FDA Says, 'Latex-Free' Claims Not Valid. Offers Draft Guidance of Recommendations for Industry

WASHINGTON — The claim “latex-free” is impossible to guarantee and should not be used on labeling of medical products, according to an FDA guidance.
“FDA is aware of no test method or combination of test methods available at this time that can demonstrate the absence of proteins or components from natural rubber latex that may cause allergic reactions in susceptible individuals,” stated the guidance, issued Monday.

FDA pointed to three tests that detect compounds related to natural rubber latex allergies, two of which meet FDA standards: ASTM D5712, which analyzes aqueous extractable protein in natural rubber, and ASTM D6499, which measures antigenic protein. ASTM D7427, which detects four principal allergenic proteins, has not been recognized by FDA as a standard yet, the agency said.

At least 13 natural rubber latex allergens have been identified, far more than can be detected in the FDA-recognized tests, the agency said.

FDA recognizes “that the complete absence of all natural rubber latex allergens is unlikely to be necessary for the safe use of medical products by individuals with natural rubber latex allergies,” it said. But existing measurements lack the specificity and sensitivity to declare a product completely free of natural rubber latex proteins or antigens, the guidance said.

No regulations mandate the labeling of medical or other products regarding natural rubber latex, the guidance explained. Manufacturers have used the terms “latex-free” or “does not contain latex” to indicate a lack of natural rubber latex, dry natural rubber, or synthetic rubber latex, it said.

“FDA believes that these labeling statements are not sufficiently specific, not necessarily scientifically accurate, and may be misunderstood or applied too widely, and therefore, it is inappropriate to include such statements in medical product labeling,” it said.

Read more by Kathleen Struck, Senior Editor, MedPage Today
http://www.medpagetoday.com/HospitalBasedMedicine/WorkForce/37895

Draft Guidance for Industry and Food and Drug Administration Staff – Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm340972.htm

The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container.  FDA is concerned that statements submitted for inclusion in medical product labeling, such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product.  Use of these terms may give users allergic to natural rubber latex a false sense of security when using a medical product.  FDA is recommending that a consistent, scientifically accurate statement be used by all manufacturers who wish to convey that natural rubber latex was not used as a material in the manufacture of a medical product or medical product container.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.