What Is FDA Small Entity Compliance Guide?
FDA publications designed to help small businesses understand and comply with specific regulations, written in plain language with practical examples and step-by-step guidance.
Why It Matters for Supplement Brands
The dietary supplement small entity compliance guides are among the most useful FDA resources for understanding claim requirements, labelling rules, and cGMP obligations. They translate complex regulations into actionable guidance — essential reading for any brand that doesn't have a full regulatory affairs team.
How It Works
FDA publishes small entity compliance guides for major supplement regulations:
- **Structure/Function Claims Guide**: Explains what qualifies as a structure-function claim vs. a disease claim, notification requirements, and the 'reasonable evidence' standard - **cGMP Compliance Guide**: Provides practical guidance on meeting current Good Manufacturing Practice requirements - **NDI Guidance**: Explains the New Dietary Ingredient notification process
These guides don't have the force of law — they represent FDA's current thinking and interpretation. However, following them demonstrates good faith compliance efforts, which matters in enforcement situations.
Common Mistakes to Avoid
- ✗Not reading these guides, which are specifically written for small supplement companies
- ✗Treating the guides as binding law rather than FDA's interpretation and recommendations
- ✗Relying solely on the guides without consulting the underlying regulations for edge cases
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