ISURA is pleased to present and explore issues important to consumers and other stakeholders in the natural health product sector, such as healthcare practitioners, manufacturers and retailers. Topics include the latest in basic and clinical research of natural health products, industry developments and achievements, regulatory changes, and media reports about the sector.
ISURA Articles
Differences in Metabolite Profiles of Dihydroberberine and Micellar Berberine in Caco-2 Cells and Humans—A Pilot Study
An ISURA research study has been published in the International Journal of Molecular Sciences. This pilot study looked at the pharmacokinetic pathway of berberine and its metabolites in vitro, in Caco-2 cells, and in human participants. Read the study abstract and find the complete article online at the International Journal of Molecular Sciences website: https://www.mdpi.com/1422-0067/25/11/5625.
A Comparison and Safety Evaluation of Micellar versus Standard Vitamin D3 Oral Supplementation in a Randomized, Double-Blind Human Pilot Study
An ISURA-led research study has been published in the journal Nutrients. This pilot study evaluated and compared the bioavailability and safety of two Vitamin D3 formulations (softgels) in healthy adults. Read the study abstract and find the complete article on the Nutrients website: https://www.mdpi.com/2072-6643/16/11/1573.
Evaluation of the Metabolite Profile of Fish Oil Omega-3 Fatty Acids (n-3 FAs) in Micellar and Enteric-Coated Forms—A Randomized, Cross-Over Human Study
A research study from ISURA has been published in Metabolites evaluating the metabolite profile in healthy humans following the use of various delivery systems for fish oil omega-3 fatty acids. Read the study abstract and find the complete article online at https://www.mdpi.com/2218-1989/14/5/265.
Characterization and Pharmacokinetic Assessment of a New Berberine Formulation with Enhanced Absorption In Vitro and in Human Volunteers
A research study from ISURA has been published in Pharmaceutics. The study investigated a new berberine delivery system to confirm higher bioavailability and improved absorption in healthy volunteers. Read the study abstract and find the complete article online at Pharmaceutics.
A Pharmacokinetic Study of Different Quercetin Formulations in Healthy Participants: A Diet-Controlled, Crossover, Single- and Multiple-Dose Pilot Study
A research study from ISURA has been published in the Hindawi Evidence-Based Complementary and Alternative Medicine Volume 2023. The pilot study evaluated the blood concentrations of quercetin in healthy participants after the administration of different formulations in single- and multiple-dose phases in a select group of ten healthy adults. Read the study abstract and find the complete article online at the Hindawi website.
A Pilot Crossover Study of Berberine and its Short-Term Effects on Blood Glucose Levels in Healthy Volunteers
An ISURA-led pilot research study has been published in the Journal of Natural Health Product Research Vol. 5, Iss. 2, pp. 1–11, an open access online publication. During the study different berberine preparations were evaluated for their effectiveness on lowering blood glucose in a pilot, open-label, crossover study conducted in healthy adults. Read the study abstract here and find the complete article online at the JNHPR website: https://jnhpresearch.com/index.php/jnhpr/article/view/33/36
19th Annual Natural Health Products Research Society of Canada Conference – June 2023
The Natural Health Products Research Society of Canada held its 19th annual conference at the University of Quebec in Montreal, this summer. As in previous years, the conference brought together researchers from across the Canadian and international Natural Health Products (NHP) community with participants coming from academia, practitioner groups, industry, and government. The conference continued the tradition of presenting research and scientific information of the highest quality covering a wide range of topics including NHPs in health aging; NHP industry innovation; the regulation opportunities for NHP research and the challenges faced in obtaining consistent laboratory tests. Learn more and see photos.
Cost Recovery for Natural Health Products: Health Canada’s Proposal and its impact on the NHP Sector?
Health Canada published a draft of its proposed cost recovery fees for Natural Health Products (NHPs) on May 12, 2023. This is part of Health Canada’s ongoing updates to its management of NHPs as part of the implementation of its self-care framework and work plan. This latest proposal can be found at on the Health Canada website. There is a 90-day consultation period with all comments required by August 10, 2023. Read on for a Q&A about this proposal and its potential imapct on the NHP industry and Canadian consumers.
Designing Vitamin D3 Formulations: An In Vitro Investigation Using a Novel Micellar Delivery System
ISURA’s laboratory director and other researchers recently published an article in the Nutraceuticals investigating the fat-soluble compound, Vitamin D (and its D3 form) in an in vitro setting and the utilization of novel micellar formulations of Vitamin D3 designed to improve absorption. Read on for the abstract. Here’s the link to the full article online: https://www.mdpi.com/1661-3821/3/2/23.
ISURA-supported article re Flavonoid Supplementation published in International Journal of Molecular Sciences
ISURA’s laboratory director and associated researchers recently published an article in the International Journal of Molecular Sciences entitled: Consideration for Flavonoid-Containing Dietary Supplements to Tackle Deficiency and Optimize Health. Read on for the abstract. Here’s the link to the full article online: https://www.mdpi.com/1422-0067/24/10/8663.
A New UHPLC Analytical Method for St. John’s Wort (Hypericum perforatum) Extracts – Article in Separations 2023
ISURA’s laboratory research groups recently published an article in Separations on a new UHPLC method to determine the hypericin content of a commonly used natural health product – St. John’s Wort. Read on for the abstract. Here’s the link to the full article online: https://www.mdpi.com/2297-8739/10/5/280.
Comparing NHP Regulations from Canada and Australia
As with other health products, the manufacture, sale, and distribution of natural health products (NHP) is now truly international. Though the market may be global, the regulation of NHPs is not, with most countries having different regulatory frameworks for these types of products. Given the complexity of the sector and differences between the various regulatory approaches, comparing national approaches does not make for easy reading. This article will provide a high-level comparison of the regulatory approaches for Canada and Australia. It will explore some common features and provide links to resources that provide more details about each regulatory approach. Read on for the full article.
ISURA Partners to Publish Article on Herbal Authentication Methods
ISURA, in collaboration with the Technical University of Braunschweig, published an article in the journal – Plants, on herbal authentication using a combination of chemical and biological test methods. The article showcases ISURA’s capabilities in the areas of morphological identification, HPTLC fingerprinting, advanced mass spectrometry, and DNA sequencing. The published test methods will help find adulterants undetectable by traditional means such as HPTLC and morphological identification. Furthermore, the data has been submitted to the National Center for Biotechnology Information (NCBI) to prevent future misidentification of horsetail plants through DNA sequencing. Find the Abstract and full article in Plants 2022, 11(19), 2562: https://www.mdpi.com/2223-7747/11/19/2562
Summary of Health Canada’s New Process for Improving Labelling for NHPs
On July 6, 2022, Health Canada published new Labelling Regulations for Natural Health Products in Canada Gazette II see: https://canadagazette.gc.ca/rp-pr/p2/2022/2022-07-06/html/sor-dors146-eng.html and a new guidance document at https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/labelling.html Read on for a summary of the new regulations and a discussion of the likely impacts.
Comparing NHP Regulations from Canada and the United States of America
As with other health products, the manufacture, sale and distribution of natural health products (NHP) is now truly international. Though the market may be global, their regulation is not, with most countries having different regulatory frameworks for these types of products. Given the complexity of the sector and differences between the regulatory approaches, comparing national approaches does not make for easy reading. Read on for an overview comparison of the Candian and US regulations for NHPs/dietary supplements.
Improved Labelling for Natural Health Products – Health Canada initiative
In June 2021, Health Canada initiated a consultation process as part of proposed changes to the regulations for labelling of Natural Health Products (NHPs). Discover more about the proposed regulations as well as the consultation process and the industry context. Read more in this Question & Answer post.
Chlorpyrifos Updates for the USA and Canada
Chlorpyrifos is an organophosphate insecticide, acaricide and miticide used primarily to control foliage and soil-borne insect pests.
In the past few months both Health Canada’s Pest Management Regulatory Agency (PMRA) and the US Environmental Protection Agency (EPA) have taken action to cancel the use of chlorpyrifos. ISURA includes chlorpyrifos pesticides as part of the more than 700 pesticides and other contaminants for which it routinely tests natural health product raw ingredients and materials. Read on for highlights from the EPA and PMRA websites.
ISURA Supports Natural Health Product Research Society of Canada
This year, the Natural Health Product Research Society of Canada welcomed almost 200 participants to the 17th annual conference entitled “Canada and the Changing Global NHP Landscape”, hosted virtually by the University of Ottawa. ISURA is proud to have been a Platinum conference sponsor. Learn more about the NHPRS and the 2021 conference.
Health Canada’s Natural Health Products Program – What the Office of the Auditor General Found
On April 22, 2021, the Office of the Auditor General or OAG tabled a report on an audit they had conducted investigating how effectively Health Canada ensured that natural health products (NHPs) available for sale in Canada are safe and accurately represented to consumers. The report also contained recommendations to the federal government as to how these issues could be addressed as well as the government’s response. Learn more about the OAG report in this Q&A.
How do you know Natural Health Products can work – The Question of Evidence?
Canada was the first country to regulate NHPs as one class of products supported by different forms of evidence which is assessed by a regulator before the product is allowed to be marketed. In most cases this approach is working well, but there are definitely questions that need to be more thoroughly explored. Things such as how can traditional evidence for a product be used in a modern, self-care setting; how do you support innovation in the market place with a respect for traditional forms of health and healing; and how do you ensure people can make an informed choice about the evidence question regarding the NHP they decide to take. This is still a work in process and one that can only truly be answered by all parts of the NHP community – regulators, researchers, practitioners and consumers – working together. Learn more about The Question of Evidence in this Q&A.
Developments in the regulation of CBD as a Health Product: Update on cannabidiol regulation in Canada
In recent years a constituent of the cannabis plant, cannabidiol or CBD, has gained a great deal of popularity both in Canada and globally for a number of health care uses. Unlike other constituents found in cannabis such as delat-9-tetrahydrocannabinol or THC, CBD does not produce a “high” or intoxication. In 2018, the Cannabis Act was passed in Canada which regulated CBDs as recreational cannabis products rather than as health products. In 2019, in response to concerns voiced by Canadians wanting to access CBD for its potential healing properties, Health Canada launched a consultation titled Potential Market for Cannabis Health Products (CHPs) that would not require practitioner oversight. Learn more about the results of this consultation in this article.
You can also check out this previous ISURA article from August 2019 for additional information – Q&A: Is CBD a Natural Health Product?
Birds – What is Happening to Them?
There are more than 11,000 species of birds sharing our planet with us. Until the early 1970s the global bird populations remained relatively stable. Then, something profound happened, and the birds began to vanish on an unprecedented scale. For instance, the North American bird population has shrunk by 3 billion in the past 50 years. Globally, the picture is even grimmer. As of 2019, some 1,469 bird species are threatened by imminent extinction.
• Why should we care?
• Why are all these birds vanishing?
• What can be done?
Learn More.
ISURA SAC Member, Dr Mary Hardy, receives ABC Excellence Award
On March 5, 2020, the American Botanical Council (ABC) announced that Mary L. Hardy, MD is the recipient of the 2019 Fredi Kronenberg Excellence in Research and Education in Botanicals for Women’s Health Award. Dr Hardy is a member of ISURA’s Scientific Advisory Committee (SAC). She is board certified in internal medicine, specializes in botanical and integrative medicine, and is a leader in integrative oncology. For more than 25 years, in both her practice and research, Dr Hardy has combined complementary and alternative medicine (CAM) with Western medicine. The ABC Fredi Kronenberg Award was created in 2018 and named in honor of distinguished researcher, educator, and longtime ABC Board of Trustees member Fredi Kronenberg, PhD, who died in April 2017. Kronenberg dedicated her professional life to the study of medicinal plants and phytomedicines for women’s health conditions. She was particularly interested in phytoestrogen-containing botanicals, such as black cohosh (Actaea racemosa), for the treatment of menopause symptoms.
How to identify natural products you can trust!
Check out this clip from Hamilton’s Morning Live show on CHCH-TV: “With rows and rows of nearly identical bottles in the vitamin aisle, how do you know what to look for? Naturopathic doctor Kate Rheaume has tips on how to find the right natural health products you can trust.” From the Feb 18, 2020 show
ISURA helps consumers identify natural health products they can trust – when you see the ISURA seal you know that product meets ISURA Standard and has been tested for purity, authentic ingredients, potency and that what’s on the label is in the bottle.
Echinacea and Turmeric: Effective and Safe!
Echinacea and turmeric are two popular and well-researched natural health products.
Read on to learn more about these two herbal natural health products that have been used as part of a healthy lifestyle for generations from two of ISURA’s experts.
FDA Releases its latest annual Pesticides Monitoring Report
In the USA, the Food and Drug Administration (FDA) has released its latest annual report – the 2017 Pesticide Monitoring Report. Ecowatch has also published an article discussing the FDA report: New FDA Report on Pesticides in Fruits and Vegetables Adds to Growing Public Health Concerns. Learn More.
Is CBD a Natural Health Product?
With the legalization of cannabis in Canada, people also have questions about related compounds like cannabinoid (CBD). In particular, there are questions about whether CBDs are natural health products (NHPs) and what implications that might have in Canada and in the United States. Check out our Q&A for recent information. Learn More.
Interesting Perspectives on Pesticides
Two recent articles discuss 1. an EPA ban of 12 pesticides that harm or kill honeybees (in Business Insider May 2019 online issue), and 2. a discussion from National Public Radio (NPR) about glyphosate’s shifting reputation from its introduction in the mid 1970s to now.
Partnering with NRC to develop analytical methods to identify and authenticate NHPs
ISURA and the National Research Council Canada (NRC) have collaborated to develop robust and affordable non-targeted analytical methods to assist the Natural Health Products (NHP) industry in reliably identifying and authenticating high quality functional ingredients (FIs). Several methods were considered and two were confirmed as providing reliable solutions and reproducible approaches to authenticate botanicals and other FIs in NHPs. Read the Summary.
Seed Banks – Preserving our planet’s future!
We can support our local seed-preserving organizations by donating seeds from our own gardens, visiting botanical gardens and perhaps making donations to support their work. Some of the most unique seeds of rare species in our professional seed bank came from small private gardens. Above all, each of us can contribute to the well-being of our planet by adopting responsible personal lifestyles, including planet-friendly diet, recycling, composting our food scraps and organic waste, and doing our best to conserve energy at home and work. Read More.
UPDATE ON PROPOSED REGULATION FOR SELF-CARE PRODUCTS IN CANADA: IMPACT ON NATURAL HEALTH PRODUCTS – NOV 2017
In early September 2016, Health Canada published Canadians on the Regulation of Self Care Products in Canada summarizing the consultation discussion to date regarding the proposed replacement of existing individual regulatory approaches for non-prescription drugs, Natural Health Products and cosmetics with an overarching system for all self-care products. Learn More in this update.
HONEY BEES IN PERIL!
Populations of the European honey bee, the most important pollinator found around the world, have decreased by 25% over the past 20 years in Europe, and by 59% over the last 58 years in North America… And this catastrophic global decrease is accelerating. There are many and complex reasons for this slide toward extinction by the European (or Western) honey bee, most of them due to humans. Read More.
ISURA donates for NMR equipment at TRU
ISURA made a recent donation to Thompson Rivers University, in Kamloops, BC, to support the purchase of NMR Lab Equipment for the university’s Industrial Training and Technology Centre. Nuclear Magnetic Resonance spectroscopy may be utilized in the chemical profiling of Natural Health Products. ISURA is pleased to support research advancing the use of NMR and chemical profiling. TRU Letter.
DRAFT GUIDELINES FOR THE FDA’S NEW DIETARY INGREDIENT NOTIFICATION PROCESS: WHAT DO THEY MEAN? – Q&A
In August 2016, the FDA published draft guidelines — “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notification and Related Issue”. The purpose of these guidelines was to 1. improve compliance with these notification requirements and 2. to help improve the quality of the information sent to the FDA. Read More.
PROPOSED REGULATION FOR SELF-CARE PRODUCTS IN CANADA: IMPACT ON NATURAL HEALTH PRODUCTS – Q&A
Health Canada began a consultation process in September 2016 to consider how to replace existing individual regulations for 1. non-prescription drugs, 2. natural health products, and 3. cosmetics with an over-arching system for self-care products. As part of this consultation a Report of Online Consultation on Modernizing the Regulation of Self-Care Products in Canada was published in March 2017. Read More.
What is so special about the International Conference on the Science of Botanicals?
Mississippi is home to the National Center for Natural Products Research (NCNPR) at the University of Mississippi. The NCPNR is widely regarded as one of the leading centres of its kind in North America and each year hosts the International Conference on the Science of Botanicals that blends research and science with the role of regulation. Read More.
CANADIAN REGULATION OF NATURAL HEALTH PRODUCTS – ANSWERING YOUR QUESTIONS
Recently there has been a lot of news about the regulations and quality of vitamins, minerals, herbals and other supplements available in Canada. To better navigate the market place, there are some important points that need to be remembered. Read More.
TAKING THE NEXT STEP – CERTIFICATION OF NATURAL HEALTH PRODUCTS IN CANADA
Can consumers have confidence in the natural health products that they purchase? Can they be sure that the active ingredients listed on the product label are really found in the product, and at the stated levels? Are they safe? Find out how ISURA will help answer these questions. Read More.
FDA WARNING LETTERS FOR DIETARY SUPPLEMENTS DATABASE MADE AVAILABLE TO PUBLIC
Recently, the Council for Responsible Nutrition (CRN) released a comprehensive online resource for consumers. This resource, allows the public to quickly and easily access FDA Warning Letters that have been sent out to dietary supplement companies in violation of regulations set forth by the FDA. While the FDA is an agency within the United States Department of Health & Human Services, the dietary supplements regulated by them are marketed globally. The implications run beyond all borders. Read More.