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 220.127.116.11*.
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…
- means use in or in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in humans;
- influencing, inhibiting or modifying a physiological process in humans;
- testing the susceptibility of humans to a disease or ailment
- influencing, controlling or preventing conception in humans;
- testing for pregnancy in humans; or
- the replacement or modification of parts of the anatomy in humans; and
- includes any other use which the law provides shall be treated as a therapeutic use for the purposes of the code; but
- 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—
- treating or preventing disease; or
- diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition; or
- effecting contraception; or
- inducing anaesthesia; or
- altering the shape, structure, size, or weight of the human body; or
- 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
- 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:
- 12/393 – Eken Power Bands 1 Day.co.nz Website Advertisement
- 09/437 – Dual Action Cleanse Television Advertorial
- 08/431 – Joint Vitality Magazine Advertisement
- 08/156 – Hydrodol Website Advertisement
- 04/138 – Silvern International Limited – Silver Colloid (Rich Text Format)
- 02/317 – Cat Media Pty Ltd – Naturopathica – Meno-Eze (Rich Text Format)
- 01/249 – “Vigorex” – Forte & Femme (Rich Text Format)
- 01/042 – Shop America -Dr. Atkins Weight-Loss (Rich Text Format)
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.
- ASA Complaints
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.
4 thoughts on “How to Read Medical Advertisements”
“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.”
The bit you need is the so called “homeopathic clause” I’d think – “Section 32: Exemptions for natural therapists and others: Notwithstanding sections 17 and 20 to 24 of this Act or anything in any licence, but subject to the other provisions of this Act and to any regulations made under this Act, any natural therapist or other person may manufacture, pack, label, sell by retail, or supply in circumstances corresponding to retail sale, any medicine that neither is nor contains— (a) A prescription medicine; or(b) A restricted medicine; or(c) A pharmacy-only medicine,—for administration to a particular person after being requested by or on behalf of that person to use his own judgment as to the treatment required.”
New Zealand Regulatory Guidelines for Medicines Edition 6.13, March 2011 also states: “A homeopathic remedy which is prepared under the principle of homeopathy in which the active ingredient to be administered is in a concentration not more than 20 parts per million, and the remedy is labelled only with the name of the active ingredient, trade name (if any) and a statement that it is a homeopathic remedy does not normally require Ministerial consent before distribution. The product label or associated advertising material must not contain therapeutic claims or indications for use. A homeopathic remedy which is labelled or advertised with claims as to its therapeutic purpose is a medicine and subject to the full control of the Medicines legislation. Sterile homeopathic preparations intended for injection or for administration to the eyes are regarded as medicines and therefore subject to the full control of the Medicines legislation.”
I’m pretty sure the regulatory guidelines are up to date, but best to check further. Hope this sheds a bit of light for you.
Thanks a lot Hemlock, that sounds like just the missing piece I was looking for :)
I found that a slightly more up to date version of the guidelines (edition 6.15 from November 2011) is available on the Medsafe website and that section at least appears unchanged – http://www.medsafe.govt.nz/regulatory/Guideline/Full%20-%20NZ%20Regulatory%20Guidelines%20for%20Medicines.pdf
I think I’ll also be able to use this information to more easily get homeopathic products removed from Trade Me. The Medicines Act section 18(4) prohibits the selling of medicines by auction in New Zealand, and Trade Me lists both medicines and supplements as “banned items”, but unfortunately both of those rules seem to be pretty widely flaunted.
Glad that helped, I’ve just checked on the act as well because amendments have been done fairly often and that “homeopathic clause” is now clause 28. It can be hard to tell what is the most current version, I was referring to some material I already had on my computer.
Only copied the first part – this part (2) is more relevant to this article but either way, it gives an big out provided the seller or the altie therapist is careful about what they do and say –
“Notwithstanding anything in sections 17 and 20 to 24, but subject to the other provisions of this Act and to any regulations made under this Act, any person may manufacture, pack, and label any herbal remedy, and sell or supply any herbal remedy, if the remedy is or is to be sold or supplied— (a) under a designation that specifies only the plant from which it is made and the process to which the plant has been subjected during the production of the remedy, and does not apply any other name to the remedy; and (b) without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy.” http://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html
Even if they do make claims that would have the effect of breaching the medicines act, I’m not sure anyone is actively following this up outside of any action by individuals using the ASA. It’s probably not worth even trying to prosecute as penalties in the act are pathetic and as low as $500 or a possible 3 month term of imprisonment (highest fine I could find was $20000). Not much compared with how much a person can sell before being caught.
I emailed Medsafe a few weeks ago asking when it might be appropriate for me to complain to them instead of the ASA, and how I might make such a complaint. Here is the response I received from Derek Fitgerald, Manager of Medsafe’s Compliance Management Branch:
“Medsafe (part of the Ministry of Health) is the regulator for parts of the Medicines Act 1981 and Medicines Regulations 1984. In relation to advertising of therapeutic products, Medsafe deals with breaches of section 20 of the Act (the requirement for the Minister of Health to give prior consent before sales, distribution or advertising of medicines takes place) and Part 4 which deals with medical advertisements.
The current regulatory scheme with regard to advertising involves industry self-regulation through the ASA codes and the associated complaints process. Advertisers are able to obtain assistance and advice on the codes and legislation from the TAPS service. Medsafe may become involved when matters cannot be readily resolved through this process. Compliance with the ASA code for advertising of therapeutic products should ensure legal requirements are met, and the code generally goes further than the medicines legislation with respect to social responsibility.
Breaches of section 20 of the Act are a matter for Medsafe and ongoing action is taken in this area. Other advertising matters are generally dealt with through the ASA complaints process, though may, from time to time, be referred to Medsafe. Matters that are not resolved through this process may be referred to Medsafe.
Note that Medsafe’s investigation and enforcement action is prioritised according to the risk to patient / consumer safety to ensure resources are used effectively.”
The Commerce Commission is also relevant, in that they enforce the Fair Trading Act 1993, but they similarly do not act on every complaint. For example, I recently made a complaint about “Healthy Bod Limited” to them based mainly on this advertisement – http://www.grabonestore.co.nz/detox-foot-patches-42
The response I received from them said:
“While we won’t be taking any action at this time, we will record the information you provided us and may use it if we get similar complaints in the future.”
I’d love to see the ASA given some teeth, so that complaints against misleading advertisements that are upheld might require not only that the advertisement be removed, but also that a retraction and/or correction be published and possibly a fine levied. At the moment there seem to be no disincentives to publishing misleading advertisements, even when they are in breach of the ASA’s codes or relevant laws.
Advertisements that only run for a short period of time (e.g. those on sites like GrabOne) are practically immune to regulation, as by the time a complaint may be considered and upheld by the ASA the ad will have run its course, and currently the only “punishment” involved in this industry self-regulation is the voluntary removal of an advertisement.