Food and supplement label reviews & claims development/substantiation
The Marketing Review Services (MRS) group at REJIMUS is responsible for compliance reviews of all copy or content associated with labeling, packaging, website copy, claims and commercial or radio scripts. Marketing copy is reviewed against the applicable GMP regulations (21 CFR Part 101) and other current interpretations or publicly documented positions of the FDA, FTC or other regulatory agency as they evolve.
Due to the training and experience reviewing hundreds of labels each month, the group also conducts Claims Development based on product formulations and relevant clinical studies as well as prepares Claims Substantiation Dossiers, which are incredibly comprehensive reports that characterize claim substantiations and assess supporting literature for a specific claim or umbrella claim. Moreover, MRS is responsible for Social Media Monitoring, a real-time third-party monitoring service for corporate online social media assets to ensure compliance of publicly accessible marketing language.
The types of materials reviewed or services include the following:
• Food, Supplement, Cosmetic and Homeopathic Labeling or Packaging • Nutritional Facts, Supplement Facts, Drug Facts, Guaranteed Analysis • Bulk Ingredient Labels • Website copy • Advertorials, Brochureware and other sales collateral • Radio & TV scripts • Social Media Monitoring for corporate Facebook, Pinterest, Twitter, company blogs, etc. • Claims Development & Claims Substantiation, Claim Substantiation Dossiers
About REJIMUS, Inc.
REJIMUS, Inc. is a regulatory management consulting firm that provides comprehensive compliance services to companies in the food and beverage, dietary supplement, cosmetic, and homeopathic/OTC industries. The firm specializes in navigating complex regulatory landscapes, including FDA, FTC, and USDA requirements. Their expertise spans across quality system optimization, facility design, product development strategy, cGMP auditing, and technical documentation such as GRAS dossiers and NDI notifications. By offering tailored consulting, litigation support, and due diligence, REJIMUS enables businesses to manage regulatory liabilities and streamline the path to market for their ingredients and finished products.
For their clients, REJIMUS serves as a strategic partner that mitigates risks associated with regulatory agency actions, such as warning letters and import detentions. The company utilizes a proprietary web-based project management system to ensure precise and scalable oversight of complex compliance programs for both startups and large multinational corporations. Their work focuses on developing robust quality assurance frameworks and training programs that uphold consumer safety while ensuring operational efficiency, helping partners achieve long-term growth and compliance excellence within their respective supply chains.
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