The Natural Health Products Directorate (NHPD) has recently released new monographs for consultation based on pre-cleared information. The consultation period is open from September 25, 2012 until October 24, 2012.
The NHPD has recently published 10 new monographs for consultation focusing on oral health, sexual health, gastrointestinal health, antioxidant and traditional uses. Newly published PCI includes monographs for the following:
The publication of these monographs is beneficial to the industry as they will help to ensure efficient review and approval of products containing PCI ingredients. Additionally, the publication of certain monographs will also assist in rectifying various challenges regarding the efficacy of ingredients, such as maca.
Maca has been traditionally used in South America as an aphrodisiac and for infertility, mental/physical energy and menopause 2,3,4. The totality of evidence for maca,(both traditional and scientific), had previously been presented to the NHPD on several occasions in an attempt to obtain a product license for single ingredient maca products. However, until now the available evidence was not deemed sufficient with respect to efficacy regardless of the types of claims (e.g. sexual health, emotional health, etc.) indicated on the Product License Application (PLA) form.
Recently, a draft monograph for maca has been published suggesting that the NHPD has finally taken an authoritative stance on the totality of evidence for maca. The draft monograph supports the novel claims “Helps to support healthy mood balance during menopause” and “Helps to support emotional aspects of sexual health” at a dose equivalent to 2-3.5 g crude maca root daily. Claims of this nature began to appear in the Licensed Natural Health Products Database (LNHPD) as early as March of this year suggesting that the NHPD recognized a need to provide a solution to the industry prior to the publication of the draft maca monograph5.
The NHPD is also offering efficacy solutions to various single ingredient antioxidant products, such as acai. The draft NHPD monograph for Acai supports the claim “provides antioxidants” for products providing any quantity of acai fruit up to a maximum of 14 g crude per day. Publication of monographs such as this allow for an expedited review of single ingredient acai products in which the efficacious use of the product for a specific health claim may have been previously challenged6.
The draft monographs are available online for consultation until October 24, 2012 and can be found at the following link: http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-sept_25-eng.php.
Comments on the draft monographs can be submitted by email, fax or mail to the NHPD:
Natural Health Products Directorate
Qualicum Tower A
New Pre-Cleared Information
Address Locator 3303B
2936 Baseline Road
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or firstname.lastname@example.org