Product Classification and Development
The category (or categories) a product may be classified into dictates the path to market access, which includes registrations, fees, ingredient restrictions, labelling requirements, and manufacturing standards that must be observed. In many cases, product classification is country-specific. For example, a “cosmetic” in the European Union may be considered a “drug” in the United States and a “natural health product” (NHP) in Canada. Sometimes, a brand owner can select from multiple regulatory pathways by altering the marketing plan for a product or by altering the formulation slightly. Changes in global regulatory definitions are always ongoing, which complicates and can make classification uncertain. As the first step working with our clients, our team of experts conducts a full product evaluation to identify the appropriate product classification(s) and make recommendations to ensure success in the desired marketplace. As part of a product evaluation, our firm will identify any potential areas of concern, provide associated costs (if applicable) for registrations, and highlight the advantages and disadvantages of the product categories potentially involved.
NHP Consulting has a systematic, proven approach to product development (formulation) that can increase sales by providing your product to the right marketplace at the right time. Our team lives and breathes the natural health industry, so we have a finger on the pulse of the types of products and ingredients consumers are looking for today and understand where and when the government is likely to change ingredient restrictions. We can bring your idea to concept through our product development services and have your novel product application ready for submission the day an ingredient shifts from restricted to permitted.
We have the in-house expertise to make sure the ingredients in your formulation are safe, used at effective levels, and match your marketing team’s vision as closely as possible. Pulling from experience in tens of thousands of product applications, our team can help propose additional ingredients for your product that will support the claims you want without adding a lot of intimidating risk information.
The Health Products team at NHP Consulting provides full turnkey product development, formulation, registration, and testing services. We can refine your idea for a new product in light of upcoming industry trends, and can suggest new and synergistic ingredients that will make your product distinct from all others on the market while supporting the claims you want. Our formulation services are highly customized, and we can work directly with your manufacturing and marketing teams to ensure swift formulation and registration processes for unique products with marketing edge you need.
Health Claim Substantiation
Another product development, pre-registration step many of our clients undertake is safety and efficacy (health claim) substantiation. This step can be coupled with the product registration process, if applicable, or completed as a standalone service. 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.