Guideline No. 01 - Therapeutic Claim/Purpose

Therapeutic Claim.  As the issue of "therapeutic claim" is central to many natural, herbal, marine and dietary supplement products in the review of advertising it will be useful to highlight the benchmarks used in relation to the Code and the Medicines Act 1981.  The Code for Therapeutic Advertising is the main benchmark against which therapeutic advertisements directly to the public are referenced.  This Code has three principles & 8 requirements.  Principle 1 of the Code encompasses compliance with the laws of New Zealand, of which the relevant legislation is the Medicines Act 1981 and the Medicines Regulations 1984.  The Code covers all the above products as well as over the counter medicines, homeopathic medicines and prescription 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 (c.f. Medsafe website www.medsafe.govt.nz for the full classification list).  If you are still unsure re the classification of ingredients it would be worth checking with Medsafe first to avoid any later expensive revision of the advertising.

The Code defines "therapeutic products" as

"a product that is represented in any way to be, or that is, whether because of the way in which the product is presented or for any other reason, likely to be taken for a therapeutic use."

The definition of "therapeutic purpose/claim" is quite comprehensive in the Medicines Act and covers some key aspects re therapeutic products and use.

 "a)      Treating or preventing disease"

"b)        Diagnosing disease or ascertaining the existence, degree or extent of a      physiological condition"

"c)       Effecting contraception"

"d)       Inducing anaesthesia"

"e)        Altering the shape, structure, size or weight of the human body"

" f)       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

"g)       Cleaning, soaking of lubricating contact lenses."

It can be seen from the above definition that it is quite comprehensive and therefore quite limiting on claims.   As a guideline terms like "relief from or reduction of a medical condition or disease" are all indicative of a therapeutic claim and would therefore be prohibited by the Medicines Act.  Mention of the disease in the historical or other context such as testimonial in an advertisement for a product is also likely to be a problem as this generally implies a therapeutic claim indirectly for the product being advertised - i.e. advertising a therapeutic claim by association.

Section 58 of the Medicines Act also expressly refers to a therapeutic purpose re the advertising of any method of treatment that "will prevent, alleviate, or cure any disease or prevent, reduce or terminate any physiological condition specified or belonging to a class of disease in the First Schedule of the Act.  This schedule covers about 60 of the common diseases for which treatments are generally produced.  The effect of this section 58 is to prohibit making therapeutic claims for these lists of medical conditions/diseases.

There is the option for a company to apply for evaluation of a product by Medsafe so that consent by the Minister of Health can be obtained for a product with a "therapeutic claim" under section 21 or 23 of the Medicines Act. The product will have an approved claim for a therapeutic purpose and be deemed to be a medicine. There will be a fee involved and a length of time for proper evaluation by Medsafe, details of which can be given be Medsafe.  Generally, however, consent will not be obtained without completion of some double-blind controlled clinical trials. Ministerial consent is for a specific approved therapeutic purpose(s) only and advertising is permitted in law only for the approved purpose(s).  This evaluation option is thus likely to be beyond the pocket of small and medium sized businesses and may not be worth it commercially, taking into account the compilation of a registration dossier.  In addition if a product is classified as a medicine then it must comply with some mandatory statements in its advertising. Account should also be taken that testimonials and healthcare professional endorsement are prohibited under section 58 of the Medicines Act for those products classified as medicines (& medical devices). Each company must take its own decision.

Otherwise a company may still advertise a product without getting consent 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.

This is a brief explanation of the guidelines used in assessing the issue of "therapeutic claim".  It does not claim to be comprehensive. There are more detailed comments for certain products such as those for weight loss and those in the memory, concentration and brain area.