Food Directorate Update: Supplemented Foods and Nutrition Labelling

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1 Food Directorate Update: Supplemented Foods and Nutrition Labelling Dr. William Yan Bureau of Nutritional Sciences, Food Directorate, Health Canada Canadian Health Food Association Expo West Regulatory Forum Vancouver, May 12, 2016

2 Outline Update on Supplemented Foods Publication of Category Specific Guidance for Temporary Marketing Authorization: Supplemented Foods Reminders TMA research Next steps Update on Nutrition Labelling Proposed changes Vegetables and fruit 2

3 Update on Supplemented Foods 3

4 Supplemented foods Supplemented foods include pre-packaged, ready-to consume beverages, beverage mixes and concentrates, powders and conventional foods (e.g. bars). During the transition from natural health products regulatory framework to the food regulatory framework, 313 Temporary Marketing Authorization submissions were received for supplemented foods of which 197 TMALs were issued. Since 2012, the Food Directorate has received approximately 670 new supplemented food submissions of which 280 Temporary Marketing Authorization Letters have been issued. Industry was informed Health Canada would be conducting a more detailed assessment and developing category-specific guidance for the supplemented food products to provide predictability. 4

Supplemented food guidance Health Canada has published the guidance, entitled Category Specific Guidance for Temporary Marketing Authorization: Supplemented

defined as a prepackaged product that is manufactured, sold or represented as a food, which contains added vitamins, minerals, amino acids, herbal or

5 Supplemented food guidance Health Canada has published the guidance, entitled Category Specific Guidance for Temporary Marketing Authorization: Supplemented Foods Similar to the Caffeinated Energy Drinks guidance, it sets out scope, compositional and labelling / advertising requirements A supplemented food is defined as a prepackaged product that is manufactured, sold or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients. These ingredients may perform a physiological role beyond the provision of nutritive requirements 5 Guidance document available:

6 Novel ingredients Some supplemented foods contain ingredients that are included solely for their purported health benefits, with no known food purpose. The majority of these ingredients are likely to be considered novel based on the regulatory definition. Recognising that the approach taken during the transition challenges the current food regulatory structure, the Food Directorate has developed an option to risk manage this sub-set of ingredients while a broader review of the Novel Food regulations is underway. 6

7 Maximum levels of vitamin and mineral addition Maximum levels have been established for vitamins and minerals to help ensure that their addition to foods does not contribute to excessive intakes. Maximum levels will not be set for amino acids. Health Canada has developed a 2 tier approach; each path corresponds to a set of maxima and, in the case of Path 2, labelling requirements. 7

8 Maximum levels Two-path approach Path 1 Captures products with a lower potential for adverse health effects Appropriate for use by the general population, 4 years Path 2 Captures products with a higher potential for adverse health effects Not intended for children, < 14 years Cautionary labelling and directions for use (as needed) The 2-path approach will help consumers to more clearly distinguish between products with a lower vs. those with a higher potential for adverse health effects 8

9 Front-of-pack labelling Health Canada is currently exploring the possibility of an identifier to be included on the principal display panel of the label for all supplemented foods to assist consumers in recognizing that these products are different from regular foods. In addition, accompanying label specifications such as standard formatting around caution statements and directions for use is also being investigated for these products. Different identifiers have been developed which will be tested with consumers. 9

10 TMA extensions As there was a delay with publishing the guidance document, most TMAs with an expiry date of August 31, 2016 were extended to February 22, TMAL listing on website updated To maintain market access beyond February 22, 2017, products must be compliant with the final version of the guidance document and all other requirements of the Food and Drug Regulations (e.g., Food additive provisions), in order to receive a final TMAL extension until December 31, To note: Provide updated copy of TMA Application form and label by August 31, 2016; and Clearly outline any changes to products in a letter. 10

11 Collection of sales and consumption incident data As a condition of the TMAL, petitioners are required to submit annual sales data and if requested, annual consumption incident data. Call for 2015 has gone out; deadline is September 1, Failure to provide information by deadline will result in revocation of the TMAL. Forms must be completed, even if zero sales/consumption incidents No reminders will be given If contact information has changed, please notify Health Canada immediately Based on the response to the call for data from 2012 to 2014, Health Canada has revoked 60 TMALs. 11

12 TMA research Health Canada has concluded that a number of information and data gaps need to be addressed to support the development of appropriate regulations for supplemented foods. As a condition of the TMA, the manufacturer or distributor is required to gather such data, in a manner agreed upon with Health Canada in advance, and submit it to Health Canada within a specified time frame. Some research has been collected on CEDs. Remaining CED TMAL holders have been notified regarding their research requirements. SF TMAL holders will be notified of their research requirements when they receive their final extension. 12

13 Next steps Several guidance documents to be updated in 2016 (e.g., TMA performance standard, general TMA guidance document). TMAL holders to be contacted regarding TMA research requirements. Consumer research to be conducted on the ability to notice, understand, assess benefits and risks, and use supplemented food label information to make informed choices. 13

14 Update on Nutrition Labelling 14

15 Background October 2013 June 2014 July 2014 June 2015 Ministerial Round tables On-line consultation with Canadians Consumer engagement sessions Triage Regulatory Impact Analysis Statement Analysis of feedback and drafting 15

16 Objectives of the proposed regulations Modernize and improve food labelling to: Reflect the latest science Enable Canadians to make informed choices about their food in order to maintain or improve their health 16

17 Proposed changes - Highlights Introduce new requirements Consistent serving sizes to make comparison easier DV footnote at the bottom of the NFt Improve the legibility of the list of ingredients Provide more information on sugars Food colours Require food colours be named by their common name in the list of ingredients Exempt fruits and vegetables from carrying NFt New health claim on vegetables and fruit 17

18 Proposed changes - Nutrition Facts table 18

Proposed changes List of ingredients INGREDIENTS: WHEAT FLOUR, FANCY MOLASSES, VEGETABLE OIL SHORTENING (SOYBEAN AND/OR CANOLA OIL AND MODIFIED PALM OIL), BROWN SUGAR, LIQUID WHOLE EGG, SUGAR, SALT,

19 Proposed changes List of ingredients INGREDIENTS: WHEAT FLOUR, FANCY MOLASSES, VEGETABLE OIL SHORTENING (SOYBEAN AND/OR CANOLA OIL AND MODIFIED PALM OIL), BROWN SUGAR, LIQUID WHOLE EGG, SUGAR, SALT, SODIUM BICARBONATE, SPICES, COLOUR CONTAINS: WHEAT, EGG, SOY Ingredients: Sugars (fancy molasses, brown sugar, sugar) Wheat flour Vegetable oil shortening (soybean and/or canola oil and modified palm oil) Liquid whole egg Salt Sodium bicarbonate Spices Allura red Contains: Wheat Egg Soy 19

20 CGI proposal - Vegetables and fruit exemption Introduce an exemption to allow prepackaged fresh fruits and vegetables to carry nutrition and health claims without triggering the NFt. 20

21 CGI proposal - Vegetables and fruit Introduce a new health claim: A healthy diet rich in a variety of vegetables and fruit may reduce the risk of heart disease 21

22 CGI proposal - Vegetables and fruit Detailed information about the basis for the proposed claim is available on the healthycanadians.ca website 22

23 CGI proposal - Vegetables and fruit Proposed conditions for foods to carry the claim: The food is: A fresh, frozen, canned or dried fruit or vegetable Not one of the following: Potatoes, yams, cassava, plantain, corn, legumes Condiments, jams, spreads, preserves, olives Fruit or vegetable juice or drink Contains less than 15% of the DV of sodium 23

24 Current status Proposal comment period was open for 75 days (ended August 27, 2015) We are in the process of reviewing and analyzing the comments Next steps: Develop recommendations based on analysis of comments Start amending regulatory package 24

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Health Canada Update. Supplemented Foods and the Healthy Eating Initiatives

Health Canada Update. Supplemented Foods and the Healthy Eating Initiatives Health Canada Update Supplemented Foods and the Healthy Eating Initiatives William Yan, Ph.D. Bureau of Nutritional Sciences, Food Directorate, Health Canada CHFA East September 15, 2017 Outline Update