Health Canada

Guidance Document Released - Reporting Adverse Reactions to Marketed Health Products
www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2009-guidance-directrice_reporting-notification/index-eng.php.

This guidance document replaces and supersedes the 1996 Guidelines for the Canadian Pharmaceutical Industry on Reporting Adverse Reactions to Marketed Drugs (Vaccines Excluded) and its 2001 revision, as well as the 2004 Adverse Reaction Reporting Guidance Document - Natural Health Products.  It is meant to clearly and consistently communicate Health Canada's expectations concerning the reporting of adverse reactions to marketed health products by market authorization holders with respect to the
Food and Drug Regulations and the Natural Health Products Regulations.

In October 2006 and in January 2008, the draft guidance document was posted on the Health Canada website for public consultation.  The guidance document has been updated and clarified as a result of the feedback received from stakeholders.  Each comment received during the consultation was carefully considered and incorporated into the document where applicable.  The Marketed Health Products Directorate (MHPD) would like to thank all those who participated in our consultation.

Risk Based Approach to NHPs
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodnatur/nhprr-rba_erpsn-gbr-eng.pdf

Health Canada Removes Purgative Use from Label for Over-the-Counter Oral Sodium Phosphate Products
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_125-eng.php

Further to the Public Warning issued March 5, 2009, Health Canada is informing Canadians that over-the-counter oral sodium products are no longer indicated for bowel cleansing. These products have either been voluntarily relabelled to remove the bowel cleansing (i.e., “purgative”) indication, or discontinued from the Canadian market. Oral sodium phosphate products should only be used as a laxative.

Natural Health Products Directorate

Notice – Deadline for Transfer of DINs to NPNs
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/bulletins/din_trans_npn-eng.php

Status of Applications/Submissions Quarterly Report - Quarter 1 (April 1, 2009-June 30, 2009)
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_1-09-eng.php

Highlights:

• 13,143 NHPs licensed since 2004
• 25,747 PLAs completed since 2004
• 2136 NHPs licensed during Quarter 1
• 779 PLAs refused during Quarter 1
• 605 PLAs withdrawn during Quarter 1

As defined by the NHPD, the "backlog" consists of the 12,635 PLAs received before April 1, 2008 which were incomplete as of that date.  All PLAs received on or after April 1, 2008 are considered regular workload and are not part of the PLA backlog the NHPD has committed itself to addressing by March 31, 2010. For the purposes of reporting, these are called "regular workload" PLAs.  To date, 47% of applications are in "backlog" and 59% of "regular workload" applications have been or are in the process of being completed. In addition, 73% of "backlog" applications and 69% of "regular workload" applications have been addressed.

Updated Monographs

Fenugreek
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_fenugreek-fenugrec-eng.php

Senna
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licenprod/monograph/mono_senna/sene-eng.php

Calcium
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_calcium-eng.php

Iron
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_iron-fer-eng.php

Borage Oil
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_borage-bourrache-eng.php

Ginkgo Biloba
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_ginko_biloba-eng.php

Seal Oil
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_seal_oil_huile_phoque-eng.php

Glucosamine
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licenprod/monograph/mono_glucosamine-eng.php

Folate
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono-folate-end.php

Milk Thistle
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono-thistle chardon-eng.php

Fish Oil
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licenprod/monograph/mono_fish_oil_huile_poisson-eng.php

New Monographs

Psyllium
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_psyllium-eng.php

Propolis
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_propolis-eng.php

Site Licence Renewal Process Change

A change to the Site Licence (SL) Renewal process will be implemented on September 1st 2009. A renewal package, very similar to the one currently in use, will be sent to valid Site Licence holders. Once received, the SL holder will now be responsible to complete the Site Licence Application (SLA) form.

Please note that no SL holder may apply for a SL amendment during the renewal process.  Changes in activities and/or site addresses must be made in a separate application from that of the renewal, in accordance with Section 32 of the Natural Health Products Regulations (NHPR).  The renewal process is to verify previously assessed information for continuing compliance with Good Manufacturing Practices (GMP) requirements outlined in Part 3 of the NHPR.

Site Licence General Information

A Site Licence (SL) must be issued prior to an applicant submitting a SL application (SLA) for Amendment. An amendment application received when no SL has been issued will be refused upon receipt. Also if an existing SL is refused, all amendment and notification submissions associated to that SL will also be refused.

Upon renewal application receipt, any site listed on the SLA that has not provided Good Manufacturing Practices (GMP) evidence will not be assessed and therefore not included on the renewed SL.  The applicant will be required to apply for the licence amendment to add such sites. However, GMP evidence is not required for sites added to a site licence within 6 months of the licence expiration date.

CHFA Welcomes New Director of Regulatory Affairs & Policy Development

CHFA's new Director of Regulatory Affairs & Policy Development, Carl Carter, started this week at the association. Carl brings with him a vast talent and unique combination of skills and experience in regulatory affairs, policy development, government relations, management and communications. His appointment reinforces our continued long-term commitment to strengthening our ever-increasing voice on regulatory and legislative issues of concern to our members. Carl may be reached at ccarter@chfa.ca or 1-800-661-4510/416-497-6939, ext. 225.

DIN Annual Notification Clarification

While the 2009 Annual Drug Notification form was due August 7, the CHFA has learned new information. We have learned that there will not be any penalty as long as Health Canada receives your Annual Drug Notification form by October 1, 2009.  If you decided to inactivate the products, a letter confirming your inactivation must be received before October 1, 2009 at which time the invoice will be issued. The Annual Drug Notification form is intended to assist you in complying with the Food and Drug Regulations.  Failure to comply may result in cancellation of existing DINs by the Therapeutic Products Directorate (TPD).

Organic Products – Sodium Nitrate

Sodium nitrate (SN), also known as Chilean nitrate, is a naturally occurring mineral that is used as a soil amendment. It is allowed for use (though restricted) by organic growers certified to the USDA National Organic Program (NOP). The Codex Alimentarious (an international standards development body which works under the World Health Organization to develop international food standards) organic production guidelines prohibits the use of SN. The International Federation of Organic Agriculture Movements (IFOAM) principles are reflected in the Codex guidelines. Canada’s Organic Regime closely mirrors the Codex guidelines and prohibits products produced using sodium nitrate from being labeled and marketed as organic in Canada after June 30, 2009.

As a part of the implementation of the Organic Products Regulations, 2009 (OPR 2009) a Stream of Commerce policy has been developed. The Stream of Commerce policy covers a 24 month period ending June 30, 2011, will allow producers and processors to phase out the use of SN, or raw materials produced using SN.

Why does IFOAM Prohibit SN?
Organic agricultural systems are built on the premise that crops should receive their primary nutrients from the soil. Nutrients from external sources are only added in as needed. In organic agriculture one of the basic principles is to feed the soil, not the plant. By contrast, conventional agriculture often directly feeds the plant. In organic farming, N is supplied in the form of organic substances, where most N is bound to organic molecules such as protein. Such compounds “feed” the soil (promote activity of soil micro-organisms), and become available for crops only after mineralization by micro-organisms. By contrast, conventional N fertilizers often contain mineral, highly soluble nitrogen similar to SN.

How does the Canadian Regulation prohibiting the use of SN in organic products effect the availability of USDA certified products in Canada?
During the winter months, Canada relies on the US and Mexico for the majority of fresh leafy greens, and many other produce items. Organic producers from these regions use sodium nitrate as a soil amendment to extend their growing season. Some grain and soybean growers also use sodium nitrate on their crops when temperatures drop.  As well as supplying the fresh market, raw materials are sold in a wide variety of forms including frozen, canned and value-added products such as soups, sauces, baby foods, juices, baked goods, breakfast cereals, etc.

Under the OPR 2009, organic producers who use sodium nitrate will be prohibited from marketing their product as organic in Canada. Producers will be required to attest that SN will not be used as a part of their nutrient regime. A recent directive from the USDA Organic Program office to their accredited certification agencies suggests that US organic processors will be exempt from the prohibition. However we have yet to see a ruling from the Canada Organic Office. Until we hear otherwise we expect that the Stream of Commerce period will provide producers, processors and regulators sufficient time to come to an understanding.

How might this impact on my business?
Given that Canada imports over 80% of its organic produce and value added products, (predominately from the U.S.) there will clearly be an impact in the marketplace, however the Stream of Commerce policy will address any immediate impact and will allow producers and processors time to address the issue. The longer term implications will only be clear as time progresses. More immediately there is a concern regarding the position of the USDA Organic Program Director Barbara Robinson: “the USDA takes this agreement seriously and will not allow the export of non-compliant NOP-certified products (i.e. products grown with sodium nitrate) to Canada as of July 1st ". Importers affected by this ruling are seeking the guidance of the Canadian Organic Office, and will be petitioning for fresh product to be included in the Stream of Commerce Policy which was launched when the OPR 2009 were implemented on June 30, 2009.

A British study that found organic food is no different when compared with conventionally produced food made news headlines across North America on Wednesday, July 29. The independent review, commissioned by the Food Standards Agency (FSA) in the United Kingdom, seemed to be a slap in the face of supporters of organic agriculture around the world. The FSA, www.food.gov.uk, is an independent government department mandated to protect the public's health and consumer interests in relation to food.

Our national newspapers reported the results of this study which took the form of a 'systematic review of literature' and was carried out by the London School of Hygiene and Tropical Medicine (LSHTM).
The CHFA was quick to respond with letters to the editor to The Globe and Mail and the National Post. Our letter was published in Friday's Globe and Mail on page A12. You can also read an online version at www.theglobeandmail.com/news/opinions/letters-to-the-editor/organic-objective/article1237228/

If you're interested in reading the stories in the national papers, here are some links:

GREENFIELD, Mass. (July 31, 2009)—In response to recent publicity concerning an article in-press for the next issue of The American Journal of Clinical Nutrition, the Organic Trade Association (OTA) reminds consumers that organic has a great story to tell.

“The broader question is about what is health and what is nutrition, and isn’t it more than just nutrient density,” said Marion Nestle, Paulette Goddard Professor of Nutrition, Food Studies and Public Health at New York University, in reference to recent buzz about the article, “Nutritional quality of organic foods: a systematic review.” “Doesn’t a food system that avoids the use of pesticides, synthetic growth hormones and antibiotics while building healthy soil and protecting natural resources promote health and nutrition? I certainly think so.”

She added, “I’m surprised that investigators of this caliber would focus so narrowly on nutrient content. There is no reason to think that organic foods would have fewer nutrients than industrially produced foods, and there are many reasons to think that organic foods have greater benefits for the environment, for pesticide reduction, and for taste, all of which affect human health at least as much — or more — than minor differences in nutritional content. I buy organic products because I want foods to be produced more naturally, more humanely, and more sustainably. I see plenty of good reasons to buy organic foods, and this study does not even begin to address them.”

Surveys of U.S. households show that one of the top reasons cited for purchasing organic is that the products are “healthier for me and my family,” but it is important to examine what consumers mean by this. As shown by findings from the 2009 U.S. Families’ Organic Attitudes & Beliefs Study, consumers say they choose organic products due to their concerns about possible effects of toxic and synthetic pesticides, synthetic growth hormones and antibiotics used in non-organic agriculture. They also want to avoid highly processed food produced without any restrictions on additives.

According to OTA’s Executive Director Christine Bushway, “Any time a consumer buys an organic product, whether food or non-food, he or she is supporting a system of sustainable agricultural management that promotes soil health and fertility, fosters species diversity, helps combat climate change, prevents damage to valuable water resources, and protects farmers and farmers’ families from exposure to harmful chemicals. In turn, this benefits the health of our planet in general, and ultimately, those who live on that planet.”

The in-press study reveals the lack of good quality research for comparing the nutritional aspects of organic and conventional agriculture. There are few studies that have been conducted with the scientific rigor required to definitively show any differences. Although this article did not see documented significant nutrient differences between organic and conventional food, it did not necessarily rule out that possibility. There is a need for much further research to see if this is the case.

This is due, in part, to the fact that very few resources over the years have been dedicated to research concerning organic agriculture and products. Fortunately, this may be changing, with the 2008 Farm Bill increasing funding for organic research five-fold over previous levels.

Developing a New Risk-Based Approach to Site Licensing for Natural Health Products - Discussion Paper

Challenges with Current Approach to Site Licensing and GMP Compliance
As previously mentioned, Health Canada determines and/or verifies compliance to GMPs for site licensing purposes by means of a paper-based review of the quality assurance report (QAR) or other GMP evidence. This current paper-based system poses various challenges which can be summarized as follows:

1. The current system is not conducive to the export market - International trade certificates issued by NHPD attest that the sites at which the products are manufactured, packaged, and labelled are compliant with Canadian requirements, but this attestation is only provided based on the paper-based review. Canadian exporters may face difficulties in exporting their products since importing countries do not have sufficient assurance that the listed sites are fully compliant with GMPs given natural health products sites are not subject to on-site verifications.

2. Lack of confidence in Quality Assurance Report - The absence of an on-site verification program, in some cases, leads to a lack of confidence that the information contained in QARs are accurate and reflective of the activities conducted at each site. Health Canada has occasionally conducted compliance verification visits and found that the information contained within site licence applications and QARs did not reflect activities conducted at the site.

3. Lack of link between product and site licensing: Although the Natural Health Products Regulations contain provisions which link the product and site components, the process for obtaining these respective licenses are separate. According to the Regulations the product license holder is responsible for ensuring that GMPs are followed throughout all stages of the manufacturing process; however, there are many instances where the product licence holder is not involved in all elements/components of the manufacturing activity.

Impetus for Change

Health Canada’s Natural Health Products Directorate (NHPD) conducted a review of the regulatory framework in 2007-2008 as part of the “Blueprint for Renewal” which is Health Canada’s plan for the modernization of the regulatory framework for food and health products. A new Risk-Based Approach (RBA) for NHPs was initiated in response to the results of this review. As part of the RBA for NHPs, the NHPD is moving forward with the development of a strengthened site licensing program that would include, but not be limited to, on-site verification of GMP compliance and modified GMP requirements for site licensing and renewal purposes.  The new approach will consider the range of products falling under the Natural Health Products Regulations and the range of activities involved in the supply chain of a finished NHP for sale in Canada, including activities conducted inside and outside of Canada.

Implementing a strengthened GMP verification process will enable Health Canada to identify risks and potential non-compliance issues much earlier in the process, thereby enhancing the safety of NHPs reaching the Canadian market. It will enhance GMP compliance throughout the industry and increase consumer confidence and trust in product quality and safety. In addition, it will address the challenges identified under the current paper-based verification system and comments related to quality received during the consultation. Enhancing GMP requirements to include quality management system principles provides a means for industry to establish and maintain quality control in the manufacturing of NHPs, to facilitate continuous improvement over the product’s life cycle, and to increase Health Canada and consumer confidence in the quality of NHPs.

Recent developments have highlighted the importance of quality in consumer products (e.g.Food and Consumer Safety Action Plan, greater focus on import safety internationally) including several compliance and enforcement incidences related to manufacturing practices (e.g. adulteration and substitutions of prescription drug benzodiazepines in sleep aids sildenafil in herbal products for erectile dysfunction, Diethylene glycol (DEG) in fluoridated toothpaste, melamine in dairy products, and microbiological and heavy metal contamination in products).

Ontario Toxics Reduction Act – Regulatory Development Consultations

The Bill 167: Toxics Reduction Act, 2009 received Royal Ascent on June 5, 2009. Since then, Ministry staff have been very busy putting pen to paper as they look to develop specific regulations that will address ‘toxics accounting’ and mandatory ‘toxic reduction planning’ for facilities meeting a specific set of criteria. The class of facilities of interest under consideration includes those facilities that are involved in “manufacturing and mineral processing activities” and that meet specific criteria (i.e. number of employees and reporting threshold). Unfortunately, further elaboration on what activities are included in “manufacturing” has not yet been proposed.

In the interim, a preliminary information session was hosted on July 2, 2009 which was followed by a technical workshop on July 16, 2009. An additional technical workshop will be held on August 6, 2009 followed by a 2nd information session (that is intended to integrate input received during both technical consultations) scheduled for August 19, 2009. We understand that the Ontario Government is pursuing a very rapid turnaround on these regulations and are interested in being in the position to release draft regulatory text by early Fall, 2009 with final regulations coming into effect by the end of the fall/early winter 2009.

CCTFA will continue to play an active role in these consultations. Note, the regulations currently being proposed only apply to those with direct manufacturing interests in Ontario; however, since the Act does allow for the development of regulations that could extend to finished goods, importers and distributors of finished product should keep their pulse on these activities, moving forward.