NHPD Continues to Issue Section 16 Notices

February 14, 2011 By

The Natural Health Products Directorate is requesting information from product license holders and applicants in light of the proposed amendments to the Food & Drug Regulations regarding enhanced labelling for priority food allergens. The following foods or protein derived from one of the following foods are considered priority food allergens: almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts, peanuts, sesame seeds, wheat, kamut, spelt or triticale, eggs, milk, soybeans, crustaceans, shellfish, and fish.

Currently those natural health products containing probiotics are the subject of Section 16 Notices because of the concern that the probiotic was derived or grown on a dairy or soy based medium.

As a product license holder and/or applicant who has received one of these Section 16 Notices you will need to confirm whether your product has come into contact with any priority allergens during the manufacturing process. If the product has not come into contact with any priority allergens during the manufacturing process, you must supply a certificate from the manufacturer confirming this. If the product has come into contact with a priority allergen during the manufacturing process you must commit to add the following statement under Cautions & Warnings, within the sooner of 6 months or the next label run: “This product has come into contact with [name of priority allergen]. Do not use this product if you have a [name of priority allergen] allergy.”

All suppliers are encouraged to review their labels to ensure that all priority allergens are clearly identified as medicinal or non medicinal ingredients and that claims that a product is “free of [a priority allergen]” are factual.

Please contact us should you require assistance in responding to a Section 16 Notice.