Industry News: The Sale of Unlicensed NHPs

Background

While the NHPD is making progress on the massive number of Product License Applications (PLAs) they have received, there are still thousands of PLAs waiting to be addressed with some of these having been submitted years ago. As of March 17, 2010 the status of submissions was as follows:
• 47,533 PLAs received (since January 1, 2004)
• 37,044 assessments completed (78%)
• 53% licensed
• 35.6% refused
• 11.3% withdrawn by applicant
• 19,642 NHPs licensed (representing 25,443 products)
• 1,144 companies have received a product license to date
The National Association of Pharmacy Regulatory Authorities (NAPRA), joined by the provincial pharmacy regulatory associations, released position statements earlier this year which stated that “Pharmacists should not sell a marketed health product without a Drug Identification Number (DIN), Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicine (DIN-HM).” This inevitably has caused much debate due to the consequences it could have on the future of the industry.

Updates

Health Canada’s Natural Health Products Direcorate (NHPD) released a Letter to Stakeholders on March 18th, 2010, acknowledging that they are aware of the challenges this issue puts forth to the industry, retailers, and consumers. It further states that they are considering options including “internal administrative improvements, continued outreach and education with industry, as well as a possible regulatory solution.”

The Canadian Health Food Association (CHFA)’s Carl Carter has been representing CHFA members’ interests in the NHPD’s Program Advisory Committee (PAC), and advocating a regulatory solution. The CHFA’s March Regulatory Report states that: “CHFA can confirm that the NAPRA representative on PAC participated at last Friday’s call and was unequivocal that NAPRA would respect any action by Health Canada that legalized the products in question. The NAPRA position statement would be amended, but likely only once the final (regulatory) solution is in place.”
For now, the debate surrounding the sale of unlicensed NHPs remains unresolved but progress is being made, so stay tuned!

Changes to International Trade Certificates
Health Canada has announced upcoming changes to the Application for International Trade Certificates (ITCs) for Natural Health Products, one of which will eliminate the Type II ITC, currently applicable to NHPs manufactured in Canada for export only. This change and others became effective April 1, 2010 with the goal of ensuring “Canada’s global reputation as a leader in the regulation of NHPs, and as an exporter of NHPs that are safe, effective and of high quality.”

The reason for the change is to ensure that the NHPD is able to attest to the safety, efficacy and quality of products exported from Canada. At present, this Type II certificate “does not provide valuable information to importing countries and is inconsistent with other international export certification schemes, such as the WHO Certification Scheme. Further, the certificate does not provide assurance to importing countries that exported products can be marketed in Canada or meet Canadian regulations.”

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Science and Research Updates

Association Between Green Tea Consumption and Tooth Loss: Cross-Sectional Results From the Ohsaki Cohort 2006 Study
Koyama Y, Kuriyama S, Aida J, Sone T, Nakaya N, Ohmori-Matsuda K, Hozawa A, Tsuji I. Prev Med. 2010 Apr;50(4):173-9. Epub 2010 Jan 25

A cross-sectional analysis of the Ohsaki Cohort 2006 Study was conducted to examine the association between green tea consumption and tooth loss. Self-administered questionnaires about green tea consumption and tooth loss were returned from 25,078 men and women in Japan, ranging in age between the 40 and 64 years. Multivariate logistic regression analysis was used to calculate odds ratios (ORs) for tooth loss using 3 cut-off points of 10, 20, and 25 teeth relative to each category of green tea consumption (1 cup per day, 1-2 cups per day, 3-4 cups per day, and 5 or more cups per day). The results indicated that consumption of 1 cup or more of green tea per day was significantly associated with decreased odds for tooth loss, with the association appearing to fit a threshold model. These findings indicate an association of green tea consumption with decreased odds for tooth loss.

Effects of Coffee Consumption on Subclinical Inflammation and Other Risk Factors for Type 2 Diabetes: A Clinical Trial
Kempf K, Herder C, Erlund I, Kolb H, Martin S, Carstensen M, Koenig W, Sundvall J, Bidel S, Kuha S, Jaakko T. . Am J Clin Nutr. 2010 Apr;91(4):950-7. Epub 2010 Feb 24

Coffee consumption is associated with a decreased risk of type 2 diabetes. A clinical trial was conducted to investigate the effects of daily coffee consumption on biomarkers of coffee intake, subclinical inflammation, oxidative stress, glucose, and lipid metabolism. 47 habitual coffee drinkers refrained from drinking coffee for 1 month; consumed 4 cups of filtered coffee per day during the second month; and 8 cups of filtered coffee per day in the third month. Blood samples were analyzed by gas chromatography-massspectrometry, bead-based multiplex technology, enzyme-linked immunosorbent assay, or immunonephelometry. The results showed that coffee consumption led to increased coffee-derived compounds, mainly serum caffeine, chlorogenic acid, and caffeic acid metabolites. These results concluded that coffee consumption appears to have beneficial effects on subclinical inflammation and HDL cholesterol, whereas no changes in glucose metabolism were found in our study. Furthermore,many coffee-derived methylxanthines and caffeic acid metabolites appear to be useful as biomarkers of coffee intake.

Impact of Cocoa Flavanol Consumption on Blood Pressure Responsiveness to Exercise
Berry NM, Davison K, Coates AM, Buckley JD, Howe PR. Br J Nutr. 2010 Jan 19:1-5

A randomised double-blind, crossover design study was conducted to investigate whether the consumption of cocoa flavanols, which improve endothelium-dependent flow-mediated dilation (FMD) can modify blood pressure response to exercise. Twenty-one volunteers (eight females and thirteen males, 54.9 (se 2.2) years, BMI 31.6 (se 0.8) kg/m2, systolic BP 134 (se 2) mmHg, diastolic BP (DBP) 87 (se 2) mmHg) consumed single servings of either a high-flavanol (HF, 701 mg) or a low-flavanol (LF, 22 mg) cocoa beverage, with 3-7-d washout between treatments. FMD was measured two hours after cocoa consumption, followed by continuous beat-to-beat assessment (Finapres) of BP before and during 10 min of cycling at 75 % of age-predicted maximum heart rate. Averaged data from two assessments on each type of beverage were compared by analysis of covariance using pre-exercise BP as the covariate. Pre-exercise BP was similar after taking the LF and HF beverages, however the BP response to exercise was attenuated by HF compared with LF. BP increases were 68 % lower for DBP (P = 0.03) and 14 % lower for mean BP (P = 0.05). FMD measurements were higher after taking HF than after taking LF (6.1 (se 0.6) % v. 3.4 (se 0.5) %, P < 0.001). In was concluded that by facilitating vasodilation and attenuating exercise-induced increases in BP, cocoa flavanols may decrease cardiovascular risk and enhance the cardiovascular benefits of moderate intensity exercise in at-risk individuals.

Improvement of Postmenopausal Depressive and Anxiety Symptoms after Treatment with Isoflavones Derived from Red Clover Extracts.
Lipovac M, Chedraui P, Gruenhut C, Gocan A, Stammler M, Imhof M. Maturitas. 2010 Mar;65(3):258-61. Epub 2009 Nov 30.

A study was conducted to evaluate the effect of isoflavones derived from red clover extracts (MF11RCE) over anxiety and depressive symptoms among postmenopausal women. 109 postmenopausal women aged 40 or more were randomly assigned to receive two daily capsules of MF11RCE (80mg red clover isoflavones) or placebo of equal appearance for a 90-day period. After a washout period of 7 days, medication was crossed over and taken for 90 days more. Anxiety and depressive symptoms were measured at baseline, 90 and 187 days with the Hospital Anxiety and Depression Scale (HADS) and Zung’s Self Rating Depression Scale (SDS). After receiving the MF11RCE compound the total HADS score decreased by 76.9% (76% for anxiety and 78.3% for depression)and the total SDS scores decreased by 80.6%. After placebo, total HADS and total SDS scores also decreased significantly in comparison to baseline but only equivalent to an average 21.7% decline. It was concluded that red clover derived isoflavones (MF11RCE) were effective in reducing depressive and anxiety symptoms among postmenopausal women.

Effect of Conjugated Linoleic Acid on Body Fat Accretion in Overweight or Obese Children
Natalie M Racine, Abigail C Watras, Aaron L Carrel, David B Allen, Jennifer J McVean, Robert R Clark, Abigail R O’Brien, Marianne O’Shea, Corey E Scott and Dale A Schoeller. 10.3945/ajcn.2009.28404.

Conjugated linoleic acid (CLA) is a supplemental dietary fatty acid that decreases fat mass accretion in young animals. A 7 ± 0.5 mo randomized double-blind placebo-controlled trial was conducted to determine CLA’s efficacy with regard to change in fat and body mass index (BMI) in children. 62 prepubertal children aged 6-10 y who were overweight or obese but otherwise healthy were randomly assigned to receive 3 g/d of 80% CLA (50:50 cis-9,trans-11 and trans-10,cis-12 isomers) or placebo in chocolate milk. 53 subjects completed the trial (n = 28 in the CLA group, n = 25 in the placebo group). CLA attenuated the increase in BMI (0.5 ± 0.8) compared with placebo(1.1 ± 1.1) (P = 0.05). The percentage change in body fat measured by dual-energy X-ray absorptiometry, and the change in abdominal body fat as a percentage of total body fat, were both smaller in the CLA group than in the placebo group. There were no significant changes in plasma glucose, insulin, or LDL cholesterol between the two groups. Plasma HDL cholesterol decreased significantly more(P = 0.05) in the CLA group (-5.1 ± 7.3 mg/dL)than in the placebo group (-0.7 ± 8 mg/dL). Bonemineral accretion was lower (P = 0.04) in the CLA group (0.05± 0.03 kg) than in the placebo group (0.07 ± 0.03kg). Reported gastrointestinal symptoms did not differ significantly between groups. It was concluded that CLA supplementation for 7 ± 0.5 mo decreased body fatness in 6-10-y-old children who were overweight or obese but did not improve plasma lipids or glucose and decreased HDL more than in the placebo group. Long-term investigation of the safety and efficacy of CLA supplementation in children is recommended.

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