REJIMUS is a preeminent regulatory consulting firm that helps companies globally in the Food, Dietary Supplement, Cosmetic and Homeopathic industries obtain the most comprehensive and fastest label review services for food, dietary supplements and other natural product labels before going to print or production. We offer an easy way to submit for supplement label review of claims, substantiations, specifications and compliance. Is your label a liability?
We specialize in FDA Compliance Consulting, Quality Development Services, Social Media Monitoring, Due Diligence, NDI and GRAS Notifications and Business Resource Services. Whether you are a start-up company focused on getting your first product to market and need to implement a quality system from scratch or you are a large established organization that needs to optimize and reduce risks and operating costs in regulatory and quality, we can enable you to achieve your goals efficiently.
FDA Guidelines for Supplement Labels ( 21 CFR Part 101 )
While many companies offer label design and production services, few review the supplement facts for compliance with cGMP regulations. Additionally, we can help identify issues that could potentially lead to costly regulatory or legal challenges with respect to language that is either not allowed or does not have suitable claim substantiation.
What is also unique about our label review services? We provide corrective language for your labels, we don’t just tell you “no!”
Key Label Review Features:
- Label presentation & positioning on packaging
- Supplement Facts and Nutritional Facts panel issues or errors
- Identification and classification of any New Dietary Ingredients
- Other critical supplement label issues and incorrect or disallowed claims
- Other applicable regulatory considerations and citations
- Product formulation recommendations
- Supplement label improvements and corrective language
- 21 CFR Part 101 Compliance
- FDA Regulations for Label Claims
Claim Substantiation Dossier:
- Claims review (for Ingredients and Finished Products)
- Literature research
- Evaluation of applicable research studies, clinical studies, etc.
- Claims development
- Professional assessment report
- Reference to other aspects of 21 CFR Part 101 Compliance