Long description: Guidance Document for Preparing a Submission for Food Health Claims Using an Existing Systematic Review

Figure: Overview of the two processes to develop a health claim submission in Canada

Long description: This figure summarizes the two options industry petitioners have to develop a health claim submission for Health Canada.

Step 1: Review the Food Directorate guidelines for preparing health claim submissions. The first set of guidelines are described in Health Canada’s Guidance Document for Preparing a Submission for Food Health Claims (henceforth referred to in this figure as “Full Submission GD”). The second set of guidelines are described in this document, Health Canada’s Guidance Document for Preparing a Submission for Food Health Claims Using an Existing Systemic Review (henceforth referred to in this figure as “Systematic Review-Based Submission GD).

Step 2: Identify the food/health relationship of interest.

Step 3: Complete the requirements described in Sections 2.0, 3.0, 4.0 of the full Submission GD.

Step 4: Referring to the list of eligible reports (Table 1(SR)) in the Systematic Review-Based Submission GD, determine whether an eligible systematic review of the scientific evidence exists to substantiate the proposed new food health claim. After this point the process diverges. If an eligible systematic review exists, the Systematic Review-Based GD may be used.  If one does not exist, the Full Submission GD should be consulted.

Step 5a: If a systematic review of the scientific evidence does not exist to substantiate the proposed new food health claim, petitioners should conduct their own systematic review of the scientific literature by following steps 1-13 in section 5 of the Full Submission GD. These steps include the following activities: develop a search strategy; execute the search; develop the selection criteria; filter the literature search results; generate reference lists; tabulate the included studies; evaluate the study quality; tabulate the study findings per health outcome; assess the evidence for causality; discuss the generalizability of the findings; discuss the meaningfulness of the effect; discuss the feasibility of consuming an effective amount of the food; and make overall conclusions.

Step 5b: If an existing systematic review of the scientific evidence is used to substantiate the proposed new food health claim, petitioners should follow the requirements outlined in sections 2.1(SR) and 2.2(SR) of the Systematic Review-Based GD. Requirements in these sections include the following activities: identify the eligible systematic review of the scientific evidence to support the health claim; update the scientific evidence (if the systematic review literature search was performed more than 12 months prior to submission); discuss the generalizability of the findings; discuss physiological meaningfulness of the effect of the food; discuss the feasibility of consuming an effective amount of the food; and make overall conclusions. The “update the scientific evidence” activity includes the following sub-activities: provide information about the original search; update the search; filter the search results; generate reference lists; and evaluate the consistency of the new evidence.

Step 6a: If petitioners have used the Full Submission GD to prepare their submission, they should complete the checklist provided in Table 16 of the Full Submission GD.

Step 6b: If petitioners use the Systematic Review-Based GD, they should complete the checklist provided in Table 10(SR) of the Systematic Review-Based GD.

Step 7: Regardless of which guidance document was used to prepare the submission, the final step in the process of developing a health claim application is to submit the petition to Health Canada for evaluation.