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TMA License for Supplemented Foods

Are you worried because your products are not meeting the FDR regulations? Fret not. Our regulatory affairs specialists will help you acquire Temporary Market Authorization (TMA) License and fulfill all necessary TMA submission requirements to meet FDR requirements and market your products.

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Temporary Market Authorization

A Temporary Market Authorization (TMA) is issued for foods that fail to meet the Canadian Food and Drug Regulations (FDR).  The purpose of TMA is to allow marketing of food so that specific data can be gathered and evaluated by Health Canada with the ultimate goal of finalizing an amendment to the FDR. 

Products that may require a TMA are foods and beverages supplemented with minerals, vitamins or other bioactive ingredients (for example, the addition of Omega-3 in orange juice). On a successful TMA submission, a Temporary Marketing Authorization License (TMAL) is issued by Health Canada, signifying official approval.

General Criteria to Be Eligible for a TMA License

All supplemented foods and beverages must meet the following general criteria  to be eligible for a TMA License:

  • The supplemented food must be safe for use under TMA conditions;
  • The food must be pre-packaged
  • They must contain a non-compliant vitamin, mineral
  • Must have amino acid and an unapproved novel food 
  • They shall neither contain alcohol and nor be represented as water 
Get Assistance to Obtain TMAL for Supplemented Foods

TMA application is different from the application for a Natural Health Product in terms of the information requested. At Quality Smart Solutions, we have been handling TMAs for our clients for a long time. We help fulfill all necessary requirements for TMA submissions, such as facilitating a pre-submission consultation with Health Canada, gathering safety data and scientific evidence, and planning advertising and marketing strategies.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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