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How to Justify Functional Claims for SFDA Product Approval

In Saudi Arabia, securing SFDA approval for food, supplement, and herbal products often hinges on how well you justify the product’s functional claims.

If your product promises benefits like “boosts immunity” or “supports digestion,” expect the SFDA to scrutinize these claims — especially for multi-ingredient or borderline products. Here's how to prepare for it.

What Are Functional Claims?

Functional claims are statements that link a product or ingredient to a specific benefit, such as:

• "Improves gut health"

• "Enhances energy and focus"

• "Reduces fatigue"

These claims must be backed by scientific evidence and clear classification to meet SFDA’s standards.

When Does SFDA Ask for Justification?

The SFDA often flags claims when:

• The product includes ingredients that aren’t well-known in Saudi regulations

• The function overlaps with medicine or therapeutic use

• The claim is not supported by regional regulatory precedent

• The label mentions effects like weight loss, mood, or cognition

Products in these categories will typically receive a request for justification documents.

How to Prepare Strong Justification

1. Use Scientific References

• Peer-reviewed journals (PubMed, ScienceDirect)

• Regulatory assessments from EFSA, US FDA, or WHO

• Clinical trials showing ingredient efficacy

2. Add Global Regulatory Status

Show that the product or ingredients are approved in:

• European Union food databases

• US Dietary Supplement Ingredient List (DSHEA)

• GCC and MENA region approvals (if any)

3. Provide Functional Classification Support

• Pharmacopoeia listing (e.g., USP, BP)

• Traditional medicine references (for herbal products)

• Food vs supplement category rationale

4. Product-Specific Evidence

• Product lab testing reports (if any support the claim)

• Dosage justification aligned with published studies

• Safety and toxicology data for the dosage used

Common Documentation to Include

• Scientific articles (translated to Arabic if requested)

• Label draft with functional claims highlighted

• Claim reference sheet mapping each claim to evidence

• Safety data sheets (SDS) and ingredient specs

Mistakes to Avoid

• Submitting generic research without linking it to your formula

• Using outdated or unverified sources

• Failing to translate documents when required

• Making borderline therapeutic claims (e.g., “treats fatigue” vs. “supports energy metabolism”)

Why This Matters for SFDA Approval

Ignoring this step can:

• Delay your file review for weeks

• Trigger classification changes or rejection

• Result in full disapproval if the claim violates SFDA policy

Products with multi-ingredient formulas or traditional medicine roots are most at risk if justification is not prepared proactively.

FAQs About Functional Claim Justification

1. Does SFDA allow functional claims at all?
Yes, if they are properly justified and don’t cross into therapeutic territory.

2. Can I copy claims from other supplements in the market?
Not always. Just because another product made a claim doesn’t mean it was approved.

3. Will English references be accepted?
Yes, but you may be asked to submit Arabic translations later in the process.

4. Can I work with an expert to justify my product?
Yes. Regulatory consultants can prepare evidence, format it correctly, and avoid red flags.

5. Are herbal claims treated differently?
Yes. SFDA may request traditional use data and globally accepted herbal monographs.

6. What happens if I don’t submit justification when asked?
Your application may be put on hold or rejected. Delays are common.

Recommended Reads:

• Explore claim labeling tips in SFDA Labeling Mistakes to Avoid in 2025

• Understand market withdrawals in SFDA Recall Plan Requirements 2025

• Get documentation tips in Fix SFDA Registration Rejection (2025)

• Learn more about SFDA barcode requirements of labeling and packaging essentials.

Need help justifying your product’s functional claims?
Use the chatbot in the bottom right corner or message our support team to avoid SFDA delays and rejection.

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