In recent years, it has become apparent that in the U.S., latex allergies are a serious and growing problem. In fact, there are approximately three million people in our country who are sensitive to the latex found in natural rubber. In recent labeling news, the U.S. Food & Drug Administration has adopted new product labeling requirements regarding latex used in medical equipment and devices, in an effort to lower the risk of exposure to latex during medical procedures in those who are allergic. Latex is most commonly found in the gloves worn by doctors, nurses, and others in the health care industry.
Many manufacturers today offer products that are labeled “does not contain natural rubber latex” and they claim they are latex-free, however the FDA found this statement to be poorly regulated due to the fact that not all products claiming to be latex-free are actually free of natural rubber latex. The agency says that in fact, it is not aware of any procedures used in testing that are able to detect the presence of latex proteins.
According to the FDA, terms used by manufacturers suggest to consumers that these products are totally free of latex, however it is possible that during the packaging or manufacturing process products may be contaminated with natural rubber latex.
Currently, the FDA is recommending that manufacturers use the labeling “not made with natural rubber latex” in cases where the product or packaging do not contain latex. This would apply to drugs, devices, veterinary products, biologics, and other FDA regulated products which contain no natural rubber latex or synthetic derivatives. In situations where a component of a product does contain latex, those components that do not contain it should include a statement regarding that specific component, and the fact that it is not made with natural rubber latex. For example, if a container contains latex but the syringe inside it does not, this type of labeling would apply.
At REA JET, we know that in recent years, the number of people who are allergic to various substances seem to be on the rise. Latex, gluten, peanuts, and other allergens have come to the forefront, requiring that manufacturers make changes to their products and labeling. We provide a wide array of coding and marking solutions for manufacturers including large and small character ink jet, laser systems, spray mark systems, high resolution ink jet, and more.