Do the Natural Health Products Regulations Benefit Canadians?

How much confidence do you have in natural health products?

Shortly after I started practicing as a pharmacist, I began giving two disclaimers whenever speaking with patients purchasing herbal products:

Compared to drugs, there is little regulation of herbal products. Variation could exist between what it says on the label and what it actually contains.

And if they have medical conditions or are taking prescription drugs, I would add,

Compared to prescription and over-the-counter drugs, the information we have on these products limited. They could have the potential to interact with other medications and medical conditions that we are not aware of. They should be used with caution.

I would give a similar disclaimer for other types of supplements and “alternative” products.

Why a disclaimer, with every patient, every time? Because the Canadian regulatory framework does not give me the confidence that natural health products available for sale in Canada are either safe or effective. Most importantly, I could not even tell patients with confidence that what was on the label was actually in the bottle.

Change is Coming. Slowly.

Until several years ago, Canadian natural health products fell into a regulatory grey zone.  Products were treated either as drugs, or as foods. Consultation began in the late 1990’s on a new framework to provide appropriate levels of  regulation and oversight to these products. In 2004, the Natural Health Product Regulations (NHPR), under Canada’s Food and Drugs Act, became a reality.  Rather than fully regulating these products as drugs, or leaving them virtually unregulated (as is done in the United States), the NHPR were a regulatory compromise: Implementing manufacturing quality and safety standards, while significantly relaxing the standards for product efficacy claims.  If randomized, double-blind, placebo-controlled trials are not conducted, (the standard for drugs), manufacturers can make claims based on “traditional uses” and other sources that are essentially anecdotal in nature. The NHP regulations include products such as nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy.

One of the most important elements of the NHP regulations was the implementation of pre-marketing registration requirements. Only products reviewed and deemed to meet minimal standards of product quality, safety, and the (relaxed) standard for efficacy claims would be permitted to be sold as of 2010. Manufacturers were given six years to meet these requirements.

I was all set to update my disclaimer. Until now.

Health Canada recent disclosed that they will not be enforcing the April 1, 2010 deadline, due to a backlog of applications. They indicate that about 60% of applications received have been processed: about 10,000 items have been approved for sale.  (Approved products will have a NPN number or a DIN-HM number on the package).  For products not already approved, as long as a manufacturer makes an application, they are permitted to continue to sell that product.  Enforcement action against products that do not meet Health Canada’s regulatory standards may not occur until 2011. Based on Health Canada’s own estimates, about 7000 NHPs remain under review.

This is disappointing for health professionals and consumers seeking quality assurance of natural health products.  For a large number of products sold in Canada (i.e., those sold without NPNs), there remains no assurance that what is on the label is what is in the bottle.  Without this quality standard being met, how can health professionals and patients infer much unapproved natural health products sold in Canada?

The Fraser Institute’s View on Regulation

Free-market/libertarian organizations like Canada’s Fraser Institute take the position that consumer rights (individual freedom) and free markets should take priority over government regulation, and their perspective on natural health products is no different. Earlier this year, the Fraser Institute published a paper entitled Unnatural Regulations: Complementary and Alternative Medicine Policy in Canada. Authored by Cynthia Ramsay, it reviewed two different (and I feel distinct) policy issues: natural health product regulation, and alternative medicine practitioner regulations. I’ll examine the former here, and save the latter for a future post.

Ramsay argues that prior to the NHP regulations, few adverse consequences were associated with NHP consumption.  Since the regulation have taken effect, there has been little impact on safety, efficacy, or quality, but there has been a decrease in the number of products available for sale in Canada. She estimates that the number of products available for sale will decrease further as the NHP regulations are further implemented. The paper concludes with the following recommendation:

“The Natural Health Products Directorate be abolished and the monitoring of NHP safety and effectiveness be left to various nongovernmental organizations.”

Here’s the paper’s view of the key issues related to NHPs:

Efficacy Despite the length of the report (60 pages) little mention is made of NHP efficacy. It states, “there is research indicating that certain treatments are beneficial” and makes reference to acupuncture – an example not relevant to natural health products. There is some discussion of calcium and vitamin D (both of which have been historically treated as drug products) and oddly, a reference to the purported health system benefits of transcendental meditation.

Ramsay goes on to cite problems with the use the randomized controlled trial to evaluate NHP efficacy, including the cost of studies and, and the difficulty with standardizing herbal products. Fair enough, but the NHP regulations offer manufacturers a dramatically lowered bar for efficacy claims. Claims based on anecdotal “traditional use” are permitted. So the regulations are only a barrier for manufacturers that want to make specific claims of benefit, where no evidence already exists.  No mention is made of clinical trials done by the National Center for Complementary and Alternative Medicine (NCCAM) which has invested over $2.5 billion of public funds into evaluating “alternative” treatments and supplements. Probably because the results  are disappointing. They don’t seem to work. Over at the Neurologica blog, Dr. Steven Novella commented,

To summarize – the government spent 2.5 billion dollars to determine that unpurified, poorly controlled drugs with generally low doses of active ingredients don’t work very well, that treatments based upon unscientific notions don’t work, and exercise and relaxation make people feel better. Oh – and they found that acupuncture does not work, proponents just haven’t noticed yet.

Efficacy is a critical issue when it comes to regulatory decisions. Without any persuasive evidence of efficacy beyond placebo, decisions on natural health product availability should then be based on the safety profile. If products are ineffective but seem harmless, we might accept that these products could be permitted for sale. However, if there is a risk of harm, regulators should scrutinize the risk-benefit perspective to determine if the benefits to consumers outweigh the risks. And when we consider risks, we should include the risk of avoidance of appropriate therapies when ineffective therapies are substituted.

Safety Ramsay details surveys showing that Canadians have little concern about the safety of NHPs. This sentiment is supported by he incidence of adverse event reports, which are rare for NHPs.  However, their absence should not be interpreted to mean evidence of safety. Lack of reporting could be due to a number of factors, including a general perception among NHP consumers that these products are safe. Conversely, it could also be due to the fact that many products  don’t seem to have any meaningful therapeutic effects. In either case, the manufacturing and distribution network for NHPs is not designed to support the collection of adverse event reports. As the purchase and sale may not include any interaction with a health professional, adverse events may not be identified.

Detailed data are presented summarizing adverse event prevalence in jurisdictions around the world, and the report compares this to adverse events reported with prescription and 0ver-the-counter drug. This argument neither establishes the safety of NHPs nor demonstrates that “conventional” medications are, by default, not beneficial. Evaluations about the marketing and sale of any product, drug or NHP, needs to be based on an evaluation of its expected benefits and known risks.

For problems with the status quo in product safety, take a look at the warnings issued by Health Canada in 2009. Over half of the warnings are for NHPs. What’s notable is that almost all of these products are not permitted for sale in Canada. Many are sourced from the United States, a country with virtually non-existent safety standards for supplements and natural health products. It’s unclear how reducing regulatory oversight will improve the safety of products sold in Canada.  It may keep the worst products off the shelves. And that includes products that are unsafe, or contain unlabelled drugs.

Quality Quality is not addressed in detail in the report, other than to suggest that organizations other than Health Canada should be given this responsibility. To a health professional regularly asked to advise on the appropriateness of NHPs, product quality is the fundamental issue:  There is no point discussing the clinical merits of a product if I cannot be assured that what is on the label is in the bottle.  Quality uncertainty with NHPs raises the risk of treatment – and that’s where my disclaimers came from. The NHP regulations will ensure manufacturing quality – this is the single biggest benefit of these regulations.  Without product quality assurances, health professionals and consumers cannot use NHPs in evidence-based ways.

Supply The report notes the possible consequences of regulation on manufacturers, and argues that small firms might not be able to compete in a marketplace with high regulatory standards for product quality, safety, and efficacy. Whether this is a problem depends on your perspective. If small manufacturers are unable to demonstrate safety, efficacy, and high manufacturing standards for the products that they sell, it’s unclear why this is a negative for the consumer. Is Canadian health care compromised by a lack of access to natural health products that cannot meet basic standards?  As a health professional, I’d rather see fewer products, with a strong assurance of quality and safety, rather than the uncertainty of the past.

The report concludes with a calculation that the NHP Directorate at Health Canada has cost about $9.1 million per year over its ten years of existence.  Based on estimate rates of adverse events and deaths, the author estimates it is costing $1.5 million per life saved and about $170,000 for each adverse event avoided. I would argue that given the uncertainty around the actual incidence of adverse events, and the size of the market (estimated at $4.3 billion in Canada), spending $9.1 million (0.2%) per year to regulate quality and safety provides reasonable value-for-money.

The Fraser Institute’s bottom line is that NHP regulation restricts consumer access to products that offer benefits, and costs more than it helps. I agree that regulation is pointless for one specific type of NHP: homeopathy. Health Canada’s inclusion of an elaborate placebo system into the NHP regulations is mystifying.  Once diluted sufficiently, all homeopathic products are the same thing: pure water.  Assigning distinct registration numbers to what are essentially all the same thing is a waste of resources. With respect to other natural health products, particularly herbal medicines, I disagree with the recommendation to eliminate the NHP directorate. However, I do accept that some consumers place a higher priority on access over any regulation of quality, safety, or efficacy claims. And this position is certainly in the best interest of those manufacturing NHPs, where it’s often framed as “health freedom”.

Freedom for Whom?

Advocates for health freedom argue that consumer choice is of greater importance than any regulation which might limit access by consumers. This argument seems to have found resonance with natural health products, which are typically positioned as as safe and effective (without any clear evidence of either). Health freedom seem to benefit the manufacturers of products much more than consumers: It’s unclear how consumers benefit from access to products when they have no assurance that the product is safe, effective, or even contains what it says on the label.  Steven Novella has discussed this topic in detail over at Science-Based Medicine, and notes,

Essentially, con artists, charlatans, and snake-oil salesmen have discovered that they can shield themselves from regulations meant to protect the public from their malfeasance by simply cloaking what they do in the flag of freedom.

They have found common cause with those who are sincere, but simply misguided – they believe that their treatments are effective and valid and are frustrated by the fact that they are not validated by science and do not meet the standard of care. Failing to win acceptance for their modality with research, they then dismiss the standard of care as biased against them, and seek to subvert it.

Even conservative author David Frum questions the lack of regulation (in America) of supplements and natural products:

Advocates for the herbal supplement industry justify their special sweet deal by championing the right of consumers to make their own “health choices.” Individual choice certainly sounds like the American way. But the fact is that most of us are not well positioned to make intelligent health choices. If we try to play our own doctor, we are going t o expose our health — and our money — to risk and exploitation.

Consider the current political activity from the Canadian natural health products industry around Bill C-6, which will tighten product safety requirements for consumer products. Critically, Bill C-6 excludes natural health products. Yet according to the Toronto Star, more than 500,000 emails have been sent to federal legislators protesting C-6, from those that believe it will eventually lead to greater oversight of natural health products in the future. Here’s a sign I spotted at the Whole Life Expo last month:

Noticed at Whole Health Expo

So while the  bill excludes NHPs, who exactly is concerned about NHP safety, enough to protest a product safety bill that doesn’t even apply?

Analysis

I see at least four different perspectives towards NHPs.

• Consumers want products that are safe, and labeled accurately. They may consult health professionals, or make their own decisions about whether the products are effective.
• Science-based health advocates argue that that product safety and quality are paramount, and efficacy statements should based on good science. They argue against lowered standards for products just because they’re deemed “natural”.
• Free market advocates question the value of most regulation that inhibits choice, emphasizing personal responsibility over government-legislated consumer protection measures.
• NHP manufacturers will generally seek a market where they face as few restrictions as possible, whether it be safety, efficacy, or quality.

Certainly, there is some common ground here.  Many will likely be agreeable to a regulatory framework that give consumer and health professionals assurance that they’re being protected from health fraud and dangerous products.  Free market advocates accept that markets operate less effectively when consumers cannot evaluate benefits and consequences (risks). And some manufacturers may welcome the regulatory verification of their own quality processes. With respect to health “freedom” claims,  I question if anyone anyone wants the ‘freedom” to be sold products that don’t contain what is claimed, or have not been evaluated to be safe.

To safely incorporate NHPs into science-based health care, we need assurance products are safe and of high quality. Herbal products stands out as the most likely to benefit from regulation. Herbals are just naturally-sourced, unpurified, drugs. Without standardization of active ingredients, it is impossible to infer anything about a particular herb. And without basic assurances of product quality and safety, the risk-benefit ratio tilts away from use. The Fraser Institute argues that this role could be performed by non-governmental, independent groups. (No mention is made of who should review efficacy claims.) Given Health Canada already has the role of approving efficacy claims and monitoring the safety of prescription and over-the-counter drugs, it’s not clear why another organization would be more capable of providing this function.

Conclusion

There should be a consistent standard of product quality and safety for all products sold in Canada, be they drugs or natural health products.  Considering natural products to be safe in the absence of any manufacturing standards and regulatory oversight does little for the health and safety of consumers, and limits health professionals from making evidence-based recommendations about their use.

The prolonged implementation period of the NHP regulations, and the continued rhetoric about “health freedom” does a disservice to Canadians seeking safe, high quality products. Until the regulations are fully implemented, and enforcement is taken against unlicensed products, questions will continue to be raised about the safety, quality and efficacy of natural health products in Canada.

For More Information / Related Reading

Barry Green of Ottawa Skeptics has written a series of superb articles on Natural Health Products:

Is Bill C-6 the new Bill C-51?

Natural Health Product (NHP) Regulation in Canada

Natural Health Products (NHPs) and Health Claims

An opinion piece on NHP regulation from the Canadian Pharmacists Journal. Comments are invited.

Interested in a perspective on American-style regulation? Terra Sigillata on conservative (and Canadian) David Frum’s call to Repeal DSHEA. And here’s Frum’s original paper, Herbal Remedies Need Real Scrutiny. And more form Terra Sigillata in the post Must people die before DSHEA is repealed? And even more on American-style (lack of) regulation for supplements: PalMD on The DSHEA is a travesty of a mockery of a sham.