• Food or Natural Health Product?
• Upcoming Training Sessions
• Regulatory Updates
• Science & Research Updates
• Upcoming Events

• Health Claims – The Natural Health Product Regulations make it difficult to attach health claims to products unless they are registered as NHPs. In order to classify more products as foods, the Food Directorate will need to allow a greater number of generalized, structure-function health claims for foods so that more applications will be able to be shifted from the NHPD.
  
  
• Natural Health Products in food-like format – In order for this type of product to be registered as an NHP it must include a dosing regime that allows it to be consumed in measured, controlled amounts. The Food Directorate’s main concern here is the potential safety hazard of consumers taking these products ad libitum.
  
  
• Certain ingredients inherently deem a product to be an NHP – There is a question of how to treat products hoping to be classified as foods but that contain ingredients that are considered to be medicinal by the NHPD, even in low amounts.
  
  
• Past precedent – If a product was previously classified as an NHP or food, will this mandate that similar products be classified accordingly?
  
  
• “Functional foods” – There are many foods that have added medicinal ingredients in the hopes of attaining health claims. Will there be guidelines on the amounts of certain ingredients that can be added and allowable claims so that these products can be classified as foods or will these be treated as NHPs?

The following courses are online real-time conferences and tutorials conducted by our scientific and regulatory experts. Save the time and money wasted on travel. Learn directly from your desk and interact live with one of our experts to get all your questions answered at once. Please click on any of the topics below for further information, or click here for answers to commonly asked questions.

Next Session:
Good Manufacturing Practices for Natural Health Products for Current and Potential Site License Holders

All facilities involved in the manufacturing, importing, packaging or labeling of natural health products in Canada should now have a Site License from the Natural Health Products Directorate (NHPD). This requirement has been in place now for over two years and in the interim, policies and procedures have changed as the NHPD has raised its expectations in terms of the documentation required to support an application. At the heart of a successful license application or renewal is compliance with the Good Manufacturing Practices (GMPs). Manufacturers, packagers, importers, and labelers must implement a GMP compliant quality system and must ensure that individuals on staff receive initial and ongoing GMP training. This course, prepared and delivered by William Morkel (about the speaker), will provide participants with the information and tools necessary to facilitate compliance with the regulations and will address issues and concerns with the interpretation and implementation of the GMP requirements. A certificate of course completion will be provided at the end of the course to all attendees as a record of GMP training.

Registration for this course includes 5 licenses.

Who should attend and why?

This course is specifically designed for potential and current Site License holders. Any personnel directly involved in the manufacturing, importing, packaging or labeling of natural health products should attend this course in order to ensure that they have adequate training to control and supervise these activities under GMP requirements.

Later Sessions:

Bringing Products to Canada: Understanding and Managing the Regulatory Framework for Natural Health Products
Wednesday, March 25, 2009

Successful Submissions: How to Get a Natural Product Number
Wednesday, April 29, 2009

Aspects of Research & Development: Conducting Cost Effective Clinical Trials and the SR&ED Tax Credit
Wednesday, May 27, 2009

Claims Substantiation: Issues and Limitations Relating to Evidence Requirements for Natural Health Product Claims
Wednesday, June 27, 2009

Have a course topic in mind that you want listed here? Email the topic to training@dicentra.ca.

Health Canada

Canadian Adverse Reaction Newsletter Volume 19 - Issue 1 - January 2009
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v19n1-eng.php

Many Canadians use natural health products (NHPs) on a regular basis, either alone or in combination with other health products. However, NHPs may be associated with potential health risks, including adverse reactions (ARs) and interactions with drugs, other NHPs or food. The January 2004 issue of the Canadian Adverse Reaction Newsletter discussed safety concerns suspected of being associated with the use of echinacea, ginkgo and St. John’s wort. The concerns were based on reports of ARs received by Health Canada from Jan. 1, 1998, to June 30, 2003. This document provides an update on ARs reported for these NHPs since that publication.

Health Canada’s Cosmetic Program - Information for Industry: Cosmetics Intended for Use on Animals
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/animals_cosmet-animaux-eng.php

Health Canada reminds manufacturers, importers, distributors and retailers that cosmetics intended for use on animals are regulated under the Food and Drugs Act and Cosmetic Regulations. Animal cosmetics must meet the same regulatory requirements as cosmetics intended for human use, which include formulation notification to Health Canada, proper labelling and safe ingredients.

Government of Canada Works to Improve Knowledge about the Safety and Effectiveness of Drugs http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2009/2009_03-eng.php

This network will enable more national research on the safety and effectiveness of drugs used by Canadians. It will link researchers through a new virtual network; help to co-ordinate a national agenda of research based on priorities identified by decision-makers; fund independent research on the safety and effectiveness of drugs in the marketplace; and, assess the risks and benefits of drug products that are on the market. Health Canada and the Canadian Institutes of Health Research (CIHR) are developing the Network, together with stakeholders. The coordinating office will be established within CIHR, a federal funding agency for health research. Today's commitment of a further $31 million over four years brings the total federal investment for this initiative to $32 million over the first five years and $10 million per year thereafter.

Natural Health Products Directorate

Reconsideration Process

The Reconsideration Process is available to applicants who want the NHPD to reconsider a decision to refuse to issue or amend a product or site licence. An applicant may submit a request that a decision be reconsidered to the NHPD for:

• Refusal to issue a Product Licence
• Refusal to amend a Product Licence
• Refusal to issue a Site Licence
• Refusal to amend a Site Licence
  

The Reconsideration Process cannot be used by applicants to resolve the following:

• Disagreements regarding Departmental policies, guidelines or standards.
• Disagreements related to changes in regulatory requirements resulting from the evolution of regulatory policy that may have resulted in other products reaching the market under less stringent or more favourable conditions.

Within thirty (30) calendar days of the date of the letter with the NHPD’s decision, the applicant must submit a letter requesting that the decision be reconsidered. The letter should be sent to the attention of the Manager, Submission Management Division at the following address:

Bureau of Product Review and Assessment
2936 Baseline Road, Tower A, AL 3300C
Nepean, Ontario K1A 0K9
Attn: Request for Reconsideration

Once the NHPD has acknowledged receipt of the request for reconsideration, the applicant must within twenty (20) calendar days of receipt of the NHPD's acknowledgement, the applicant must submit a comprehensive document to the NHPD, which outlines the applicant’s position and includes full supporting information, cross-referenced to previously submitted data, as applicable (an electronic copy of this document, if available, should be provided as well). Should the applicant wish to meet with Directorate officials, this should be indicated when filing the comprehensive document. The purpose of this meeting is to allow the applicant to clarify his or her position. Neither the applicant’s nor the NHPDs position will be debated nor will a reconsideration decision be made at this meeting.

The reconsideration will be based only on the information and material upon which the original decision was made. Any new information referenced or contained in the comprehensive document will not be taken into consideration and will be returned to the applicant for appropriate severances.

Within twenty (20) calendar days from the receipt of the applicant’s supporting comprehensive document or from the date of the meeting if one is requested, the Director General will inform the applicant of the Directorate’s decision to uphold or overturn the original decision. Where the Directorate upholds its decision to refuse to issue or amend a licence, a final notice that sets out the reason(s) for the refusal will be sent to the applicant. Where the Directorate’s decision is overturned, a licence will be amended, issued or the application will be reinserted into the assessment process at the point it was at when the refusal was issued.

NHPD Status of Submissions Quarterly Report, Quarters 1 and 2, Fiscal Year 2008-2009 - Highlights

Since the implementation of the Natural Health Products Regulations in January 2004, Health Canada has received 31,868 Product Licence Applications (PLAs). Of this total, over 18,300 PLAs have been completed, including the issuance of over 8800 Product Licences.

The recent introduction of a simplified attestation system for certain types of products, including some Homeopathic Medicines (HMs) and Transitional DIN NHPs, has also contributed tremendously to improved performance and licensing. Under this new approach, these product types are licensed within a matter of days (5 to 10) and the resources required to assess them have been considerably reduced.

The NHPD has completed over 95% of the 2004-2005 PLA Backlog. Efforts are now focussing on the non-traditional and traditional PLAs that are still in queue for assessment.

80% of Non-Traditional PLAs have undergone an initial assessment under the new review process that started in May of 2008.

Veterinary Drugs Directorate

Consultation - Final Report of the Task Force on Own-Use Importation (OUI) of Veterinary Drugs http://www.hc-sc.gc.ca/dhp-mps/consultation/vet/consultations/oui-iup/index-eng.php

The Task Force was asked to provide a final report outlining concrete recommendations and strategies to address the issue of personal use importation of veterinary drugs. Health Canada welcomes this report and will review it carefully in order to determine the best strategy to address the issue. In the meantime, the report is being released by Health Canada for broader consultation and to solicit comments from all stakeholders. Comments should be forwarded to the Veterinary Drugs Directorate no later than March 5, 2009.

A key concern regarding the current OUI Policy administered by Health Canada was the fact that it appears to compromise the integrity of the Canadian regulatory process for animal drugs since product could potentially be imported without having to demonstrate that it meets Canadian safety and environmental standards. This leads to concerns about safety as well as concerns relative to trade since most developed countries in the world do not have the same or similar regulatory provisions.

Therapeutic Products Directorate

Consultation - Draft Guidance Document Acetaminophen Labelling Standard
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/acetaminophen-eng.php
This consultation is open for comment starting January, 19, 2009 until March 20, 2009.

Inverse association of carotenoid intakes with 4-y change in bone mineral density in elderly men and women: the Framingham Osteoporosis Study.
Sahni S, Hannan MT, Blumberg J, Cupples LA, Kiel DP, Tucker KL.
Am J Clin Nutr. 2009 Jan;89(1):416-24.

A cross-sectional and longitudinal analysis was conducted in 334 men and 540 women in this Framingham Osteoporosis Study. The analysis evaluated the associations between total and individual carotenoid intake (alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, and lutein+zeaxanthin) with bone mineral density at the hip, spine, and radial shaft and the 4 year change in bone mineral density. Analysis showed that associations between lycopene intake and 4 year change in lumbar spine bone mineral density were significant for women, as were intakes of total carotenoids, beta-carotene, lycopene and lutein+zeaxanthin with 4 year change in trochanter bone mineral density in men. The authors concluded that carotenoids showed protective associations against a 4 year loss in trochanter bone mineral density in men and in lumbar spine in women. Results support a protective role of carotenoids for bone mineral desisty in older men and women.

PMID: 19056581

Neurodevelopmental outcomes of preterm infants fed high-dose docosahexaenoic acid: a randomized controlled trial.
Makrides M, Gibson RA, McPhee AJ, Collins CT, Davis PG, Doyle LW, Simmer K, Colditz PB, Morris S, Smithers LG, Willson K, Ryan P.
JAMA. 2009 Jan 14;301(2):175-82.

A study was performed to determine the effect of meeting the estimated DHA requirement of preterm infants on neurodevelopment at 18 months corrected age. The study was a randomized, double-blind controlled trial enrolling infants born at less than 33 weeks gestation at 5 Australian tertiary hospitals, with follow-up to 18 months. A high-DHA enteral feeds compared with standard DHA from day 2 to 4 of life until term corrected age was undertaken. Measurements were based on the Bayley Mental Development Index at 18 months corrected age. Makrides, et al. did not observe statistically significant benefits in boys or babies born weighing less than 1250 g. However, they did say that there appeared to be a reduction in the proportion of babies with significant mental delay in these groups with high-DHA treatment. Investigators did observe an 80% reduction in the proportion of baby girls with significant mental delays when they had a diet rich in docosahexaenoic acid (DHA).

PMID: 19141765

Influence of a combination of Lactobacillus acidophilus NCFM and lactitol on healthy elderly: intestinal and immune parameters.
Ouwehand AC, Tiihonen K, Saarinen M, Putaala H, Rautonen N.
Br J Nutr. 2009 Mar;101(3):367-75. Epub 2008 Jul 18.

The study evaluated a combination of lactitol (a sugar alcohol used as a replacement bulk sweetener for low calorie foods with approximately 40% of the sweetness of sugar) and Lactobacillus acidopilus NCFM versus placebo twice daily and a double-blind parallel trial on healthy elderly subjects. Results indicated that stool frequency was higher in the synbiotic group than in the placebo group and a significant increase in faecal L. acidophilus NCFM levels was observed in the synbiotic group, after baseline correction. In contrast to the generally held opinion, the study subjects had faecal Bifidobacterium levels that were similar to those reported in healthy young adults. These levels were, nevertheless, significantly increased by the intervention. Immune marker measurements revealed that PGE2 levels were different between treatments and IgA levels changed over time. These changes were modest which may relate to the fact that the volunteers were healthy. Spermidine levels changed over time which may suggest an improved mucosal integrity and intestinal motility. Overall, the results suggest that lactitol combined with L. acidophilus NCFM twice daily may improve intestinal microbiota and mucosal functions.

PMID: 18634707

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