Taking the Next Step – Certification of
Natural Health Products in Canada
Challenges and Solutions
A growing number of consumers are choosing natural health products as a legitimate and sound healthcare option. At the same time, the media continues to raise questions about the quality and safety of such products. The latest media report comes from the United States where the Attorney General for the State of New York recently commissioned a study of certain private label herbal medicines available in some of that country’s largest retailers. Though there are serious questions about both the quality of the study, as well the appropriateness of DNA barcoding (the analytical method used to test these US products), it does nevertheless cast a shadow on the natural health product market in general.
The accuracy of label claims is a key issue for the natural health products industry and it is directly related to the quality of raw materials used in the manufacture of such products. The natural health product industry is now global with raw materials increasingly coming from outside of Canada. Some of these raw materials may be substitute products, or contain contaminants, such as pesticides, bacteria, heavy metals, or other impurities.
This raises questions regarding the safety and integrity, actual or perceived, of the industry. 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?
Made in Canada
According to Statistics Canada the natural health product sector in Canada is a $3.2 billion a-year industry. It`s a sector that is highly regulated. In fact, Canada1 has established one of the highest standards for natural health products, and is considered a global leader in this area. Natural health products cannot be sold in Canada unless they have undergone a review by Health Canada, and are then approved and licensed with a Natural Product Number (NPN).
Health Canada uses a two-part process for licencing natural health products. First, it reviews product licence applications to ensure that products are safe, effective and of high quality. Applications for product licences must include details regarding the quality and safety of medicinal and non-medicinal ingredients used (and which follow established standards), along with supporting scientific research.
Second, Health Canada requires that Canadian companies who manufacture, import, package, or distribute natural health products must be compliant with Good Manufacturing Practices (c-GMP). Manufacturing best practices are critical considering that contaminants can be inadvertently introduced during processing or manufacturing.
Products that are compliant with the foregoing regulations and are approved and licensed by Health Canada are then assigned an eight-digit Natural Product Number (NPN), which must appear on product labels.2
Post-approval Quality Control
The challenge of ensuring product quality extends beyond the pre-market approval process. Health Canada does post-market monitoring to ensure compliance with their regulations.
However, the natural health product industry also has a responsibility to provide ongoing self-inspection and testing of its products. Continuous quality control through laboratory analysis of raw materials through to finished products is essential. Self-regulation, along with government-based regulations, are essential to ensure that ingredient lists and potency claims on labels are consistent with product contents. Ultimately, the goal is to ensure that consumers have access to products that are safe, uncontaminated, of high quality, are of guaranteed potency, effective, and properly labeled.
Industry Solutions—Supporting Self-Regulation
In 2014, a significant step was taken toward ensuring the integrity of natural health products with the establishment of ISURA. ISURA’s core mandate is to serve as an analytical competence centre for the analysis of natural health products at all stages of processing and manufacturing. As a not-for-profit organization, ISURA works closely with manufacturers, distributors and retailers to provide a mechanism for self-regulation that further protects the consumer, as well as the health of the industry.
Specifically, ISURA’s certification programs works to:
- Help insure the safety and purity of natural health products
- Confirm that claims made on product labels harmonize with actual product contents
- Enable consumers to make more informed choices regarding natural health products
- Increase consumer confidence in natural health products through rigorous testing
Natural health products that have undergone and passed the battery of laboratory tests are then granted the ISURA seal of approval, which guarantees that the products are safe, uncontaminated, of high quality, are of guaranteed potency, GMO-free, and are properly labeled.
How ISURA Supports the NHP Industry
ISURA Laboratories has been created to provide raw material suppliers, manufacturers and distributors with the following services:
- Comprehensive product testing for quality, purity, potency, and label integrity
- Testing for more than 400 potential contaminants:
- Pesticides, fungicides, herbicides
- Heavy metals such as lead, mercury and cadmium
- Residual solvents
- Un-targeted profiling3
- Non-GMO analysis (verification of the absence of GE elements)
ISURA’s in-house test centre takes a comprehensive approach to product analysis, and uses state-of-the-art equipment and expertise, which includes:
- Thin layer chromatography
- High performance liquid chromatography
- Gas chromatography
- Mass spectrometry:
- Headspace Gas Chromatography
- Gas Chromatography Triple-Quadrupole
- Ultra-high Performance Liquid Chromatography Triple-Quadrupole MS
- Inductively-coupled Plasma
(For more details on these text methods, please visit http://isura.wpengine.com/product-certification/)
- Real-time polymerase chain reaction (PCR) to detect genetically modified (GMO) or genetically engineered (GE) plant material
- Sensitive and precise test methodology for GMO screening
- Detects even trace levels of GMO materials
- Enables product testing at the molecular level for DNA authentication of herbal raw material
This analytical equipment and associated test protocols meet or exceed international standards for natural health products set by organizations such as:
- ABC (American Botanical Council)
- CRN (Council for Responsible Nutrition)
- FDA (United States Food and Drug Administration)
- HC (Health Canada: Natural and Non-prescription Health Products Directorate)
- United States Pharmacopeia (USP)
An Emerging Analytical Method
At ISURA we are committed to supporting the development of new and improved testing protocols that enhance product analysis. We are actively working on new untargeted profiling approaches to enable ingredient profiles for chemical taxonomy and identification of compounds that are not expected to be in a product (“contaminants”) by rapid analytical methodologies.
DNA Barcoding Technology
DNA barcoding is a relatively new and still developing analytical method used to quickly “fingerprint” or authenticate a species using a snippet of DNA (human, animal, plant, etc.) vs. the whole genome.
A well-known example of adopting DNA barcoding to authenticate a species was its use to expose “fish fraud,” as reported by the Canadian media in 2013. DNA barcoding revealed that cheaper fish were being miss-labelled as more desirable and expensive species.
DNA Barcoding for Natural Health Products?
Considerable controversy exists regarding whether DNA barcoding is an appropriate analytical method for product authentication or “fingerprinting” of natural health products.
Various Canadian and international research experts have weighed in on the accuracy of DNA barcoding when used for natural health products. The consensus is that it is premature to adopt this technology as a stand-alone analytical method for natural health product authentication, particularly in the case of products that have been processed, such as herbal extracts.
DNA barcoding looks for a specific DNA fragment, which due to the processing can become denatured and may no longer be identifiable. However, the product could still contain the desirable active ingredients from the original plant. The limitations of DNA barcoding thus leads to false-negatives—test results suggesting that there are no plant actives in the product when in fact there are.
In that regard, the Food and Drug Administration (FDA) (responsible for regulation of natural health products in the US), has stated that DNA barcoding technology is not an analytical method that they use for authentication of such products.4 Nor has DNA barcoding technology been validated for natural health products by Health Canada.
ISURA will employ DNA barcode testing in a limited manner—where the science supports its use—and only as a complementary method in its suite of test methods. However, ISURA only considers DNA barcoding results within the context of the degree of processing that the product has undergone.
The issue of quality control and the integrity of the natural health products industry is critically important to all stakeholders in the supply and manufacturing chain, and to health care providers and consumers. Everyone knows that it only takes one “bad actor” who makes an unsubstantiated claim or lets a contaminated raw material to slip into production . . . to capture the media’s attention and cause consumers to question high quality products.
The natural health products industry in Canada has benefited from a continuum of improvements—at the regulatory level; the accumulation of the evidence-based efficacy; sophisticated analytical methodologies; and improved safety. However, more needs to be done by manufacturers and suppliers to earn and maintain consumer confidence by increased self-regulation with a focus on quality control. This is best achieved through a verification and certification program that ensures that natural health products sold in Canada meet the highest standards for safety, integrity, purity and potency.
To learn more about how ISURA is working with all stakeholders, and its certification and seal of approval program—we encourage you to contact us today. Until then, stay tuned as we continue to report on the checks and balances of this essential industry.