One of the most pervasive yet appealing health myths is the idea that natural equals safe. It’s a statement that’s repeated constantly by manufacturers of supplements and “natural” health products. It’s been the primary argument used, with considerable success, 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. It’s effectively a buyer-beware marketplace in most parts of the world, with little accurate information available to consumers. But supplement manufacturers aren’t content with the minimal regulation that’s currently in place – they want health “freedom”. In this case, “freedom” means the right to sell any product, while being exempted from safety and regulatory requirements. New Canadian legislation is poised to raise safety standards for drugs and enhance the ability of regulators to recall dangerous products, yet consumers of natural health products are left behind. The legislation proposes to exempt anything considered a “natural health product”. This is not only bad public policy, but it has the potential to cause avoidable harm. After all, shouldn’t users of supplements and natural health products be entitled to the same safety and quality standards as those that use prescription drugs? If the supplement industry gets its way, the answer will be “no”. (There is an opportunity until June 10 for you to provide feedback on this legislation – see below.)
In late 2013 the Canadian government introduced Bill C-17, the Protecting Canadians from Unsafe Drugs Act. Also called “Vanessa’s Law”, the bill is named after the daughter of Terence Young, a Canadian Member of Parliament whose daughter died of an adverse drug reaction. The Act has been written to enhance and strengthen Canadian food and drug regulations, and is expected to bring Canadian regulations in line with international best practices for drug regulation. The Act will do the following:
- give government the authority to recall drugs from the market (it currently must ask the manufacturer’s permission, and the decision is at the manufacturer’s discretion)
- increase fines to manufacturers from $5,000 to $5,000,000 per day for companies that do not comply with the Food and Drugs Act
- the ability to require companies to undertake post-marketing (real-world) research
- the ability to force a manufacturer to change a drug’s label because of new harms or risks to health
- make adverse event reporting mandatory for hospitals.
These changes are overdue in Canada, and welcome. There is an interesting exemption. The act applies to “therapeutic products” which is defined as:
a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations
Even the preamble makes it clear – there are apparently no issues with natural health products:
And whereas new measures are required to further protect Canadians from the risks related to drugs and medical devices, other than natural health products
What are the consequences of excluding natural health products? Tainted drugs can be recalled, but not contaminated or mislabelled supplements (which have been documented with Canadian products). Adverse event reporting becomes mandatory for drugs and even “medical devices” (e.g., bandages) but reporting on herbal products and other supplements is not. And oddly, even some drug products are considered “natural health products” (e.g., some decongestants). The result of this legislation, if passed intact, will mean the extent to which consumers will be protected from unsafe products will vary.
Drug safety disasters like thalidomide led to the pharmaceutical regulatory framework that is generally in place around the world today. Amazingly, manufacturers of supplements and other “alternative” medicine products have been largely successful in circumventing these safety rules, convincing regulators that “natural” equals “safe”, and therefore, should be exempted from regulation. In the USA, the framework is DSHEA, which removed the onus of demonstrating safety and efficacy from the manufacturer and put the requirement to demonstrate harm on the FDA – exactly the same scenario as drugs in the early 1900′s. In Canada, the Natural Health Product regulations had a similar effect, and implemented a lowered bar for non-drug supplements. Today even homeopathic remedies in Canada are deemed safe and effective and approved with unique recommended uses.
Is there any rationale that would exempt natural health products from stronger regulatory oversight? Some (particularly the industry) point to the lack of evidence of harms. And from one perspective, that is true. Despite their widespread use, surveillance of supplements (the limited amount that occurs) reveals generally few adverse events. It could be that many products lack meaningful pharmacologic activity — either positive or negative. An adverse event is probably less likely in placebos that have no beneficial effects. But beyond efficacy, there are several other factors, unique to supplement use, that may contribute to the perception (and under-reporting) of harms from supplements. I’ve mentioned several reasons before, which include:
- Consumers believing natural products are safe may be less likely to associate adverse events with supplement use.
- Supplements don’t require a prescription. No health professional may be involved in measuring the response to therapy, who might be able to identify adverse events as part of a monitoring plan.
- Side effects and harms may not be reported, as some are reluctant to share concerns with health professionals.
- Consumers may not know how to manage an adverse event, and to whom they should report an adverse event. They may be unwilling to describe health consequences to the vendor of a product, or report in a setting like a natural foods store.
- Users may have a distrust of “conventional” medicine which drove their initial use of the product. When adverse events were identified, they may be reluctant to consult “conventional” health care providers for assistance.
- Some fear of losing access to supplements, which may drive a reluctance to report adverse events.
- Supplements are commonly used for short intervals for self-limiting conditions, and long-term harms may not appear (or be detectable).
If you don’t look for it, you won’t find it. And if you set the system up to minimize even the potential of reporting, it should be no surprise that supplements are not associated with a lot of safety concerns or reports. And that’s exactly what the bill’s exemption of natural health products will do – reinforce a weak regulatory structure and make no meaningful improvements in transparency or accountability from supplement manufacturers.
The Canadian advocacy organization Bad Science Watch has organized a campaign to press for changes in Bill C-17. It is proposing two amendments:
- Removing the natural health products exemption.
- Requiring companies to disclose all clinical trials data that exists for a product in an “all trials” clinical trials database.
The bill has been referred to a Standing Committee on Health which will meet on Tuesday June 10. There is a draft letter at Bad Science Watch, with the email address of the Members of Parliament that will be considering the bill. There is also a draft letter prepared by AllTrials, which elaborates on the rationale for a registry (yet does not address the NHP exemption.) If you want to provide comments that will be considered, you must do so by Tuesday, June 10.
Canadian consumers deserve equal protection from unsafe health products, no matter how they are categorized. In light of the questionable efficacy, safety, and product quality standards of natural health products in Canada, there is no clear rationale why Natural Health Products should be exempted from newly proposed safety enhancements. In addition, Bill C-17 represents an important opportunity to bring greater transparency to clinical trial data – a move with the potential to improve health care not just for Canadians, but for patients worldwide.