Regulatory Focus™ > News Articles > FDA Calls for Changes to Latex Labeling Statement to Reduce Confusion

FDA Calls for Changes to Latex Labeling Statement to Reduce Confusion

Posted 08 March 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has published a new draft guidance document regarding the labeling of medical products not made with natural rubber latex (NRL).

NRL is found in numerous medical products, most prominently latex gloves, vial stoppers and condoms, and is noted for its elastic properties.

In a statement, FDA explained that repeated or prolonged exposure to NRL can result in patients developing allergies or sensitivity to NRL, generally in the form of skin-site reactions. More severe and potentially dangerous reactions can include anaphylactic shock and respiratory distress.

In light of these concerns, some manufacturers have moved to using latex alternatives, and have taken to the habit of labeling these products as "latex free" or with statement indicating that the product "does not contain natural rubber latex."

Natural vs. Synthetic

However, these statements are "not scientifically accurate," FDA explained, and should not be used.

"The terms 'latex free' and 'does not contain natural rubber latex' suggest that the medical product is completely without NRL," FDA wrote. "However, even when medical products are not made with NRL, there is a chance that products can become contaminated with NRL allergens during manufacturing or packaging processes."

In its guidance, FDA notes that there are three tests used to detect the presence of NRL compounds: ASTM D5712, D6499 and D7427. The former two are FDA-recognized standards, while the latter is at this time unrecognized.

But even those tests are unable to demonstrate the absence of NRL proteins that could cause an allergic reaction in patients. "Additionally, it is not necessary for a medical product to be completely without NRL allergen proteins to be considered safe for use by some individuals with NRL allergies," FDA added.

The guidance notes that there are at least 13 allergens within NRL, and patients' sensitivity to each vary from person to person. "There is no one threshold level of exposure that can be considered safe, but rather many levels that are a function of the allergen, the risk group, the exposure route, the immune status of the individual and, perhaps, other factors as yet unidentified," FDA explained.

The statement can also cause confusion given the varying types of latex, of which synthetic varieties do not always contain the proteins that typically cause allergic reactions.

New Statements to be Recommended

Instead, FDA said it will recommend a more generic statement: "Not made with natural rubber latex." Variations might also include an approximation of "<product X> is not made with natural rubber latex."

"These statements … communicate that natural rubber latex was not used as a material in the finished product or as a material in the container," FDA explained. "At the same time, the statement does not make the unsupportable claim that the medical product is 'free' of or 'does not contain' natural rubber latex (i.e., materials or contamination), which may promote a false sense of safety to users who are allergic to natural rubber latex."

FDA noted that the changes should prove useful in promoting consistently between labeling used by FDA, medical professionals, manufacturers and end users.

Comments on the draft guidance are due to FDA by 8 June 2013.


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