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Out-Law Analysis | 04 Feb 2021 | 10:30 am | 10 min. read
Advertisers of cosmetic products must be careful not to stray into 'medicalising' their goods when making claims about the benefits they can bring to consumers. Doing so runs the risk of non-compliance with strict regulations around the marketing of medicinal products.
The distinction between advertising a product as having purely cosmetic properties and effects and advertising a product as having medicinal properties and effects is not always straightforward or clear.
Though guidance has been produced to assist advertisers, different rules apply around the world and often the difference between whether a product is considered a cosmetic or a medicine is decided by the way it is presented to and understood by consumers. To illustrate the point, we have taken a look at a real-life advert that was assessed by the UK's advertising regulator and looked at how other regulators around the world may have considered the case under the rules that apply in their jurisdiction.
In 2017, the UK's Advertising Standards Authority (ASA) ruled that adverts for a product called Sanex Advanced AtopiCare, manufactured by Colgate-Palmolive, were in breach of UK advertising rules. The regulator had considered the adverts following a complaint raised by Unilever.
Unilever's complaint was that the adverts made medicinal claims for unlicensed products. The ASA agreed
The adverts, which appeared in the press and on the company's own website in text and video form, made a number of claims about the product.
The press ad read: "Very dry, red skin? It could be Atopic. If your skin is red, reactive or very dry, it could be atopic. The Sanex Advanced AtopiCare Body Lotion has been especially developed for dry, atopic skin to help relieve dryness and soothe skin ..."
Text on the website included: "Developed with dermatologists for specific skin needs. Clinically proven results."
The video posted on the website showed a close-up image of skin cells that became red and went back to their normal colour following application of the product. The video also featured a voice-over which stated that the product "soothes dry, atopic skin from the very first use".
Unilever's complaint was that the adverts made medicinal claims for unlicensed products. The ASA agreed.
Advertising in the UK is self-regulated. However, in the event of a consumer or competitor complaint, the advertising is regulated and judged by the ASA.
The legislative framework in the UK has changed since Brexit
In its ruling on the Colgate-Palmolive advert in 2017, the ASA had regard to both UK and EU legislation, including the Human Medicines Regulations in the UK, which implements the EU Medicinal Products Directive, and the EU's Cosmetic Products Regulation.
The legislative framework in the UK has, however, changed since Brexit. The Human Medicines Regulations still apply, but the Cosmetic Products Regulation has been effectively converted, with amendments, into domestic regulations. The amended regulation now sets out the requirements that must be met before cosmetics products can be placed on the market in Great Britain. The existing EU Cosmetic Products Regulation continues to apply in Northern Ireland.
The ASA also considered guidance produced by the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory agency in the UK responsible for medicines and medical devices, as well as the CAP Code, which is the UK's rule book for non-broadcast adverts.
A product is defined as a medicine under the Medicinal Products Directive if it is either presented as having properties for treating or preventing disease in humans or if it would have pharmacological, immunological or metabolic action on physiological functions when administered to humans.
Conversely a cosmetic is, broadly, a product intended for placing in contact with external parts of the body with a view 'exclusively or principally' to cleaning them, perfuming them or protecting them.
The 'presentational' limb of a medicine is a fundamental consideration for anyone advertising a cosmetic; if it is presented as a medicine, the advertiser will have inadvertently made medicinal claims for an unregulated product which is prohibited. Advertisers can consult guidance such as the Cosmetic, Toiletry and Perfumery Association's guide to cosmetic advertising claims, as well as the European Commission's own guidance on borderline products to ensure their advertising does not stray in to the regulatory framework for medicines.
The ASA's ruling in relation to Colgate-Palmolive's advertising of the Sanex product is interesting because, whilst reviewing and applying the applicable legislation and guidance, it focused in on the 'presentational' factors of the advertising. In reaching its verdict that the cosmetic was presented as a medicine, the ASA said that the following factors were critical:
Similar to the UK, advertising in Ireland is self regulated by the industry. In the event of a consumer or competitor complaint, advertisements are governed by the Advertising Standards Authority of Ireland (ASAI) and by reference to a Code of Standards for Advertising and Marketing Communications in Ireland (the Code).
Claims regarding health and beauty products and treatments should be backed by substantiation and, where relevant, should include the results of reputable trials on human subjects
Regulation by the ASAI is subordinate to and complements legislative controls on advertising and sales promotions, which include national regulations implementing the EU's Medicinal Products Directive and Cosmetic Products Directive. Additional regulations that are relevant include the EU's Cosmetic Products Regulation and the EU's Regulation on common criteria for the justification of claims used in relation to cosmetic products, for which there is corresponding guidance.
Cosmetic products and medicines are treated in Ireland in a similar way to that of the UK. Primarily, when considering advertisements of this nature the ASAI will be guided by Section 11 of the Code which governs advertisements in relation to heath and beauty. According to this section a high level of scrutiny will be applied by the ASAI in relation to all marketing communications for medicines, medical devices, treatments, health-related products and beauty products – cosmetics.
The Code states that claims regarding health and beauty products and treatments should be backed by substantiation and, where relevant, should include the results of reputable trials on human subjects. Additionally, secondary medicinal claims made for cosmetic products must be limited to any preventative action of the product and may not include claims to treat disease.
Particularly in relation to cosmetics the Code states that claims about the effect that a cosmetic has on, or in, the skin should distinguish between the composition of the product and any effects caused by the mode of application.
In the absence of any medical evidence and substantiation for a product, advertisements claiming any medical benefits are likely to be upheld by the ASAI as being in breach of the Code.
In a decision last year the ASAI noted that compliance with the Code is assessed in the light of that advertisement's probable effect when taken as a whole and in context and that claims about health and beauty products and treatments should be backed by substantiation, including where relevant, "the results of robust and reputable trials on human subjects, of sufficient rigour, design and execution as to warrant general acceptance of the results".
The Advertising Standards Authority of Singapore (ASAS) regulates advertising and ensures compliance with the Singapore Code of Advertising Practice (SCAP). The ASAS has powers to ask for the withdrawal or modification of adverts. Separately, cosmetics and medicines are regulated by the Health Sciences Authority (HSA) which has oversight over all aspects including the advertisements of cosmetics and medicines and requires compliance with SCAP.
The structure of the SCAP sets out general guidelines applicable to all advertisements. It also has specific rules for specific areas. These include 'Exhibit F' which concerns 'medicinal and related products and advertisements containing health claims'.
If certain physiological effects are claimed, whether in writing or visually, these claims should be backed by evidence specifically directed at establishing this within the context of established scientific knowledge
The preamble to Exhibit F states: "Special care should be taken by advertisers to ensure that the spirit as well as the letter of those provisions is scrupulously observed." Exhibit F applies to advertisements for "medicines, medical and surgical treatments and medical devices", "other products which claim or imply therapeutic or prophylactic qualities" and "any product advertised, whether wholly or in part, upon the basis that it may improve, restore or maintain the user’s health or his physical or mental condition". It is clear that Exhibit F of the SCAP would govern the presentation of a cosmetic with medical claims.
The ASAS will ask the advertiser to substantiate any claims in the advert, such as the involvement of medical specialists, such as dermatologists. That evidence should be readily available at the time the advert is published. In addition, if certain physiological effects are claimed, whether in writing or visually, these claims should be backed by evidence specifically directed at establishing this within the context of established scientific knowledge.
The presence of the video, reference to dermatologists and clinically proven results, and the statement that the product 'relieves' dry skin, would likely bring the advert within the scope of Exhibit F. The advertiser would need to hold evidence to substantiate all claims.
The advertising of cosmetics in Germany is regulated by the industry itself. A consumer or a competitor is able to file for injunction before a court. If advertising misleads consumers, it breaches a market conduct rule of the German Unfair Competition Law. Jurisdiction for any claims relating to such a breach therefore lies with the national courts.
Dr. Nils Rauer, MJI
According to German law on advertising in the field of healthcare, any advertising for a medicine is prohibited if the product is not approved as a medicine
In assessing such claims, the courts would consider provisions contained in the German Drug Act (AMG), which transposes the EU's Medicinal Products Directive into national law, as well as the German law on advertising in the field of healthcare.
The average consumer's understanding and the purpose indicated for the product in the advert are decisive in determining whether the product is deemed a medicine or a cosmetic.
By using the term "atopic" the advertising describes a specific disease pattern, which is different compared to just “dry” or “red” skin. The reference to a medical term would be enough for the product to be deemed as being presented as a medicine; the average consumer will interpret that claim to mean that the product will provide relief for or even heal their condition. Consequently, it would be deemed a medicine according to section 2 of the AMG. According to section 3a of the German law on advertising in the field of healthcare, any advertising for a medicine is prohibited if the product is not approved as a medicine.
In France, the General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), the French medicines agency (ANSM) and the Self-Regulation Authority for Advertising (ARPP) provide guidance in relation to advertising of cosmetics, in particular on health claims for borderline products.
DGCCRF and ANSM are primarily responsible for enforcement. Competitors and consumers associations may also initiate civil liability proceedings before courts, to seek an injunction and damages, as well as criminal liability proceedings.
In France, the advertising of cosmetics is regulated by statutory provisions. Of particular relevance are the Public Health Code, which implements the Medicinal Products Directive, the EU Cosmetic Products Regulation, and France's Consumer Code.
According to case law, if a product is considered to have been presented as a medicine then this is enough in itself for it to be considered as a medicine, without any regard to scientific data on the actual effect of the product on the body
In considering whether a product is being presented as a medicine, the courts in France usually take into account several factors such as the reference to a disease in the advert or on the packaging, the galenic form of the product, the reference to a dosage and/or contraindications or other safety information. According to case law, if a product is considered to have been presented as a medicine then this is enough in itself for it to be considered as a medicine, without any regard to scientific data on the actual effect of the product on the body.
In assessing what should be considered a disease, courts have adopted a broad approach and found, for instance, that an arnica spray presented as having anti-pain properties or a cream presented as having anti-acne properties fell into the category of medicines.
To reduce the risk of non-compliance, businesses should ask themselves some core questions in relation to the products they are promoting:
Businesses should also be alert to changing rules and new guidance. The Association of the British Pharmaceutical Industry is currently consulting on proposed changes to the ABPI Code of Practice, which is applicable in the UK only. The changes are expected to take effect later in 2021. Cosmetics Europe has also published updated guidance relating to the principles of responsible advertising and marketing, in particular in relation to cosmetics products.
Co-written by Huw Cookson, Bryan Tan, Erika O’Donnell, Michael Finn, Marina Jonon, Jules Fabre, Marieluise Schurer and Alex Bibi of Pinsent Masons. A version of this article was first published in the Regulatory Rapporteur journal by The Organisation for Professionals in Regulatory Affairs.
12 Jan 2021
08 Jul 2020
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