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Health claims provided on a food or dietary supplement label denote there is a relationship between the product and its health benefits for its consumers. However, there are regulations in place that require scientific evidence to substantiate a claim. Any statements or advertising made on a product that are misleading or false can also violate state or federal consumer protection laws. Based on extensive training and experience reviewing hundreds of labels each month and hundreds of thousands of claims over the years, the MRS group also provides Claims Development and Claims Substantiation based on product formulations and relevant qualified studies. REJIMUS generates the most comprehensive Claims Substantiation Dossiers in the industry, which are technical and regulatory reviews of supporting literature for a specific claim; when a given claim cannot be substantiated with scientific evidence as is, alternative language is provided where feasible. Whether on a label, packaging, website, blog, social media platform, or other types of advertorial mediums, having adequate and qualified data to support the claim is a requirement. Having study references or articles on file is not sufficient to meet the FDA’s requirements; a technical analysis of each claim is a necessity.

Claims Substantiation and Development

Areas of support include:

• Claims Review
• Claims Substantiation Dossiers (for Foods, Supplements, Medical Food, Cosmetics)
• Structure Function Claims
• Statutory Claims and Statutory Disclaimer
• Declarations
• Prop 65
• Health Claims
• Ingredient Claims
• Content Claims
• Other positional/marketing claims
• Requirements for Claim Substantiations
• Research and qualification of studies
• Guidance for Organic and NonGMO claims – petitions and applications

Content and Claims Review

Websites, social media, videos blogs are all governed under 21 CFR Part 101, which considers all advertisement of such products controlled speech, not free speech. We can guide and train on the labeling regulations, and then create the study design and protocols or manage the testing lab to confirm label claims. We also offer an easy way to submit labels 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.


Claims Substantiation Contact Form