Staying in Touch with Consumers |
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dicentra is now offering a new service to assist you with the consumer side of your business through our Bilingual Consumer Response Center. This new service puts dicentra in the “middle man” position between you and consumers. Through efficient communication and record keeping, we promise to ensure regulatory compliance while maintaining and supporting your branding and marketing needs. The ultimate goal is to increase consumer loyalty and thus increase your sales!
Consumers offer a wealth of information which is often overlooked by manufacturers and distributors in all industries, including natural health products. A direct line of communication between the end users of your products and your own decision makers has numerous benefits. It may seem time consuming and labour-intensive to maintain, but it will increase your regulatory control as well as provide you with detailed information about your market. At dicentra, we can assist and advise you on how to efficiently take advantage of the opportunities and information your consumers can provide to you.
Service that Supports your Brand
Consumers often view products as coming from a faceless company, and are often frustrated when they are unable to get past an automated telephone system or standard reply email when in need of answers or assistance. Surprise your consumers by putting humanity into your business equation and reap the benefits of a brand associated with not only it’s product but it’s service.
Furthermore, dissatisfied consumers can be extremely harmful to your brand and hence your business due to the power of word-of mouth marketing. Negative experiences with products will occasionally happen, but quality service and a trained ear can turn that negative experience into a positive one. This reinforces your brand in the eyes of consumers despite their initial negative experience. Wouldn’t you rather consumers were discussing their positive experience with your products with their friends, family and colleagues?
Educating Consumers
In the natural health industry, consumers have numerous questions regarding products and ingredients, the answers to which directly impact their buying decisions. Consumer inquiries have an extremely wide scope, and it would be a business risk to expect that these questions can all be satisfactorily answered by point-of-purchase personnel or by reading a label. The consistency and currency of information is also an important concern considering the dynamic nature of the industry. By answering your consumers’ questions, you show them that their health is important to you and thus earn their loyalty to your brand.
Regulatory Compliance
Wouldn’t you prefer to be the first to know about potential quality assurance issues stemming from your manufacturers or manufacturing process? A line of communication with consumers highly increases the likelihood that you will be the first-to-know when there is a potential safety or regulatory concern in your manufacturing process, thus giving you ownership of your brand.
Is your company in full compliance with Health Canada’s Adverse Reaction Reporting System? An established and efficient method of recording, reporting, and responding to such incidents will make compliance easy, and who better to advise you on this subject than our team at dicentra.
For more information please contact us.
Erin Riggs, BA
dicentra, Inc.
erin@dicentra.ca
Tel. 416-361-3400 ext 232
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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:
Save Time and Money: How to Simplify Quality Testing Requirements for Natural Health Products
Testing costs can add considerably to the overall production costs of natural health products. This is particularly true since the implementation of the Natural Health Product Regulations in 2004. Companies are complaining that the new testing requirements are reducing profit margins and placing undesirable strain on day-to-day business operations.
While testing is necessary (and mandatory) to ensure product quality, there are many ways to minimize the testing burden. This course, prepared and delivered by William Morkel (about the speaker), will explore potential means of streamlining your testing program to make it more cost effective while still adhering to regulatory and GMP requirements. William Morkel, Senior Quality Assurance Specialist at dicentra has fifteen years of experience working in the field of pharmaceutical and natural health products quality assurance and often delivers lectures on GMP issues with Health Canada.
Course Information
Wednesday, July 29, 2009 at 2 p.m. ET
Presented by William Morkel
60 minutes, followed by a 30 minute Q&A session
Who should attend and why?
Individuals involved in quality assurance and control, regulatory affairs, purchasing, and business management should all attend this course. Companies importing their products into Canada from a foreign country are particularly encouraged to attend this course.
Later Sessions:
ALERT! The Deadline for the Transfer of DINs to NPNs is Almost Here: How to Beat the Rush and Keep Your Products on Shelves
Wednesday August 12, 2009 at 2 p.m. ET
Good Manufacturing Practices For Natural Health products for Current and Potential Site Licence Holders
Wednesday, August 26, 2009 at 2 p.m. ET
Simplify Compliance: Developing New Products and Choosing Raw Materials with Product Licensing in Mind
Wednesday, September 30, 2009 at 2 p.m. ET
Creating Compliant Labels for Natural Health Products in Canada
Wednesday, October 28, 2009 at 2 p.m. ET
Classification of Products at the Food-Natural Health Product Interface – A Deeper Look
Wednesday, November 25th, 2009 at 2 p.m. ET
Successful Product Submissions: How to Get a Natural Product Number
Wednesday, December 9, 2009 at 2 p.m. ET
Have a course topic in mind that you want listed here? Email the topic to training@dicentra.ca.
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Health Canada
Canadian Adverse Reaction Newsletter, Volume 19 - Issue 3
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v19n3-eng.php
Canada and China Renew Plan of Action for Cooperation in Health for 2009-2011
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2009/2009_94-eng.php
On June 18th, the Honourable Leona Aglukkaq, Minister of Health, and Dr. Chen Zhu, Minister of Health for the People’s Republic of China, signed a Plan of Action for continued cooperation between the two countries on health priorities of mutual concern. The areas covered by this agreement include research and regulation, and this 2009-2011 agreement builds on the 2005-2008 one to further Canada and China’s track record of cooperation in the field.
Government of Canada Acts to Protect Newborns and Infants from Bisphenol A in Polycarbonate Plastic Baby Bottles
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/current-courant-eng.php
The Government of Canada is moving forward with proposed regulations to prohibit the advertisement, sale and importation of polycarbonate plastic baby bottles that contain bisphenol A, otherwise known as BPA, to reduce newborn and infant exposure to this substance.
Natural Health Products Directorate
NHP Online solution
http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/eplaguide-eng.php
The latest version of the e-PLA – version 1.1.0 – is released and available to prepare and submit:
- new product licence applications (with the exception of homeopathic licence applications – to be available later this year)
- responses to Information Request Notices (IRNs)
- amendments and notifications for licensed products.
The e-PLA offers many advantages when used to prepare a product licence application:
- High degree of completeness and accuracy of application form content
- Label text more consistent with labelling standards when the built-in label text generator feature is used
- Standard terminology such as Ingredient names and properties captured according to the international standards maintained in the NHP Ingredients Database
- Highly-effective built-in support for preparing Compendial applications
- Reduced incidence of subsequent IRNs for the same application
- Quick and accurate preparation of potential future notifications and amendments for these successful licence applications by re-using the same completed e-PLA.
By this fall, the e-PLA will be the only acceptable vehicle for submitting natural health product licence applications. All other versions of the NHP application form will be withdrawn from service.
Status of Submissions Quarterly Report - 4th Quarter
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_4-09-eng.php#a3
Abbreviated Labelling Standards for Natural Health Products – Discussion paper
http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/abbr_lab-abr_eti-eng.php
Veterinary Drugs Directorate
Submissions Containing Clinical Data from Studies Conducted outside of Canada
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_gcp_avis_bpc-eng.php
Health Canada is reminding sponsors of its expectation that the clinical studies submitted in support of a Canadian market authorization were conducted in accordance with internationally recognized Good Clinical Practice standards that guide the ethical and scientific conduct of clinical research.
This Notice applies to submissions for all product lines, specifically: (1) medical device licence applications subject to the Medical Devices Regulations; (2) product submissions pursuant to the Food and Drug Regulations (including pharmaceuticals, biologics, radiopharmaceuticals and veterinary products); and (3) applications for a natural health product licence pursuant to the Natural Health Products Regulations.
Canadian Food Inspection Agency
Canada and U.S. Reach Agreement to Create More Opportunities for Organic Producers
http://www.inspection.gc.ca/english/corpaffr/newcom/2009/20090617e.shtml
On June 30th, 2009 an agreement came into effect that allows Canada to export certified organic products to be marketed in the U.S. as organic without the need for additional American certification. Similarly, Canada would also deem imports of U.S. organic products certified under their organic regime as meeting the Canadian requirements for organic products. **Both the Canada Organic Biologique logo and the USDA Organic seal may be used on certified organic products from both countries.
Under this arrangement, the Canadian Food Inspection Agency (CFIA) has the ability to recognize certification bodies in the U.S. and ensure they are complying with the Canadian standards.
Organic Products Regulations 2009
http://www.gazette.gc.ca/rp-pr/p2/2009/2009-06-24/html/sor-dors176-eng.html
New Organic Logo
http://www.inspection.gc.ca/english/corpaffr/newcom/2009/20090624e.shtml
These new regulations apply to domestic and imported products. Regardless of origin, all products seeking organic certification must meet Canada's standards. To this end, an equivalency arrangement was recently reached with the United States to allow Canadian and American products to be certified as organic in either country. This agreement gives Canadian consumers more organic choices and organic farmers increased trade opportunities.
Canada Organic Office - Operating Manual
http://www.inspection.gc.ca/english/fssa/orgbio/man/orgbiomane.shtml
Canadian Health Food Association
CHFA Continues to Lobby for Changes to NHP Regulations Implementation
CHFA had a productive day on Parliament Hill on June 4. The day, organized by CHFA's lobby team in Ottawa at Impact Public Affairs, was an important step in addressing the continuing challenges with the implementation of the NHR Regulations.
Five CHFA members participated in strategic meetings with MPs from all parties in the House of Commons, with two major issues for discussion during these meetings:
- The massive backlog in license applications that shows little sign of being reduced with significant approvals
- The perceived looming 2010 deadline for product approval that must be clarified sooner rather than later.
CHFA members urged MPs to address the growing backlog without resorting to wholesale rejections of pending applications. Ms. Wasylycia-Leis agreed to make such a motion at the Standing Committee on Health that the NHPD must push back the 2010 deadline if there is no credible plan to meet it.
2009 Annual Notification – To all DIN Owners
http://www.chfa.ca/media/pdf_files/RegAffairs/2009%20annual%20package%20english.pdf
NOTE: Health Canada has also strongly encouraged DIN holders whose products meet the definition of a NHP to submit a transitional DIN application by September 1. If the DIN holder chooses to keep the DIN active they will be responsible for paying the annual DIN fee in full for the upcoming year. These DIN holders will not be eligible to receive refunds and their DINs will be discontinued on December 31, which is also the end of the 6-year transition period for product licensing for natural health products currently holding a DIN.
Competition Bureau
Competition Bureau Issues Draft Enforcement Guidelines relating to “Product of Canada” and “Made in Canada” Claims for Comment
http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/03096.html
The proposed draft guidelines introduce, in particular, a distinction between "Product of Canada" and "Made in Canada" claims. "Product of Canada" claims will be subject to a higher threshold of Canadian content (98%), while "Made in Canada" claims will remain subject to a 51% threshold of Canadian content but must be accompanied by a qualifying statement. In both cases, the last substantial transformation of the product must have occurred in Canada.
CCTFA
Natural Health Products Directorate: Product Licence Application (PLA) - Deficiency Notice
Missing information from the PLA that is considered crucial for processing application(s) PLA will be identified in a check list and the application will be returned to the applicant. Submission numbers will not be generated for such applications. In order to re-apply, a complete PLA including the required missing information indicated needs to be provided.
Crucial information:
- Missing application type
- Missing attestation signature
- Missing Designated Party Authorization form
- Missing contact information
- Missing Canadian Representative Information (if necessary)
Health Canada Finalizes Good Manufacturing (GMP) Guidelines 2009 Edition (GUI-0001)
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-let-eng.php.
This edition includes modified and/or new terminology, the incorporation of most GMP questions and answers, additional requirements such as annual product quality review, additional interpretations, and an updated table of requirements. The GUI-0001 will become effective six months from the date of posting. |
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Science & Research Updates |
Folic acid, Pyridoxine, and Cyanocobalamin Combination Treatment and Age-Related Macular Degeneration in Women: The Women's Antioxidant and Folic Acid Cardiovascular Study.
Christen WG, Glynn RJ, Chew EY, Albert CM, Manson JE.
Arch Intern Med. 2009 Feb 23;169(4):335-41.
A randomized, double-blind, placebo-controlled trial was conducted to evaluate risk reduction of age-related macular (ADM) degeneration. 5442 female subjects age 40 years or older having preexisting cardiovascular disease or having 3 or more cardiovascular disease risk factors participated. Subjects were randomly administered a combination of folic acid (2.5 mg/d), pyridoxine hydrochloride (50 mg/d), and cyanocobalamin (1 mg/d) or placebo for an average of 7.3 years of treatment and follow-up. The results showed a lower rate of diagnosis (55 cases) in the combination group as opposed to the placebo group (82 cases) over the duration of the study (relative risk, 0.66; 95% confidence interval, 0.47-0.93 [P = .02]).
The authors concluded that daily supplementation of folic acid, pyridoxine, and cyanocobalamin may reduce the risk of AMD in women at high risk of cardiovascular disease.
PMID: 19237716
Various Doses of Soy Isoflavones do not Modify Mammographic Density in Postmenopausal Women.
Maskarinec G, Verheus M, Steinberg FM, Amato P, Cramer MK, Lewis RD, Murray MJ, Young RL, Wong WW. J Nutr. 2009 May;139(5):981-6. Epub 2009 Mar 25.
A study was conducted to evaluate the relation between isoflavone supplementation and mammographic density, a strong marker for breast cancer risk. The Osteoporosis Prevention Using Soy (OPUS) study, a multi-site, double-blinded, and placebo-controlled trial assigned 406 postmenopausal women 80 or 120 mg/d of isoflavones each or a placebo for two years. Mammographic density analysis was conducted on 358 women ( 88.2%), 303 of whom had a complete set of three mammograms, 49 had two, and six had only one mammogram. The results showed significant breast density decrease by 1.6% per year across groups (P < 0.001).
Authors concluded that in this randomized two year trial, isoflavone supplements did not modify breast density in postmenopausal women, and the findings offer reassurance that isoflavones do not act like hormone replacement medication on breast density.
PMID: 19321587
Effect of Calcium from Dairy and Dietary Supplements on Faecal Fat Excretion: a Meta-Analysis of Randomized Controlled Trials.
Christensen R, Lorenzen JK, Svith CR, Bartels EM, Melanson EL, Saris WH, Tremblay A, Astrup A.
Obes Rev. 2009 Jun 1. [Epub ahead of print]
Earlier studies have shown that dietary calcium intake is inversely related to body weight and body fat mass, with one explanatory mechanism being that dietary calcium increases faecal fat excretion. A meta-analysis evaluating randomized, controlled trials of calcium via supplementation or dietary intake has been performed using random-effects model with changes in faecal fat excretion expressed as standardized mean difference.
The results found that an increased calcium intake resulted in increased excretion of faecal fat by a standardized mean difference of 0.99 (95% confidence intervals: 0.63-1.34; P < 0.0001; expected to correspond to approximately 2g day(-1)) with moderate heterogeneity (I(2) = 49.5%) indicating some inconsistency in trial outcomes. However, the dairy trials showed homogeneous outcomes (I(2)=0%) indicating consistency, therefore the authors estimated that increasing the dairy calcium intake by 1241 mg per day resulted in an increase in faecal fat of 5.2 (1.6-8.8) g per day. This result supports the potential relevancy of dietary calcium intake in relation to weight management, but the authors do suggest that long term studies are required to establish this link.
PMID: 19493303
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Newsletter Info |
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.
dicentra inc.
21 Phoebe Street
Toronto, Ontario
M5T 1A8 CANADA |
Phone: 1-416-361-3400
1-866-NHP-EASY (647-3279)
Fax: 1-416-361-3304
Email: info@dicentra.ca
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Copyright 2009 dicentra inc. All rights reserved. dicentra inc. has made every effort to be accurate. Errors may appear and are inadvertent. |
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