Temporary Marketing Authorization (TMA) Applications
Foods in Canada must comply with the requirements set out in the Food and Drug Regulations. Originally, food products that were supplemented with ingredients such as vitamins, minerals, amino acids and novel herbal or bioactive ingredients were introduced to the market as natural health products (NHPs). Health Canada now recognizes that these products have greater resemblance with food items regarding product format, history of use, representation to consumers and public perception.
When a food product lies outside of the Food and Drug Regulations, such as foods supplemented with vitamins, minerals and/or other bioactive ingredients, a regulatory amendment must be made.
View our recent blog post, What You Need to Know About the Supplemented Food Regulations in Canada.
Health Canada permits certain non-compliant foods, such as energy drinks, to be sold with these amendments. In this case, a Temporary Marketing Authorization (TMA) may come into play. A TMA allows time (i.e., 2 to 5 years) for information generation in support of an amendment.
In order for your supplemented food to be eligible, it must meet the following criteria:
- Safe for use under the conditions of the Temporary Marketing Authorization;
- Contain a non-compliant vitamin, mineral or amino acid; and/or
- Contain an unapproved novel food.
With your direction, our regulatory affairs specialists will fulfill all necessary TMA application requirements for your product, including safety data, required research, facilitation of a pre-submission consultation with the government (if desired), proposed area designated for sale and planned advertising.
Looking for more information on TMAs? Contact a member of our team today or email us directly at email@example.com. You may also request a customized quote and we will contact you with details within two business days.