Submission on the Regulation of Natural Health Products

The Society for Science Based Healthcare is an advocacy group whose membership consists of consumers, activists, scientists, and healthcare practitioners. We work to ensure that patients’ right to make an informed decision about their healthcare is protected. In particular, we often work to counter misinformation made regarding health products and services.

As the vast majority of products we become aware of that are promoted in a misleading manner would be considered “natural health” products (NHPs) under the Natural Health and Supplementary Products Bill, we have keenly felt the effect of a lack of regulation.

The Ministry of Health’s 2007 review of 263 New Zealand websites in the natural healthcare industry found that 78% of them made therapeutic claims about at least one of the products they sold[1], making them non-compliant with the legislation at the time.

In recent years, members of the Society for Science Based Healthcare have lodged over 200 successful complaints with the Advertising Standards Authority regarding misleading information used to promote health products[2], the vast majority of which were NHPs. Despite this and our other activities, the overall state of the New Zealand complementary healthcare industry appears to have changed little. It is still disappointingly easy to find misleading claims made about natural health products, and disappointingly hard to avoid them.

We welcome the opportunity to make a submission on the regulation of natural health products. It is our hope that, by introducing regulation to what has effectively been an unregulated industry in recent years, the amount of misinformation used to promote natural health products in New Zealand will be drastically reduced. Ideally, the Natural Health and Supplementary Products Bill and its associated guidelines should create an environment in which consumers can rightly feel assured that they will be able to make an informed decision about whether or not to purchase these products.

Health benefit claims should include product names and weak health claims

Under the current system, in which the advertising of natural health products is regulated by the advertising industry via the Advertising Standards Authority (ASA) and the Therapeutic Advertising Prevetting System (TAPS), a distinction is made under Guideline 13 between “Health Claims” and “Therapeutic Claims”[3]. This has allowed low level health claims that a product will “support the normal physiological function” to escape regulatory oversight, as they can be made without evidence to substantiate them.

We have seen examples of these claims made in TAPS approved advertisements, which the advertiser was subsequently unable to support with credible evidence when a complaint was lodged with the ASA:

ASA Complaint 14/260 (Health 2000; Go Healthy Vir-Defence)

  • “It helps build immune health”
  • “help support the body when bugs do hit”
  • “designed to support recovery from ills and chills”

It seems likely to us that such claims would fall under the definition of a health benefit claim. However, if this is not the case for all health claims of this nature, then the definition should be expanded to include them so as not to leave any loopholes through which a health benefit can be claimed or implied for a product without being supported by credible evidence.

It is also important that product names are considered in assessing whether or not a health benefit claim is being made. The current industry self-regulation does not assess product names, which allows for health claims to be implied for products through names such as “Go Health Vir-Defence”, “Naturo Pharm Coldmed Relief”, and “SleepDrops”.

Clarity regarding forms of evidence

Prior to this consultation, we had regretfully been under the impression from Principle (d) of the Natural Health and Supplementary Products Bill that health benefit claims would be allowed to be supported by traditional evidence of use.

The bill’s definition of traditional evidence is essentially evidence of longstanding traditional use, but the Principle (d) of the bill says that health benefit claims can be supported by either scientific or traditional evidence. We were concerned this could allow evidence of historical use to be applied inappropriately to support claims that a natural health product is effective. We are pleased to have found in the Draft Guidelines for Natural Health Products Evidence Requirements that this is not exactly the case.

However, in order to make it easier for consumers to be made aware of this distinction, we submit that the wording of Principle (d) of the Bill should be changed. We propose the following wording:

that health benefit claims made for natural health and supplementary products should be supported by scientific evidence, and claims of traditional use should be supported by evidence of traditional use

This would reflect the appropriate distinction made in the Draft Guidelines for Natural Health Products Evidence Requirements between traditional claims and scientific claims.

Evidence of use must not be used to imply evidence of efficacy

Labels on healthcare products should not be misleading, even by implication. Typically, consumers will expect the answer to the questions “what is it for?” and “what does it do?” to have the same answer. However, in cases where a product has claims of traditional use for a health benefit on its label, yet there is no credible scientific evidence that the product can convey this benefit, consumers may be misled by claims of traditional use.

For example, a label saying a natural health product is “Traditionally used in Western herbal medicine to relieve nasal congestion” could mislead consumers into believing that there is credible scientific evidence the product can “relieve nasal congestion”.

As the purpose of allowing claims of traditional use to be made when supported by evidence of traditional use is to aid consumers in making informed decisions about natural health products, it is important that they should not be left with an untrue impression of efficacy.

Although the bill requires that natural health products must make a summary of evidence publicly available, which we consider commendable as it should greatly assist consumers in making informed decisions, many consumers will still make decisions based only on the information on the label.

In order to prevent consumers from being misled we propose that, for products supported by traditional evidence of use but not by scientific evidence, it should be required that the label states the product’s efficacy is not supported by scientific evidence. Evidence of use is not evidence of efficacy, and consumers should not be misled to believe otherwise.

Testimonials should not be allowed in advertisements

The Medicines Act 1981 Section 58(1)(c)(iii) effectively prohibits the use of testimonials in “medical advertisements”. As anecdotal evidence can be simultaneously very convincing and very misleading, this is an important measure for preventing consumers from being misled about the effects of medicines.

Even in the context of a medical consultation, patients can find it very hard to understand that what appears to benefit one person may not benefit another. Similarly, there is often confusion about the natural variation in symptoms with time and how any medication, whether prescribed or otherwise, may have perceived effects simply through the healing effects of time.

Clause 40C of the Natural Health and Supplementary Products Bill regards advertisements relating to natural health and supplementary products. However, it does not include any provisions equivalent to Section 58(1)(c)(iii) of the Medicines Act. With the exemption of claims of traditional use on product labels, we propose it would be appropriate to add a similar provision to Clause 40C, or at the very least in the associated guidelines, prohibiting the use of testimonials in advertisements relating to natural health and supplementary products.

Complaints and audits should be clear and transparent

In the interest of consumer protection, audits of product notifications should be conducted in a transparent manner. Once complete, both the outcome of an audit and the analysis behind it should be made public. For audits that are prompted by a complaint, this complaint should also be made public. The system used by the Advertising Standards Authority can be used as a good example of how this can be done.

The same should apply to applications for a product notification that has previously been cancelled, in that the Authority’s assessment should be made publicly available. When a product notification is suspended or cancelled, its status should be made public in a manner that makes it clear when and why it was changed.

These transparency measures will help protect consumer rights by making consumers aware when products are not compliant with the regulation, and why this is the case.

It should be straightforward for any member of the public to find out how to complain about a non-compliant product, and to lay a complaint. We would also like to see more details of how these audits will be conducted and under what circumstances a complaint would or would not result in an audit.

Audits should be prompted by new evidence

In cases where new evidence is brought to the Authority’s attention that affects at least one completed product notification, it would be appropriate to commence an audit to determine if the new evidence means the health benefit claims made for the products are no longer supported by the totality of the evidence.

In some cases, such as when the new evidence is relevant to a number of product notifications, it may be appropriate to audit multiple product notifications to ensure they are still compliant, and to inform the notifiers of the new evidence so they can have the chance to either withdraw or amend the notification instead of face it being suspended or cancelled.

There should be sanctions for non-compliant product notifications

Although the Natural Health and Supplementary Products Bill allows fines to be issued if a natural health product is sold without a notification or in a manner that is not consistent with its notification, it seems that for cases in which a notification contained false or misleading information there is no penalty aside from the suspension of the notification.

We feel this is inadequate. There should be a deterrent from filing inadequate notifications that allow ineffective or unsafe products to be sold legally, up until the point at which the notification is captured by an audit or a complaint.

Judging by the current and past state of the natural health market[1][2], we find a large proportion of these products are sold alongside health benefit claims that are not adequately supported by the available scientific evidence. It seems likely that similar behaviour will continue once the bill comes into effect, and we anticipate that as a society we will be identifying a large number of non-compliant product notifications, and submitting complaints about them, during this period.

Because the proposed regulations rely on a system based on audits and complaints instead of approval, we hope there will be adequate resources allocated to deal with the volume of complaints. Because the regulations involve making summaries of evidence available for all notified products, as well as the health benefit claims the evidence is meant to support, this will allow for organisations such as us to vet some of the product notifications and complain about those that we feel are not compliant. There should also be robust procedures in place to deal with these complaints.

Businesses with a poor compliance record should require approval

Section 16B(3)(b) of the Natural Health and Supplementary Products Bill requires that the Authority must be satisfied that grounds for having cancelled a product notification no longer apply, before a new notification for that product is permitted. In effect, products which have had notifications cancelled become part of an approval-based system instead of a notification-based system.

We feel it would be appropriate to allow for similar measures to be taken against organisations with a record of completing product notifications that, on examination, are found to be non-compliant. For example, after a certain number of product notifications from the same business are cancelled within a particular time period, future product notifications from that company should require approval, at least for a period of time during which they prove they are able to comply with the regulations.

Homeopathic products should not be exempt

The Draft Guidelines for Natural Health Products Evidence Requirements notes that:

Homeopathic medicines are exempt from the requirements of the NHP scheme as they contain less than 20 parts per million (ppm) of the active ingredient.

Although it is sensible to exempt such products from the requirements regarding approved ingredients, exempting them from the other requirements of the bill will perpetuate the current environment in which consumers are often misled about the effects of homeopathic products.

Instead of exempting homeopathic products from the regime entirely, they should still be required to be notified, and to comply with other requirements of the bill such as making a summary of evidence available to support all health benefit claims made about the products.

Although homeopathic products are likely to have a low risk profile, consumers still have the right to make informed choices regarding these products. The consultation document notes that:

One aim of the legislation is to help consumers make choices about the products they buy.

This aim is not met regarding homeopathic products if they are exempt from the regime.

Exempting them may also lead consumers to have a false sense of security regarding homeopathic products. Homeopathic products are widely considered to be “natural health products” by consumers. With knowledge that this bill protects them against misleading health claims made regarding these products, consumers may falsely come to believe that the bill also protects them against misleading health claims made regarding homeopathic products.

This exemption will also capture some products that are not typically marketed as homeopathic. For example, health benefit claims are commonly made for colloidal silver products, but these cannot be sold at concentrations greater than 10 ppm[4]. By excluding these products from the notification process, health benefit claims made about them will continue to be unregulated.

Also, by exempting these products from the regulation there will be no audits in place to ensure that the products really do contain less than 20 ppm of the active ingredient. There have been cases internationally, including in the USA[5], where products marketed as homeopathic have been found to be adulterated.


Thank you for giving us the opportunity to make this submission. We hope it is useful, and would welcome the opportunity to engage further on the regulation of this industry.

Sincerely,

Mark Hanna
Chair, Society for Science Based Healthcare

References

Submission on the Regulation of Natural Health Products