FDA issues draft guidance for accurate labeling on medical products that are not made with natural rubber latex

What do adhesive bandages, blood-pressure monitoring cuffs, sanitary napkins, ventilator bellows, wheel chair cushions, and dental dams all have in common?

If you guessed natural rubber latex or a synthetic derivative you are correct! If you answered this question correctly, then you more than likely suffer from a latex allergy or know someone who does. According to the United States Department of Labor, latex allergy was first recognized in the late 1970’s.¹ There are several types of synthetic rubbers that are referred to as latex, as well as the natural substance derived from the rubber tree.² Symptoms of a latex allergy may include skin rash, flushing, hives, and asthma.₂ Approximately 1 in 6 people may be sensitive to natural rubber latex.¹ Within the health care industry, it is estimated that up to 12% of healthcare employees are latex sensitive.

Food and Drug Administration (FDA) released a draft guidance document, “Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.”³ This draft guidance recommends the use of more appropriate and accurate language to include in the labeling of medical products that do not contain natural rubber latex (either in the manufacture of the product or the product container).^3-4 FDA is discouraging the of verbiage stating that a medical product is “latex-free” or “does not contain latex” and feels that such language could give some users a false sense of security. Although there are a few tests that are used to detect the presence of natural rubber latex compounds, FDA is aware of no test that can prove natural rubber latex proteins are completely absent from a medical product. Therefore, “not made with natural rubber latex,” is the suggested language that manufacturers should use on labeling.

This draft guidance is open to public comment! Comments on this draft guidance are due to FDA by June 8, 2013.³ When submitting your comments, please remember to refer to the exact title of this guidance document! You can submit electronic comments to www.regulations.gov or you can submit written comments and suggestions to the following address:

Division of Dockets Managements

Food and Drug Administration

5630 Fishers Laner

Room 1061 (HFA-305)

Rockville, MD 20852

-RSpelich ^_^

References

1.) OSHA. Safety and Health Topics – Latex. Available at: http://www.osha.gov/SLTC/latexallergy/index.html. Accessed on 11 March 2013.

2.) State of NJ Department of Health. Latex Allergy: A guide to Prevention. Available at: http://www.state.nj.us/health/surv/latex.shtml. Last updated on 17 July 2012. Accessed on 11 March 2013.

3.) FDA. Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm340972.htm. Last updated on 8 March 2013. Accessed on 11 March 2013.

4.) FDA. There’s No Guarantee of ‘Latex Free’. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm342641.htm. Last updated on 11 March 2013. Accessed on 11 March 2013.