By Stephen Daniells
As seen in Nutra Ingredients-USA.
BRADENTON, FL – Annie Eng, CEO, HP Ingredients, announced that its signature botanical ingredient, ParActin® Andrographis paniculata, has been granted a product license from Health Canada.
The Natural and Non-prescription Health Products Directorate (NNHPD) has concluded that HP Ingredients’ application for ParActin is in compliance pursuant to section 7 of the Natural Health Products Regulations (NHPR).
License # 80109555 was granted in April for ParActin 50% total andrographolides (comprised of andrographolide, 14-deoxyandrographolide, neoandrographolide): specifically, that 1 capsule 150 mg twice daily “Helps to relieve joint health associated with osteoarthritis of the knee.”
Eng commented, “Canadian consumers will now be able to purchase ParActin-containing supplements clearly for joint health, and can be comfortable discussing usage with their osteopaths, general practitioners and naturopaths.”
Although this claim can only be used by marketers in Canada, Eng noted, it shows the trust by a national regulatory agency in the sufficiency of research demonstrating the efficacy of a relatively small dose (150 mg twice a day) of ParActin for joint support. “Further, this license reinforces the 40 years plus clinical research experience of Dr. Juan Hancke of the Universidad Austral de Chile, and Chief Scientific Officer of HP Ingredients.”
Health Canada claims are viewed with interest by the Australian TGA and EU’s EFSA, for direction regarding allowing claims while independently reviewing the clinical studies. “Health Canada is sometimes looked at as the ‘gold standard’ when reviewing claims, because two double-blind placebo-controlled, peer-reviewed published human studies are required to make the claim,” Eng emphasized. “Health Canada licensure also provides our US customers that are marketing ParActin in the US (and around the world) the confidence when making DSHEA-compliant structure function claims.”
The two published human clinical trials of ParActin are:
Hancke et al. Clinical Rheumatology, 2009 DOI 10.1007/s10067-009-1180-5
Juan L. Hancke, Shalini Srivastav, Dante D. Cáceres, Rafael A. Burgos “A double-blind, randomized, placebo-controlled study to assess the efficacy of Andrographis paniculata standardized extract (ParActin®) on pain reduction in subjects with knee osteoarthritis. May 2019 https://onlinelibrary.wiley.com/doi/abs/10.1002/ptr.6339
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