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Monthly Newsletter - Issue 1 - December 2008
Provided by dicentra inc.
www.dicentra.ca

  Topics

• Introduction
• NHP 2010 Deadline: Will January 2010 Be Another Y2K?
• Upcoming Training Sessions
• Regulatory Updates
• Science & Research Updates
• Upcoming Events

• Question of the Month


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 Introduction

dicentra is a leading international scientific and regulatory consulting firm with specialized expertise in the areas of Natural Health Products & Dietary Supplements, Food & Nutrition, and Cosmetics.

We have created this newsletter to keep industry members up-to-date on the latest issues pertaining to scientific and regulatory affairs. Since this is our first newsletter, we welcome any comments to may have. Please review our Upcoming Training Sessions or Question of the Month. These are sections created to fulfill dicentra’s mission to serve the industry as a source for education and trusted scientific information. We hope you enjoy this issue and we wish you and your family a safe and happy holiday season.

- The dicentra Team


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 NHP 2010 Deadline: Will January 2010 Be Another Y2K?

There is a lot of buzz in the industry over what will happen come January 1, 2010, as if hordes of inspectors and customs agents are just waiting to pounce at the stroke of midnight. Some are under the impression that this is the deadline for all natural health products to obtain an NPN in order to be legally sold. In reality, all NHPs must currently hold an NPN or DIN to be sold legally in Canada. So what is this January 1, 2010 deadline all about? This is the deadline, as established in the Natural Health Product Regulations, by which NHPs that currently hold a DIN must be transferred to the NHPD and licensed accordingly. So when the NHPD states in their Overview of the NHP Regulations Guidance Document that “All natural health products must comply with all the Regulations by January 1, 2010”, this is referring specifically to DIN products.

“But,” you may ask, “can’t I legally sell my product if I have a submission number?” The answer is no. However, in recognition of the ongoing backlog, the NHPD has stated that they will not focus their enforcement action on those products that do not pose an undue risk and that were issued submission numbers before the applicable category deadline1. The site license deadline for manufacturing packaging, labelling, and importing NHPs (December 31, 2005) has, of course, come and gone and is currently being enforced. But it appears that the NHPD will continue to apply their current compliance approach to product licencing so long as the backlog persists (the January 1, 2010 deadline notwithstanding).

Like the Y2K bug, January 1, 2010 will likely dawn on the industry not with a bang but with a whimper.

1For details of the NHPD’s approach to enforcement refer to the Natural Health Products Compliance Guide, January 2007 - Version 2.1, available on the NHPD’s website.


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 Upcoming Training Sessions

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:
Challenges and Solutions for Registering a Probiotic Product with the NHPD

Jon-Paul Powers, Ph.D., a former assessment officer of the NHPD, has prepared and will deliver this course to discuss the current requirements for probiotic products. Topics covered include the evidence required for probiotic characterization and strain identification as well as a discussion of antibiotic resistance, resistance transfer and biochemical parameters that are of concern to the Natural Health Products Directorate. The unique requirements to support health claims for probiotics will also be discussed as well as what can be done to improve the likelihood that your probiotic product will be approved.

Date: Wednesday, January 28, 2009
Time: 2 p.m. Eastern Standard Time
Duration: 60 minutes, followed by a 30 minute Q&A session
Speaker: Dr. Jon-Paul Powers, Ph.D.
Who should attend and why?

This course is specifically designed for companies with probiotic-containing products. Company executives, marketing managers, and regulatory personnel would all find the content of this course valuable.

pdf Click here to register. (108kb)

Later Sessions:
Good Manufacturing Practices for Natural Health Products for Current and Potential Site License Holders
Wednesday, February 25, 2009

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 24, 2009


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 Regulatory Updates


Food and Nutrition
Health Canada Warns Consumers not to use two vitamin C supplements due to potential health risk

Health Canada is warning Canadians, especially expectant mothers, not to use two vitamin C products sold under the brand names New Roots Herbal Vitamin C8 and Vitazan Professional Vitamin C Advanced Ascorbate. These products were improperly manufactured using vitamin A instead of vitamin C, exposing consumers to potential risks of adverse events.

Advertising Standards Canada
ASC E-newsletter - November 2008

At the Oct. 29, 2008, ASC Board of Directors meeting, the Board approved the addition of the following to the Interpretation Guidelines for the Canadian Code of Advertising Standards:

Interpretation Guideline #3 – Environmental Claims
When evaluating complaints involving environmental claims that allegedly are misleading or deceptive, [ASC’s Consumer Response] Council may, in exercising its judgment, take into account the standards proposed by the Canadian Standards Association and the Competition Bureau of Canada in the Special Publication PLUS 14021, Environmental claims: A guide for industry and advertisers.

Health Canada
October 2008 edition of the Canadian Adverse Reaction Newsletter is now available online

Use of Codeine Products by Nursing Mothers
Health Canada is advising the public, especially nursing mothers, about the very rare but serious health risk to breastfed babies posed by codeine use in mothers. Once ingested, codeine is converted by the body into morphine.  Some people convert codeine into morphine more rapidly and completely than others. The babies of nursing mothers who rapidly metabolize codeine may be at increased risk for morphine overdose due to higher-than-expected morphine levels in breast milk.

Natural Health Products Directorate
Draft Guidance Document - Drug Master Files (DMFs)
Comments on this document should be forwarded within 60 calendar days to: bps_enquiries@hc-sc.gc.ca

Consultation - Draft Guidance Document - Human-Use Antiseptic Drugs
This consultation is open for comment starting November 26, 2009 until February 6, 2009. Please select and read through the link titled "consultation document." Once read please submit your comments via email, fax or by mail to: Policy_Bureau_Enquiries@hc-sc.gc.ca


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 Science & Research Updates

Effect of combined folic acid, vitamin B6, and vitamin B12 on cancer risk in women:
a randomized trial.

Zhang SM, Cook NR, Albert CM, Gaziano JM, Buring JE, Manson JE.
Journal of the American Medical Association, November 5, 2008, 300(17): 2012-21.

A seven-year long randomized, double-blind, placebo-controlled trial of 5,442 female subjects evaluated a combined folic acid, vitamin B6 (pyridoxine hydrochloride), and vitamin B12 (cyanocobalamin) treatment on cancer risk. Overall, the results showed that the combination had no significant effect on the overall risk of total invasive cancer or breast cancer. However, the authors did note that after performing a detailed statistical analysis a significantly reduced risk was observed for total invasive cancer and breast cancer among women aged 65 years or older. Furthermore, the study solidifies the safety of long term supplemental use of folic acid, vitamin B6 and B12.

Abstract: PubMed 18984888

Gum arabic establishes prebiotic functionality in healthy human volunteers in a dose-dependent manner.
 

Calame W, Weseler AR, Viebke C, Flynn C, Siemensma AD. 
British Journal of Nutrition, December, 2008, 100(6): 1269-75.

A four-week long, fifty-four-subject, randomized, double blinded, double-controlled trial with six parallel test groups was published evaluating the efficacy of prebiotic efficacy of gum arabic upon consumption. Varying doses utilized in the study eluded to different amounts of gum arabic with respect to efficacy of the trial. The authors concluded that gum arabic bears prebiotic efficacy within a dose range similar to or lower than inulin, as established via the quantitative development of bacteria in stool samples.

Abstract: PubMed 18466655

Ginkgo biloba for prevention of dementia: a randomized controlled trial. 

Dekosky ST, Williamson JD, Fitzpatrick AL, Kronmal RA, Ives DG, Saxton JA, Lopez OL, Burke G, Carlson MC, Fried LP, Kuller LH, Robbins JA, Tracy RP, Woolard NF, Dunn L, Snitz BE, Nahin RL, Furberg CD.
Journal of the American Medical Association, November 19, 2008, 300(19): 2253-62.

A randomized, double-blind, placebo-controlled clinical trial conducted in 5 academic medical centers in the United States between 2000 and 2008 concluded that Ginkgo biloba, at 120 mg twice a day, was not effective in reducing either the overall incidence rate of dementia or Alzheimer’s disease in elderly individuals with normal cognition or with mild cognitive impairment.  A strong response from the natural health products industry has been received since the publication of the study criticizing the quality of the trial and its short comings.

Abstract: PubMed 19017911

Effect of glucomannan on plasma lipid and glucose concentrations, body weight, and blood pressure: systematic review and meta-analysis.
Sood N, Baker WL, Coleman CI.   
American Journal of Clinical Nutrition, October, 2008, 88(4): 1167-75.

Authors from the University of Connecticut Schools of Medicine and Drug Information recently published a systematic review and meta-analysis investigating the impact of glucomannan on plasma lipid and glucose concentrations, body weight, and blood pressure. The authors concluded that glucomannan appears to significantly lower total cholesterol, LDL cholesterol, triglycerides, body weight, and fasting blood glucose, but not HDL cholesterol or blood pressure.  The authors also noted that glucomannan did not appear to be as effective for specific subgroups of people, such as pediatric patients, patients receiving dietary modifications, and patients with an impaired glucose metabolism.

Abstract: PubMed 18842808


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 Upcoming Events

CHFA Expo Quebec 2009
www.chfa.ca
January 16-18, 2009
Hilton Bonaventure, Montreal, Quebec

CHFA Expo West 2009
www.chfa.ca
April 2-5, 2009
Vancouver Convention & Exhibition Centre, Vancouver, British Columbia


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 Question of the Month

Please e-mail any question you may have relating to scientific or regulatory affairs to peter@dicentra.ca One question will be answered by one of our experts each month and published in the following Monthly Newsletter.


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  Newsletter Info
dicentra Inc. International Scientific & Regulatory Consultants. Your Souce for Trusted Natural Products Scientific Information

To subscribe to this newsletter please visit www.dicentra.ca and add your e-mail address. If you have any items that you would like added to this newsletter please e-mail Peter at peter@dicentra.ca for review.

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