Health regulations are generally established to protect patients and consumers. When it comes to dietary supplements, they have long favored the supplement industry at the expense of the consumer. When written and enforced appropriately, regulation can give consumers access to safe products that are labelled correctly and give reassurance that what is on the label is actually in the bottle. That is exactly what we have in countries with rigorous regulation of the pharmaceutical drug industry. But the natural products industry has consistently fought oversight in the United States, Canada, and other countries, in order to reduce the regulatory requirements and the burden to ensure their products are safe, effective, and manufactured to a high quality standard. While this undoubtedly is useful to manufacturers, the benefits to consumers have been less clear. Yes, there are a lot of products available to buy. But can you trust them? Most countries have chosen to take a “light touch” with these products, exempting them from most of the requirements placed on over-the-counter or prescription drugs. Now a new audit, from Canada, gives a sort of report card to consumers on the health consequences of a “hands off” regulatory approach.
American vs. Canadian regulations: Two approaches
In the United States, the Dietary Supplement Health and Education Act of 1994 (DSHEA) established the regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA can only intervene to pull products off the market if they are adulterated or misbranded. It notes:
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
DSHEA draws a crude distinction between food and drugs meaning that many product can be considered “supplements” when they are more appropriately categorized as drugs. In addition, manufacturers can put virtually any claim on a supplement, without any requirement to provide evidence it works, as long as it’s accompanied by what’s called the Quack Miranda Warning: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease“. The regulation of marketing claims is effectively left to the Federal Trade Commission (FTC), which can prosecute manufacturers for fraud. There is also a lack of rigorous oversight of manufacturing practices, nor is there industry standardization of ingredients, or even purity guarantees. It is truly a manufacturer’s market.
Canada took a slightly different approach when regulating supplements. Like the American approach, the Natural Health Product Regulations were a compromise – not requiring pharmaceutical-level oversight and regulation, but establishing basic expectations and standards. Canada defines a “natural health product” as one of:
- vitamins, minerals, and probiotics
- herbal remedies
- homeopathic remedies
- traditional medicines e.g., (Chinese and Ayurvedic)
- amino acids and essential fatty acids
In contrast with the United States, natural health products must be licensed by Health Canada in order to be sold. To obtain a license, manufacturers must submit evidence of efficacy. While this sounds reasonable, the evidence standards are laughable. The TV show CBC Marketplace decided to test Health Canada’s standards several years ago. They applied for approval to market a homeopathic remedy they named “Nighton” (an anagram of “nothing”) to be used to treat fever and pain in infants and children. For evidence, they submitted a few pages photocopied from an old homeopathy textbook. No trials were conducted and no safety data was provided. Without any questions, their product was approved and licensed as a “natural health product”, and for a time, was listed in the national database of health products Health Canada declared were “safe, effective, and of high quality.” This isn’t exceptional. You will find hundreds homeopathic remedies on store shelves in Canada that have been approved for sale by Health Canada. Since 2004, 91,000 licenses have been granted for natural health products. Frustratingly, these products are sold alongside over-the-counter drugs, which are regulated to much stricter standards. Only a close inspection of the label can tell an informed consumer if a product was approved under this licensing framework.
The other major component of the Canadian regulations is site certification. Health Canada not only approves products, it approves the sites that manufacture them. Manufacturers must provide information demonstrating that it meets Good Manufacturing Practices (GMP). GMP are manufacturing standards to ensure accuracy, precision, and safety of products. GMP includes processes and people that are fully trained and qualified. Unlike drug manufacturers, Health Canada does not pre-inspect facilities that manufacture natural health products – it relies on attestations and documentation.
On paper, these requirement look to be modestly more rigorous than the American approach. But do they work? The Office of the Auditor General of Canada recently completed an audit of Health Canada’s approach to natural health products to determine if these products are safe and accurately represented to Canadians. The results give some clues to the consequences of light regulation, which may hint at what is occurring in other countries.
Safe? Effective? Health Canada can’t say
The Office of the Auditor General of Canada is independent of Health Canada (and the federal government) and is responsible for providing information and advice to the Canadian Parliament. This audit was intended to determine if natural health products available to Canadians are safe and properly labelled. To do so, they examined the licensing process for both products and manufacturing sites, verifying if Health Canada obtained sufficient information before a product was sold. It also examined if Health Canada took action after a product was licensed to manage any health risks related to these products.
Safety and efficacy assurances lacking
Health Canada requires supplement manufacturers provide a written attestation that they follow good manufacturing practices. They do not inspect facilities before products enter the market. Here is what the auditors found:
- The auditors pulled a sample of 25 site licenses. In 13/25 licenses, Health Canada relied on inspections from other countries. In 10/13, there was no assurance these inspections included natural health product manufacturing processes.
- For the remaining 12 sites, Health Canada failed to verify one or more components that would demonstrate GMP.
- The audit noted that good manufacturing practices cannot be verified until after production has started. However, when products are manufactured and sold is not disclosed to Health Canada, so it could not verify that health products sold were manufactured in sites that met GMP requirements.
Health Canada failed to respond to serious product issues after they entered the market
The auditors found that Health Canada would react to complaints about labeling and advertising, but did little to actively prevent misleading or inaccurate information from being given to consumers by manufacturers. Even when it took action, it was not always successful in addressing the issue.
88% of products were advertised with misleading information
Here I think I’ll just quote from the report:
We found that Health Canada did not sufficiently monitor whether product label information and advertisements met the product-licence conditions. We found that the department monitored product labels and advertisements in response to complaints instead of monitoring the market using a risk-based approach. To gain an understanding of the market, we examined a sample of 75 licensed products for sale on Canadian websites. We found that 88% of these products were advertised with misleading product information. Also, 56% of the products we examined were marketed with misleading label information—label information that included one or more of the following problems:
- health claims not authorized by Health Canada because they might not have been proven, such as claims to relieve fatigue, enhance endurance, or burn fat
- an erroneous statement that the product was recommended for children of ages 3 and older when it was authorized only for adolescents and adults
- an incomplete list of risks and authorized ingredients
- the wrong dosage of medicinal ingredients
- product label information, such as safety warnings, printed very small (that is, in a 4-point font); on paper, font sizes under 8 points are difficult to read without magnification; according to Health Canada, poor readability of the printed label information contributes to incorrect product use
Limited monitoring of products and manufacturers
Regulators in Australia and Europe inspect all supplement/natural health product manufacturers on an established cycle (e.g., once every four years). Health Canada has no program for routine on-site inspections. Because of the sheer number of products approved (91,000 since 2004) it has been unable to monitor licensed products and their manufacturers. Many products have been approved by Health Canada but never sold (like the CBC’s product described above). This may be due in part to the fact that Health Canada does not charge licensing fees for these products, unlike any other health product it regulates. Consumers are bearing the entire cost of this ineffective regulatory framework, and manufacturers pay nothing.
Incredibly, Health Canada doesn’t know where approved products are actually manufactured: Fewer than 5% of licence holders actually disclosed this information to the regulator.
Health Canada started to inspect manufacturers in 2016. The audit found:
- Health Canada inspected 6% of active licensed companies between 2017 and 2019. Sites were chosen because of high-risk products (e.g., sterile products) or because they had a poor compliance history.
- In almost half of the sites it inspected, it took regulatory action because of significant health issues. Seven site licenses were cancelled, and five product licenses were cancelled.
- In some cases, site licenses were eventually renewed, but without verifying companies met other GMP requirements.
- In the case of license renewals, 22 of a sample of 25 were renewed without verifying sites were following GMP requirements.
Additional activities revealed poor patterns of compliance. This statement, buried in the audit report, was remarkable:
Health Canada conducted other activities to gather compliance information, which also exposed quality problems with certain manufacturers. For example, in 2019, the department reviewed 35 companies’ testing results for 2 products that each company had recently released for sale. The department found problems at all sites, including the use of expired raw materials, unacceptable amounts of contaminants, and product tests that did not confirm the product expiry date. For half of the 35 companies, Health Canada took regulatory action, such as issuing a notice of intent to suspend the site licence, because the problems were serious.
Limited monitoring of unlicensed products
Health Canada is expected to monitor regulators like the FDA to identify high-risk products that may be available in Canada. The auditors found no program to actively monitor this. Despite the ease of accessing products online, Health Canada did little monitoring of non-compliant products. Importantly, the auditors found dozens of products advertised to treat or prevent cancer, a claim which is forbidden for these products.
Regulation that favor manufacturers also hurt consumers
One of the most pervasive yet appealing health myths is the idea that “natural” equals “safe”. It’s a statement that has repeated constantly by manufacturers of supplements and “natural” health products. And this argument has been used successfully, in Canada and elsewhere, to give these products completely different regulatory structures than exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. This Canadian audit reveals a sad consequence of weak regulation. Canadians can’t trust that what is on the label is actually in the bottle, and Health Canada isn’t ensuring that these products is safe and effective. Health Canada agrees with the audit findings. Time will tell if things change for the better. Until then, this is buyer-beware marketplace, and consumers are quite literally paying for it.