Product Safety and Health Claim Assessment
Safety and efficacy substantiation services are intended to provide our clients with confidence in their desired marketing claims well ahead of a product launch. Ideally, we are presented with a product at the idea stage, with direction on the types of claims desired. Our role is to investigate whether or not such claims are supported by rigorous data – published or proprietary – and we have an extensive database of catalogued research to pull from.
In Canada, Natural Health Product (NHP) claims are very broadly defined, and the severity of the claim determines the rigor of the evidence required by Health Canada. Our founder and CEO, Brian Wagner, was instrumental in Health Canada revising their standards of evidence for licensing NHPs in 2007-2009, and our team is sought out for its unique abilities to substantiate highly desired claims. We provide our clients with full evidence summary reports, including lists of supporting references, with suggestions on alternate wording and even alternate claims. Our resources are the best in the industry, and we have access to some of the most unique libraries in North America to substantiate traditional medicine claims.
In the USA, some product claims are permitted simply based on the product’s nutrient composition while others, such as structure/function claims for dietary supplements, require FDA notification and evidence substantiation. We provide our clients with references to substantiate dietary supplement structure/function claims, as well as give suggestions and advice to ensure compliance with this particular claim category. In addition, we can file the required FDA notification and provide label compliance reviews for all food and dietary supplement products.
Europe permits two types of claims on food and food supplement labels: nutrition claims and health claims, but they allow limited flexibility on how these claims may be used. Nutrition claims must be based on specific regulatory requirements and health claims must be “authorized” and listed in the EU Register on nutrition and health claims. Clients wishing to make claims based on ingredients other than vitamins and minerals (i.e. probiotics, botanicals), will find the European market even more difficult. To date, the EU has not authorized any health claims based on these types of ingredients, with a list of claims based on botanical ingredients “on hold” since 2010. These “on hold” claims can continue to be used until the EU makes their final determination.
NHP Consulting can provide early-stage consultation on a product’s safety/efficacy profile as well as evaluate the marketing potential of any health claim based on the available evidence and / or regulatory requirements in Canada, the EU, the USA, and abroad.