FDA labeling compliance requirements vary for each product. In general, information on the label must be truthful and not misleading, labels should include all the required information for the product category, wording and formatting should be easy for consumers to understand.
Below are basic requirements for each product category.
- Ingredient list
- Nutrition information panel
- Allergen warnings
- Name and address of the manufacturer.
- Net quantity of contents
- Intended use of the device
- Directions for use
- Warnings and precautions
- Sterilization information (if applicable)
- Manufacturer information
- Drug facts table.
- Intended use of the drug with active ingredients concentration.
- Warnings and precautions.
- Directions of use
- Inactive ingredients
- Manufacturer information
- Expiration date
- Principal Display Panel (PDP)
- Product Name
- Identity Statement
- Net quantity and Ingredient list
- Warning and Precautions
The FDA provides comprehensive guidance documents to help navigate the complexities of labeling compliance.
The FDA does not pre-approve labels, so manufacturers are responsible for ensuring compliance.
Liberty management Group, LTD as a leading FDA consulting firm provides assistance with Food, Drug, Medical devices and Cosmetics labeling compliance.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us
www.fdahelp.us