Proposed NHP Changes in Canada: Bad Idea?
This is a topic of high interest to me, as it speaks to the free market access of health products in Canada. On Friday, Health Canada put out a consultation paper outlining their wish list of proposed regulatory changes in Canada. From what I can tell, no one likes this proposal.
The proposal came out of left field. I am told that Health Canada had high level briefings with trade associations (including CHFA and CHPC), but this was not what I would call a “consultation”.
In a nutshell, the proposal is seeking to combine the regulatory scheme for cosmetics, natural health products and OTC drugs, all into one system. Their reasoning is that, if products of the same inherent risk are making the same claims, they should be regulated in the same way. So far, not an unreasonable premise.
Manufacturing standards for quality would be required for all such self-care products (a new term), including cosmetics. No changes were discussed for GMP manufacturing standards for nhp’s, neither for drugs.
Cosmetics would be blended into the current nhp regulatory oversight, but it’s largely unclear how this would affect cosmetics. My take-away is that cosmetics would have to be notified (same as they are today), but would likely have to declare ingredients by exact concentration and such ingredients would have to be acceptable against a certain list. So, not only a negative list (like the current Hot List), but also against a positive list (like the NHP Ingredients Database). They may also require some kind of “tracking number” on the label to identify that they have been in fact notified. This suggests a pre-market notification process to me.
OTC drugs, from the proposal, appear unchanged. From what I read, OTC drugs would remain at their current licensing standards, however some lower risk OTC drugs may have a lower evidence burden for efficacy depending on the claim being made. For example, a very safe non-natural active ingredient claiming to treat acne, but which does not have a labelling standard or NNHPD monograph, may come to market with less evidence. But again, this is not discussed specifically in their proposal.
Natural health products (nhp’s), on the other hand, are where the real impact would be seen. Most of their proposal has to do with nhp regulation, and they are proposing to divide nhp’s into three “categories” – low risk, medium risk, and high risk. Sounds familiar, but it gets more intricate. Remember, the devil is always in the details – and if we are to learn anything from the 2004-2010 licensing crisis, it is always in the details.
First, their major proposed change is to redefine a health claim. As of Friday, their proposal is to effectively treat all non-restorative structure-function claims, non-specific health claims, and generalized health claims, as simply “claims” – not “health claims”. If this sounds familiar it should; this is the model in the USA under DSHEA. Basically, the proposal is that Health Canada would not review/license such claims, and their only oversight of claims would be what they are (now) calling “health claims” – claims for the treatment, prevention or diagnosis of diseases/conditions. Basically, a health claim is, under this proposal, a statement for improving something that is abnormal, diseased or unhealthy. A product that claims to simply “promote bone health” isn’t making a health claim, under this new interpretation.
This is a huge reversal of policy. Of the 100,000 or so nhp’s licensed on the market today, the vast majority of them are not making “health claims” in this new definition. Apparently they’re just making “claims”, and Health Canada doesn’t think they’re real. Not real enough to license.
In the past, Health Canada always struggled with this. After all, Health Canada in 2003-2004 decided to not create a third category of products and treat nhp’s as a subclass of drugs (according to the Food and Drugs Act). In the Food and Drugs Act, a drug is represented/sold for use in “restoring, correcting or modifying organic functions in human beings” as well as treating/preventing diseases/disorders. In theory, a drug could therefore be a product that simply “modifies an organic function”.
The Natural Health Products Directorate (NHPD, now called NNHPD) in 2004-2006 greatly struggled with the definition of a health claim. They were hesitant to license structure-function claims that were non-restorative, and they had a terrible time with so-called generalized health claims (or non-specific health claims) such as “promotes bone health”. It is my opinion that the licensing crisis of 2004-2010 – when the NHPD had a backlog of over 12,000 applications and made no progress through it – was absolutely based on their inability to define what constitutes a health claim.
The NHPD, under Scott Sawler, in 2009-2010 proposed sweeping changes to the regulation of natural health products, and started allowing simple and non-specific claims based on a fair level of evidence. This cleaned up the backlog, and allowed almost every product on the market to achieve a licence (called a Natural Product Number).
For my industry colleagues who fought this good fight beside me, we fought this battle alongside the CHFA and lobbied extensively to “save our natural health products”. Our message was that we are not drugs – and can’t be treated as drugs. We don’t want to be drugs. We want the ability to make claims, to come to market when there is no safety risk, and let consumers decide for themselves.
The other important proposal here is that, should a product make a claim that is not a health claim, they have to include some kind of disclaimer on the label. Something similar to what we see in the USA, I would imagine (e.g., “Health Canada has not reviewed the statements made about …”). Basically Health Canada is saying that they don’t think consumers understand these claims, and/or they don’t feel there is any real scientific evidence to substantiate them. The claim “Promotes bone health” in their minds is not something they want to be a part of. They want consumers to decide on their own – do their own research, they say – and their way of telling consumers to do this, is to put a disclaimer on the label.
Before I get into more about claims, let me also put out their other proposals, which are equally troublesome. First, they want to introduce cost recovery fees finally – we all knew this was coming, and probably it will be hard to stop them from doing this. So, today there are no review fees for getting an NPN – but in the near future it could cost $1000 to $2000 per product – or more, depending if it’s medium or high risk. An OTC DIN fee is around $1700 per SKU.
Perhaps the most troubling, though, is the re-emergence of inspectorate powers. Health Canada wants the legal right to force a company to recall an nhp, and to have higher powers of penalty and inspection. If this sounds familiar, it should. In 2008 the government announced Bill C-51 which would do just this. There was such a tremendous uproar from the health products industry, that they backed away. At the time, Minister Tony Clement came under intense heat over the bill (interviewed for Alive Magazine here). CHFA helped organize a campaign. So, here we go again. Perhaps the Liberals don’t remember the old bill.
If It Ain’t Broke
There’s an old saying, “if it ain’t broke, don’t fix it”. Apparently Health Canada thinks something is broken and wants to fix it. So, what’s broken?
Health Canada says they did a survey in April this year from 2,500 Canadian consumers asking about how “informed” they feel when purchasing nhp’s, cosmetics and OTC drugs. As stated in the consultation document (though I have not seen the actual survey results), only 19% considered themselves well informed when purchasing nhp’s, compared to 29% for cosmetics and a whopping 37% for OTC drugs. Health Canada did not outright say this, but they should have – it really doesn’t seem to matter what category of self-care product it is, Canadians don’t feel well informed. Is 37% for OTC drugs staggeringly low? So, basically, one in 3 Canadians buying cold medicine don’t feel well informed? And only one in five feel well informed about natural health products?
But again, this is not something that’s broken. Canadians, like most people in the world, don’t read labels. But that has to be true for toys, a bed for my kid I bought from Ikea, or the toaster that absolutely warns me not to stick my fingers in the bread holes. Consumers are confronted with massive amounts of information every day – and, frankly, it’s tiring to read. I would say we’re all sick of reading.
I have an issue with how Health Canada put out their consultation paper. They say they want feedback from stakeholders (including consumers), but they’re not presenting us with the survey results. They didn’t even present us with the statistical analysis. Was there a statistically significant difference in the group of responses for the 19%, 29% and 37%? Were there between-group differences? We don’t know. They didn’t tell us.
29% for cosmetics and 37% for OTC drugs. Let’s assume there was no statistically significant difference (i.e., no meaningful difference) between these, which means Canadians feel pretty much just as informed about buying cosmetics as they do about buying OTC drugs. Why is that? OTC drugs come with a hefty amount of literature with the product. Despite this, Canadians feel just as informed?
They don’t read labels. Period. But please, Health Canada, treat us like intelligent people and provide us with the data and statistical analysis to make a real decision on your survey.
Even if the results were statistically significant, why would this be a problem? If only 19% of Canadians feel “well informed” when buying an nhp, what’s the harm? I mean, how much do any of us really know about the products we buy? Are we putting ourselves in danger? Is that multivitamin going to give me cancer? What’s the risk in Canadians making uninformed decisions when purchasing nhp’s? After all, Health Canada has assessed the safety at minimum.
Last week I bought a box of pens and none of them worked. The label didn’t stop me from buying them, and I’m out a few bucks. Should Health Canada protect me from making bad purchases?
Many of the claims currently on nhp products are hard to gauge efficacy anyways. “Promotes cardiovascular health” is a great claim – but hard to prove based on the level of data Health Canada would want for a drug. But where’s the harm?
Health literacy has, time and time again, proven to be a stumbling block for Health Canada. Their only tools for regulating health products are (1) allowing/prohibiting them; or (2) dictating what appears on the label. Canadians likely expect all products allowed on the market to be safe (right or wrong), but if their only other tool it seems is labelling.
Does changing the label content really improve health literacy? If a product had a claim “promotes bone health” and then also a disclaimer that the claim wasn’t reviewed by Health Canada – would this improve how “informed” they were about making the purchase? I am saying no, it makes no improvement. In fact, I am saying that it would make it worse. Now there’s a claim that can be made without any review and Health Canada is saying they haven’t reviewed it. Sounds worse. And the disclaimer would be in both French and English, I would imagine, so here’s even more crowded label. Crowded labels are probably read even less.
Surely Health Canada has more creative ideas on improving health literacy for self-care products, other than slapping a disclaimer on the label. If Canadians are ill-informed about products they are buying, is this the government’s role to improve this? Again, what’s the harm? If a consumer decides not to read the label or do their own research – and is much they can find out themselves should they desire – shouldn’t this be their choice? Should our government protect us from our own ignorance and poor decision making?
We’ve Been Here Before
The truth is, we fought this battle years ago and thought we found a cease fire. The NHP Regulations and NNHPD guidance documents as they are today, do in fact allow for most products to come to market with some kinds of claims suggesting to the consumer what the product is for. Overall it’s fairly good.
But we’ve been here before. We fought hard to have the kind of regulatory oversight we have today, and in my opinion the system is world class. No other country in the world – and I know, because we consult for all major markets – has the kind of system that Canada has. We are a world class regulator. With the exception of lack of on-site audits for quality standards (which I would welcome), the system works.
Moving to a DSHEA kind of approach is a step backwards. If anything, consumers will be even more confused with the disclaimers, and with products suddenly not having licences. Consumer confidence in health products in general would diminish. So suddenly the government feels these claims aren’t legitimate? – even though they approved them in the past?
I had thought this issue would be behind us, but this is a powerful reminder that as an industry we need to keep watch.
Gaps and Holes
In addition to the proposal being unjustified, as detailed above, there are glaring holes in their proposal. For example, would low-risk products need to be imported by a site licence holder? Or could anyone import them for resale? What happens to the NPN that was obtained legitimately in the past? – would it suddenly be worthless?
What if a manufacturer wanted to make a real health claim on a so-called low-risk product? For example, a prevention claim for a calcium product? The proposal suggests they wouldn’t allow this. No health claims for low-risk products.
Or what happens if a medium risk formulation (risk is based on the composition, remember) wants to make a treatment claim? Or what if a high-risk formulation (based on composition) wants to make a softer claim?
What type of “science” would they suddenly require for the high-risk category of products? For example, safety studies on the finished product (similar to drugs)? Product-basd efficacy? Double blind randomized controlled trials for a claim such as “Prevents gingivitis”?
In the licensing crisis of 2004-2010, the major problem was the standards of evidence for efficacy (making health claims). This proposal doesn’t mention what the standards would be. However, I would guess they would be closer to the OTC drug standard, which is quite high. So now, if you want to make a real health claim, you’re pretty much coming to market with an OTC drug.
Based on my talks with clients and industry associations, this proposal will die almost as soon as it started. It was so poorly conceived, with such short-sightedness (and forgetfulness of past mistakes), that backlash will be strong. Larger pharma companies I know from fact are also not pleased with this – and the major cosmetic companies are dead against this.
If we see any kind of regulatory change, I am guessing the only aspects of this that will survive are introducing review fees, cosmetic notifications being managed by NNPHD (new name now? NNCHPD?) but remaining largely the same, and perhaps a greater emphasis on quality inspections at the manufacturing level (which we’re already seeing). Otherwise, there is nothing else here that the industry will accept.
If the industry takes a back seat through all of this and does not act, the following could happen:
- Some 80% of marketed products (and almost all cosmetics) would need to change their labels, especially by adding a disclaimer about non-licensed claims.
- Products already with an NPN but now deemed high risk, will have to renew their NPN’s under the new framework. Likely they will do this by allowing them to keep their NPN’s but making the NPN’s expire, and the new standards would apply at renewal.
- Many products would simply disappear from the market, either from ineligibility under the new standards for high-risk products, or else suppliers would lose confidence in the future of the market.