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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 nor be represented as water 

Supplemented Food Facts Table (SFFT) Requirement

Due to the new amendments, all supplemented foods are required to have an SFFT which replaces the Nutrition Facts Table (NFT) although they are still quite similar.  According to the “Directory of SFFT Formats,” the SFFT requires the name and absolute amount of each supplemental ingredient under the mandatory “Supplemented with” heading.  When vitamins, minerals, and nutrients are added to a product, they’ll also be included under this heading.  A statement to interpret this will also be mandatory on supplemented foods to clarify that the amounts of supplemental ingredients declared by your SFFT include both supplemental and naturally occurring quantities. 

Supplemented Food Facts Table
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.

Frequently Asked Questions

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 nor be represented as water 

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.

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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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