NHP Health Claims Substantiation Support

A health claim is any representation in labelling or advertising that states, suggests, or implies that a relationship exists between consumption of a food or an ingredient in the product and a person’s health.

Claims that are placed on health products can help consumers make smart decisions about their choices.  Therefore, it is vital to ensure that they are not misleading in any way. If the Health Canada Directorate determines that they are,you can face strict penalties and your product will be removed from the market.

Health claims are necessary for any health product. The claims provide consumers with crucial information and enable them to evaluate and buy your product to meet their health requirements.

Health claims should not mislead consumers. Instead, these claims must be accurate and truthful. All health claims that appear on your NHP labeling and advertising must be substantiated based on scientific evidence to ensure they are truthful and properly represent the function they serve for your product. In Canada, health claims are important for product licensing.

In the US, while there is no licensing process for dietary supplements, health claims make consumers believe that you have exercised your due diligence for substantiating your claims. FDA can request this substantiation information from you at any time. It is therefore important to have strong scientific supporting evidence to ensure that any health claims for foods or supplements are substantiated in a systematic and comprehensive way. This will lead to the successful marketing of your products along with averting any regulatory risk. The scientific requirements and regulations to substantiate health claims can differ depending on the type of claim, the jurisdiction of interest, and the product in question.

Our team of technical experts can help you prepare the scientific evidence and claim substantiation dossiers that can be provided to the regulatory agency. We will substantiate your health claims by analyzing published information, reviewing unpublished data, and going through other sources of information to assure that proper evidence is in place to support your health claims for structure-function, prevention, or physiological benefit.

• We carry out a health claims review.
• We provide feedback on whether your claims can be substantiated or not.
• We provide recommendations and/or alternate options.
• We advise you of appropriate health claims based on product formulation.
• We guide you if you haven’t yet considered health claims and need expert guidance.