Tag: Medsafe

Then and Now: The New Zealand Complementary Medicines Industry

Supplements

In 2007, the Ministry of Health undertook a review of the “complementary medicines industry” in New Zealand, and found that a significant majority of companies weren’t complying with consumer protection legislation.

The review was never made public, but when I saw it mentioned in a recent article in North & South magazine I asked the ministry for a copy. It has been released to me under the Official Information Act.

Since it was written in 2007, both the industry and the regulations have undergone changes, so the review’s findings won’t be accurate now. However, I think it’s worthwhile looking at it to get a general understanding of the relationship between this industry and its regulators.

North & South June 2015

The June edition of North & South has published an article that Peter Griffin and I co-wrote about the implications of a recent Press Council ruling. Excluding letters to the editor, this was the first time something I’ve written has appeared in mainstream print media. Filled with vain excitement, I purchased a magazine for the first time.

When I saw the cover of this issue, promoting a story by Donna Chisholm entitled “Truth (and Lies) About Supplements”, I realised that it was a much better reason for me to buy this magazine than just to see my own name in print. I wasn’t disappointed either, the story is a great summary of the issues surrounding supplementation, and it’s written from a New Zealand perspective. I’d recommend that everyone interested in this topic pick up a copy of North & South to read it.

This is something I’m interested in so I already follow the news on this topic. A lot of what was discussed in the article I’d already seen, but there was also some very interesting stuff in there that I’d never heard anything about before. One of those things was a review of New Zealand natural health websites that the Ministry of Health undertook in 2007, apparently finding that nearly 80% of them were not complying with the Medicines Act:

[Natural Products NZ executive director Alison] Quesnel’s confidence in the veracity of claims made in New Zealand may also be misplaced. A Health Ministry review of 263 industry websites in 2007 found nearly 80 per cent making illegal therapeutic claims. A later “compliance awareness programme” discovered that more than half the ads on websites for natural products made therapeutic claims, with a third of the websites making “high-level” claims.

Chisholm, Donna (2015). The Truth (and Lies) About Vitamins. North & South, June, p41

When trying to find this review online, the closest I could find was a Regulatory Impact Statement that the Ministry of Health published in 2010, about “The Development of a Natural Health Products Bill”. This document doesn’t contain the review, it only references some of its results.

After Donna Chisholm told me that she found the information from her article in this document but didn’t have a copy of the review, I contacted the Ministry of Health to ask if it was available anywhere online, and if it wasn’t if they could send me a copy. They interpreted my email as an Official Information Act request, and within a couple of weeks the report appeared in my inbox.

EDIT 2015/05/31 3:44 pm: As Thomas Lumley has pointed out in the comments, they were entirely correct to interpret it in this way. I just hadn’t thought of it as an OIA request at the time.

Usually I use the great website FYI to make OIA requests. It’s a great service which I’ve mentioned before, that allows OIA requests to be made in a way that makes both the request and the response public. It was relaunched this year with sponsorship from the New Zealand Herald. This time, however, I didn’t realise at first that my email would be interpreted in this way, so the request and response aren’t hosted on FYI.

However, I have uploaded the report and made it available here: Overview of the New Zealand Complementary Medicines Industry. I found it quite interesting reading, and a bit disappointing that it was never released publicly until now, when it’s 8 years old. Please keep that in mind when reading it.

The report gathered information on businesses operating in this industry to produce estimates about the industry as a whole. The report includes information like the proportion of companies of various sizes (e.g. < 10 employees). Once again, remember this report is 8 years old at the time I’m writing this, so the state of the industry has certainly changed since then.

The section which I found most interesting by far is, of course, Non-Compliance. Here’s the blurb for that section (the emphasis is mine):

Of the companies where it was possible to obtain specific details about their products, an assessment was made of the level of non-compliance with the current Medicines Act (1981) and the Dietary Supplements Regulations (1985). Non-compliance was defined only on the basis of the presence of therapeutic claims associated with the product and no attempt was made to determine any other aspect of non-compliance e.g. the presence of scheduled medicines. Dietary supplement-type products (intended for oral use) carrying therapeutic claims and other products (including foods, cosmetics and complementary medicines) carrying therapeutic claims (i.e. unlicensed medicines) all came under the umbrella of “non-compliant”.

Medsafe. (2007, August 29). Overview of the New Zealand Complementary Medicines Industry.

Any product that is promoted with therapeutic claims as defined in the Medicines Act (this definition was updated in July 2014) is considered a medicine for regulatory purposes. I’m not a lawyer, and I’ve never been involved in the approval process for a medicine, but my understanding is that means it needs to go through a process that requires rigorous evidence to support its safety and efficacy, then before it can be sold it must be approved by the Minister of Health.

This is why products that haven’t gone through this process but still have therapeutic claims made about them are “unlicensed medicines”. Because the claims make them medicines for regulatory purposes, but they have not been approved. They might do what they’re claimed to do or they might not, but what they have in common is skirting the regulations that require them to back up claims of safety and efficacy.

It also means that the same product could be treated as an unlicensed medicine in one context but be perfectly acceptable in another. For example, if I advertise bananas as a cure for cancer, then that’s an unlicensed medicine. If I advertise bananas as a tasty fruit, that’s perfectly acceptable.

The review reported the number of compliant vs. non-compliant products found, as well as companies with and without non-compliant products:

Number of Non-compliant Products
Non-Compliant 6253 (51%)
Compliant 6008 (49%)
Total no. products found 12,261
Number of Companies with Non-compliant Products
No. of companies (%)
Compliant 58 (22%)
Non-compliant 205 (78%)
Total no. companies 263

To get some rough idea of the completeness of this review, the Ministry of Health’s natural health products bill regulatory impact statement I mentioned earlier, which I believe was written in 2010 and is an interesting document to read, estimates that there are around 6,600 products and 450 companies in total. However, they also noted that the estimate of 6,600 products might be a significant underestimate and that the real number might have been as high as 20,000.

The regulatory impact statement describes this as “A systematic review of websites undertaken in March 2007”, and gives some examples of non-compliant claims:

Examples of low level claims included claims for providing relief from the symptoms of arthritis or psoriasis, relieving the symptoms of seasonal allergies such as hay-fever, relief of pre-menstrual tension, or temporary relief of the pain of gout, headaches or migraine. Higher level claims included claims for preventing, treating or curing serious diseases, such as cancer.

Ministry of Health. (2010). Regulatory Impact Statement. The Development of a Natural Health Products Bill.

The review broke down the level of non-compliance into low and high severity, and reported the average for different companies:

The severity of non-compliance was also assessed. The severity of non-compliance was based upon the type of therapeutic claims being made by the company for their products and was divided into either high (claims of efficacy about a product for serious diseases and conditions including cancer, depression, diabetes etc.) or low (therapeutic claims likely to be appropriate for a low risk medicine). An “average severity” of the therapeutic claims made be [sic] each company was grouped into low or high.

Medsafe. (2007, August 29). Overview of the New Zealand Complementary Medicines Industry.

Severity of Non-Compliance per Company
Average severity of non-compliance No. of companies (% of total)
Low 144 (74%)
High 50 (26%)
High for >80% of products in catalogue 26 (10%)

The type of product was also reported for non-compliant products:

The non-compliant products (i.e. those carrying therapeutic claims) were further subdivided into cosmetic, food, dietary supplements and complementary medicines to provide some information about the types of products that were non-compliant. Cosmetics included products which were intended to have a primarily cosmetic purpose eg. moisturisers with anti-aging claims and food included products consumed in a normal diet such as fruit drinks carrying therapeutic claims. Dietary supplements included vitamins and minerals and products generally meeting the definition of a dietary supplement according to the Dietary Supplements Regulations 19851 apart from the claims made. Complementary medicines included products that did not fall into any of the above categories, including creams and balms with no primary cosmetic purpose and herbs with a traditional history of use as a medicine.

1 Dietary supplement means any amino acids, edible substances, foodstuffs, herbs, minerals, synthetic nutrients, and vitamins sold singly or in mixtures in controlled dosage forms as cachets, capsules, liquids, lozenges, pastilles, powders, or tablets, which are intended to supplement the intake of those substances normally derived from food.

Medsafe. (2007, August 29). Overview of the New Zealand Complementary Medicines Industry.

Unsurprisingly, as this was a review of the “complementary medicines industry” and “complementary medicines” was the catch-all category, most non-compliant products were in that category. I’m not sure why the total number of non-compliant products is lower than the 6253 non-compliant products reported earlier in the review.

Areas of Non-Compliance
Number (% of total)
Cosmetics 250 (5%)
Foods 252 (5%)
Dietary supplements 1357 (27%)
Complementary medicines 3170 (63%)
Total number of non-compliant products identified 5029

This was all 8 years ago, so what’s happened since? I don’t have any comparable data on how the state of the industry compares to these results today, but the Regulatory Impact Statement document I’ve mentioned a few times offers some insight here. Here’s what was done following this review:

In a subsequent compliance awareness programme, the websites reviewed contained advertisements for over 12,000 products with just over half of these advertisements including therapeutic claims. Out of 355 websites reviewed as part of this programme, 107 were found to be making high-level claims.

Ministry of Health. (2010). Regulatory Impact Statement. The Development of a Natural Health Products Bill.

Miracle Cure!

That’s roughly 30% making high-level claims, which is higher (although possibly not significantly) than the 26% found in the review. Overall non-compliance is “just over half”, compared with 78% from the earlier review. So it’s not entirely clear what impact this “compliance awareness programme” had, but if I had to guess based on what information I have it seems it may have resulted in some low level claims being removed but had no effect on high-level claims.

I asked for this in my OIA request as well, but no written report was prepared so I was just sent the raw data. Unfortunately, this came in the format of a spreadsheet saved as a PDF. It’s text searchable, but given the format and inconsistencies with how results are reported within the file it’s not easy to tell what it says about the industry overall. Also, presumably as it was only ever intended to be an internal document, it contains some strange stuff. For example, it reports Deer Velvet NZ as having 3 out of 1 non-compliant complementary medicines and notes that Crombie and Price “Have homeopathic lollipoops for kids”, whatever that might mean.

You can look at the data yourself here: Compliance of complementary medicines manufacturers 2 October 2007

EDIT 2015/05/31 5:48 pm: Thanks again to Thomas Lumley, who pointed out on Twitter that the open source software Tabula is able to pull the data out of that PDF and turn it into a CSV. I’ve made a CSV version created with Tabula available as well. Here’s a link to it on Google Drive, note that Drive doesn’t display large CSVs very well but you can download it or, if you’re signed in with a Google Account, open it as a Google Spreadsheet: Compliance of complementary medicines manufacturers 2 October 2007

The Regulatory Impact Statement document also has a section on “Compliance and enforcement difficulties” which I found very interesting (emphasis mine):

It has long been recognised that the regulation of natural health products is inadequate and working on achieving new legislation has been underway for close to 20 years. Because new legislation has been anticipated, only limited amendments have been made to update existing legislation, and enforcement activities have largely been limited to dealing with the most serious breaches, such as promoting a product as a cure for cancer when that product is not an approved medicine, or supplying a product that purports to be a dietary supplement but contains undeclared ingredients that are prescription medicines.

Enforcement actions usually arise following investigation of a complaint or concerns about product arriving at the New Zealand border. Enforcement is complicated because the interface between the Medicines Act and Dietary Supplements Regulations is not clearly stated. As a consequence it is usually unclear whether non-compliance should be dealt with under food or medicines legislation. The outcome is generally destruction of product or removal from the market, rather than prosecution. The penalty for non-compliance is extremely low ($500) in comparison with similar legislation and does not act as an effective deterrent.

Enforcement of the Dietary Supplements Regulations has long been problematic due to the large number of breaches relating to the prohibition of therapeutic claims. Past attempts to raise awareness and enforcement of the legislation relating to natural health products met with resistance from both suppliers (who fear they will lose sales) and consumers (who fear they will lose access to products they consider are important to their health and well-being).

There is no provision in the Regulations for a register of dietary supplement products or suppliers. Hence it is difficult to trace suppliers and take appropriate action to protect the public from harm when safety issues arise.

Ministry of Health. (2010). Regulatory Impact Statement. The Development of a Natural Health Products Bill.

This was written 5 years ago. In that time, new legislation has continued to be anticipated: the Natural Health and Supplementary Products Bill was introduced in September 2011 and passed its second reading in March 2013, but hasn’t progressed since then. Throughout this period, enforcement of consumer protection legislation to prohibit misleading therapeutic claims has remained very low. Even in cases where I’ve submitted complaints, months have often passed before any action was taken by Medsafe.

This makes it sound like the sooner this bill passes, the better. But if the Natural Health and Supplementary Products Bill passes in its current state, it will allow “traditional evidence” to be used to support health claims. It defines this essentially as evidence of use:

traditional evidence means evidence of traditional use of a substance based on knowledge, beliefs, or practices passed down from generation to generation

Natural Health and Supplementary Products Bill 324-2

On the other hand, the bill also requires that summaries of the evidence used to support health claims be provided on a public website in section 13(2A):

Before completing the product notification, the product notifier must make available on an Internet site, in respect of each health benefit claim made for the product, a summary of the evidence that the product notifier relies on to support the claim.

Natural Health and Supplementary Products Bill 324-2

I think that part of the bill is fantastic, but I don’t think it will be directly useful to consumers. Surely only a very small minority of consumers will bother to go online to check what evidence is used to support health claims. In cases where claims are supported only by evidence of traditional use, I think a large number of consumers could be misled, and that seems to me like a pretty big loophole in a piece of legislation intended to protect consumers from misleading health claims about “natural health and supplementary products”.

I hope that the bill will pass soon, so that the “natural health” industry will not continue to be effectively unregulated as it has been for years, but I also hope that before this happens the bill will be fixed so that the only evidence permitted to support health claims is evidence that actually supports those health claims.

An Example of Some Advertising Tricks

By definition, when it comes to telling the truth, advertisers have a conflict of interest. They want you to buy whatever they’re advertising, so they’re going to try to show it in its best light. Often, this means using psychological tricks, and these tricks generally work best when consumers aren’t aware of them.

For example, most people are aware that the reason why products cost $39.90 instead of $40.00 is that they sound significantly less expensive, even though the difference is miniscule. Consumers tend to be aware that advertisers are prohibited from “false advertising” – they can’t tell us anything that isn’t true – and that advertising is regulated. This tends to give us a sense of security when it comes to taking advertisers at their word. Unfortunately, there are a lot of ways in which medical advertisers in particular can, and do, take advantage of this.

In today’s edition of my local newspaper, there was a full page ad placed by “The Natural Health Co”. This advertisement contains a lot of these tricks that can be used by medical advertisers to mislead consumers without technically breaking the rules, so I thought I’d use it as a case study to point out some of these tricks.

First thing’s first, here’s the advertisement:

image-Z111804-0001-page-001

The most common trick is one that I’ve written about before. The industry regulators of medical advertisements in New Zealand draw a distinction between “therapeutic claims” and “health claims”. Although they sound very similar to the consumer, the important difference is that the advertiser is only required to substantiate therapeutic claims. Any health claims they make can be entirely unsubstantiated and, to my knowledge, if they’re false there is no penalty. To quote the guidelines:

Health Claims are defined as claims which support the normal physiological function.

An example of a health claim made in this advertisement is “Supports cardiovascular health”, which is said for a couple of products in this advertisement. As far as I can tell, the reason why advertisers are allowed to make these claims without oversight is that they are not well-defined, and claims like that technically just mean it won’t interfere with normal physiological function, i.e. what would happen anyway in a healthy person.

So, when this advertisement says a product “Supports muscular and nervous system health”, you should interpret it as saying “This product will not interfere with your muscular or nervous system health if you’re already healthy”, and as far as I know they’re not even required to have evidence to support that.

That’s why advertisers can get away with saying that glucosamine and chondroitin supplements work “for maintenance of healthy joints”, despite the fact that statements that these substances have beneficial effects on joint health do not seem to be strongly supported by quality evidence.

Another trick used by these advertisers is making a point out of what is contained in the product. This allows the consumer to draw certain conclusions without the advertiser having to suggest them directly. It’s important to remember that advertisers will always put their best foot forward. If there’s evidence to show that a product has a beneficial effect, then they will say that instead of only saying “Potent antioxidant”.

Most people think they understand what that means (it’s good for you, right?) but, unfortunately, most people also lack the medical expertise required to make good health judgements, and are easily influenced by information like this.

I expect that’s the main reason why health-related testimonials in medical advertisements are prohibited by section 58(1)(c)(iii) of the Medicines Act 1981. Unfortunately, Medsafe seems extremely apathetic when it comes to enforcing this; I’ve contacted them about numerous violations but as far as I can tell they’ve never done anything about them. While it seems intuitive that more information is better, some types of information tend to lead to misinformed health decisions, and testimonials are foremost amongst these.

There are a lot of examples of marketing tricks used in this advertisement. I wouldn’t be surprised if there’s not even a single piece of useful information about the therapeutic properties of one of these products that is backed up by any evidence at all.

Feel free to point out more instances of marketing tricks in this ad, or mention others that you’ve seen in medical advertisements. Unfortunately, “health claims” are almost everywhere in medical ads in New Zealand. Keep an eye out for the word “supports”, as it’s usually a strong indicator that they’re making a health claim and therefore likely don’t have evidence to support it.

How to Read Medical Advertisements

Lately, I have been familiarising myself with how medical advertisements are regulated here in New Zealand. In doing this, I have come to realise that regulatory bodies do not always interpret advertisements in the same way as I would expect the public to interpret them.

This sort of discrepancy can be, and frequently is, exploited by advertisers of medicine, both legitimate and less so. While it may be in the advertisers’ interest to have these differences in interpretation as it allows them to mislead the public about the effectiveness of their product, for the exact same reason it is not in the best interest of consumers.

In this article I describe how advertisers and regulators appear to interpret medical advertisements, and the implications of their interpretations. I hope that understanding this might enable others to understand what these ads are really saying. It is my sincere hope that, after reading this, you will never look at another medical advertisement in the same way again.

The first step I took in this project was familiarising myself with the codes of the Advertising Standards Authority (ASA), particularly those relating to therapeutic products and services. Their codes for weight management and ethics were also relevant. Based on these, I’ve submitted 11 complaints to the ASA since my first complaint last year, and I have more drafts that haven’t been submitted yet for various reasons.

As well as looking through the ASA’s codes, I’ve searched through previous decisions made by the Advertising Standards Complaints Board (ASCB) so I might better understand the codes’ application. The ASA website lets you search decisions from 2006 onwards, but older decisions can still be found by searching on Google within 203.152.114.11*.

If the ASCB decides to uphold a complaint, they request that the advertiser voluntarily withdraw the advertisement. As far as I am aware, it is at least very uncommon for an advertiser to refuse this request (the ASA website states that “This request is invariably followed.”) but the ASA does not have any actual legal authority with which they can enforce their decisions and they are unable to investigate breaches of the law as they only have jurisdiction over their codes.

When it comes to statutory regulation, Medsafe (part of the Ministry of Health) administers the Medicines Act 1981 and Medicines Regulations 1984, and the Commerce Commission enforces the Fair Trading Act 1986. For the most part, however, the advertising industry regulates itself via the ASA.

In reading past ASCB decisions about therapeutic advertising, I noticed that the ASCB frequently recommends the use of “TAPS”, the Therapeutic Products Pre-vetting System. Information on TAPS is available on the Association of New Zealand Advertisers (ANZA) website: TAPS.

Unfortunately, and somewhat counterintuitively, TAPS seems in practice to serve the opposite purpose of the ASA. The ASA and their codes mainly focus on protecting the consumer, particularly from misleading claims. In contrast, TAPS seems to focus on allowing advertisers to make whatever claims they want without running afoul of the ASA or the law. To see an example of this, see TAPS guideline 13, Examples of Health Claims in contrast to Therapeutic Claims Digestive System.

In this guideline, TAPS details the difference between a “therapeutic claim” and a “health claim”. “Health claims” are defined within this guideline as…

claims which support the normal physiological function.

“Therapeutic claim” essentially has 2 sets of definitions. One can be found within the ASA’s Therapeutic Products Advertising Code and the other in the Medicines Act 1981. The ASA defines “Therapeutic Use”, where a therapeutic claim is a claim for therapeutic use. Medicines Act defines “Therapeutic Purpose”, where a therapeutic claim is a claim for a therapeutic purpose. Both of these sets of definitions are fairly broad.

The ASA’s Therapeutic Products Advertising Code defines therapeutic use as…

Therapeutic use

  1. means use in or in connection with:
    1. preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in humans;
    2. influencing, inhibiting or modifying a physiological process in humans;
    3. testing the susceptibility of humans to a disease or ailment
    4. influencing, controlling or preventing conception in humans;
    5. testing for pregnancy in humans; or
    6. the replacement or modification of parts of the anatomy in humans; and
  2. includes any other use which the law provides shall be treated as a therapeutic use for the purposes of the code; but
  3. does not include any use which the laws provides shall not be treated as a therapeutic use for the purposes of this code.

The Medicines Act defines a therapeutic purpose as…

Meaning of therapeutic purpose
In this Act, unless the context otherwise requires, the term therapeutic purpose means—

  1. treating or preventing disease; or
  2. diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition; or
  3. effecting contraception; or
  4. inducing anaesthesia; or
  5. altering the shape, structure, size, or weight of the human body; or
  6. otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way; or
  7. cleaning, soaking, or lubricating contact lenses.

TAPS guideline 1 – Therapeutic Claim/Purpose – has this to say about whether or not products are to be considered medicines:

Whilst natural, herbal, marine and dietary supplement products are not classified as medicines they would come under the Medicines Act for two reasons that might not be obvious. This means that certain herbal or dietary supplement products would be deemed to be a medicine for two reasons. This is because of a) a therapeutic claim as per the Medicines Act or b) the ingredients in the product which could be classified as a medicine under the Classification of Medicines

I’m not a lawyer, and in reading through the Medicines Act I haven’t been able to determine which section in particular causes this outcome. If anyone is able to shed any more light on this I’d be very grateful.

What I get from this, though, is that any advertisement that includes a therapeutic claim as defined in section 4 of the Medicines Act (quoted above) should be treated as a medical advertisement.

The guideline goes on to describe how advertisers can effectively circumvent this (emphasis mine):

a company may still advertise a product without getting consent [from the Minister of Health] and without a “therapeutic claim”. Essentially there is leeway for certain health or nutritional claims or statements relating to the normal physiological or biochemical function. This is covered generally by such statements as “assists or supports the normal physiological function”. Even terms like “enhancement” “fortify” and “improvement” would need to be used with care and would generally be a problem, as they imply an improvement or acceleration to the normal function. Often it is a simply a question of wording. For example, a statement such as “provides nutritional support for a healthy immune system” escapes therapeutic specificity whereas, “prevents, treats or cures flus or viruses” attracts liability and would be prohibited under the Medicines Act.

Here are some examples of “health claims” from TAPS guideline 13, which it claims “would not breach the Medicines Act”:

Aids healthy digestion

Helps restore normal bowel flora

Aids normal bowel function

According to TAPS, at least, none of the above claims would qualify for a therapeutic claim. This means that they would be considered to not require substantiation. For this reason, it is of the utmost importance for consumers to be able to distinguish between a therapeutic claim and a health claim. Therapeutic claims in advertising are required both by law and by industry regulations to be substantiated, whereas it seems health claims may be freely made without any supporting evidence whatsoever.

TAPS approval for an advertisement is something that the ASCB considers when an advertisement has been complained about, but it is not enough to prevent a complaint from being upheld. Here are some examples of previous ASCB decisions in which a complaint was upheld due to a breach of the Therapeutic Products Advertising Code despite the advertisement having attained TAPS approval:

Given the recommendations in the TAPS guidelines, it should be reasonable to assume that any advertisement with TAPS approval which makes health claims instead of therapeutic claims does so because it would be unable to substantiate those claims if a complaint were submitted to the ASA. It’s also likely that any claims containing a modifier such as “may” or “could” will be similarly unsubstantiated.

Advertisements with TAPS approval may cite a TAPS approval number, but as far as I’ve been able to find this gives no more information than that the advertisement has been approved, as there is no publicly accessible database of TAPS approvals and their details that I have been able to find.

Many complaints have not been upheld by the ASCB because the advertiser successfully managing to convince them that no therapeutic claims were made, even though the advertisement contains content likely to be interpreted by the public as a therapeutic claim. For example, take this complaint: 07/113 – BioMag Television Advertisement, which was not upheld by the ASCB.

For those of you unfamiliar with this product, it’s a magnetic underlay for your bed that is apparently intended to relieve pain. Here are some statements from a Woolrest Biomag NZ representative in response to complaint 07/113:

I have never said “underlays increase circulation“, on television. In fact I haven’t mentioned the word circulation this year, and in previous years under TAPs [sic] guidance I have only ever spoken of “supporting circulation“.

The word arthritis has never been used in our TV ads, in fact we do not refer to any specific pain conditions and never have.

[The complainant] also alleges we say the BioMag relieves pain. This is wrong. We are always careful to say it “could” relieve pain, as indeed tens of thousands of our clients can attest.

This sort of behaviour is representative of advertisers of products like this when responding to ASA complaints. Typically, their defense relies on convincing the ASCB that their advertisement contains no therapeutic claims, as opposed to providing substantiation for the claims they’ve made. For another example, see complaint 12/393, which I’ve already mentioned in the list above as having been upheld despite TAPS approval. The advertiser’s response to this complaint rested on the argument that no therapeutic claims were contained within the advertisement. In this case, the ASCB disagreed and, as the claims had not been substantiated, the complaint was upheld.

There are 2 main ways in which advertisers avoid the use of therapeutic claims.

First, by making “health claims”, which sound like therapeutic claims but tend to be technically meaningless (what the TAPS guidelines have called “escaping therapeutic specificity”). For example, a claim that a product “supports normal immune function” sounds as though it means it supports or improves immune function, but the advertiser could defend the claim by saying that by specifying that it supports normal immune function it does not imply that any physiological process is affected and therefore does not constitute a therapeutic claim.

Second, by using language in such a way as to not make an “absolute” claim. Often this involves qualifiers such as “may” and “could”, but it can also include words that normally would seem to imply therapeutic claims to the public, such as “supports”. For example, the complaints board decided not to uphold complaint 12/402 based partly on this:

Turning to the other claim that “the base of apple cider vinegar … assists your body in breaking up the mucous associated with winter ills and chills” the Complaints Board said the word “assists” was not an absolute claim.

Because of this, when reading, watching, or listening to a medical advertisement it is important to do a few things to make sure you are not misinterpreting it:

  • Identify “health claims”, as opposed to “therapeutic claims”, and realise that they most likely have not been substantiated.
  • Interpret every positive claim in the most conservative way possible. For example, if a product “may reduce pain”, it probably means “may not reduce pain, and hasn’t been proven to reduce pain”.
  • Interpret everything literally. Exaggeration and “puffery” are typically not allowed in medical advertisements, so you shouldn’t need to worry about misinterpreting something in this way. For example, if a product “helps resist winter ills and chills”, this does not mean “helps resist colds and the flu”. This also means that “supporting normal function” does not mean “supporting function”, as “normal function” refers to function when not interfered with.

Expect advertisers to always put their best foot forwards. If they are allowed to say their product “relieves cold and flu symptoms” then that is what they will say. If they say something like “helps you overcome winter ills and chills naturally” instead, it’s likely because they are not allowed to make the former, more definite claim.

Here are 2 examples of advertisements that are misleading yet manage to escape regulation.

1. Eken power bands: Golf Centre | Your Chemist

ASA complaint 12/393, already mentioned twice above, was upheld because an advertisement for this product implied unsubstantiated therapeutic claims:

Designed to assist with Strength, Balance, Flexibility, Endurance

Now that they cannot make such claims, the advertisements listed above instead simply list the same attributes without any description. It is still implied that the product is intended to improve the attributes, but not in such a way as a complaint would be likely to be upheld.

2. Detox foot patches: GrabOne

ASA complaint 12/502 was settled after someone complained that “the advertisement contained false and misleading claims that were not supported with evidence”. In response to this, the advertisers changed the advertisements so that the same false, misleading, and unsupported claims are still implied but are not made in such a way as to make a complaint likely to be upheld.

Note that this advertisement has a TAPS approval number. Instead of acting in the public’s interest by not allowing the advertiser to make false claims, they have helped them to make the same claims in such a way as the public will interpret them as claims and the regulators will not, effectively allowing them to escape regulation.

Finally, remember that not every advertisement is in line with the ASA’s codes and the relevant legislation. If you think an advertisement makes a therapeutic claim that is not valid and/or has not been substantiated, I encourage you to research it further and, if it appears your concerns are warranted, submit a complaint to the ASCB. Unsubstantiated therapeutic claims are in breach of the ASA’s Therapeutic Products Advertising Code principle 2.

*I have set up a search engine for this within my installation of Google Chrome, so I can search previous ASA decisions by entering “ASA ” into Chrome’s Omnibar on my computer. To do this yourself, click “Manage Search Engines…” inside Chrome’s Settings, scroll down and enter the following details to create a new search engine:

  1. ASA Complaints
  2. asa
  3. https://www.google.com/search?q=site%3A203.152.114.11+%s

Now, for example, if you want to search for “homeopathy” within previous ASA decisions you would just need to type “asa homeopathy” into Chrome’s omnibar and it will find all decisions containing the term “homeopathy”, including those from before 2006 like this decision from 2003.