Welcome To RegXComply
Health, Nutritional & Marketing Claim Substantiation Services
Health, nutritional, and marketing claims are powerful tools for consumer engagement—but they must be accurate, substantiated, and compliant with local regulations. GCC authorities, including MOHAP, SFDA, MOPH, and ESMA, strictly monitor claims to protect public health and prevent misleading advertising. RegXComply provides comprehensive claim substantiation services for food, dietary supplements, nutraceuticals, and functional products. We ensure that your claims are scientifically supported, legally defensible, and fully compliant, enabling safe market entry, consumer trust, and enhanced brand credibility.
Understanding the Regulatory Requirements
Claim substantiation is governed by strict GCC regulations to prevent false or misleading marketing:
Authorities: MOHAP (UAE), SFDA (Saudi Arabia), MOPH (Qatar), GSO (GCC-wide)
Types of Claims:
- Health Claims: Nutrient function or disease risk reduction
- Nutritional Claims: “Low fat,” “high fiber,” “sugar-free,” etc.
- Marketing Claims: Product positioning statements, benefits, or performance claims
Scientific Substantiation: All claims must be backed by scientific evidence, including clinical studies, published literature, or validated analytical tests
Labeling & Packaging: Claims must appear accurately on labels and promotional materials, in Arabic and English
Prohibited Claims: Unverified health benefits, disease treatment statements, or exaggerated performance statements are prohibited
Documentation:
Authorities require detailed evidence dossiers demonstrating the validity of claims
Non-compliance may lead to fines, product recall, rejection at import, or reputational damage.
Products Covered
- Food and beverage products
- Dietary supplements and nutraceuticals
- Functional foods and fortified products
- Cosmetics and personal care products with health-related claims
Our Services / How It Works (Expanded):
1. Claim Identification & Review
- Identify all health, nutritional, and marketing claims used across product portfolio
- Evaluate accuracy and potential regulatory risks
2. Scientific Evidence Assessment
- Review existing clinical studies, lab data, and literature to substantiate claims
- Identify gaps requiring additional research or testing
3. Regulatory Alignment
- Ensure claims comply with GCC authority guidelines (MOHAP, SFDA, MOPH, GSO)
- Align with permitted health and nutritional statements
4. Documentation Preparation
- Compile claim substantiation dossiers, including study references, test results, and technical reports
- Provide structured documentation ready for regulatory submission
5. Corrective Recommendations
- Suggest modifications or clarifications to non-compliant claims
- Develop alternative compliant statements where necessary
6. Label & Marketing Material Review
- Ensure claims are accurately reflected on packaging, labels, and promotional content
- Verify Arabic and English compliance
7. Authority Submission Support
- Assist with claim approval processes where required
- Liaise with regulators for clarification and expedited approval
8. Ongoing Monitoring & Updates
- Track changes in GCC regulations and guidelines for claims
- Recommend updates for continuous compliance
9. Training & Awareness
- Educate marketing, R&D, and regulatory teams on claim substantiation and compliance
- Build internal capabilities for future claims
10. Market Entry Advisory
- Ensure substantiated claims meet international and GCC market expectations
- Minimize risk of fines, recalls, or disputes with authorities
FAQ
Frequently Asked Questions
What is claim substantiation?
It is the process of validating health, nutritional, or marketing claims with scientific evidence to ensure regulatory compliance.
Are all claims subject to regulatory review?
Yes — GCC authorities review health, nutritional, and marketing claims for accuracy and compliance.
What documents are required?
Clinical studies, lab reports, technical dossiers, and supporting literature.
How long does claim substantiation take?
Typically 10–15 business days depending on the number of claims and available evidence.
Can RegXComply support ongoing claim monitoring?
Yes — we continuously track regulatory updates and recommend adjustments to maintain compliance.
Work With Us
Ensure your product claims are accurate, scientifically supported, and compliant. Contact RegXComply today for expert claim substantiation services.
200+
Companies Advised
500+
Product Registered
$25M+
Cost Savings