Dicentra Newsletter Issue 2 for 2011

June 1, 2011 By

Welcome Spring and Summer 2011

After a long cold winter it’s with extreme excitement that we welcome the spring and the coming summer. Spring always brings with it a feeling of renewal and enthusiasm for new developments and progress forward. In light of this statement, there is an issue that needs to be brought up for discussion that, despite its consequences, receives little attention and is surely due for review and renewal.

As a regulatory consultant, Dicentra often assists its clients in meeting the regulatory requirements to ship Canadian made products to the United States and U.S. made products to Canada. I’m sure that those of you familiar with the processes involved would agree with me when I say that the paper work requirements are a nightmare, seemingly unnecessary and that they impede the ability for companies on both sides of the border to do business. In fact, it’s probably safe to say that the main impediment to greater trade and investment between Canada and the U.S. is not the presence of tariffs and quotas but rather the unnecessary differences in product regulations.

Nowhere is this more apparent than with the trade of dietary supplements between both countries. As an example, a Canadian made supplement with a gelatin capsule (or any product containing animal-derived components) bound for export to the U.S. market must be accompanied by special permits from the United States Department of Agriculture and also from the Canadian Food Inspection Agency. It’s understandable that these requirements are put in place to protect the safety of a U.S. consumer. No one wants to consume a gelatin capsule, for example, derived from BSE cattle. The issue is the time it takes to acquire some of these permits. It may take 3 to 4 months before both permits are obtained. The same goes for U.S. made dietary supplements. You may be looking at a 3 to 5 month bottleneck before the appropriate authorities at Health Canada finally review and approve a foreign manufacturer and issue the necessary licenses to export the product to Canada.

In light of these types of problems U.S. President Barack Obama and Canadian Prime Minister Stephen Harper met last February to announce a collaborative effort on reducing barriers to open trade and established the Regulatory Cooperation Council. As a follow up to this, the U.S. Department of Commerce announced in March that it was seeking public input to help identify regulatory divergences between Canada, the U.S. and Mexico in an effort to reduce or eliminate differences that hinder trade and reduce competitiveness. It was announced at the G8 meeting last week in France that following the review of these public consultations an ambitious action plan will be announced this summer. Let’s keep our fingers crossed that our industry’s frustrations were well heard and that changes are in store for us.

We would love to hear your comments and your experiences in dealing with these issues. You can visit our LinkedIn Group where this article is also posted and open for comments. And as always, don’t forget to sign up for our free regulatory update webinars. Our previous update had nearly 200 companies tune in and the next one is on June 22.

Science and Research Updates

Marchbank T, Davison G, Oakes JR, Ghatei MA, Patterson M, Moyer MP, Playford RJ. The nutriceutical bovine colostrum truncates the increase in gut permeability caused by heavy exercise in athletes. Am J Physiol Gastrointest Liver Physiol.2011 Mar;300(3):G477-84.

Prolonged strenuous exercise can affect the integrity of the intestinal barrier and may result in loss of function and inflammation of the intestine. Long distance runners have been reported to commonly experience gastrointestinal complaints such as cramps, diarrhea, nausea, and bleeding which is likely due to a combination of physiological factors, one of which is increased gut permeability. In this double-blind crossover trial, 12 healthy males were supplemented with 20 g of bovine colostrum daily for 14 days. Following a 14 day lead-in period, the subjects participated in exercise trials. The results of the study suggest that supplementation with 20 g bovine colostum daily was associated with truncated exercised-induced gut permeability when compared to placebo control.

Nova E, Viadel B, Wärnberg J, Carreres JE, Marcos A. Beneficial effects of a synbiotic supplement on self-perceived gastrointestinal well-being and immunoinflammatory status of healthy adults. J Med Food. 2011 Jan-Feb;14(1-2):79-85.

Synbiotic preparations containing a combination of probiotics and fermentable fibre are considered beneficial for the restoration and maintenance of colonic flora. The suggested health promoting effect of probiotics is the enhancement of mucosal immune defenses. The main objective of this study was to evaluate the effects of a synbiotic product containing five lactic acid bacterial strains and fructo-oligosaccharides on self-perceived gastrointestinal well-being and immunoinflammatory status of healthy adults. In a randomized, double-blind, placebo-controlled clinical trial, 42 healthy adults were given a supplement containing equal quantities ofLactobacillus acidophilus La5, Bifidobacterium animalis ssp. lactis B12, L. delbrueckii ssp. Bulgaricus, Streptococcus thermophilus, L. paracasei ssp. paracasei and fructo-oligosaccharides or a placebo supplement. The subjects were asked to subjectively evaluate any alleviation in previously reported gastrointestinal symptoms and report any improvement in bowel habits over the 6 week intervention period. Following supplementation, improvements in self-perceived bowel habits and gastrointestinal symptoms were observed more often in the symbiotic group when compared to placebo control.

Rahbar AR, Nabipour I. The hypolipidemic effect of Citrullus colocynthis on patients with hyperlipidemia. Pak J Biol Sci. 2010 Dec 15;13(24):1202-7.

Elevated levels of low density lipoprotein (LDL) and triglycerides and reduced high-density lipoprotein (HDL) levels are often associated with an increase in coronary heart disease. Various traditional herbal remedies have been suggested as beneficial for the treatment of elevated serum cholesterol and triglyceride levels. Citrullus colocynthis has been traditionally used as an anti-diabetic remedy in tropical and subtropical countries. While this herb has minimal effects on cholesterol and triglyceride levels in diabetic patients, this study aimed to evaluate the effects of C. colosynthis seed on the lipid profile in non-diabetic individuals. In this randomized, double-blind, placebo-controlled clinical trial, 100 non-diabetic patients with hyperlipidemia were given 300 mg C. colosynthis seed or placebo daily for 6 weeks. During the trial, serum triglyceride and cholesterol levels were measured following an overnight fast. The results of the study suggest that supplementation with C. colosynthis seed has a beneficial effect on fasting triglyceride and total cholesterol levels in hyperlipidemic patients when compared to placebo control.

Rowe CA, Nantz MP, Nieves C Jr, West RL, Percival SS. Regular consumption of concord grape juice benefits human immunity. J Med Food. 2011 Jan-Feb;14(1-2):69-78.

Immune cells, such as γδ T cells, predominate as major surveillance cells in the epithelial linings of the intestine, lung, and genitourinary tract where they recognize non-protein compounds. It has been suggested that these cells respond to pathogen-associated stimuli similar to those of innate immune cells. This study aimed to assess the effects of grapes as immunomodulators by investigating their role on γδ T-cell function. In a 9-week double-blind, randomized, placebo-controlled parallel intervention, 85 healthy men and women (ages 50-75years) were provided with 100% Concord grape juice or placebo and asked to consume 360 ml of the beverage daily. The overall results of this study suggest that Concord grape juice enhanced preservation of serum antioxidant activity and improved proliferation of γδ T cells when compared to placebo control.

Thank you for reading. We can be reached at 1-866-647-3279 or at dicentra.com

Your Dicentra Team