WASHINGTON — The Food and Drug Administration has issued a draft guidance document for the medical product industry on how to label medical products that do not contain natural rubber latex.
The purpose of the document, appearing March 11 Federal Register, is to make recommendations on appropriate language to convey to latex-sensitive persons that natural rubber latex was not used to manufacture a product or product container, according to FDA.
"FDA is concerned 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," the agency said in the Federal Register notice.
According to the draft document, it applies to all FDA-regulated medical products for which NR latex was not used in its manufacture or packaging.
Currently, there are no regulations requiring manufacturers to state the absence of NR latex in rubber products or packaging, though some companies include "latex-free" on their labels, FDA said. However, these labels are not necessarily scientifically accurate and can be misleading, it said.
There are various tests from ASTM International that measure various compounds related to natural rubber latex allergies, according to the draft document. But FDA is not aware of any existing tests or combination of tests that can categorically demonstrate the absence of allergenic proteins, it said.
The document recommends that when the phrase, "Not made with natural rubber latex" is used as a label, it must apply to both the product and its packaging. When such a label is appropriate only for certain components of a product, such as a vial stopper, the label must name the specific component—i.e. "The vial stopper is not made with natural rubber latex."
Manufacturers that use statements such as "latex-free" should update their labeling to use the new phrase, FDA said.
Interested parties have until June 10 to submit written or electronic comments on the draft document.
