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Advertising to the public
Complying with the Therapeutic Goods Advertising Code (No. 2) 2018
Part 3 - Requirements relating to particular therapeutic goods
Guidance on specific Code provisions
The numbering of the sections corresponds to the numbering of the Code provisions for ease of cross-reference. However, this guidance does not cover all sections of the Code so the numbering may not be sequential.
This part of the Code, which sets out requirements relating to particular types of therapeutic goods, does not apply to:
- consumer medicine information
- patient information leaflets for implantable medical devices
23 Complementary medicines
To simplify the discussion of this section a "claim" is limited to being a therapeutic claim in an advertisement about an indication that is supported by evidence of traditional use by a particular paradigm (see below for examples). Where an advertiser is relying on traditional evidence to support a claim in an advertisement, the fact that it is "traditionally used" and the paradigm applicable to that claim must be prominently displayed or communicated in the advertisement. Otherwise the consumer may be misled about the type of supporting evidence for the medicine. While this section of the Code does not prescribe the inclusion of the ingredient in the disclosure, it may be misleading not to do so for certain medicines. Particular care in this respect must be taken with the presentation and content of the disclosure for multi-ingredient, multi-paradigm medicines. Making broad disclosures of paradigms for these types of listed medicine medicines apart from misleading the consumer, can also lead to the advertising of actual or implied indications that are not included in the entry for the medicine which may breach applicable sections e.g. sub section 22(5) of the Act.
The form of the disclosure is not prescribed by this section of the Code, however the language and content must carry the intent of the disclosure for the intended audience of the advertisement. Words to the same effect are acceptable as it is not the intent of the Table to prescribe how the claims and disclosures should be combined or presented.
Paradigms include, but are not limited to:
- traditional Chinese medicine
- Ayurvedic medicine
- western herbal medicine
Where evidence from multiple paradigms is relied upon for a single ingredient and claim, the advertisement needs only to disclose one of those paradigms. This applies to both single or multi ingredient medicines. This does not prevent the advertiser from disclosing more than one paradigm for that claim should they wish.
Where the medicine being advertised contains multiple ingredients and claims then the paradigm(s) must be linked to the appropriate claim and where needed to avoid being misleading, the ingredient.
For further information, refer to the Guidelines on the evidence required to support indications for listed complementary medicines.
Analgesic medicines can pose particular risks to consumers, and so must prominently display or communicate the following warning statement:
- INCORRECT USE COULD BE HARMFUL
Such advertisements are prohibited from implying that the consumption of analgesics is safe, or that analgesics have relaxing, tension-relieving, sedative or stimulating effects. This recognises the particular harms that inappropriate or excessive use of analgesics have caused in the past and can continue to cause.
25 Vitamins and minerals
Advertisements for vitamins and minerals must not claim or imply that they are a substitute for good nutrition or a balanced diet, or that they are in any way superior to, or more beneficial than, dietary nutrients or that supplementation is necessary for the maintenance of normal health when the diet is not inadequate.
Advertisers should also be aware of the requirements relating to vitamins in Schedule 2 of the Regulations. Part 1, item 3 of Schedule 2 of the Regulations prohibits certain representations in relation to vitamins. Only the substances listed in Part 3 of Schedule 2 may be referred to as vitamins and then may only be referred to by the names specified in that part. Further, Schedule 2, Part 1, item 9 prohibits certain representations about the recommended daily or dietary intake or allowance of a vitamin or mineral.
26 Therapeutic goods that are for weight management
Consumers seeking to lose weight are may be susceptible to marketing. For these reasons, there are special requirements for the advertising of goods for weight management.
Weight management is defined in subsection (4) of this provision as including claims about weight loss, weight control, weight maintenance, measurement reduction, clothing size reduction and hunger suppression.
For an advertisement for a weight management good to convey the balance required by subsection (1), the need for a healthy energy controlled diet and physical activity must receive adequate prominence in relation to the weight management claims.
Claims that are likely to contravene subsection (2) of this provision include claims that a therapeutic good can eliminate some or all of an individual's calorific intake.
Advertisers should also consider guidance from TGA and NHMRC in relation to weight loss products and what can constitute typical results.
For listed medicines, see Evidence guidelines - Part B: Further technical guidance.
For listed assessed medicines, see Assessed listed medicines evidence guidelines - 5. Evidence requirements and standards.
Consistent with the requirement that advertising of therapeutic goods must not undermine public health messaging, there are special requirements around the advertising of sunscreens that claim or imply that the sunscreen will prevent any of sunburn or skin cancer. It is also essential that, given Australia has one of the highest incidences of skin cancer in the world, consumers are aware that sunscreen use is only one element of sun protection. Other protections (like a hat, shirt, sunglasses and the use of shade) are necessary, as is the regular re-application of sunscreen.
Statements or visual representations to the effect that prolonged high-risk sun exposure should be avoided and frequent re-application or use in accordance with directions is required for effective sun protection must be prominently displayed or communicated.
This approach is also consistent with the permitted indications for sunscreens, which require sunscreen labels to carry a message to the effect that 'Prolonged exposure to the sun should be avoided, it is important to wear protective clothing, hats and eyewear when exposed to the sun'.