Cosmeceuticals: advertising rules and claims

The annual growth is expected to continue at a stunning rate of 9.5% and the market is expected to reach $72 billion by 2009.1

Another market trend report published by Packaged Facts in 2005 stated that sales of cosmeceuticals in the US would reach $12.4 billion in 2004 (of which $6.4 billion was for the skin care products) and continue to grow to over $16 billion by 2010. The new product trends would centre on “anti-ageing everything” with a strong demand for botanicals.2 The annual global spending on OTC cosmetics and cosmeceuticals to enhance appearance is at an all time high of $230 billion.3

The current and projected bright future outlook of the business is motivated and fuelled by the baby boomers’ relentless demand for eternal youth and further enabled via the seemingly endless supply of new scientific discoveries of the ageing process and fantastic claims of more effective delivery systems and exotic new ingredients often touted as the next best “something-ceutical”.

A significant amount of media coverage has been devoted to the topic of anti-ageing in recent years. The many ways a cosmetic product can bring eternal beauty and youth to a consumer appears to be as inexhaustive as the imagination of any creative marketer. It is estimated that an average American encounters at least 1,500 advertising messages daily. Many of them contain age-reversing, appearance rejuvenating claims such as “Ageing is reversible and optional”, “Regenerate damaged skin”, “Penetrates deeply into the layers of the skin”, “Erase wrinkles and boost collagen synthesis within 10 days”, “Stimulates cellular metabolism within days”, etc.

But how convincing are these messages? An Australian survey conducted by CoreData and NEWS.com.au reported that 55% of the respondents did not trust the accuracy of the scientific claims made by cosmetic companies and many were cynical about those claims.4

In addition, how are cosmetic products regulated in terms of advertising and promotion? Are cosmeceutical products a new regulatory sub-category of cosmetic products? Or are they regarded as medicinal products? Are there any specific rules regulating their product claims and substantiation standards?

Legal distinction in US

In the United States, the regulatory requirements for cosmetics and drugs are established by the Federal Food, Drug & Cosmetic Act (FD&C Act), enacted in 1938 and enforced by the Food and Drug Administration (FDA). The act defines cosmetics as: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance”.5

Drugs are defined by the FD&C Act as: “(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease… and (B) articles (other than food) intended to affect the structure or any function of the body of man or other animals.”6

Products are classified by the Act based on their intended use. A product’s intended use may be established through its direct advertising or product claims. However, the FDA advises that consumer perception and expectation of the product also constitutes the basis for determining the intended use, be it through direct advertisement or indirectly implied promotional messages.7,8

The FDA sets forth very specific requirements governing cosmetic product labelling including details such as the product identity display, the placement of the name and place of business, appropriate ingredient listing, an accurate statement of the net quantity of contents, appropriate directions for safe use, and appropriate warning statements when deemed necessary. Labelling is defined to include all written, printed, or graphic material that appears on the products, containers, packaging inserts, and any material accompanying the product. So, effectively, any promotional material and statements including those appear on the internet, product catalogues and flyers are considered cosmetic product labelling. These requirements are regulated under two main regulations: the FD&C Act and the Fair Packaging & Labeling Act (FPLA).

The FDA’s main enforcement focus for cosmetic labelling is on “misbranding”. To qualify for a cosmetic product, the labelling must not imply any physiological effect, must not suggest structure/function impact, must not mention ingredients that are commonly regarded as drugs, and must not mention unapproved colour additives. Incorporating drug claims in the cosmetic labelling causes the product to be considered misbranded and will lead to the FDA enforcement action.

Global situation: cosmetics vs drugs

The global definition of a therapeutic drug is quite similar, most agreeing that a drug is intended for the diagnosis, cure, mitigation, treatment or prevention of diseases via some means of physiological action. But when it comes to cosmetics, differences exist in major world markets including Australia, US, EU, Canada and Japan.

In Australia, a cosmetic is defined as: “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”. Similar to the classification standard practised in the US, a cosmetic product will be considered a therapeutic product if it intends to treat, alleviate or prevent disease; or claims to affect the structure or functions of the human body or have therapeutic effects; or contains ingredients possessing therapeutic effects.9 Two major factors are used to differentiate cosmetics from the therapeutic product: the composition of the product, and the proposed use and claims of the product. According to the third edition of Guidelines for Cosmetic Claims published by the Therapeutic Goods Administration on 9 May 1997, cosmetics may not make therapeutic claims unless they are listed in the Australian Register of Therapeutic Goods.10

The Canadian Food & Drugs Act defines a cosmetic as: “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes”. Similar to the US FDA, Health Canada further stipulates that claims of physiological effect are not allowed for cosmetics. A cosmetic product making a therapeutic claim (e.g. to prevent or treat disease) will be classified as a drug under the Food and Drugs Act and a drug identification number (DIN) will be required.11 The Japanese Pharmaceutical Affairs Law regulates all pharmaceuticals, quasidrugs, cosmetics and medical devices in Japan. Its definition of a cosmetic is stated as: “a substance with mild effect on the human body which is intended to be put on the human body for the purpose of cleansing, beautifying, enhancing the attraction, changing the appearance, or maintaining the skin or the hair healthy”. This definition allows cosmetics to have a mild effect on the human body.12

In the European Union, the 7th Amendment of the Cosmetic Directive (original Directive 76/768/EEC) defines a cosmetic as: “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.”13 The Directive further instructs in Article 7a, 1(g) that a proof of effect claimed for the cosmetic product be kept readily accessible to the competent authorities of the Member State. Based on this definition, one can expect the cosmetic products to show some “effect”.

Even though the product classification standard may differ, the regulatory requirements for cosmetics are quite similar for these major markets in terms of demanding the manufacturer to carry the full responsibility of product safety, not requiring pre-market product approval and registration, establishing cosmetic-specific Good Manufacturing Practice (GMP) industrial guidelines and imposing no restrictions on sales distribution channels.

Cosmeceutical products labeling

The term “cosmeceuticals” has been widely used by the cosmetic industry to refer to cosmetics that also possess drug-like effects. Anti-ageing products are among the fastest growing in the skin care market, and many of them are claimed to be cosmeceuticals – able to deliver rejuvenation benefits far beyond skin moisturisation or merely covering up wrinkles.

Consumers are bombarded with scientific sounding advertisements claiming enhanced cellular turnover rate, DNA repair, molecular energy renewal at the mitochondria level, and collagen synthesis stimulation, etc.

However, the US FDA does not recognise the “cosmeceuticals” as a valid product class nor does it plan to include it as a sub-category of cosmetics and warned it will apply the same “structure and function” standard to determine the classification of anti-ageing products. If a product is intended for cosmetic use but its claims also suggest physiological (drug-like) properties, the product will be subjected to both drug and cosmetic regulations.14

Health Canada takes a similar stance on cosmeceuticals as the US FDA. It does not recognise them as a legitimate product category. The product will be regulated either as a cosmetic or a drug depending on the claims it makes and/or the composition of the product. Acceptable cosmetic claims provided in the Guidelines for Cosmetic Manufacturers, Distributors and Importers15 include wording such as: “softens skin”, “reduces the look of cellulite”, “removes oil”, “helps eliminate odour-causing bacteria”, “soothes”, or “helps prevent the look of ageing”. Using phrases such as “heals”, “slims/slimming”, “stops acne”, “kills germs”, “eliminate wrinkles” may lead the Canadian authority to consider them unacceptable cosmetic claims.

The Australian National Coordinating Committee on Therapeutic Goods gave the following examples as industrial guidance for anti-ageing cosmetic product claims:16

Acceptable cosmetic claims