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Revised: 20 November 2013

Compliance

Weight Management / Weight Loss Products

Since the Ministry of Health review of advertising requirements for medicines in New Zealand there has been a tightening of controls to reflect its findings. Particular attention has been paid to the advertising of products for weight management. Recently new medicines have been registered for weight loss and this has also focused attention on the area and highlighted the fact that there are other products being advertised about which therapeutic claims for weight loss are made. These other products have not been granted consent to be distributed or to make those claims.

The Therapeutic Advertising Pre Vetting Service has been set up by the Advertising Standards Authority to provide industry with a tool to assist companies to comply with the advertising requirements of the medicines legislation, and these guidelines have also been developed to assist advertisers.

The rules are simple, if an advertiser wishes to claim that a product induces weight loss then that product must have consent to be distributed in New Zealand, and be registered as a medicine. The distributor must make the decision whether to promote his product as a medicine and make a permitted weight loss claim, or whether to promote it as a weight management product and not make a weight loss claim - before entering the market.

These guidelines will assist advertisers and distributors in making that decision.

WEIGHT LOSS PRODUCTS

A 'medicine' is defined as a substance or article other than a medical device that is manufactured, imported, sold or supplied wholly or principally for administering to one or more human beings for a therapeutic purpose . Section 3, Medicines Act 1981

'Therapeutic purpose' includes:

  1. Altering the shape, structure, size, or weight of the human body.
  2. Otherwise preventing or interfering with the normal operation of a physiological function, whether permanently of 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.
Section 4, Medicines Act 1981

A weight loss product clearly has a therapeutic purpose and is considered to be a medicine.

NB. Obesity is a condition listed in Part II of the First Schedule to the Medicines Act 1981.

The distribution and sale of a medicine (i.e. a product intended for a therapeutic purpose) without the consent of the Minister of Health is an offence under Section 20 of the Medicines Act 1981. You are not able to make therapeutic claims for a product unless it has the Minister's consent to be distributed as a medicine.

In the case of a non-compliant advertisement for a medicine, both the advertiser and the publisher can be liable under Sections 57, 58 and 59 of the Medicines Act 1981.

WEIGHT MANAGEMENT PRODUCTS

The labeling and promotion of products intended for weight management should not represent the product as having a therapeutic purpose. This means they may not:

  1. Alter the shape, structure, size or weight of the human body (cause weight loss), or
  2. Speed up the metabolism or
  3. Suppress the appetite

nor may they claim to do so.

Consideration should be given to the following:
  • Check the ingredients; make sure the product contains no scheduled medicines, for example ephedrine. Advice on this can be obtained from your local Medicine Control Office. (See attached list.) * If the product works by increasing metabolism then the product is a medicine because it interferes with the normal operation of a physiological function. * If the product acts as an appetite suppressant, it is a medicine.
  • If the product introduces bulk and has limited nutrient value yet suppresses the appetite it is a medicine.
  • If an advertisement offers quick weight loss results it is misleading and in breach of the legislation.
  • Is the advertisement for a Weight Management system?
    • Programmes such as "Jenny Craig" or "Weight Watchers" work by limiting food intake and requiring exercise. Programmes such as these are not controlled under the Medicines Legislation and nor is their advertising. They are subject to the Advertising Code requirements however - which is administered by the Advertising Standards Authority.
    • If such a programme also promotes special foods, meal replacements or dietary supplements to be taken in conjunction with the dietary and exercise regimes, then those products must comply with the requirements of the food and dietary supplements legislation.
    • Weight Programmes are defined as a comprehensive approach to the problem of weight, requiring personal visits and follow-up by the consumer with supervision by a trained professional re diet, exercise etc. In addition the companies running Weight Programmes do not sell or promote any consumable weight loss product.
  • Check the wording of advertisements and promotional material.

    Examples of wording that suggest a therapeutic purpose:

    Weight loss
    Weapon against ugly flab
    Increased energy levels
    Increasing thermogenesis
    Burning fat
    Increasing metabolism
    Controls appetite
    Suppress appetite
    Rapid weight management
    Fat Burning Formula
    Weight reduction
    John lost 6 kilos
    John shed 6 kilos
    Reduce the flab
    I can now take a size 6 blouse instead of a size 10
    My trousers are too big
    I need to buy smaller trousers
  • Pictures of grossly overweight people, pictures of very thin people (Unrealistic Outcome as per Principle 3 of the Code) and Before and After photographs are not acceptable.
  • Suggested statements for use in advertisements for Weight Management Programmes and Products

    "This product is part of a weight management programme. Weight programmes should include (healthcare) professional advice on diet, exercise and lifestyle changes. This is not a meal replacement and appropriate advice on diet is important. Weight management programmes take time and personal commitment to be effective".

    Or

    "Weight management programmes take time and personal commitment to be effective, and also require diet, exercise and lifestyle changes. Ask your health professional for advice. Always read the label and use as directed"

  • Brand Names
    Care should be taken with the name of the product to ensure that the name does not imply a therapeutic purpose e.g. weight loss.
    Names that indicate removal of fat, for instance, imply a therapeutic purpose and are in breach of the Medicines Act. Care must be taken to ensure that the advertisement does not indicate a therapeutic purpose when considered in conjunction with the product name.
    Note: There are currently products on the market that do not comply with this requirement and consideration will have to be given to phasing out such names or registering the product. It is likely that proposed legislation will require some form of registration for these products.
  • Thermogenesis

    Statements such as "increases fat burning" or "increases the burning of fat into energy" and "thermogenic", "creating heat" etc. are indicative of the acceleration of a normal physiological function and are therefore in breach of the Medicines Act.

  • Consumer Warnings and information

    It is appropriate to include a consumer warning on products containing guarana and caffeine

    e.g. " Note: contains caffeine: Unsuitable for children or caffeine sensitive people. May cause sleeplessness and increased heart rate". This is because the consumer may unknowingly be increasing their caffeine intake to a level that could adversely affect their health.

  • Testimonials
    1. For products that do not have consent to be distributed as medicines
      The use of testimonials making therapeutic claims for weight loss is not permitted under the Medicines Act 1981 section 58 (1) (c) (iii). Often it is in the testimonial that a therapeutic claim is made indicating that the product has a therapeutic purpose and should therefore be classified as a medicine under the Medicines Act 1981.
      Before and after photographs are not permitted since these are pictorial testimonials.
    2. For products that have consent to be distributed as medicines.
      The use of testimonials is not permitted, neither are before and after photographs. Weight loss claims that comply with the approved indications as stated on the data sheet may be made.
    3. For Weight Management Programmes and Clinics
      As these advertisements offer a weight management programme and there is no consumable product that induces weight loss involved, then the use of before and after photographs and testimonials is permitted, but these should be qualified with a statement such as "Individual case only, results will vary." The Advertising Standards Authority Code for "Advertising of Weight Management" is a useful guide.
  • Classifieds Advertisements
    These advertisements have space problems and tend to attract attention by using a highlighted therapeutic claim. This is not acceptable.

Note: Weight loss products that have consent to be distributed as medicines should comply with the Guidelines for Advertising Prescription Medicines Direct to the Consumer OR The Guidelines for Advertising Over the Counter Medicines Direct to the Consumer, whichever is appropriate.

Relevant Industry Codes of Practice

It is recommended that advertisers consult the following self-regulatory Codes of Practice:

  • Advertising Standards Authority "Code for Therapeutic Advertising"
  • Advertising Standards Authority code " Advertising of Weight Management"

Advertisements for weight management/weight loss products need to be pre-vetted for compliance with legislative and industry code requirements. The Advertising Standards Authority (ASA) Code is based on agreement between the ASA and the organisations that represent the media in which the advertisements are published. In association with the ASA, one of the contributing members, the Association of New Zealand Advertisers (ANZA) has set up the Therapeutic Advertising Pre-vetting System (TAPS) to provide this service. Organisations must first register with ANZA, PO Box 9348, Newmarket, Auckland, phone 64 9 300 5932 in order to use the TAPS service.

Contact details for TAPS are:

Nigel Andrews
LAPS & TAPS Adjudicator
43 Tirohunga Drive
Henderson
Waitakere 0612
Ph (09) 836 2680
Fax (09) 837 5057
Email: nigel@rubicon.net.nz

or

Peter Pratt
96 Hazelwood Ave
Karori
WELLINGTON
Ph (04) 938 6409
Fax (04) 934 6409
Mobile 027 4921230
E-mail peterpratt@paradise.net.nz

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