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FDA Issues Draft Guidance for Manufacturers to Accurately Label Medical Products Not Made with Natural Rubber Latex

Posted on Wednesday, October 9, 2013

The U.S. Food and Drug Administration issued draft recommendations to medical product manufacturers for providing accurate information about products that are not made with natural rubber latex (NRL).

NRL is a milky fluid found in rubber trees and other plant sources. Prolonged or repeated exposure to NRL can result in sensitivity or allergy. Mild reactions may include skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, anaphylactic shock may occur.

The FDA is encouraging manufacturers of FDA-regulated medical products to stop using statements on labels such as “latex free” or “does not contain natural rubber latex” because these statements are not scientifically accurate. Instead, the FDA recommends manufacturers use the labeling statement – “not made with natural rubber latex” – to indicate when NRL was not used as a material in the medical product or product container. 

“Consumers rely on and expect accurate labeling and product information, especially when they are concerned about allergic reactions,” said William Maisel, MD, MPH, deputy director for science in the FDA’s Center for Devices and Radiological Health. “Our recommendations regarding natural rubber latex provide consistent, scientifically accurate language for health care providers, patients and consumers who want to avoid this material due to possible sensitivity or allergy.”

The terms “latex free” and “does not contain natural rubber latex” suggest that the medical product is completely without NRL. 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. There is no test to show that a medical product is completely free of NRL allergens. 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.

Also, phrases such as “latex free” that are not specific about the kind of latex being referred to can cause confusion. Latexes may be natural or synthetic. Synthetic latex, such as nitrile and polyvinyl chloride, does not contain the proteins responsible for NRL allergy.

People most at risk for NRL sensitization include those who frequently use NRL gloves such as physicians, nurses, dentists, medical technicians, hairdressers, housekeepers, and food service workers. Employees in facilities that manufacture products containing NRL are also at risk. 

Consumers concerned about NRL allergies should check the medical product label, if readily available, or ask their health care provider if the product of interest contains NRL. 

Today’s draft recommendations would apply only to FDA-regulated medical products, such as drugs, medical devices, biologics and veterinary products. The law does not require medical product manufacturers to state on the product labeling when NRL has not been used in the manufacture of the product or product packaging. However, medical device manufacturers are required to include a caution statement on the labeling of devices that are made with NRL.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products

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