5. Claim Requirements

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5. Claim Requirements

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Food Supplements
Australia

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

5.1 Overview of Claims

5.1.1 Types & Definitions

Product claims typically used for foods and dietary supplements (nutrition content claims, health claims) do not apply to medicines in Australia. Medicines have indications which are defined in clause 3 of the Act [1] as: "indications, in relation to therapeutic goods, means the specific therapeutic uses of the goods".

Therapeutic use is defined as: "use in or in connection with:

(a) preventing, diagnosing, curing, or alleviating a disease, ailment, defect, or injury in persons; or

(b) influencing, inhibiting, or modifying a physiological process in persons; or

(d) influencing, controlling, or preventing conception in persons; or

(e) testing for pregnancy in persons; or

(f) the replacement or modification of parts of the anatomy in persons".

Note: since therapeutic goods include devices, the definition reflects the range of possible therapeutic uses, and not all apply to medicines. A medicine must have at least one indication of use since the definition of a therapeutic good is that it must have a therapeutic action.

The term 'claim' is not well defined in any of the therapeutic goods legislation. The term is used to mean any statement in relation to a medicine, whether therapeutic or not. For example, 'Product x is gluten free', and 'Product y (fish oil capsule) is enteric coated to prevent a fishy aftertaste' are not indications but are claims. However, all indications are claims in relation to a product. Often the terms "claims" and "indications" are used interchangeably in various documents, even when the subject is referring to indications.

5.1.2 List of Prohibited Claims

Prohibited Representations (Indications)

The following are prohibited for all therapeutic goods:

(a) a representation regarding abortifacient action;

(b) a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre-disposition to, one or more of the following: (i) neoplastic disease; (ii) sexually transmitted diseases; (iii) human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS); (iv) hepatitis C virus (HCV); (v) mental illness. (Item 10 of Schedule 2, Part 1 in Ref [7]).

Restricted Representations (Indications)

Under Section 42DD of the Act [1] some representations are restricted, that is, they can not be used in advertising unless approval is granted on a case-by-case basis. An advertisement about therapeutic goods that refers to a form of a disease, condition, ailment, or defect identified in a part of the Therapeutic Goods Advertising Code as a serious form of a disease, condition, ailment, or defect is a restricted representation.

Clause 28 of the Advertising Code [8] states: "A form of a disease, condition, ailment or defect is a serious form if:

(a) it is medically accepted that the form requires diagnosis or treatment or supervision by a health practitioner who is suitably qualified, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or

(b) there is a diagnostic (including screening), preventative, monitoring, susceptibility, or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up; but does not include:

Sponsors may apply for permission to advertise restricted representations, based on public health criteria set out in the Advertising Code which also describes how to apply.

5.2 Nutritional Claims

5.2.1 Permitted Claims

N/A.

5.2.2 Nutritional Claim Registration

N/A.

5.3 Health Claims

5.3.1 Permitted Claims

Product claims typically used for foods and dietary supplements (nutrition content claims, health claims) do not apply to medicines in Australia.

Level of Indications

Indications may be:

1. Low level: indications that are drawn exclusively from the Permitted Indications list [2]. These include health enhancement, health maintenance, prevention of a dietary deficiency (as permitted), or for a disease, ailment, defect, or injury other than a 'serious form' of those diseases. Low-level indications cannot refer to, or imply the prevention, alleviation, or cure of any form of a disease, ailment, defect, or injury. Low-level claims may not refer to a restricted or prohibited representation.

2. Intermediate level: Indications that are not appropriate for the list of permitted indications but are not high-level indications. They are generally more definitive, relate to more serious health conditions, and may present a higher risk to consumers than low-level indications. These may refer to: the prevention, alleviation, or cure of a non-serious disease, ailment, defect, or injury, or to restricted representations (i.e. a serious form of a disease). These must not refer to the prevention, alleviation, or cure of a restricted representation (i.e. a serious form of the disease) or contain a prohibited representation.

3. High level: Indications that refer to the prevention, alleviation, or cure of a serious form of a disease, ailment, or injury (i.e. restricted representations). The diseases referred to by this category of indication may not naturally resolve within a timely manner and may have undesirable effects that may persist or worsen if effective treatment is not pursued in a timely manner. They must not refer to a prohibited representation.

More information is available on the TGA website [3].

Note: some terms are described in the section "Lists of the Prohibited Claims" in section 5.1.2.

Listed Complementary Medicines (AUST L)

Only low-level indications i.e. those taken exclusively from the Permitted Indications list [2].

Listed Complementary Assessed Medicines (AUST L(A))

Low-level indications (as above) plus at least one intermediate-level indication.

Registered Complementary Medicines (AUST R)

High-level indications that are not suitable for the Listed and Listed Assessed pathways, plus intermediate and low-level indications, as above. It should be noted that some of these medicines are registered due to their composition, not because they necessarily have high-level indications.

5.3.2 Health Claim Registration

A) Existing Health Claims

Listed Complementary Medicines (AUST L)

The evidence requirements to support low-level indications are outlined in the Evidence Guidelines [4]. This describes the two types of evidence (scientific and traditional use), search strategies, assessment of the evidence, and the two levels of low-level indications (non-specific and specific) including minimum evidence requirements (Tables 4 and 5).

The evidence package checklists are available on the TGA website [5]. It is not mandatory to use the TGA templates. Evidence is not submitted as part of a Listing application for medicine. However, the submitter attests that they hold evidence in line with the requirements. At any time, the TGA may request the evidence package and a percentage of Listed medicines undergo a randomized post-market review which includes the evidence package.

Listed Assessed Complementary Medicines (AUST L(A))

For the low-level indications, the evidence guidelines and checklists above apply. However, the evidence package needs to be submitted for the pre-market efficacy assessment.

For the intermediate indications, there is a separate evidence guideline [6] that outlines the requirements, including the three application categories. Further information on the application process in provided in section "6. Registration Processes".

Registered Complementary Medicines (AUST R)

Evidence for the indications (all levels) is submitted as part of the medicine application. The submission is in a Common Technical Document (CTD) format and all evidence and documentation requirements are described in the references in section "6. Registration Processes".

B) New Health Claims

New Permissible Indications (Low-level claims)

Applications can be made for either a new permissible (i.e. low-level) indication or a new indicator qualifier (refer to Ref [4] for information on indication qualifiers). General information is available on the TGA website [10]. To apply, there is an electronic form on the TBS electronic portal [11]. This requires a Client ID within the portal and information on how to obtain this is available here [12].

Applications need to meet the criteria set out in Ref [10]. The application fee is AU $1,118 (Jan 2023).

Intermediate and High-Level Indications

New indications are negotiated with the regulator as part of the marketing approval process or, for existing medicine approvals, during an application to change the marketing authorization. Fees vary, depending upon the types of submissions since most applications include other changes (e.g., labeling).

List of documents and other requirements for new health claim approval

For low-level indications (which will be entered in the Permissible Indications list) the new indication permission requires an online application that is generic, that is, it is not made in association with a particular medicine. Or as part of the efficacy section in the other product applications for all indications that are not low-level. (Please refer to section "6. Registration Processes”).

Estimated cost and duration for new health claim approval process

Fees and charges for all changes (including indications changes) are in the TGA's schedule of fees and charges [13]. The actual charge depends upon the amount of technical review for the evidence package.