Ashwagandha root extract is a well-known adaptogen, recognized for its potential to reduce stress, improve energy levels, and support overall well-being. While it is widely used in the Natural Health Products (NHPs) industry, Health Canada has made a decision regarding its use as a supplemental ingredient in foods, affecting companies that may want to include it in their products. This article outlines the key aspects of Health Canada’s decision and what it means for manufacturers.
Previously, ashwagandha root extract was permitted for use in food products on a case-by-case basis under Health Canada’s Temporary Market Authorization Letter (TMAL) process. However, with the introduction of the Supplemented Food Regulations in July 2022, the TMAL process was phased out. Now, ingredients must be included in the List of Permitted Supplemental Ingredients to be used in food products. Ashwagandha, initially considered for this list, has undergone further evaluation by Health Canada’s Food and Nutrition Directorate.
Health Canada assessed the safety of ashwagandha root extract as a supplemental ingredient and concluded that there is insufficient evidence to support its safe use in foods. While it has been used in supplements, there is no substantial history of its use in food products, which prompted Health Canada’s decision to exclude it from the List of Permitted Supplemental Ingredients. As a result, ashwagandha root extract cannot currently be used in supplemented foods in Canada.
In addition to ashwagandha root extract, Health Canada has evaluated and published decisions on over 30 other ingredients for potential incorporation as supplemental ingredients. Ingredients like Green Tea Extract, Phosphatidylserine, and Alpha GPC have been incorporated and permitted as supplemental ingredients. Each evaluated ingredient has a corresponding decision publication detailing the reasons for acceptance or rejection. For the full list of evaluated ingredients, you can access the publication here.
If you are a manufacturer looking to include ashwagandha root extract in your food products, it’s important to understand the requirements for reconsideration. Health Canada has provided a guide on what information is needed to support a request for reconsideration, which includes detailed toxicological and nutritional safety data. You can access the full guidance here. Ensuring you meet these standards will be critical in gaining approval for future use of ashwagandha in foods.
Navigating the evolving regulations surrounding supplemented foods can be challenging. Whether you need assistance with submitting reconsideration requests or advice on regulatory compliance, dicentra is here to help. Contact us today to ensure you’re prepared and compliant with Health Canada’s requirements.