTM D5712 assay. A newer directive put out for comments suggested changing the recommendation was put out for comment in 1999 and no further updates have been noted. As far as we know gloves are the only product to have specific latex protein specifications.

We are marketing a device that contains NRL, but there are no guidelines for NRL protein levels, what do we do? If you are looking for guidance for your device the best way to proceed is to approach the committee that establishes standards for the device. It may be through the ASTM or another such organization, or the FDA section that regulates the device, and push for the inclusion of such specifications to the standard. It is our understanding that the FDA will not set protein levels but would prefer that these levels are set through the governing bodies, such as the ASTM, which oversee the the specifications for such products. Why push for an additional specification? Buyers who have concerns about latex allergies would like to know that the products/devices they are purchasing meet some standard for protein levels and that they are unlikely to cause an allergic reaction or sensitize an individual. Without such data they may be very reluctant to purchase the product.