LABEL REVIEWS, SUBSTANTIATION & LABEL REMEDIATION
REJIMUS is proud to offer the most comprehensive label and packaging reviews for Food and Beverage, Dietary Supplement, Cosmetic, and Homeopathic/OTC product labels. These reviews are intended to educate our customers and help bridge the gap between creative labeling copy efforts by marketing teams and meeting the marketing and labeling compliance requirements managed by quality and regulatory personnel.
We offer an easy way to submit labels and packaging for review of claims, specifications, formatting and general compliance. What makes our service unique is that we’ll also provide you with what you can say on the label or actually augment the language so you can get it right the first time. While many companies offer label design and printing services, few have the additional expertise to review for compliance with the every changing regulations. Additionally, we can identify ingredient or formulation issues that could potentially lead to costly regulatory or legal challenges down the road, allowing you to revisit the product faster.
Enhanced Label Reviews
Enhanced Label Reviews evaluate:
• Label Presentation, Packaging and Formatting
• Facts Panel Accuracy, Issues or Errors
• Claim Identification and Evaluation for Substantiation (e.g. Health Claims, Nutritional and Ingredient Content Claims, Certification Claims, Structure-Function, etc.)
• Key regulatory references
• Identification of potential New Dietary Ingredients requiring notification
• Label claim modifications, footnotes, and other recommendations
• Screening for potential adulteration issues
Label Remediation is an add-on to our Enhanced Label Reviews for product labeling or packaging. Photoshop (.psd) or Adobe Illustrator (.ai) files can be amended using the ELR reports as a guideline during the standard turn-around time of 3-5 business days that is print-ready so as to minimize further review times or latency of making the necessary corrections including of corrective language, formatting, claims and much more. The remediated files are considered the property of the client and therefore can be edited further for future modifications as needed.
Claims Substantiation and Claim Development
Label Reviews evaluate all language or copy on a given labeling or packaging to ensure compliance with the applicable regulations to determine general allowability or disallowance. If a claim has been identified requiring further certification, evidence of support, or substantiation, we build the complete Substantiation Dossier for the product, including performing the literature research and study qualifications to compile a complete dossier in support of each given claim. For any third-party claim certification, we can prepare the entire submission and walk the label through the process to achieve the content or positional claim to ensure adequate evidence is on file to meet your FDA, FTC or USDA regulatory requirements when requested by a regulatory inspector.
Compliant Label Design
Compliant Label Design is a new service offering from REJIMUS. Customers get label and package designs compliant to the applicable product regulations that help ensure the starting framework or templates are correct. Photoshop (.psd) or Adobe Illustrator (.ai) files are created and customized for the client to meet the necessary compliance requirements. Overall layout, formatting, positioning, font-type and/or sizes, facts panel designation and other compliant design options are included with specified regulatory references. Clients can revert final labels or packaging designs with the completed the facts panel information and/or claims to enable expedient reviews, saving substantial time and costs.