WASHINGTON—The U.S. Food and Drug Administration has issued a consumer advisory, “Don't Be Misled by "Latex Free' Claims,” warning users of natural rubber latex products that some labels on medical gloves and other devices are too vague to be helpful.
Some manufacturers and suppliers of latex products said they welcome the FDA advisory, which is based on a December 2014 guidance document from the agency recommending that the “Latex Free” label be dropped. Others declined comment, pending a review of the agency directive.
“Their purpose for getting out this document is a good one,” said Bill Doyle, president and CEO of Duluth, Ga.-based Vystar Corp., a manufacturer of patented, ultra-low protein natural rubber latex for a wide variety of markets. “They're looking out for consumers and probably not just within the health care community.”
Frank Mantero, senior vice president of communications and marketing for glove manufacturing giant Ansell Ltd., said his company's legal and regulatory staff are reviewing the FDA advisory. “At this point, we are not in a position to comment,” he said.
The FDA issued its advisory March 26. “If you're allergic to natural rubber latex, FDA has good news for you,” the document began. “In the future, you are less likely to be misinformed about the absence of this allergen in such products as medical devices. To avoid false assurances about this hazard to your health, FDA is recommending to manufacturers to stop using the labels "latex-free' or "does not contain latex.' “
To date, no tests exist that can demonstrate the total absence of allergy-triggering proteins in natural rubber latex, the agency said.
“Without a way to verify that a product is completely free of these proteins, a claim that it is "latex-free' is scientifically inaccurate and may be misleading,” it said.
The advisory cites a Federal Register notice from Dec. 2, 2014, which recommended to latex medical device manufacturers that they use the label, “not made with natural rubber latex,” if in fact the device contains no NR latex.
The FDA said that 1 to 6 percent of the general population is sensitive to NR latex, and it quoted the Occupational Safety and Health Administration as saying that the percentage rises to 8-12 percent within the health care community.
Latex in adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches and blood pressure monitoring cuffs can cause allergic reactions ranging from skin rashes to anaphylactic shock, the FDA said.
“It is not possible to predict in advance just how much exposure to natural rubber latex might cause reaction in any specific person,” the agency said.
Statements such as "latex-free' aren't specific enough to avoid confusing the public, the FDA said.
“For example, products containing nitrile and polyvinyl chloride are made of synthetic latex that does not contain those proteins,” it said. “Further, these statements do not account for the potential for accidental contamination of the medical product with natural rubber latex allergens during manufacturing or packaging.”
The FDA advised consumers to use non-latex gloves for activities that involve biological materials such as blood and bodily fluids and also for activities such as house cleaning, yard work and wall painting.
“If you choose latex gloves for appropriate barrier protection, use powder-free gloves labeled as having reduced protein content,” the agency said. “Also, when wearing gloves, do not use oil-based lotions since they can cause the gloves to deteriorate.”
Vystar's Doyle said the FDA directive gives his company no pause. “We're a latex producer, and we're happy to hear about this,” he said.
Phoenix-based Yulex Corp., manufacturer of hypoallergenic natural rubber latex from the desert shrub guayule, said it supported the FDA advisory, with the caveat that it is a latex supplier and not a latex product manufacturer.
“Yulex commends the FDA for trying to protect latex allergy-sensitive individuals by asking product manufacturers to not provide a false sense of security,” a Yulex spokeswoman said. “Ultimately, it is the responsibility of the product manufacturer to make decisions on product labeling.”