Regulatory Updates

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July 25, 2011

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Natural Health Product Directorate -NHPD http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php
July 25, 2011Natural Health Product Directorate (NHPD) Stakeholder Bilateral Meeting Program – Meeting with the Direct Sellers Association (DSA)
Item 1: Update on the status of revised NHPD guidance for standards of evidence.
  • The NHPD is proceeding with approval and release of updated guidance, following a focused consultation with the Natural Health Products Program Advisory Committee (NHP-PAC), and will provide the guidance to stakeholders once available, by NHPD email message (BEEP), and will make the information available on the Health Canada website.
  • The DSA will provide IRN numbers for specific examples raised, to the NHPD for review. The NHPD reaffirmed the availability of other meeting options, including submission and issue specific meetings to discuss issues where review of information is required.
  • For the direction sought by the DSA on animal studies, the NHPD noted that it does not accept this alone as sufficient evidence for safety and efficacy and referred the DSA to current guidance and to the NHPD response to NHP-PAC Report #1. More clarity will be provided on this and other identified evidence areas in the updated guidance.

Item 2: Update on the status of natural health products compliance and enforcement activities

  • The Health Products and Food Branch Inspectorate (HPFBI) continues its compliance promotion period within a risk-based approach for NHPs (see POL 0001). Stakeholders will be advised on the status of compliance implementation as information becomes available with reasonable lead-in time given.

Item 3: Update on the status of guidance for product quality and testing

  • On October 23, 2009, NHPD shared a draft of Version 3.0 of the Quality Guidance Document via the NHPD email message service “BEEP” to all stakeholders. It was essential that NHPD share this document in order to allow applicants to take advantage of the new pilot project application stream – Abbreviated Labelling Standards – which required use of the Finished Products Specifications Form. The BEEP message was clear in stating “During this pilot period, Version 2.0 of the “Evidence for Quality of Finished Natural Health Products Guidance Document” will remain posted on the Health Canada website and should continue to be consulted for all application types except AbLS PLAs.”
  • NHPD continues to apply the requirements of Version 2.0 of the Quality Guidance Document until such a time when Version 3.0 is published on the NHPD website. However, NHPD can re-send the draft version 3.0 of the Quality Guidance Document which was shared in October 2009 upon request.
  • The NHPD is proceeding with approval and release of Version 3.0 of the Quality Guidance Document, following a focused consultation with the NHP-PAC, and will provide the guidance to stakeholders once available, by BEEP, and make the information available on the Health Canada website.
  • The DSA will forward IRN numbers for the specific product testing issues raised, to the NHPD for review and follow-up as needed.

Item 4: Update on the status of NHP-PAC recommendations and NHPD guidance on weight loss natural health products

  • The NHPD anticipates receiving NHP-PAC recommendations on Weight Loss/Weight Management NHPs (NHP-PAC Report #4) shortly and will be proceeding with finalization and release of guidance or these products following a focused consultation with the NHP-PAC. Guidance will be provided to stakeholders, by BEEP, and will be made available on the Health Canada website. To support a durable/robust solution, the NHPD will process product licence applications for this group of products once guidance is completed.

Item 5: Update on activities related to the Risk-Based Approach to Site Licensing

  • The NHPD is proceeding with approval of the RBASL concept and will continue to inform and consult with stakeholders.
  • The DSA will provide more specific information, for clarification, on use of corporate audits, to the NHPD for information and consideration.

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_06-01-11-eng.php
 

 

FDA http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm

Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm
 
Natural Products Association http://www.npainfo.org/index.php?src Dietary Supplement Makers Hear from the FDA and the Experts at Industry’s First NDI Education SessionWASHINGTON, D.C. – The Natural Products Association (NPA) held the dietary supplement industry’s first education session about the recently released New Dietary Ingredients (NDI) Draft Guidance by the Food and Drug Administration (FDA). The NPA webinar, “NDI Guidance: What You Need to Know,” was attended by nearly 150 manufacturers, trade media and industry stakeholders on July 11. A CD-ROM of the webinar, PowerPoint slides and text of the NDI guidance is available for sale at www.NPAinfo.org/NDIGuidance.
http://www.npainfo.org/index.php?src=news&submenu=Press&srctype=detail&category=pressreleases2011&refno=336
Council for Responsible Nutrition-CRN
 		 http://www.crnusa.org/ CRN Submits Comments to FDA, Docket FDA-2011-N-0410, on Premarket Notification for a New Dietary Ingredient http://www.crnusa.org/pdfs/CRNComments_FDA_ProposedCollectionInfoPremarketNotificationNDI072511.pdf
CRN Submits Comments to FDA, Docket FDA-2011-N-0403, on Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
http://www.crnusa.org/pdfs/CRNComments_FDAProposedCollectionInfo_SubstantiationDSClaimsUnderFDCAct072511.pdf
 
Natural Products Insider http://www.naturalproductsinsider.com/ What the NDI Guidance Means to the Supplement IndustryThe curtain has been lifted, and the dietary supplement industry has been given a window into FDA’s perspective regarding the highly anticipated New Dietary Ingredient (NDI) Notifications: Draft Guidance for Industry. The dialogue initiated after the release of the Draft Guidance has been dominated by more questions than answers. Specifically: Are commonplace dietary ingredients currently on the market that require manufacturers to file a retro-active NDI notification? Does every dietary supplement that contains an NDI necessitate its own separate NDI notification? There is even the possibility dietary ingredients already consumed widely with no evidence of a safety risk may now not meet the definition of a dietary ingredient at all.
http://www.naturalproductsinsider.com/articles/2011/07/what-the-ndi-guidance-means-to-the-supplement-industry.aspx
Organic Trade Association http://www.ota.com/index.html Canadian organic sector celebrates trade deal with EuropeOTTAWA, Canada (July 5, 2011) –Canada and the European Union have reached an historic agreement to recognize each other’s organic standards and laws, after nearly four years of formal negotiation.
This is the world’s second such agreement. In June 2009, the Canadian Food Inspection Agency and the United States Department of Agriculture signed the very first “organic equivalency arrangement,” which opened the significant U.S. organic market to Canadian exports.
The global organic trade is now estimated at over $55 billion per year, with 96% of this represented by the U.S. and EU markets. Canada is now the only country in the world able to deal directly with these two key markets through its domestic standards.
“This is an absolute game-changer for Canadian farmers and food manufacturers,” said Matthew Holmes, Executive Director of the Canada Organic Trade Association, and an organic sector advisor to the Government of Canada on international trade and market access. “With full access to European markets, suppliers, and ingredients, Canada’s organic sector now has a strategic edge. This agreement will increase trade and boost Canada’s organic sector, from the farm to the consumer.”
http://www.organicnewsroom.com/2011/07/canadian_organic_sector_celebr.html
 

 

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