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Cosmetic claims guidelines
In September 2007, a new framework for the regulation of cosmetic products was implemented following amendments to the Industrial Chemicals (Notification and Assessment) Act 1989. This Act is administered by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The Act legally underpins the Cosmetics Standard 2007 and this Standard is supported by the NICNAS Cosmetic Guidelines 2007. Both documents are available from the NICNAS website.
To assist with facilitating this new regulatory framework, on 11 June 2008 the TGA adopted a new Therapeutic Goods (Excluded Goods) Order No. 1 of 2008.
In view of the above developments, the NCCTG has rescinded and the TGA has now archived the NCCTG Cosmetic Claims Guidelines (May 1997) as a historical document.
Enquiries about the regulation of cosmetic products should be directed to NICNAS in the first instance.
Cosmetic claims guidelines
This document was issued by the National Co-ordinating Committee on Therapeutic Goods (NCCTG) (following input from the Cosmetic, Toiletry and Fragrance Association of Australia) to provide guidance in relation to the cosmetic/therapeutic interface in respect of product claims.
Products may not make therapeutic claims unless included in the Australian Register of Therapeutic Goods (ARTG).
Foreword
This document is intended to provide guidance in relation to the cosmetic/therapeutic interface in respect of product claims. The following table is intended to provide examples covering the most common areas of comparison and is not an exclusive or exhaustive listing.
Products are determined to be either "cosmetics" or "therapeutic goods" based on two factors:
- the composition of the product and the proposed use of the product.
Composition - The composition of a product does not necessarily determine its classification. However, it is quite possible that an ingredient, or the concentration of an ingredient, may make the product unsuitable for classification as a cosmetic.
Proposed use - According to the definitions of the terms "therapeutic goods" and "cosmetic products" in respective legislation, the key consideration for the classification of a product is its proposed use. The claims made in package inserts, in advertisements, and especially in product labels, indicate to the consumer the intended use of the product.
It is also important to consider the context in which the product is marketed. Claims that indicate the product is a therapeutic good (drug) cannot be made for a product marketed as a cosmetic.
The Therapeutic Goods Administration administers the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations. Products subject to this legislation are "therapeutic goods", i.e. products intended for "therapeutic use" which includes 'modifying a physiological process.' Normally, cosmetic products do not come within the ambit of this legislation. However, if a product claims to modify a physiological process (or treat or prevent disease) then it falls within the ambit of the legislation and requires inclusion in the Australian Register of Therapeutic Goods prior to supply of the goods.
Specific legislation concerning cosmetic products is the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations administered by the Federal Bureau of Consumer Affairs. The scope of the legislation is limited to requirements concerning ingredient labelling information. "Cosmetic product" as defined in the information standard means a substance or preparation intended for placement in contact with any external part of the human body, including the mucous membrane of the oral cavity, and the teeth, with a view to:
- altering the odours of the body; or
- changing its appearance; or
- cleansing it; or
- maintaining it in good condition; or
- perfuming it; or
- protecting it.
The Industry Association representing the manufacturers and distributors of cosmetics - the Cosmetic, Toiletry and Fragrance Association of Australia (CTFAA) tel 02 9927 7370 - has a Code of Conduct which also provides guidance concerning the cosmetic/therapeutic interface.
Acceptable versus unacceptable claims
A claim can be a word, a sentence, a paragraph, or simply an implication. The attached tables show examples of acceptable and unacceptable cosmetic claims. Column A contains claims that are clearly cosmetic-oriented, while Column C contains claims that are clearly unacceptable for a cosmetic. Column B is ransitional, and illustrates how choice of terminology influences the acceptability of a claim. (A blank entry in the table indicates that no suitable example is available.)
The examples in the tables should only be used as a guide and are not to be taken as the final authority. A prudent practice for cosmetic companies to follow would be to seek expert/legal advice to ensure that proposed cosmetic claims that they wish to make are not in breach of the Therapeutic Goods Act 1989 and/or the Trade Practices Act 1974.
Example
Consider the use of the word "relieves" under the subject "skin" in the table. The use of this word implies that the product relieves the user (or parts of the user) of something. The following cases arise:
- When the word "relieves" is used in a claim such as "relieves skin dried by wind", there is a cosmetic implication. Hence this case appears in Column A of the table.
- When the word "relieves" is vaguely used (e.g. relieves itching), the claim cannot be considered cosmetic in nature unless it is qualified in some way. This case, then, appears in Column B.
- When the word "relieves" is qualified in the claim "relieves and soothes irritated skin", the product being described would not be acceptable as a cosmetic. Therefore, this case appears in Column C. (Note: the rejection of a product as a cosmetic does not necessarily ensure its acceptance as a drug. In this example, the product might be insufficiently medicated to be effective as a drug).
Cosmetic claims and the Therapeutic Goods Act 1989
Where products are labelled and presented (including by way of presentation and representation in the marketplace and media) as being explicitly for cosmetic purposes only, a product name of itself would not make the product a "therapeutic good" unless that name makes a reference to a disease, ailment or defect of the human body. If to the reasonable consumer a product name suggests that the product is likely to be used in, or in connection with preventing, diagnosing, curing or alleviating that disease, ailment or defect, the product will be held to be a 'therapeutic good', and therefore subject to the full provisions of the Therapeutic Goods Act 1989.
Cosmetic claims and the Trade Practices Act 1974
Where a claim about a cosmetic is misleading or deceptive, it is open to the Australian Competition and Consumer Commission to bring court action for fines or court orders to stop the offending action. Fines for companies for a breach of these provisions can be up to $200 000 for companies and $40 000 for individuals. It is also open for a private party (eg. a competitor or user of the product) to bring a court action for damages or an injunction.
If the target audience lacks a degree of scientific sophistication, scientific and technical terms and symbols should not be used unless they are accompanied by a clear and accurate statement of their meaning. It is not appropriate to rely on consumers receiving a point of sale explanation of what scientific, technical or other unfamiliar terms mean.
It must be born in mind that the test for misleading or deceptive conduct is objective: is the claim likely to mislead or deceive? The test is not whether the marketer intended deception to occur.
Where a statement is made that is (or purports to be) of a factual character, the Act will be breached unless the statement is capable of substantiation.
A marketer may make a statement about something that will happen in the future. However, where the marketer cannot show there were reasonable grounds for making the statement at the time it was made - the statement will be misleading.
NCCTG cosmetic claims guidelines
This document is issued by the National Coordinating Committee on Therapeutic Goods (following input from the Cosmetic, Toiletry and Fragrance Association of Australia) to provide guidance in relation to the cosmetic/therapeutic interface in respect of product claims. Products may not make therapeutic claims unless included in the Australian Register of Therapeutic Goods.
| Subject | Column A Acceptable wording for a cosmetic |
Column B Unacceptable wording for a cosmetic claim unless sufficiently modified to provide a cosmetic implication |
Column C Unacceptable wording for a cosmetic (but not necessarily acceptable for a drug) |
|---|---|---|---|
| Active ingredient | cosmetic active ingredient | medicinal (therapeutic) ingredient | |
| Ageing, anti-wrinkle |
|
|
|
| Astringent |
1 Usually contains alcohol or equivalent |
2 Cosmetic sense of astringent by means of physical surface effect (eg. aftershave lotion). |
|
| Bio, biological |
|
|
|
| Comedomes, acne, pimples, blackheads |
|
|
|
|
Contour creams3 3 See also - Astringent, Skin |
|
||
|
Dentifrice NB: In terms of Section 7 of the Therapeutic Goods Act 1989, toothpastes are declared to be 'not therapeutic goods' providing:
|
|
|
|
| Deodorant |
|
|
4 Antiperspirants are regulated as therapeutic goods |
| Hair |
|
makes your hair stronger |
|
| Healthy |
5 "Healthy" in the sense of "clean." |
|
|
| Mouthwash |
|
|
|
| Nails |
|
|
reference to growth resulting from nourishing fingernails |
| Nourish |
|
|
|
| Perfumes (fragrances, colognes, toilet water) |
|
||
| Relax |
|
|
|
| Repair |
|
||
| Respiration |
|
|
|
| Revitalise |
|
|
|
| Skin - (Cleansers, Soap) |
|
|
|
| Skin - (Facial Peels) |
|
|
|
| Skin - (Moisturisers) |
6 Barrier creams, for example |
7 Soothes wind-burned skin, for example |
|
|
Sun, suntan products, aftersun treatments, sun protection, tanning accelerators NB: Primary sunscreens and secondary sunscreens which state an SPF number, category description or other therapeutic use are regulated as therapeutic goods. Secondary sunscreens with no claimed SPF number, category description or other therapeutic use may be marketed as cosmetics.9 |
|
|
|
|
8 Dyes, some barrier creams, self tanners, sunless tanners for example. (This type of product should include a warning that it does not provide sun protection.) 9 The two exceptions to this are tinted facial make-up products (other than moisturisers) and preparations for application to the lips which are tinted and unmedicated ie. these products may state the actual sun protection factor & equivalent category description. |
|||
| Therapy, treatment |
|
|
|
|
Vitamins [NB: Oral vitamin supplements are regulated as therapeutic goods, as are topical products containing vitamins (eg. creams) if intended for a therapeutic effect] |
|
||
Agencies with regulations, standards and guidelines concerning cosmetic products in Australia
Permissible ingredients:
National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
GPO BOX 58
Sydney NSW 2001
Tel 1800 638 528
Fax 02 8577 8888
Ingredient labelling requirements:
The Australian Competition and Consumer Commission
PO Box 1199
Dickson ACT 2602
Tel 02 6243 1111
Fax 02 6243 1199
NCCTG Guidelines concerning the cosmetic - therapeutic boundary in relation to advertising claims:
National Co-ordinating Committee on Therapeutic Goodsbr /> Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Tel 02 6232 8636
Fax 02 6232 8687
Packaging & warning requirements for 'scheduled poisons':
National Drugs and Poisons Schedule Committee
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Tel 02 6289 3200
Fax 02 6289 3299
Industry Association:
The Cosmetic, Toiletry and Fragrance Association of Australia
(Level 9, 140 Arthur Street, North Sydney)
Private Bag 938
North Sydney NSW 2059
Tel 02 9927 7370
Fax 02 9955 0032
General advertising claims:
The Australian Competition and Consumer Commission
PO Box 1199
Dickson ACT 2602
Tel 02 6243 1111
Fax 02 6243 1199