Background
Summary of Council decision:
The ad was Upheld in relation to ad (c) only.
Ad description
Three ads for Clean and Clear skin products, seen on www.cleanandclear.co.uk in January 2018:
a. A product listing for Deep Action Cream Wash featured text stating, "Deep clean your skin to help prevent breakouts. This creamy wash containing menthol cleans deep into your pores to help prevent spots and leave you feeling fresh-faced and ready for the day - whatever life throws at you!”. An embedded video featured a girl demonstrating how to use the product. She stated, "After two weeks of using it, spots were reduced".
b. A product listing for Blackhead Clearing Daily Scrub featured text stating, "The formula lifts away dirt, oil and impurities to help reduce blackheads and prevent them from coming back". Further text stated, "The blackhead-clearing formula dissolves blackheads deep down into the pores".
c. A product listing for Advantage Spot Control Treatment Gel featured text stating "clinically proven to start clearing spots in just 4 hours … The unique spot-fighting formula will quickly remove excess oil, helps fight problem-causing bacteria and purify skin”.
Issue
Two complainants challenged whether the ads made medicinal claims for unlicensed products.
Response
Johnson & Johnson Ltd said that Clean and Clear was a well-known cosmetic brand for clear skin. They said that the overall presentation of the products in the ads was clearly cosmetic, and consumers would not expect such products to be medicines. They believed that each of the products featured in the ads met the definition of a cosmetic product outlined in the European Regulation 1223/2009/EC (the Cosmetics Regulation).
Johnson & Johnson said that spots developed when the skin produced too much oil (known as sebum), which becomes trapped in pores by a build-up of skin cells and/or dirt. Blackheads showed up when there was too much oil on the skin and pores became blocked. When bacteria began to form, this resulted in a visible black dot on the skin. In order to keep pores open, products such as Clean and Clear could be used to remove excess sebum and exfoliate the skin.
Johnson & Johnson said that in relation to the Deep Action Cream Wash, the product had a primary cosmetic function to cleanse the skin. It was presented with the final cosmetic purpose to keep the skin in good condition, and did not claim to treat disease or adverse conditions. They therefore believed that any efficacy claims made in the ad were secondary claims, which were permissible under the Cosmetics Regulation, subject to sufficient evidence being held.
Johnson & Johnson stated that the Blackhead Clearing Daily Scrub had a primary cosmetic function to lift away dirt, oil and impurities. As a result it was presented to “help reduce blackheads and prevent them coming back”, with the final cosmetic function to keep the skin in good condition. The claim, “the blackhead clearing formula dissolves blackheads deep down into the pores” described the cleansing action of the product. As above, they believed that any efficacy claims made were secondary claims.
Johnson & Johnson said that, in relation to the Spot Control Treatment Gel, the product was designed to be used on specific areas of the face as and when needed to exfoliate blocked pores and remove excess sebum to keep skin in good condition. They stated that the ad did not claim to cure or heal spots. The Clean and Clear Brand was not targeted at consumers with a clear medical condition such as acne. Rather, it was intended for consumers with oily, spot-prone skin looking for products to help keep their skin in good condition by helping to clear the occasional spot.
Assessment
Upheld in relation to ad (c) only
The ASA noted that Article 1(2) of the Medicinal Products Directive 2001/83/EC made clear that a substance was deemed to be a medicinal product either by virtue of its function or by virtue of its presentation. We understood that meant that a product could be rendered medicinal by its functional effect on the body, or by presenting itself as having properties for treating or preventing disease. A medicinal claim was a claim that a product or its constituents could be used with a view to making a medical diagnosis or could treat or prevent disease, including an injury, ailment or adverse condition. Article 2(2) of the same Directive explained that where a product fell within a definition of a “medicinal product” and within the definition of a product covered by other European legislation, including the Cosmetics Regulation, the provisions of the Medicinal Products Directive applied.
The Cosmetics Regulation defined a cosmetic product as a product the primary purpose of which was to clean, perfume, change appearance, protect, keep in good condition, or correct body odour. We noted that the European Commission published a Guidance Document on the demarcation between the Cosmetics Products Directive 76/768 and the Medicinal Products Directive 2001/8318 (the Demarcation Guidance Document). In relation to the definition of a cosmetic product, the Guidance stated that, “A product may have a principal cosmetic purpose and also a secondary purpose to maintain the health. A secondary preventive purpose does not exclude the classification of a product as a cosmetic product. However, if the product in question falls also within the definition of medicinal product (be it by virtue of its presentation or by virtue of its function, which is to be decided on a case-by-case basis), the principle of non-cumulation applies …”. We therefore understood that it was possible for a “cosmetic product” (defined in the Cosmetics Regulation) to have a secondary purpose to maintain the health without meeting the definition of a “medicinal product”, but that where a product met the definition of both a medicinal product and a cosmetic product the provisions of the Medicinal Products Directive applied.
We noted that under the CAP Code, medicinal claims could be made for a medicinal product that was licensed by the MHRA. We considered that the issues under the Code were whether or not the claims in the ads amounted to: 1. medicinal claims; 2. secondary claims made for products squarely fitting within the Cosmetics Regulation definition of cosmetic products, which would need to be limited to preventive action and would need to make no claims to treat disease, including adverse conditions; or 3. non medicinal or medical claims but claims consistent with the products’ status as cosmetic products.
We sought advice from the MHRA. They considered that acne was an adverse medical condition and that claims that stated or implied that a product could prevent or treat acne were medicinal claims. In their view, “spots” would most commonly be associated in public perception with acne, and therefore claims to prevent or treat them would also likely be seen as medicinal. However, they did not consider claims to prevent blackheads to be medicinal claims, as blackheads were not an adverse medical condition.
We also referred to the Manual of the EC Working Group on Cosmetic Products (Sub-Group on Borderline Products) on the scope of the application of the Cosmetics Regulation (the Manual). While the most recent version of the Manual post-dated the ads as they were originally seen, we considered that it provided useful guidance on interpretation of the terms “spots” and “acne”. The Manual stated, “Acne is a state of the skin that is often characterised by the presence of persistent spots, excessive seborrhoea, infection, inflammation and skin damage. Therefore, products that are presented, either explicitly or implicitly, for use in the prevention or treatment of acne (e.g. Acne vulgaris) or other inflammatory lesions of the skin (such as papules and pustules) do not fulfil the definition of a cosmetic product and, as such should not be placed onto the EU market under the cosmetics regulatory framework”. It also stated, “products that function to prevent the formation of spots or function to protect the face from spots through a cleansing action may fulfil the cosmetic definition depending on how the product is presented, the claims that are made about the product and the ingredients used in the product. Such products should not make explicit or implicit claims related to the prevention or treatment of acne. Claims made for products used for spots should comply with the functions expected of a cosmetic product such as to clean, protect or keep the skin in good condition by effectively removing clogged sebum duct (so-called "pores"), accumulated sebum and debris from the skin given that such effects are generally considered to only affect the appearance of primary comedones but do not prevent or treat acne”.
We considered that consumers would likely understand “acne” to refer to the widespread, persistent occurrence of skin inflammations, commonly referred to individually as “spots”, which we understood to be caused by clogged sebum ducts. We acknowledged that the term “spots” was commonly used by consumers to describe a range of skin issues, including those caused by normal teenage development or hormonal cycles, at lower levels and on a less frequent basis, which would not be considered as problematic as more severe or persistent outbreaks of skin blemishes. We therefore considered that consumers’ understanding of “spots” would be highly dependent on the context of the claim. It could be acceptable for claims to help prevent spots to be made in relation to products that squarely met the requirements of the Cosmetics Regulation, provided that advertisers made clear that they were intended, as a secondary outcome of a function that was clearly presented as primarily cosmetic, to prevent the occurrence of occasional, individual spots or small numbers of spots, as opposed to acne (as it would likely be understood by consumers).
We understood that blackheads were non-inflamed, open pores blocked by oil or dirt, resulting in pigmentation. We considered that a product that was presented as having a physical effect to remove blackheads would likely be regarded by consumers as having a cosmetic, rather than a medicinal, action.
We understood that the active ingredient in the Deep Action Cream Wash in ad (a) was 2% salicylic acid, which acted as an exfoliant and was authorised for use in cosmetic products. We considered that the product did not correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, and therefore it did not fall under the functional limb of the definition of a medicinal product as defined in the Medicines Directive. The product was a facewash, and based on its presentation, we considered that consumers would understand that it was primarily intended to remove dirt and oil from the surface of the skin, and exfoliate the pores, which we agreed was a cosmetic function. The ad stated, "Deep clean your skin to help prevent breakouts" and “cleans deep into your pores to help prevent spots”. We noted that the claims were presented in conjunction with the mode of action of the product (cleansing/exfoliating) and there was no text or imagery referring to more serious occurrences of spots, or acne. In the context of the ad, we considered that the consumers would understand the claims to mean that the product could help prevent occasional, low-level occurrences of spots such as might be experienced as part of normal teenage development or hormonal cycles, by removing substances from the skin that could cause spots to form. A further claim in the video stated, "After two weeks of using it, spots were reduced”. We considered that the time period mentioned in the claim implied that the product could reduce the number of spots users would experience in future, by helping to prevent them, rather than treat existing spots. Because we considered that the product was primarily presented as a cosmetic, and that consumer understanding of the claims would be in line with the secondary claims that could be made in relation to a cosmetic (as described in the Demarcation Guidance), we concluded that the claims in ad (a) were not medicinal and did not breach the Code on that basis.
Ad (b), for the Blackhead Clearing Daily Scrub, stated "The formula lifts away dirt, oil and impurities to help reduce blackheads and prevent them from coming back”. The product achieved the effect by using 2% salicylic acid and cellulose beads, and we noted that it did not meet the functional definition of a medicine. We understood that blackheads were not an adverse medical condition. We considered that consumers would understand those claims to mean that the product was primarily intended to cleanse and exfoliate the surface of the skin, thereby helping to physically remove blackheads from open pores, as well as the dirt and oil that could cause them to recur. We therefore considered that the claims in ad (b) were not medicinal, and in keeping with the product’s status as a cosmetic. As such, we concluded that the claims in ad (b) did not breach the Code.
The product in ad (c) contained 2% salicylic acid, and, as above, we accepted that it did not meet the functional definition of a medicine. However, the product was named Advantage Spot Control Treatment Gel, and the web page stated, “clinically proven to start clearing spots in just 4 hours” and “unique spot-fighting formula”. The description of the product focused mainly on its ability to clear individual spots, and we considered that consumers would understand that its primary purpose was to treat existing spots, and therefore it could not carry a secondary preventive claim. We considered the claims amounted to medicinal claims. We concluded that ad (c) made medicinal claims for an unlicensed product and therefore breached the Code.
Ad (c) breached CAP Code (Edition 12) rules
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
and
12.11
12.11
Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach rule 12.2.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA.
(Medicines, medical devices, health-related products and beauty products). Ads (a) and (b) were investigated under the same rules but were not found in breach.
Action
Ad (c) must not appear again in the form complained about. We told Johnson & Johnson Ltd not to make medicinal claims for unlicensed products, in particular claims that stated or implied that their products could prevent or treat acne, or treat spots. When making claims to prevent spots, we told them to ensure that the products and claims in question met the requirements for secondary preventive claims for cosmetic products.
