On December 2, 2014, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the labeling of products and packaging that are not made with natural rubber latex. If a manufacturer wishes to state that his product and its packaging do not contain latex, FDA recommends that he use the following statement when labeling:
“Not made with natural rubber latex.”
The statement is recommended for all FDA regulated medical products (including devices, drugs, biologics, and veterinary products) for which natural rubber latex or any synthetic derivative was not used in the manufacturing of the product, its container, or its packaging.
If only a certain component of a product is not made with natural rubber latex, the manufacturer should adjust the statement to reflect that. For example, if a syringe was not made with latex, but its packaging was made with latex, the statement should be as follows:
“The syringe is not made with natural rubber latex.”
FDA published the guidance because of the agency’s concern that statements currently being used, such as “latex-free” or “does not contain latex”, are not scientifically supportable and may mislead consumers, which can be dangerous for people who are allergic to latex. According to FDA, it’s impossible to be sure that a medical product is completely free of the allergens associated with reactions to natural rubber latex. FDA’s suggested statements inform consumers that a product was not made with natural rubber latex without suggesting that it is completely void of all allergens related to latex reactions.
Registrar Corp can review medical product labels for FDA compliance. Our Label and Ingredient Review Specialists will cross-reference a product’s labeling with numerous regulatory documents, from the Code of Federal Regulations to guidance documents and warning letters. Registrar Corp also offers other services for medical product companies, such as registration, listing, and U.S. Agent services. For more information about Registrar Corp’s services or FDA’s regulations for medical products, contact +1-757-224-0177 or chat with a regulatory advisor 24/7 at https://www.registrarcorp.com/LiveHelp.