On May 20, 2014, the Natural and Non-prescription Health Products Directorate (NNHPD), formerly known as the Natural Health Products Directorate (NHPD), issued a new monograph for ”workout supplements”, a subcategory of natural health products (NHPs) directed to the sports and fitness market. In Canada, a natural health product must be licensed prior to market. The licensing process comprises a pre-market review where the product is assessed for safety, efficacy and quality by the NNHPD according to evidence submitted by the applicant. A monograph is a tool to facilitate the product licence application process – it comprises a set of pre-cleared information supporting the safety, efficacy or quality of a medicinal ingredient or NHP that the NNHPD has reviewed and determined to be acceptable. Monographs are a means of leveraging previous licensing decisions of the NNHPD in order to decrease unnecessary red tape in bringing to market well characterized products. The monograph for workout supplements amalgamates information relating to many ingredients commonly used in the industry, such as creatine, caffeine and the various amino acids, proteins and carbohydrates typically found in pre- and post-workout drinks and pills. The key information for marketers of NHPs in this area is the acceptable dosing for such ingredients and the kinds of marketing claims that can be made for the ingredient/product (these are often interrelated). Notably, a monograph can serve as a means to streamline the regulatory process, for example by adopting the dosing and claims described in the monograph. Alternatively, it can serve as a starting point for showing what additional dosing and claims might be supported by the literature and acceptable for a new NHP. Summary by: John Lucas

E-TIPS® ISSUE

14 08 13

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