No More Latex-Free Claims, Recommends FDA
The Food and Drug Administration (FDA) is recommending that manufacturers stop using the labels “latex-free” or “does not contain latex” due to the scientific inaccuracy of these claims.
Because the FDA is not aware of any tests that can show a product contains no natural rubber latex proteins, which can cause allergic reactions, label claims that a product is “latex free” or “does not contain latex” are scientifically inaccurate and may be misleading. The FDA adds that not all types of latex are from natural rubber and contain the proteins responsible for natural rubber latex allergy. In addition, these statements may not account for the potential for accidental contamination of the medical product with natural rubber latex allergens during manufacturing or packaging.
The agency issued a final guidance document in December 2014 advising firms who want to indicate that natural rubber latex was not used in the manufacturing of their product to state on the label that it was “not made with natural rubber latex.”
For more information visit FDA.gov.