From this month’s NHPD Monthly Communiqué – 3 new monographs and 20 revised monographs. As well, a clarification to Natural Health Product advertising claims:
The purpose of this article is to clarify the review of advertising claims in proposed label texts by the Natural Health Products Directorate (NHPD).
The NHPD reviews proposed label texts as per the labelling requirements set out in Part 5 of the Natural Health Products Regulations. Part 5 does not outline any requirements with respect to advertising claims and as such, the NHPD will no longer review advertising claims indicated on the label texts. Applicants are responsible for ensuring that advertising claims on the labels of their products do not contravene Section 9 of the Food and Drugs Act.
Section 9(1) of the Food and Drugs Act states that “No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.”
Advertising claims will not be reviewed during assessment with the exception of comparative claims and “clinically proven/tested” claims. The NHPD may request additional evidence to support comparative and “clinically proven/tested” claims. Furthermore, compendial applications with comparative claims that require additional evidence may see their applications transferred to the non-traditional assessment stream. If the claim is removed, the application can remain in the compendial assessment stream.
For more information, click on the above link.