Honey Bees in Peril!

Marisa Nichini
June 19, 2018
                         
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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.

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ISURA donation for NMR Lab Equipment at TRU

Marisa Nichini
December 12, 2017
         
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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 that will help advance the use of NMR and chemical profiling.

TRU letter to ISURA re Donation to NMR Lab Equipment Fund

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Draft Guidelines for The FDA’s New Dietary Ingredient Notification Process: what do they mean?

Marisa Nichini
August 25, 2017
       
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Before we discuss the FDA’s Draft Guidelines for the New Dietary Ingredient (NDI) notification process we need to recap the way dietary supplements are regulated in the USA. Contrary to much of what you may have read recently in the media, the dietary supplement market in the USA is not unregulated but largely falls under a specific piece of legislation called the Dietary Supplements Health Education Act of 1994 (DSHEA). In addition to outlining items such as how a dietary supplement is made, what claims can be made about the supplement, and the need for the reporting of adverse events, DSHEA defines exactly which dietary ingredients can be included in a dietary supplement. Key to the NDI process is determining when should a company inform the Food & Drug Administration (FDA) when they what want to bring a new dietary ingredient to market.

If there is a NDI, does that mean that there is an Old Dietary Ingredient (ODI)?

Not officially but for practical reasons when DSHEA came into effect on October 15, 1994 any dietary ingredients on the market prior to this date were “grandfathered in”, that is considered to be legally available. Any ingredients introduced to the market after that day required that the FDA be notified via the NDI notification process.

What’s happening to the FDA’s NDI notification process now?

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.

If DSHEA came into force in 1994, why is it necessary to publish these guidelines now?

The best answer to that is to look at the current dietary supplements market and the number of notifications made to the FDA to date. When DSHEA came into effect in 1994, it was estimated that there were 4,000 products on the market. The estimate number of products on the market in 2012 was just over 55,000 with almost 6,000 new ones entering annually. Between 1994 and 2014, the FDA had received less than 1,000 NDI notifications. So you can see that there is something of a disconnect between the FDA and industry and when a notification was required.

What do I need to know about these new draft guidelines?

The draft guidelines published in 2016 are an updated version of draft guidelines previously published. As you can imagine the 2016 draft guidelines are very detailed but largely focus on when a NDI notification needs to be made, how it will be processed including anticipated timelines, and what sort of information needs to be included in notification itself. More information about the draft guidelines can be found at www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm

What has been industry’s reaction to these draft guidelines?

Given how important NDI notification is to the industry, it is not surprising that the FDA has received many comments from both individual companies as well as the main industry associations. Key industry members have been supportive of the need for improved guidelines to strengthen the FDA’s ability to support public health and the safety of products. However, they have also raised a number of important concerns.

Industry’s concerns with the proposed guidelines:

How do you precisely identify what was on the market before October 15, 1994?

This question is commonly seen as one of, if not the, most important one to be answered. Though many different forms of evidence such as sales records, sales contracts and even product catalogs can be used to show that an ingredient was on the market before October 15, 1994, there is a need for an authoritative list of the grandfathered ingredients to allay confusion and ambiguity. Also, since prior to DSHEA the legal status of dietary supplements was unclear, it may be difficult to identify all the dietary supplements on the market at that time.

Is a NDI notification required when you combine two or more dietary ingredients?

Though the NDI guidelines apply to dietary ingredients and not finished dietary supplements, there is some debate whether the 2016 draft guidelines would and should require the combination of two or more NDIs in a finished dietary supplement to require a specific NDI notification. There is much debate as to whether or not this is contained within the intent of DSHEA. Given the number of dietary supplements on the US market that contain more than one NDI, this topic could have a significant impact.

Within the draft guidelines, what exactly do “manufacturing changes” and “chemical alteration” mean?

The dietary supplements industry is very dynamic and innovative, and many changes in extraction and manufacturing techniques have been developed since the passing of DSHEA in 1994. There is much debate as to whether the use of these “newer” techniques (e.g. super critical CO2 extraction) should trigger a NDI notification, particularly when these techniques are now considered to be the norm or best practice. It is one thing if changes and chemical alteration pose a safety issue, but quite another if they make for a superior quality dietary supplement. One option may be to create a list of approved processes used in manufacturing, another may be to focus on situations where safety may be compromised.

How should synthetic copies of botanical and herbal ingredients be addressed?

When DSHEA was passed in 1994 there were synthetic versions of a number of vitamins and minerals on the market, however, the advent of synthetic plant equivalents is a relatively new phenomenon. Though congress did not distinguish between natural and synthetic versions in DSHEA, the FDA has taken the position that synthetic copies of botanicals are not dietary ingredients at all. Some industry members have said that this is the wrong approach and that requiring companies to submit a new NDI notification may be the best way to ensure that dietary supplements containing synthetic versions of ingredients are appropriately regulated.

What kind of impact will this have on the dietary supplement industry?

This, of course, depends on what is contained in the final guidelines. In many ways, adoption of these guidelines could provide for an updated and more appropriate regulation of dietary supplements.

That being said, the impact could be significant and very resource intense for both the industry submitting the notifications and the FDA in dealing with them. If the current draft guidelines are approved as they are, the costs involved would be very substantial for the industry.

Have any decisions about the draft guidelines been made yet?

No, the FDA is still considering all the comments it has received and is continuing to consult with all members of the sector. One of the main questions — How to deal with the creation of an authoritative list of dietary ingredients available pre-DSHEA? will be explored at a workshop set for the Fall of 2017. When finalized, details of this workshop will be posted on the FDA Workshop page at www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

About the author: Dr. Michael Smith is trained as a pharmacist and a naturopathic doctor and is recognized internationally as an expert in Natural Health Products 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.

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Proposed Regulation for Self-Care Products in Canada: Impact on Natural Health Products

Marisa Nichini
April 6, 2017
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What is being proposed by Health Canada?

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.

Though not final, for lower risk self care products, Health Canada is proposing 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 will 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 or review by Health Canada or individually reviewed by Health Canada.

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

More information about what is being proposed 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. Health Canada should be commended and supported in recognizing the importance of self-care. The challenge is whether newer regulations, such as the NHPR, should be the priority rather than continuing what had been 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.

If there are changes to the NHP regulations how long will it be before we see these changes?

It depends on what Health Canada decides to do after it has considered all the comments made in response to its proposal. If Health Canada does want to proceed with radical changes as proposed in the consultation document, then it is very likely that a change in the regulations will be required. This will take a number of years to complete with consultations at every stage of the way. If, on the other hands, Health Canada does not make major changes and reverts to the original plan of ensuring that the three types of regulations remain separate with changes focused on making sure that they work better together as a set of regulations, then changes could be made in far less time. Irrespective of what is being proposed, consultations must be ongoing throughout the process and Health Canada has made a commitment to do this.

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.

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.

Will the changes help consumers make informed choices about choosing NHPs?

Until we know exactly what is being proposed, this question cannot be completely answered. In reviewing the Health Canada proposal, it seems that less information would be provided to consumers on the labels of products and that quality issues would not be addressed appropriately. This could limit the ability of consumers to make informed choices about NHPs.

So, has there been any progress since this document was published?

There was quite a response from Canadians—Health Canada received over 3500 comments to the proposal document with about 70% of the comments coming from consumers. At the time of posting this article Health Canada has not yet published a “What we heard report”, however it does seem to be taking the comments received very seriously. To continue the consultation process, Health Canada is planning to host two series of town hall meetings across Canada in the spring and early summer of 2017. Each series will focus on specific aspects of what is being proposed. It appears that Health Canada has heard the comments that have been made and are expanding the discussion topics to include those dealing with quality, particularly concerning good manufacturing practices and site licensing.

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.

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ISURA Standard for Certification

Marisa Nichini
December 3, 2015
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INTRODUCTION

The safety of natural health products (NHP) is paramount to all stakeholders—growers, raw material suppliers, manufacturers, regulators, retailers, healthcare providers, and ultimately consumers. Everyone in the global NHP supply chain recognizes how crucial it is to ensure that only products of the highest quality and integrity reach consumers. Increasingly, consumers want to know what is in the NHPs they are buying and they want that information right on the product label. The natural health product industry’s integrity and future will be determined by the effectiveness of its response to these challenges.

ISURA is an independent, non-profit analytical testing and certification organization. Its mandate is to provide certification services for stakeholders and serve as an analytical competence centre for the analysis of NHPs at all stages of processing and manufacturing with the following goals:

  • Augmenting the safety of NHPs
  • Ensuring label accuracy
  • Increasing consumers’ confidence in NHPs
  • Providing education on NHPs
  • Supporting research and development for improved test methodologies and analytical equipment.

The standards for ISURA’s certification services for NHPs are among the world’s highest. They meet or exceed standards or recommendations for NHPs set by organizations such as:

  • AOAC (Association of Official Analytical Chemists)
  • CFIA (Canadian Food Inspection Agency)
  • CRN (Council for Responsible Nutrition)
  • EU (European Union)
  • FDA (United States Food and Drug Administration)
  • HC (Health Canada: Natural & Non-prescription Health Product Directorate)
  • TGA (Therapeutic Goods of Administration of Australia)
  • USP (United States Pharmacopeia)
  • WHO (World Health Organization)

Furthermore, ISURA’s laboratories meet strict Standards Council of Canada guidelines for laboratories, and are compliant with ISO 17025 laboratory standards.

 

1.0         ISURA CERTIFICATION STRATEGY AND SEAL OF APPROVAL OVERVIEW

The ISURA Seal of Approval is a scientific certification. To earn the ISURA Seal of Approval, NHPs must undergo a full-range of laboratory tests that confirm that the product is:

  • Authenticated,
  • Contaminant-free/Safe from contamination/ Adulterant-free,
  • Non-GMO compliant,
  • Accurately and inclusively labeled/Has label integrity/Meets potency claims.

ISURA Laboratories lie at the core of the ISURA certification strategy. ISURA’s in-house test centre takes a comprehensive approach to product analyses, and utilizes a combination of state-of-the-art equipment, such as:

  • Mass spectrometry (MS):
  • Headspace Gas Chromatography
  • Gas Chromatography Triple-Quadrupole
  • Ultra-high Performance Liquid Chromatography Triple-Quadrupole
  • Inductively-coupled Plasma (ICP)
  • Real Time Quantitative Polymerase Chain Reaction System (qPCR)
  • DNA Sequencer
  • High performance liquid chromatography (HPLC)
  • Ultraviolet-visible Spectrophotometer (UV-Vis)
  • Infrared Spectrometer (IR)
  • Microplate Spectrophotometer
  • Microplate Fluorometer and Luminometer

These instruments enable the use of proven testing methods to identify and quantify potential contaminants as well as confirm the presence of specific active ingredients and excipients in product samples.

ISURA employs both targeted and un-targeted approaches to NHP analysis and profiling.

  • Un-targeted profiling is a more general, less-sensitive analysis designed to identify a wide-range of unknown compounds or contaminants in a test sample. This approach looks for fraudulent adulterants, substitutions or contaminants not known to be present.
  • In contrast, targeted analysis is more sensitive, and can verify and quantify specific active ingredients or contaminants in a test sample.

ISURA offers verification and certification to NHP distributors – for finished products, and to manufacturers – for raw materials, finished products, and responsible processing and handling practices.

2.0         ISURA STANDARD: AUTHENTICATION, PURITY, POTENCY, PROCESSING & HANDLING

2.1         AUTHENTICATION:

ISURA provides product identification and authentication based on chemical testing methods that produce profiles of test samples that can then be compared to applicable reference profiles or the source botanical material. Currently, ISURA confirms identification of test samples using High Performance Liquid Chromatography (HPLC), Mass Spectrometry profiles, and Fourier Transform Infrared Spectroscopy (FT-IR).

INNOVATION: As a leading edge analytical testing centre, ISURA is committed to research and innovation, and determining how best to incorporate such knowledge into routine use within the NHP industry. As such ISURA seeks to include appropriate advanced analytical tests into its laboratory testing methods as they become available, validated, and prove to be reliable and feasible.

At this time, ISURA is developing standardized techniques for testing raw materials and NHPs using DNA barcoding analysis and Quantitative-Polymerase Chain Reaction (qPCR) in order to authenticate the active ingredients in a NHP. This work is important as some NHPs, such as herbal extracts or other highly processed ingredients, may not contain intact DNA material, therefore a valid, reliable, replicable protocol also needs to be developed to enable the testing of the biological material from which such extracts or ingredients were obtained.

ISURA is also establishing a larger library of chemical fingerprinting profile for NHPs and investigating the best ways to utilize techniques such as: nuclear magnetic resonance (NMR), mass spectroscopy profiles, chiral profiles, compound specific isotope ratio profiling (GC-Combustion-IRMS), and other emerging test methods.

2.2         PURITY:

ISURA tests for a wide-range of potential contaminants, including GMO (genetically modified organisms). Through its advanced testing, ISURA can certify a NHP is below standardized safe thresholds for more than 500 contaminants and that it is non-GMO compliant.

2.2.1      Non-GMO verification:

The ISURA threshold limit for detectable GMO is 0.1% in tested samples, compared to the higher threshold limits for the European Union at 0.9%, and the Non-GMO Verified Project at 0.25% (for seeds and propagation materials) and 0.9% (for human food ingredients, supplements).

ISURA utilizes Quantitative-Polymerase Chain Reaction (qPCR), also known as Real-Time PCR, to verify non-GMO compliance of a NHP: qPCR is used to detect genetically modified organisms (GMO) DNA sequences in the product or the raw material. At this time, it is the most sensitive and most reliable test method available for GMO screening as it looks at the DNA found in a NHP, detects specific GMO sequences and quantifies the amount of genetically modified DNA. The qPCR testing method can detect and quantify extremely low GMO concentrations of 0.01% in a wide range of materials, often even after they have been processed.

2.2.2      Other Contaminants:

Contaminants may be present in a NHP due to environmental contaminations, cultivation practices or production processes. ISURA verifies if potential contaminants are present in a NHP, and if they are present that they are within established safe threshold limits for human consumption as part of its certification process.

ISURA employs advanced testing methods and equipment, including highly sensitive mass spectrometry, that are capable of identifying and quantifying more than 500 contaminants – many more than the number of detectable contaminants identified in the United States Pharmacopeia (USP) standard.

The following is a summary of the types of contaminants ISURA tests for:

  • Pesticides,
    • insecticides,
    • herbicides,
    • fungicides,
  • Mycotoxins,
  • Persistent organic pollutants: dioxins, PCBs, PAHs,
  • Solvent residues,
  • Toxic heavy metals,
  • Microbiological contaminants,
  • Radiation contamination at ultra-trace concentration levels (very low levels)

Threshold limits for specific contaminants vary with the type of contaminant, the product being tested, and its intended use. See the Appendices for listings of ISURA threshold levels for exemplar contaminants.

 2.3         POTENCY: Label Integrity

ISURA requires that all certified products and materials be tested at the finished product stage to ensure label integrity – that is, to demonstrate that the potency of the active ingredient(s) in the finished product meets or exceeds that stated on the product label, and that all active ingredients noted on the finished product label are, in fact, present.

ISURA utilizes its advanced equipment and technology to confirm that the potency of a NHP is due to the stated active ingredient(s) and not due an adulterant(s). In this context, an adulterant is a substance that may be added to a product to give a false result with respect to its potency. For example, melamine may be added to a whey protein product in order to inflate the apparent amount of protein in it; however melamine is not a whey protein and may even be harmful in high doses. If one was simply testing for the presence of protein vs. whey protein, then the melamine would “read” as protein in a test sample.

To verify potency, and whether or not adulterants are present, ISURA uses instruments such as HPLC, UV-Vis and microplate spectroscopy, and standardized test methods published as regional, national or international standards by reputable scientific/technical organizations (i.e. USO, FCC) or in relevant scientific journals or texts. This enables ISURA to certify that a finished NHP, or even a raw material, contains the stated active ingredient(s), is adulterant-free, and has label integrity.

2.4         PROCESSING & HANDLING

In addition to product tests, ISURA offers verification and certification to manufacturers with respect to the manufacturing (processing and handling) of NHPs according to industry best practices. Good Manufacturing Practices (GMP) must be in place for manufacturers of NHPs. ISURA requires documentation confirming current compliance with GMP and reserves the right to conduct on-site audits at its discretion.

ISURA requires all certified products to demonstrate (via documentation review and verification) traceability and up-to-date compliance with the applicable current Good Manufacturing Processes (cGMP) of the country of manufacture, including site licences and facilities registration. This documentation review includes confirming compliance, as applicable, with the following regulatory bodies:

  • CFIA (Canadian Food Inspection Agency)
  • FDA (United States Food and Drug Administration)
  • HC (Health Canada: Natural & Non-prescription Health Product Directorate)
  • TGA (Therapeutic Goods of Administration of Australia)
  • USP (United States Pharmacopeia).

 

CONCLUSION

ISURA is committed to supporting consumer confidence in and access to safe, high quality NHPs by providing valid, reliable, robust analytical testing and certification services to the natural health product industry. As an independent, non-profit analytical testing and certification organization, ISURA is very well-placed to conduct innovative research and development for improved test methodologies and analytical equipment.

ISURA will review its Standard and certification requirements at least once a year, and will communicate any changes in its certification requirements to its clients within 30 days of the approval and issuing of such changes. ISURA will work with existing certification clients to achieve compliance with any new ISURA Standard/certification requirements within 90 days of the client being notified of such changes.

The natural health product industry is a global industry. When consumers see the ISURA Seal of Approval on the label of a NHP they can rest assured that the product is safe, has label integrity, is of proven quality and potency, and has been manufactured using Good Manufacturing Practices.

APPENDICES

ISURA Contaminants Threshold Limits Summary Oct 2017 including pesticides, solvents, and other contaminants.

 

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Canadian Regulation of Natural Health Products – Answering Your Questions

Marisa Nichini
November 27, 2015
   
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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

Are vitamins, minerals and other supplements regulated in Canada?

In a word yes, these types of products often referred to as “supplements” are regulated as Natural Health Products or NHPs for short.

What is a Natural Health Product?

Natural Health Products are defined by Natural Health Product Regulations as:

  • Vitamins and minerals;
  • Herbal remedies;
  • Homeopathic medicines;
  • Traditional medicines such as traditional Chinese medicines;
  • Probiotics; and
  • Other products like amino acids and essential fatty acids

The regulations and Health Canada require NHPs to be “safe to use as over-the-counter products and not need a prescription to be sold”.[1] If a prescription is required due to such things as the amount that needs to be taken or the illness it is being used to treat, then the product will be regulated as some other form of therapeutic good such as a prescription drug.

How are NHPs regulated in Canada?

As with things such as drugs, foods and medical devices, in Canada NHPs are regulated under the Food and Drugs Act. In fact, unlike in countries such as the United States where products such as these are regulated as a type of food, in Canada, NHPs are regulated as a type of drug with specific regulations developed to reflect the sector’s specific characteristics.

The Canadian NHP Regulations take a life cycle approach in that they look at both what happens before (premarket) and after (post-market) a NHP is available for sale. Before a NHP can be sold, a product license must be obtained from Health Canada and requires information such as the product’s ingredients (both medicinal and non-medicinal), what it can be used for, any potential side effects or things that should be avoided and recommended dosage. When a NHP is licensed by Health Canada it is assigned a Natural Product Number (NPN) that must be displayed on the product’s label. Also, a site license providing details of the site where the product is made and verification that they follow recognized Good Manufacturing Practices (GMPs) must also be submitted and approved by Health Canada. Again, both of these steps must be successfully completed before a NHP can be sold.

Regulatory oversight does not end once the NHP is on the market. Products are required to submit any details they receive about unexpected or serious adverse effects they discover. This approach allows Health Canada to make sure the information that they have is current. At any point, if a problem is identified either with safety or product quality, Health Canada can take action to mitigate this risk. These steps can range from requiring new labeling to asking that the product be stopped for sale. More information about the Canadian NHP regulations can be found at www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php.

What kind of evidence is needed to support a product claim?

The NHP regulations recognize the importance of scientific research as well as a respect for traditional forms of health and healing. This approach supports innovations in the market place together with the health care traditions that reflect Canada as a multi-cultural nation. To do this, the NHP regulations balance the type and quantity of the evidence with the claim a company can make on the label.

For example, if a company wishes to make a claim based on traditional evidence, then the product license application needs to make reference to a set of approved texts being used. These claims are appropriately limited and must used wording such as “Traditionally used for………” If a company wants to make a specific clinically-proven claim, then in most cases, they must submit results from a high quality clinical trial for review by scientists at Health Canada.

Since there are so many similar products on the Canadian market, Health Canada has developed an extensive set of NHP monographs for the most popular ingredients such as echinacea, glucosamine and fish oils. These monographs are constantly updated when more information comes to hand. If a company wants to use one of these monographs in a product license application, then their product must comply completely with the monograph regarding such things as dosage, indication for use, usage and warning labels. Health Canada audits these types of NHPs once they are on the market to make sure that companies are following the contents of the monograph they are using. You can learn more about the NHP monographs at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/index-eng.php.

Remember, a NHP cannot be marketed for anything but a self-limiting condition or for health promotion. So, for conditions such as heart disease, cancer and serious infections, the only route open for approval is as a prescription drug or biologic therapy.

Are the claims for NHPs evaluated less stringently than for conventional drugs?

The claims that specific NHPs can make are assessed in a way appropriate for the products themselves. For conventional prescription drugs, the evidence required reflects the serious conditions they are intended to treat together with the potential for serious side effects. This can only be obtained through extensive clinical trials. For a number of drugs used over-the-counter, many of which have been available for many decades, a monograph system is used just like with NHPs.

How were these NHP regulations developed?

Input from all sectors of the community was sought in both the development and implementation of the NHP regulations. This input came through numerous consultations held across the country ranging from large meetings to face-to-face conversations as well as information received on line. They reflect a gold standard in how to develop modern health product regulations.

How can I find out more about what specific products are regulated?

Health Canada maintains the Licensed NHP database which lists all the approved product licenses in Canada, and also provides some information as to whether the licenses are active or not. This database lists the NPN (Natural Product Number), approved claim, ingredients, recommended dosage as well as any possible side effects or safety concerns. This information being on line from a government agency is pretty unique in world. More information can be found about the Licensed NHP database at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php

Are the Canadian NHP regulations current?

Yes, they are very current and are considered by many to be cutting edge. They came into force in 2004 and are one of the newest regulatory frameworks for a therapeutic good or food in Canada at the moment. They are newer than the frameworks for prescription drugs, for over-the-counter drugs, biologics and foods, in some cases by decades.

These regulations are not static and change to reflect the sector. For example, some products in a food-like format such as energy drinks or supplements were initially regulated as NHPs. Since this may confuse consumers, these products are now more appropriately regulated as a type of foods. Also, Health Canada is considering whether they need to strengthen regulations around site licenses by requiring more detailed inspections.

How do the Canadian regulations compare to the regulation of similar products in other countries?

There is no uniform approach used around the world with respect to NHP regulation. Some countries simply have a basic registration system where companies must notify the national regulator if a product is marketed. Most countries have no specific process in place at all. Many countries have no specific process in place, not even a national registry for NHPs. Canada is one of only a few countries that have specific regulations for NHPs that ensure that all such products must be approved by a national regulator before they can be put on the market.

Should I be concerned about the quality of Natural Health Products available in Canada?

Though the Canadian consumer is in a better position than most consumers in other countries, concerns about quality should always be front and centre when you decide to take, or not take, a NHP. The market for NHPs is now global and very lucrative, with source ingredients and even finished products coming from places around the world. This has meant continued concerns about products containing or being adulterated by cheap ingredients, impurities or, in some cases, pharmaceutical drugs.

What should I look for in selecting a NHP?

Consumers should only take NHPs that are approved by Health Canada. For non-homeopathic NHP such as herbal medicines, vitamins and minerals, this can be confirmed by looking on the product’s label for an 8-digit Natural Products Number (NPN). An approved product has all the required information on the label including dosage, ingredients, and indications as well as any safety issues. Always remember to inform members of your health care team what NHPs you are taking.

[1] www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php

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FDA Warning Letters for Dietary Supplements Database Made Available to Public

Marisa Nichini
January 17, 2015
     
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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 (http://www.crnusa.org/FDAWLDB/form.html). 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, and thus this new CRN driven online tool is of great value to invested and concerned consumers from all over the world.

The CRN is a prominent trade association that represents manufacturers and suppliers of dietary supplements and functional foods. Like the FDA, the CRN is based in the U.S. but theoretically helps set the tone for regulatory compliance of dietary supplements on a more global scale. These supplements, are directly relevant to consumers, considering the fact that the brands addressed by the CRN are found in local and national grocery stores, pharmacies, natural food retailers, and other sources where consumers can order items online. The mainstream nature of these natural products has created the necessity of organizations such as the CRN. To date, they represent over one-hundred manufacturers and suppliers, ensuring that members comply with quality control regulations and relevant ethical checks and balances. The new CRN tool providing access to related FDA Warning Letters puts a much needed public face on these manufacturers/suppliers, and their products. Read further to learn more about this database, including an answer to the question – is it enough?

What Consumers, Manufacturers, and Suppliers Need to Know About the CRN Tool for Dietary Supplements

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