This is Dicentra’s first newsletter for 2011. We will be releasing these newsletters every three months and the purpose of the newsletter is to keep our readers up to date on important issues related to our industry and to keep you informed on developments within Dicentra.
In addition to our newsletter we will also release Special Alerts on an ongoing basis outlining issues that we feel you should be immediately informed about. Feel free to forward this newsletter onto your colleagues and encourage them to sign up for our Newsletter and Special Alerts to ensure that they stay informed as well.
We would like to begin the year by welcoming Scott Sawler as the new Director General of the Natural Health Products
Directorate (NHPD). Mr. Sawler comes with a wealth of experience and a strong understanding of the industry’s needs and we are excited to see his enthusiasm for the industry’s development at work.
Last year was our first year in providing the industry with free regulatory updates delivered via webinar every quarter. The response was very exciting and our last update had over 100 companies from across Canada and the world sign in. We will continue to deliver these updates as a sign of our commitment to keep our industry educated and informed. Please see the dates announced for this year in the article below and make sure to sign up.
2011 is expected to bring new developments, and new challenges are bound to follow. We will remain at the forefront of these developments and will continue to be here to help with any particular challenges you may face. We will also be attending many more industry events this year. You can have a look at these to the column to the left. Feel free to contact us if you would like to arrange a meeting with one of us at any of these functions.
Wishing you great success for the year,
Peter Wojewnik and the Dicentra Team
The Natural Health Products Directorate is requesting information from product license holders and applicants in light of the proposed amendments to the Food & Drug Regulations regarding enhanced labelling for priority food allergens. The following foods or protein derived from one of the following foods are considered priority food allergens: almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts, peanuts, sesame seeds, wheat, kamut, spelt or triticale, eggs, milk, soybeans, crustaceans, shellfish, and fish.
Currently those natural health products containing probiotics are the subject of Section 16 Notices because of the concern that the probiotic was derived or grown on a dairy or soy based medium.
As a product license holder and/or applicant who has received one of these Section 16 Notices you will need to confirm whether your product has come into contact with any priority allergens during the manufacturing process. If the product has not come into contact with any priority allergens during the manufacturing process, you must supply a certificate from the manufacturer confirming this. If the product has come into contact with a priority allergen during the manufacturing process you must commit to add the following statement under Cautions & Warnings, within the sooner of 6 months or the next label run: “This product has come into contact with [name of priority allergen]. Do not use this product if you have a [name of priority allergen] allergy.”
All suppliers are encouraged to review their labels to ensure that all priority allergens are clearly identified as medicinal or non medicinal ingredients and that claims that a product is “free of [a priority allergen]” are factual.
We can be reached at 1-866-647-3279 or at dicentra.com
In order to fulfill Dicentra’s mission to serve the natural health products industry as a source for education and trusted scientific and regulatory information, we offer free quarterly regulatory updates (every 3 months) through an online webinar.
These webinars are meant to keep you and all of your coworkers up-to-date on the latest issues pertaining to scientific and regulatory affairs. The main focus of each webinar will be for anything important pertaining to natural health products and their regulations in Canada. Examples include a summary of the Natural Health Products Directorate’s status of submissions reports, the latest regulatory status of ingredients, new published monographs, and all other important issues. We will also cover major issues related to other product categories that may have an effect on natural health products.
All webinars are presented by a qualified member of our team and will last approximately 30 minutes. Sit back and enjoy our interpretation and navigation to help propel your business forward at no cost.
The 2011 dates are March 23, June 22, September 21 and December 7. Click here to sign up.
|Oral intake of purple passion fruit peel extract reduces pain and stiffness and improves physical function in adult patients with knee osteoarthritis. Nutr Res. 2010 Sep;30(9):601-6.
Osteoarthritis (OA) is considered a degenerative disorder involving cartilage degradation, accompanied by local inflammation that accelerates joint destruction and represents the most common joint disorder among adults. This randomized, parallel-group, double-blind, placebo-controlled trial aimed to assess the role of the Passion Fruit Peel (PFP) extract containing bioflavonoids with antioxidant and anti-inflammatory activity in alleviating symptoms of knee OA. Thirty-three OA patients were given 150 mg concentrated PFP extract or matched placebo daily for 60 days. The results of this study suggest that PFP may be an alternative treatment to help reduce the symptoms associated with OA.
Pigmented potato consumption alters oxidative stress and inflammatory damage in men.
J Nutr. 2011 Jan;141(1):108-11.
Purple Potato (PP) cultivars have been found to contain 186% more antioxidants than their White Potatoes (WP) counterparts. The purpose of this randomized, placebo-controlled study was to evaluate the effects of consumption of pigmented potatoes on oxidative stress and inflammation biomarkers in healthy adult males. Twelve healthy males were supplemented with 150 g of cooked yellow potato (YP), WP or PP daily for 6 weeks. Levels of oxidative stress and plasma Interleukin-6 (IL-6) levels were observed to be lower in the PP group following 6 weeks of potato supplementation suggesting that pigmented potatoes may be beneficial for use as an alternative anti-inflammatory.
Consumption of wheat aleurone-rich foods increases fasting plasma betaine and modestly decreases fasting homocysteine and LDL-cholesterol in adults.
J Nutr. 2010 Dec;140(12):2153-7.
Betaine is a component found at relatively high concentrations in wheat grain, particularly in the bran and aleurone fractions. This parallel, single-blinded, placebo-controlled intervention trial aimed to investigate the effects of cereal products enriched with wheat aleurone on plasma betaine and related biomarkers in apparently healthy, older, overweight men and women at risk for metabolic syndrome. Eight participants were provided with aleurone-enriched bread (in the form of rolls) and ready-to-eat cereal products, containing 9 g aleurone each. The participants were asked to consume 3 of the aleurone-containing products daily for 4 weeks. The results of this study suggest that aleurone may be a good source of betaine to help decrease plasma tHcy, a risk factor for cardiovascular disease.
Prebiotic evaluation of cocoa-derived flavanols in healthy humans by using a randomized, controlled, double-blind, crossover intervention study.
Am J Clin Nutr. 2011 Jan;93(1):62-72.
Effective probiotics have low digestibility and bioavailability, are selective for the growth and metabolism of commensal bacteria, and alter the microbiota to a healthy composition. The aim of this randomized, double-blind, controlled, crossover human clinical trial was to validate the prebiotic potential of flavanol-containing supplements for 4 weeks. Study participants were instructed to consume either a high-cocoa flavanol (HCF) or low-cocoa flavanol (LCF) beverage containing 494 mg and 29 mg cocoa flavanols, respectively. The results of this study suggest that supplementation with a high dose of cocoa flavanols may have significant effects on the growth of select gut microbiota in vivo.
Thank you for reading. We can be reached at 1-866-647-3279 or at dicentra.com
Your Dicentra Team