FDA: Stop using 'latex-free' label on medical products

The U.S. Food and Drug Administration (FDA) has issued draft recommendations to medical product manufacturers for providing consumers with 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.

In particular, 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."

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, the FDA noted. In addition, 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 also are at risk.