Bradenton, FL—Annie Eng, CEO of HP Ingredients, announced that the company’s signature botanical ingredient, ParActin Andrographis paniculata, has been granted a product license (License # 80109555) from Health Canada. A press release from the company explains that the Natural and Non-prescription Health Products Directorate (NNHPD) concluded that HP Ingredients’ application for ParActin is in compliance pursuant to section 7 of the Natural Health Products Regulations (NHPR).
The license for ParActin 50% total andrographolides (comprised of andrographolide, 14-deoxyandrographolide, neoandrographolide) specifies that 1 capsule of 150 mg twice daily “Helps to relieve joint health associated with osteoarthritis of the knee.”
“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,” Eng said in the press release, noting that while this claim can only be used by marketers in Canada, it shows the trust by a national regulatory agency in the sufficiency of research demonstrating the efficacy of a relatively small dose of ParActin for joint support.
The two published human clinical trials on ParActin:
- 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
Eng added that the 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.”
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According to the release, the Australian TGA and EU’s EFSA view Health Canada claims 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 said. “Health Canada licensure also provides our U.S. customers that are marketing ParActin in the U.S. (and around the world) the confidence when making DSHEA-compliant structure function claims.”