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Some foods in Canada do not fit within the existing compositional or regulatory requirements of the Food and Drug Regulations or Safe Food for Canadians Regulations (SFCR). In these cases, a Temporary Marketing Authorization (TMA) may provide a pathway to market the product while Health Canada evaluates whether regulatory changes are appropriate.
Products that may require a TMA can include specialized food products such as meal replacements or nutritional supplements, as well as other foods with novel formulations, compositions, or intended uses that fall outside established regulatory standards. We can help determine whether a TMA is an appropriate pathway, assess the product against applicable regulatory requirements, identify potential compliance gaps, and develop the scientific and regulatory rationale needed to support an application. A successful TMA application results in a Temporary Marketing Authorization Letter (TMAL), which permits the product to be marketed in Canada subject to specified conditions.
From regulatory strategy and submission preparation through interactions with Health Canada, our regulatory affairs specialists can help companies navigate the TMA process with greater clarity and confidence by fulfilling submission requirements, gathering safety data and scientific evidence, facilitating pre-submission consultations when desired, and planning marketing and advertising strategies.
Learn how we can help you navigate the regulations surrounding TMA applications in Canada.
