The U.S. Food and Drug Administration (FDA) issued draft recommendations to medical product manufacturers for providing consumers with more accurate information about products not made with natural rubber latex (NRL), which can cause sensitivity or allergy in users.
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.
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.
