21 CFR Part 101 - REJIMUS Header

REJIMUS is a preeminent regulatory consulting firm that helps companies globally in the Homeopathic, Food, and Dietary Supplement industries obtain the most comprehensive and fastest label review services for food, dietary supplement, and other natural product labels before going to print or production. We offer an easy way to submit for supplement label review of claims, specifications, and compliance. Is your label a liability?

We specialize in FDA Compliance ConsultingQuality Development ServicesSocial Media MonitoringDue DiligenceNDI 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 print or production services, few review the supplement label and supplement facts for compliance with cGMP regulations. Verification of a label against the formulation or considering alternatives to ingredient claims, structure-function claims and substantiation are all required. 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. If the language or copy is not correct, do you know how to fix it? We do!

Key Supplement Label Review Features:

  • Label presentation & positioning on packaging
  • Supplement label facts panel issues or errors citations
  • Identification and classification of any New Dietary Ingredients
  • Other critical supplement label issues and incorrect or disallowed claims
  • Corrective marketing language and copy
  • Advice on formulation or testing considerations for label claims
  • Other applicable regulatory considerations and citations
  • Product formulation recommendations
  • Supplement label improvements
  • 21 CFR Part 101 Compliance

 

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