Prior to introducing a supplement to a given market, brand owners must confirm that the supplement formula, label, manufacturer, importer, and all related businesses comply with the relevant regulations for the supplement category in each market. Called “natural health products;” “dietary supplements;” and “food supplements,” in Canada, the USA, and the EU, respectively, supplement products are most easily identified by the presence of vitamins, minerals, probiotics, herbal/botanical ingredients, amino acids and/or the presence of a health claim on the product label.
Every country has their own requirements for the supplement category that specify how a product has to look, what ingredients it may (and may not) contain, and what marketing and health claims may (or may not) be made on the label Depending on the market, supplement regulations may require pre-market approval (licensing) or notification to regulatory authorities. In Canada, supplements (“natural health products, NHPs”) must be licensed by Health Canada, and the licensing process involves a complex application substantiating the safety and efficacy of the product. Other countries, such as the USA, do not specifically approve supplements for the market, but defer the responsibility for screening the product and its label against relevant regulations to the brand owner. Some aspects of a product or its marketing may trigger a requirement for product notification to the US FDA, and other products can come direct to market following the screening.
In addition to a product and its label, the businesses and processes involved in product manufacture and distribution are also subject to country-specific requirements and regulations. Generally speaking, supplement manufacturers must follow Good Manufacturing Practices (GMPs), and many countries require formal approval (licensing) of manufacturing and importing facilities. All processes involved in supplement manufacture, testing, storage, and distribution must be carefully designed and confirmed in line with the regulations. Post-market activities such as handling consumer complaints and product recalls, responding to enforcement actions from regulators, and changing products or processes must also be handled with careful attention to ensure a product remains compliant in every market.
The range of ingredients and claims that may be restricted in any given market makes product formulation, screening, registration and label creation daunting to the outsider, and selling a product into multiple markets necessitates review of the product against all relevant regulations. Our firm is the premiere consulting firm of choice by top North American manufacturers, and we have licensed some of the most complex products on the marketplace. We offer a wide range of services to help guide you through the various labeling, marketing, and registration processes required for sale throughout Canada, the USA, the EU, and other international markets.