ISURA SAC member Dr Mary Hardy recipient of ABC Excellence Award

Marisa Nichini
March 6, 2020
0

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.

Read More

How to identify natural products you can trust!

Marisa Nichini
March 2, 2020
0

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 has been tested for purity, authentic ingredients, potency and that what’s on the label is in the bottle.

Read More
Isura logo

FDA Releases Latest Annual Pesticide Monitoring Report

Marisa Nichini
October 30, 2019
0

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.

Highlights from the Report summary include: In FY2017, the “FDA found that 96.2% of domestic and 89.6% of import human foods were compliant with federal standards.” The Report also provides results of a two-year “Herbicides assignment that began in FY2016, with a total of 879 samples of corn, soy, milk and eggs analyzed for glyphosate and glufosinate, and 1119 samples of selected grains and root crops analyzed for acid herbicides over the two-year period. Residues of glyphosate or glufosinate were not found in any egg or milk samples. Glyphosate and/or glufosinate residues were found in 59.5% of the corn and soy grain samples, but none exceeded the established tolerances.”

 

Read More

Is CBD a Natural Health Product?

Marisa Nichini
June 6, 2019
                       
0

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.

Read More

Partnering with NRC to develop analytical methods to ID and authenticate NHPs

Marisa Nichini
October 5, 2018
             
0

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.

Read More

Seed Banks – Preserving our planet’s future!

Marisa Nichini
July 9, 2018
     
0

Q. What is the role of a Seed Bank?

A seed bank plays number of important roles:

  • A reservoir of seeds of rare, endangered, and extinct species, as well as heirloom and proven man-made cultivars for future generations.
  • A source of seeds of unadulterated, non-hybridized true-crop plant species for seed propagation programs.
  • A preventative “seed buffer” against the genetic materials contamination of GMO.
  • A source of seeds destined for the seed-exchange with private and institutional seed-banks globally.
  • A living database of seed reference standards/examples, against which seeds will be compared and judged in the future.
  • As biodiversity “vaults” for the future.

Q. How are True Species seeds being preserved?

World-wide, there is increasing evidence that human activities degrade the environment, cause species decline and extinction, interfere with the planet ecological balance and biodiversity, and much more …

The acceleration of the hybridization and genetic modification of plant species also contributes to the negative impact of human activities. This represents a serious threat to the natural biodiversity of “true plant species” or unadulterated, non-hybridized plant species found in their natural form.

Man-made interspecies and genetically modified organisms (GMO) hybridization represent a great risk to true plant species. Canada’s natural health products industry is concerned about these developments, and an industry leader has taken proactive steps to preserve true plant species for the future generations by:

  • Maintaining a comprehensive seed-bank, designed as a long-term viable seeds depository.
  • Actively searching for the seeds of rare, endangered and extinct plant species worldwide.
  • Propagating true plant species for seed harvest.
  • Encouraging and participating in seed-exchange programs among seed collectors and seed-banks worldwide.

Q. How many Seed Banks are there world-wide?

In 2010, the United Nations Food and Agriculture Organisation reported that there are some 1,750 gene banks worldwide, with about 130 of them each holding more than 10,000 additions. Of the total 7.4 million samples conserved worldwide, national government gene banks conserve about 6.6 million, 45% of which is held in only seven countries, down from 12 countries in 1996. This increasing concentration of collected and preserved genetic diversity in fewer countries and research centres highlights the importance to ensure access in all countries. There are a number of global initiatives supporting seed preservation including:

  • The Global Crop Diversity Trust’s Svalbard Global Seed Vault, built inside a sandstone mountain in a man-made tunnel in the permafrost of the frozen Norwegian island of Spitsbergen, part of the Svalbard archipelago. It is designed to survive catastrophes such as nuclear war and has almost a million seed samples received from contributing seed banks, typically as “copies” of existing seeds.
    The Millennium Seed Bank is an initiative of the Royal Botanical Gardens, Kew and housed at the Wellcome Trust Millennium near London, United Kingdom. This global project is the largest seed bank in the world with space for the storage of billions of seed samples in a nuclear bomb proof multi-story underground vault. Its aim is to have in storage every plant species possible with its next major goal to have 25% of the species in the bank by 2020.
  • Navdanya, located in Uttrakhand, India, is an agricultural research centre that seeks to protect seed biodiversity and the livelihoods of small farmers. This seed bank conserves only unpatented seeds as a key element of Navdanya is the belief that people should have a right to save and share seeds. More than 5,000 crop varieties have been preserved, with a particular focus on grain species. More than 50 community seed banks are associated with Navdanya and together they have preserved nearly 3,000 species of rice.
  • Located on the campus of Colorado State University, USA, the National Center for Genetic Resources Preservation (NCGR) is home to one of the world’s largest gene banks. The centre is unique in that it hosts germplasms, or collections of genetic information, of plants, animals, insects, and microorganisms. In its plant division, the centre contains pollen, meristem tissue, and cell cultures. The NCGR works to ensure that its germplasms maintain the same genetic properties over time, so that traits do not change as reproduction occurs. In addition to hosting over 8,000 species of seeds, the NCGR supports genetic research and agricultural development.
  • The Vavilov Research Institute (VRI) in St Petersburg, Russia was established in 1921 and now has 12 research stations throughout the country. The stations’ seed banks house a combined total of some 60,000 seed varieties, and their herbariums contain 250,000 plant specimens. The VRI has a strong focus on fruit species, particularly berries, with more than 1,000 types of strawberries in its collection.

Q. What Can We Do to Preserve Plants and Other Species?

We can all contribute and play an active personal role in reversing these negative trends.

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. We can also collect seeds in nature and start our own seed collection (mini seed bank) in our own gardens, and exchange seeds with our neighbours and other like-minded individuals. 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.

It all takes effort, but it is well worthwhile for our own well-being and that of planet earth, as well as future generations.

 

About the author: Jan V. Slama is a research scientist and educator with ISURA. He manages an active seed preservation program with a focus on herbal botanical species. He is also recognized for his work in api-pharmacological and apitherapeutical studies, with an emphasis on researching bee propolis.

Download this as a PDF ISURA Info Sheet

Read More

Update on Proposed Regulation for Self Care Products in Canada: Impact on NHPs

Marisa Nichini
June 19, 2018
       
0

What is being proposed by Health Canada?

It has been well over a year since this process started, so this update also includes some useful background information on Health Canada’s consultation re. self-care products.

In early September 2016, Health Canada published a consultation document titled Consulting Canadians on the Regulation of Self Care Products in Canada proposing the replacement of existing individual regulatory approaches for non-prescription drugs, Natural Health Products and cosmetics with an overarching system for all self-care products.  In this new system, products would be categorized as being either lower, medium or higher risk self-care products. Categorization would depend on such things as the type of claim being made and the ingredient it contains.

In this initial proposal, for lower risk self care products, Health Canada proposed a notification system with no pre-market review of information by the department. In this category, products would not be able to make claims about the diagnosis, treatment, prevention, mitigation of a disease or condition and may need to carry a disclaimer saying that the claim has not been reviewed by Health Canada. In effect, this is a similar approach taken to that in the United States.

For medium and higher risk products, Health Canada would review applications and allow a higher level of indication referred to as a Health Claim. Health Claims would need to be supported by “scientific evidence” or “scientific proof” either supported through approved monograph[1] or review by Health Canada or individually reviewed by Health Canada.

In addition to this classification system, Health Canada also plans to create a more comprehensive and consistent approach to items such as recall provisions, authority to require labeling changes, and cost recovery mechanisms.

There was quite a response from Canadians —Health Canada received over 3,500 comments to the initial proposal document with about 70% of the comments coming from consumers. Health Canada collected and summarized the these comments and feedback in a What We Heard Report available online.

The consultation process continued in 2017 with Health Canada holding a series of national town halls, in addition to having meetings with groups from consumers, industry, academia. An updated proposal document has yet to be published, but various modifications to the original proposal document were presented at these town halls and meetings.

As for next steps, Health Canada is now planning to create a number of working groups and expert advisory groups that will work over the winter to come up with an updated proposal in 2018.

More information about what is being proposed and the process to date can be found at http://healthycanadians.gc.ca/health-system-systeme-sante/consultations/selfcare-autosoins/document-eng.php

 What are self-care products?

 Generally, self-care products are health care products available to consumers that can be selected and used without direction from a health care provider such as a medical doctor, pharmacist, naturopathic doctor or nurse. In this document, Health Canada considers a self-care product to be made up of three different product groups: cosmetics; Natural Health Products such as vitamins, minerals, herbal medicines and traditional medicine; and non-prescription drugs such as acetaminophen and conventional cough remedies.

How are self-care products currently regulated in Canada?

 Though cosmetics, Natural Health Products and non-prescription drugs all fall under the Food and Drugs Act, they are actually regulated in three distinct ways:

  • Cosmetics are regulated under a post-market system, that is manufacturers and importers must notify Health Canada within the first 10 days a cosmetic is sold in Canada providing details of such things as ingredients and company contact information.
  • Natural Health Products (NHP) are regulated under the Natural Health Products Regulations (NHPR) that are the most current and up to date regulatory framework for any therapeutic product. The regulations are pre-market which means Health Canada is required to review information provided by the manufacturer or importer and approve all NHPs before they are allowed to be sold on the Canadian market. This information includes evidence to support the claim being made, as well as information about risks and dosage ranges. Companies must also submit information about where the product is made and a site license is required before a product can be sold. All approved NHPs for sale on the Canadian market must carry an 8-digit Natural Product Number (NPN) or a Drug Identification Number-Homeopathic Medicine (DIN-HM; for homeopathic medicines).
  • Non-Prescription Drugs are regulated largely like other conventional drugs. Like NHPs, companies must submit evidence to support safety and efficacy as well as information about where the product is made. Since all non-prescription drugs are conventional or mainstream health care products, unlike NHPs they only need to consider “scientific” evidence rather than that from traditional forms of health-care such as traditional Chinese medicine.

 Isn’t appropriate regulation of self-care products important?

Absolutely and in fact in its most recent strategy for traditional medicines, the World Health Organisation (WHO) has identified the regulation of self-care products as a key priority.[2] Health Canada should be commended and supported in recognizing the importance of self-care. The challenge is whether changing the newer regulations, such as the NHPR, should be the priority rather than continuing what was initially planned: to focus on revising the more dated regulations such as those for non-prescription drugs.

Why is Health Canada looking to change the way self-care products and NHPs are regulated?

Health Canada says that currently there are three separate sets of regulations—the cosmetic regulations, the Natural Health Product Regulations (NHPR) and the Food and Drug Regulations, depending on the type of self-care product. This may lead to confusion in market place making it difficult for consumers to understand how these products are regulated and what that means for product claims, the differences in the types of evidence used to support a use and what approval by Health Canada means for each of these three categories of products. There is also concern that the current complex set of regulations do not work well together and that there is the potential for the same product to be classified as a cosmetic, a NHP or a non-prescription drug depending on what claim the product is making and what ingredients it contains. Health Canada also cites inconsistencies in its powers to recall products deemed to be unsafe or to require label changes to reflect new evidence.

I thought the NHPR were very new, why change them now?

Yes, the NHPR are the most current and complete framework for any health product category in Canada and were developed through extensive consultation with all stakeholder groups, including the public. In addition, the NHPR were developed at the request of the Canadian government that recognized the importance of such things as the importance of evidence from traditional forms of health and healing.[3]

What is the problem with having claims based on “scientific evidence” and “scientific proof”?

Before we can answer this question we need to know what Health Canada means by these terms. Does this mean that the evidence used for conventional drugs such as randomized clinical trials can only be used to support health claims? Does this include scientific evidence currently respected within the NHPR? Should traditional forms of evidence such as traditional Chinese medicine and medical herbalism be recognized as valid proof by Health Canada and included in the definitions of “scientific evidence” and “scientific proof”. One question that still needs to be answered is why Health Canada has moved from recognizing a broader and respectful range of evidence for a claim base that includes traditional forms of health and healing to requiring that everything to be scientifically proven.

So, has any progress been made?

Until Health Canada provides a new proposal document (expected in 2018) it is difficult to fully answer this question.  Will it strengthen or limit consumers’ ability to make informed choices? We still don’t know.

Although Health Canada has presented various options at the town halls and consultations, they have been reluctant to share, officially, more detailed information. This includes the various presentations made at the recent town halls. The reason Health Canada cites for this is that the process is ongoing and that until they have reached a final proposal, they don’t want to confuse participants in the consultation.

From the presentations made at the various town hall meetings, it does seem that Health Canada have identified product quality as an important topic, especially as it relates to good manufacturing practices and site licensing. In addition, the importance of accurate labeling, the role of product identification numbers and the need to ensure that consumers have the necessary information to make informed choices have been identified as key.

Despite having gone through a number of iterations, the presentations consistently present the idea of a three-category system within one regulatory approach. This concept still implies that similar claims should be based on similar forms of evidence and that “scientific” evidence will be needed to support therapeutic claims. The fundamental role of traditional and historic evidence in supporting product claims and informing consumers is still uncertain.

So, what do you think?

From what we have seen to date, Health Canada still wants to make quite radical changes to how NHPs are regulated in Canada—a lengthy and detailed process. If this is the case then, just as when the NHP regulations were developed, Health Canada will need to publish exactly what they are proposing in the Canada Gazette I and then provide a limited time for Canadians to respond with their comments. Health Canada will also need to conduct a detailed analysis of what impact any changes will have on the NHP sector.

Big questions still need to be answered before any formal regulatory changes are seen. Most notably, the importance of evidence from traditional forms of health and healing in a multicultural Canada, the role of product identifiers, and what exactly needs to be on a product label. Hopefully these questions will be answered by Health Canada and if changes to the regulations or guidelines are proposed that they will share a new official and complete proposal so that Canadians know the plans for the future. If changes are to be made, they should not be rushed.

Though I still commend Health Canada for highlighting the importance of self-care products and agree with the need to update the current dated regulations for non-prescription medicines and cosmetics, do we really need to radically overhaul NHP regulations that only came fully into effect a few years ago? It does seem that what is being proposed is to replace a three-category system (cosmetics, NHPs and non-prescription drugs) with another three-category system that could end up capturing the exact same set of products.

Though the current NHP regulations are modern, “state of the art” regulations, they are not perfect. After being in force for a number of years, we now know what works and what doesn’t. We have an opportunity now to fix any problems as well as use lessons learned from the NHPR in updating the regulations for cosmetics and non-prescription medicines. This, in my opinion, is where the focus should be.

You can keep up to date with developments as well as the dates and times for the town-hall meetings by going to https://www.canada.ca/en/health-canada/topics/self-care-products.html. This is an opportunity for you to make your opinions heard.

 

About the author: Dr. Michael Smith is trained as a pharmacist and a naturopathic doctor and is recognized internationally as an expert in NHPs and Complementary and Alternative Medicine. For more than 10 years, he worked in senior regulatory positions at the then Natural Health Products Directorate, Health Canada and the Therapeutic Goods Administration in Australia. In addition to his work as a consultant, he is an Adjunct Professor at the National Center for Natural Products Research at the University of Mississippi in the USA and an Adjunct Fellow at the National Institute of Complementary Medicine at Western Sydney University in Australia. Michael is a member of ISURA’s Scientific Advisory Committee.

[1] A monograph typically sets out information such as claims, dosage and potential side effects preapproved that are permitted by Health Canada.

[2] http://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/

[3] http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/53_recommend_nhp-cps_tc-tm-eng.php

Read More

Honey Bees in Peril!

Marisa Nichini
June 19, 2018
                         
0

Honey bee decline

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. Despite its name, the European honey bee is also quite common in North America and other parts of the world. Indeed, Colony Collapse Disorder (CCD), a term coined for the general decline in the honey bee population, is now a worldwide phenomenon. And this catastrophic global decrease is accelerating.

There are many and complex reasons for this slide toward extinction by the European honey bee, most of them due to humans. The outcome of this situation maybe serious for humanity also, since the loss of the pollinators such as honey bees, will have a major impact on the global availability of foods for people. Albert Einstein predicted this situation, when he said: “Mankind will not survive the Honeybees disappearance for more than five years.”

Major challenges for the honey bee

While the European honey bee (Apis mellifera) is the most common species of honey bee, there are many challenges for the humble honey bee, which affect her chances for survival:

Loss of flowers/food

One of the most important factors restricting bee populations is food availability, in both urbanized and agricultural settings. Land conversion to housing, roads, parking lots, etc. means less access to food sources for bees and isolates patches of flowering plants. Intensively farmed regions with mass-flowering crops that bloom at the same time provide insufficient variety for bees which require nectar and pollen throughout the foraging season. So, less and less available natural food can weaken and even lead to the death of honey bee colonies. [1]

Bee-killing pesticides

The widespread use of pesticides in agriculture is another direct threat to honey bees. More than 150 identified pesticides and fungicides have been found in honey bee pollen, and nectar samples. These represent a direct threat to the life of the honey bees and their developing larvae. The worst offender (worldwide) is a group of pesticides called “neonicotinoids”, which cause both acute, and chronic, poisoning of the honey bees, by destroying their central nervous system. Other pesticides either directly kill the bees, or destroy their immune system. [2]

When pesticides were used in the past, they were sprayed on leaves or the stem of the plant. This left the pollen and nectar for the bees mainly unaffected. However, with the introduction of GMO (Genetically Modified Organism) crop species that contain pesticide components within the plants’ DNA and therefore in the plants’ pollen and nectar, the entire food supply of a hive of honey bees may be contaminated. [3]

Intensification of agriculture

The loss and fragmentation of grasslands, old fields, shrub lands, forests, and hedgerows has also led to the weakening of honey bee colonies. The large industrial-style monocultures (the use of a single species for a food crop such as corn, wheat, soybean, etc.) commonly found in North America and much of Europe are not natural, and are only sustained with the application of high amounts of fertilizers, pesticides and through the use of heavy machinery. Monocultures result in a lack of biodiversity within and around croplands, and limit the amount of food to which pollinators have access. Industrial practices such as tillage, irrigation, and the removal of woody vegetation also destroy the natural habitat of the pollinators, such as honey bees, accelerating their demise. [4]

Parasites

Parasites, like the Varroa mite, have been identified as a major cause of honey bee colony loss. There is growing evidence that exposure to pesticides compromises the immune system of bees, making them vulnerable to the infestations of parasites, such as Varroa mite (Varroa destructor) and small hive beetle (Aethina tumida). [5]

Herbicide application

Large-scale herbicide application drastically reduces non-crop plant diversity and abundance, and thus limits food availability for bees. [6]

Climate change

The consequences of climate change, such as increasing temperatures, changes in rainfall patterns, and more erratic or extreme weather events, also impact pollinator populations, including the honey bee. [7]

Does the honey bee have a future?

One of ISURA’s industry partners – Natural Factors has a Research Apiary at its organic farms, where they have conducted long-term beekeeping management studies, with an emphasis on bee products, disease prevention, optimal bee-friendly husbandry, and the development of non-toxic, plant-based miticides (naturally occurring compounds that kill off mites). Natural Factors has also focused on using optimal biogenic farming techniques, which serve as a template for other farmers and beekeepers to follow.

As one of North America’s largest manufacturers of nutritional products, Natural Factors is committed to conserving and supporting honey bee populations by actively producing and seeking sources of contaminant-free raw materials.

ISURA’s ability to test for more than 500 contaminants, including pesticides, provides natural health products consumers, and industry partners like Natural Factors, with the confidence that ISURA-certified products are safe and made from contaminant-free raw products.

Working together, ISURA and Natural Factors are dedicated to providing safe, contaminant-free natural health products which come from honey bee-friendly farms and sources. This in turn helps to ensure a healthier future for honey bees by supporting optimal biogenic farming techniques and practices, and conserving land with diverse and healthy food sources for honey bees.

 

References:

  1. Reshetiloff, Kathy (July 31, 2012) Bay Journal “Without pollinators, our flowers, food supply face a stinging loss.”
  2. Al-Waili, N., Salom, K., Al-Ghamdi, A., Ansari, J.A. (2012) The Scientific World Journal, Volume 2012, Article 930849
  3. Stanford, Malcolm T. (2014) Apiservices, “The World of GMOs – How it Relates to Beekeeping”
  4. Klein, A-M, Vaissière, B.E., Cane, J.H., Dewenter I.S., Cunningham, S.A., Kremen C., Tscharntke T. (October 27, 2006) Importance of pollinators in changing landscapes for world crops.
  5. Nagaraja, N and Gopal, D.R. (December 21, 2009) ISBN-8180940594, Honey Bees: Diseases, Parasites, Pests, Predators and their Management
  6. Coblentz, B.A. (December 17, 2015) Mississippi State University Extension, “Herbicides, not insecticides are biggest threat to bees.”
  7. Potts, S.G., Biesmeier, J.C., Neumann, P., Kremen C., Schweiger, O., Kunnin, W.E. (February 24, 2010) Trends in Ecology and Evolution Vol.25 No.6. “Global Pollinator Declines: Trends, Impacts and Drivers”

Author:

Jan V. Slama is a research scientist and educator. His work in api-pharmacological and apitherapeutical studies span over 35 years, with the special emphasis on researching bee propolis.

Read More
Older
Newer
©2023 ISURA. All Rights Reserved.