What are the rules about advertising therapeutic goods like supplements?

In Plain English

Advertising therapeutic goods, such as supplements, in Australia is regulated to ensure that the information presented to consumers is accurate and not misleading. Here's a breakdown of the key rules:

  1. Registering the Goods: Some therapeutic goods need to be registered to be advertised to consumers. If they aren't registered and are of a certain type, they cannot be advertised.
  2. Health Warnings: If a therapeutic good needs a warning label, that warning must also be included in any advertisement for the product.
  3. Specific Types of Goods: There are extra rules for advertising certain therapeutic goods like analgesics, sunscreens, complementary medicines, and weight management products. For example, ads for analgesics must include a warning about potential harm from incorrect use. Ads for weight management products must promote a healthy diet and exercise and can't suggest the product reverses overeating.
  4. Testimonials: Testimonials must be real and reflect typical results. People involved in selling the product, their family, or certain organizations (like government agencies or healthcare professionals) generally can't give testimonials unless specific disclosures are made.
  5. Endorsements: Certain groups, like government bodies (unless specifically allowed), hospitals, and healthcare professionals, can't endorse therapeutic goods.
  6. Samples: Giving out samples is restricted to certain types of therapeutic goods that are listed in Annexure 2 of the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 and don't contain certain scheduled substances.
  7. Public Health Campaigns: Ads can't go against current public health campaigns.
  8. Scientific Claims: Any scientific or clinical claims must be easy to understand and backed by evidence. Research references must be properly cited.
  9. Advertising to Children: Ads can't be directed at children under 12. For those 12 and over, it's restricted to specific goods and must not contain certain scheduled substances.
  10. Mandatory Statements: Certain ads, like those for goods only available from a pharmacist, must include specific statements (e.g., "Ask your pharmacist about this product").
  11. Restricted Representations: Claims about serious diseases require approval from the Secretary of the Department of Health.
  12. False or Misleading Ads: The Secretary can prevent the advertisement of therapeutic goods if the advertisement contains false or misleading information.
  13. Compliance with the Therapeutic Goods Advertising Code: All advertisements must comply with the Therapeutic Goods Advertising Code.

Detailed Explanation

The advertising of therapeutic goods in Australia is heavily regulated by the Therapeutic Goods Act 1989 and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. Key aspects of these regulations include:

  • Registration and Advertising (Chunks 10, 11):
    • Regulation 7 of the Therapeutic Goods Regulations 1990 prescribes certain therapeutic goods that, if not included in the Australian Register of Therapeutic Goods (the Register), must not be advertised to consumers.
    • Therapeutic goods that are not prescribed and not included in the Register may be advertised to consumers.
  • Health Warnings (Chunk 10):
    • A "health warning" is defined as a warning, contra-indication, precaution, or restriction required on the label or instructions for use, and is reasonably necessary to inform a consumer's purchase decision.
  • Specific Requirements for Certain Therapeutic Goods (Chunk 10):
    • Analgesics: Advertisements must contain the warning statement: "INCORRECT USE COULD BE HARMFUL."
    • Complementary Medicines: If claims are based on traditional use, a statement about reliance on traditional use must be included.
    • Sunscreens: Advertisements claiming prevention of sunburn or skin cancer must depict sunscreen as one component of sun protection and advise avoiding prolonged high-risk sun exposure and frequent re-application.
    • Weight Management Products: Advertisements must promote a healthy diet and physical activity, avoid suggesting the product reverses overeating, and ensure testimonials are consistent with average consumer results.
  • Testimonials and Endorsements (Chunks 10, 11):
    • Testimonials must comply with the Therapeutic Goods Advertising Code and must be consistent with the product label, directions for use, and accepted indications.
    • Testimonials cannot be from people involved in the production, marketing, or supply of the goods, their immediate family (unless disclosed), or certain organizations and corporations.
    • Advertisers must verify the content and identity of the person making the testimonial.
    • Endorsements cannot be given by government entities, hospitals (except community pharmacies), healthcare professionals, or organizations representing healthcare consumers (unless disclosures are made).
  • Samples and Incentives (Chunk 11):
  • Consistency with Public Health Campaigns (Chunk 6):
    • Advertisements must not be inconsistent with current public health campaigns.
  • Scientific or Clinical Representations (Chunk 6):
    • Scientific or clinical terminology must be easily understood, and claims must be consistent with scientific or clinical evidence.
    • References to research must identify the researcher, financial sponsor (if known), and provide proper citation.
  • Advertising to Children (Chunk 6):
    • Advertisements cannot be directed to children under 12 years old.
    • Advertisements may only be directed to children 12 years and over if the goods are listed in Annexure 1 of the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, meet specific conditions, and do not contain substances listed in Schedules 2, 3, 4, or 8 of the current Poisons Standard.
  • Mandatory Statements (Chunk 6):
    • Advertisements for goods containing substances in Schedule 3 and Appendix H of the current Poisons Standard must state: "ASK YOUR PHARMACIST ABOUT THIS PRODUCT."
    • Advertisements for goods only available through a health professional must state that the goods are only available for supply through a health professional.
  • Restricted Representations (Chunks 277, 35):
    • A "restricted representation" refers to a serious form of a disease, condition, ailment, or defect identified in the Therapeutic Goods Advertising Code.
    • Use of a restricted representation requires approval from the Secretary of the Department of Health, who must be satisfied that the representation is accurate, balanced, and not misleading (Therapeutic Goods Act 1989 s 42DF).
  • Offences and Penalties (Chunks 35, 37):
    • Advertising therapeutic goods with a prohibited representation without permission, or not containing a required representation, can result in offences and penalties under the Therapeutic Goods Act 1989 s 42DL.
    • Penalties include imprisonment and/or significant penalty units.
  • False or Misleading Advertisements (Chunks 33, 34):
    • The Secretary may prevent a person from advertising therapeutic goods if the advertisement contains false or misleading information (Therapeutic Goods Act 1989 s 42DKB).
  • Compliance with the Therapeutic Goods Advertising Code (Chunk 37):