The Debate Surrounding the Sale of Unapproved Natural Health Products Continues
Despite Health Canada adopting a risk-based enforcement policy until at least March 31 in acknowledgment of the Product License Application (PLA) backlog, the recently passed January 1, 2010 deadline continues to be a source of debate within the industry.
With thousands of PLAs still waiting to be addressed or completed, immediate enforcement of the Natural Health Product Regulations (NHPR) would have a serious impact on the industry and its consumers. Industry stakeholders attending the NHPD workshops last fall were given the opportunity to express their concerns, and were reassured that the transition into an enforcement policy would be gradual. Health Canada has since released information sheets on this topic which acknowledge the backlog, announce their risk-based approach to enforcement, but confirm that yes the Natural Health Product Regulations are in effect.
The National Association of Pharmacy Regulatory Activities (NAPRA), the Ontario College of Pharmacists (OCP) and the Order of Pharmacists of Québec (OPQ) have sent position statements to pharmacists which state 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).” Industry members are asking why these associations feel the need to go beyond Health Canada’s enforcement policies
The Canadian Health Food Association (CHFA) is in communications with the involved parties and the Natural Health Products Directorate (NHPD), in an attempt to maintain uninterrupted consumer access to new and existing NHPs. TheirSave Our Natural Health Products campaign, which was launched last October, encourages industry members and consumers to take action by writing to Members of Parliament.
What can you do to ensure the sale of your NHPs continues uninterrupted? Keep your retail customers and consumers informed, direct them to the above-linked information sheets provided by Health Canada, and most importantly be sure that all your products have submission numbers.
For more information on obtaining a license for your NHPs, dicentra.com
The Canadian Marketplace and Regulations door Dietary Supplements
Featured on Natural Products Insider
With 71% of Canadian adults reporting that they have used a natural health product (NHP), and 38% reporting that they use at least one NHP on a daily basis, the Canadian market is definitely inviting to companies looking to expand. However, since the introduction of the Natural Health Product Regulations, the requirements for importation, licensing, and labelling make market entry a difficult task.
Dicentra’s Peter Wojewnik examined this topic in an article featured on naturalproductsinsider.com in January. Visit their website to read the full article. To learn more about this topic, be sure to register for our upcoming Webinar “Expanding Your Market to Canada: Opportunities and Obstacles and Revealed.”
Science and Research Updates
Tripterygium wilfordii Hook F versus sulfasalazine in Rheumatoid Arthritis Treatment
Goldbach-Mansky R, et al. Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):229-40, W49-51.
Extracts of the medicinal plant Tripterygium wilfordii Hook F (TwHF) have been used in China for centuries to treat a spectrum of inflammatory diseases. A randomized controlled trial involving 121 patients with rheumatoid arthritis (RA) was conducted to compare the benefits and side effects of TwHF extract with those of sulfasalazine for the treatment of active RA. The primary outcome was the rate of achievement of 20% improvement in the American College of Rheumatology criteria (ACR 20) at 24 weeks. The conclusion was that in patients undergoing 24 weeks In of treatment who could also use stable oral prednisone and nonsteroidal anti-inflammatory drugs, attainment of the ACR 20 response criteria was significantly greater with TwHF extract than with sulfasalazine.
Choline and Risk of Neural Tube Defects in a Folate-fortified Population
Shaw GM, et al. Choline and Risk of Neural Tube Defects in a Folate-fortified Population. Epidemiology. 2009 Sep;20(5):714-9.
Folic Acid is known to reduce the risk of neural tube defects (NTDs), however they continue to occur despite supplementation and folic acid fortification. A study was done involving 180,000 pregnant women in which 80 NTD-affected cases were identified. 409 pregnancy controls were randomly selected and it was observed that risk of NTD increased with lower levels of total choline and descreased with higher levels. Although this was the first study conducted on total Choline levels’ effect on NTD-affected pregnancies, it may offer a useful clue for understanding NTDs in a folate-fortified population.
Vitamin D3 in the Elderly
Bacon CJ, et al. High-dose oral vitamin D3 supplementation in the elderly. Osteoporos Int. 2009 Aug;20(8):1407-15.
In response to concern that vitamin D supplementation doses are likely inadequate and complies suboptimally with daily medication, a study was conducted involving 63 elderly people randomized to three different dosing regimens of Vitamin D: a 500,000IU loading dose, the loading dose plus 50,000IU per month, or 50,000IU per month. The study studied the three regimens’ effect on 25OHD levels and found that large loading does of vitamin D can quickly and safely normalize 25OHD levels in the elderly, and that monthly dosing is similarly effective and safe but takes 3-5 months for plateau 25OHD levels to be reached.
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