Recommendations for Labeling Medical Products Without Natural Rubber Latex
This guidance applies to all FDA regulated medical products (devices, drugs, biologics, and veterinary products) where natural rubber latex or its synthetic derivatives were not used in manufacturing the product, its container, or packaging.
What You Need to Know? 👇
What is the FDA’s recommended labeling statement for medical products not made with natural rubber latex?
The FDA recommends using “Not made with natural rubber latex” instead of terms like “latex-free” or “does not contain latex.” For specific components, use “The
Why does the FDA discourage using “latex-free” labeling on medical devices?
The FDA considers “latex-free” scientifically inaccurate because no analytical methods can reliably detect all natural rubber latex proteins that cause allergic reactions. This labeling may give latex-allergic users a false sense of security.
Which FDA centers regulate medical products covered by this latex labeling guidance?
This guidance applies to products regulated by CDRH (devices), CDER (drugs), CBER (biologics), and CVM (veterinary products). Each center has specific contact persons for questions about latex labeling requirements.
Are there established threshold levels for natural rubber latex allergens in medical products?
No threshold allergen levels exist for natural rubber latex. At least 13 distinct allergens have been identified, and sensitivity varies among individuals and exposure routes, making it impossible to establish universal safe levels.
What analytical methods are available to test for natural rubber latex proteins in medical devices?
Three main methods exist: ASTM D5712 (total protein), ASTM D6499 (antigenic protein), and ASTM D7427 (four specific allergens). However, none can demonstrate complete absence of all allergenic proteins.
Is it mandatory to include latex labeling statements on medical products?
No regulations require manufacturers to state that natural rubber latex was not used. However, if manufacturers choose to include such statements, they should use FDA’s recommended scientifically accurate language.
What You Need to Do 👇
Recommended Actions
- Review current product labeling for any “latex-free” or “does not contain latex” statements
- Update labeling to use the FDA recommended statement “Not made with natural rubber latex” or component-specific version
- Contact appropriate FDA Center for guidance on the regulatory mechanism to update labeling
- Consider removing latex-related statements entirely if not necessary
- Ensure understanding that no current test methods can guarantee complete absence of latex proteins
- Document the basis for any latex-related claims in product labeling
Key Considerations
Non-clinical testing
- No current analytical methods can identify all proteins and components in natural rubber latex that may lead to allergic reactions
- Three test methods available (ASTM D5712, ASTM D6499, ASTM D7427) but none can demonstrate complete absence of latex proteins
Labelling
- Do not use terms “latex-free” or “does not contain latex”
- Use “Not made with natural rubber latex” for the entire product
- Use “The [specific component] is not made with natural rubber latex” when referring to specific components
- Manufacturers should update existing labeling to use the recommended statements or remove latex-free type statements
Safety
- No threshold allergen levels are available for natural rubber latex-allergic individuals
- Multiple routes of exposure must be considered (respiratory, percutaneous, oral, and parenteral)
- At least 13 distinct allergens identified for natural rubber latex allergy
Relevant Guidances 🔗
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms 📂
- ASTM D5712: Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and its Products Using the Modified Lowry Method
- ASTM D6499: Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products
- ASTM D7427: Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins in Natural Rubber and its Products Derived from Latex