Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the Advertising Standards Authority.
What are acne and spots?
Are acne and spot products classed as medicines or cosmetics?
What claims are likely to be problematic if a license is not held?
What claims are likely to be acceptable?
What about prescription acne and spot treatments?
What about medical devices and therapies?
What are acne and spots?
The causes and definitions of acne are complex and variable. The ASA and CAP consider that consumers are likely to understand the term “acne” to refer to the widespread, persistent occurrence of skin inflammations, commonly referred to individually as “spots”, which are typically caused by clogged sebum ducts.
The ASA and CAP understand that consumers are likely to interpret the term “spots” as a reference to a wider range of skin issues with a variety of causes, levels of severity and extent of occurrence. As such, the likely interpretation of a reference to “spots” in ads is going to depend on the surrounding content. As such, in some instances, references to spots could be interpreted as a reference to acne.
“Blackheads”, on the other hand, are likely to be seen as a reference to non-inflamed or open pores blocked by oil and dirt and the term is not likely to be confused with “spots” or “acne”.
See Advice on Medicinal Claims
Are acne and spot products classed as medicines or cosmetics?
Before considering the type of claims that are likely to be acceptable, marketers are advised that they should firstly ensure they understand how their products are likely to be classified.
Medicines
Article 1(2) of the Medicinal Products Directive 2001/83/EC defines a medicine as:
- Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;
- Any substance or combination of substances which may be used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnos
If a marketer’s product is classed as a medicine (under the above definition) then it would need to be licensed as such by the MHRA before it can be marketed.
Medicinal claims are not permitted in ads for products which are not classed, and therefore cannot be licensed, as medicines.
Cosmetics
Article 1(1) of the Cosmetics Directive defines a ‘Cosmetic Product’ as a product, the primary purpose of which is to clean, perfume, change appearance, protect, keep in good condition, or correct body odour.
It is important to note that cosmetic products may have a principal cosmetic purpose (e.g. to clean the skin) and a secondary preventative purpose (e.g. “keep your skin in good condition”). Therefore, a cosmetic product can have a secondary medicinal preventative purpose but still be classified as a cosmetic product.
With that in mind, CAP Code rule 12.1 states:
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.
Depending on how marketers present a product and its function (including this ‘secondary’ function), something that is seemingly a cosmetic product will sometimes meet the definition of a medicinal product, therefore triggering the need for a medicines licence.
If a product meets the definitions of both a cosmetic AND a medicinal product, then the provisions of the Medicinal Products Directive will apply as this piece of legislation takes precedence over the Cosmetics Directive.
Marketers who are unsure about the classification of their product should read MHRA’s Guidance Note 8 – A guide to what is a medicinal product in the first instance.
What claims are likely to be problematic if a license is not held?
Claims to “treat” acne or spots are likely to be considered medicinal and therefore would only be acceptable if the marketer holds a medicines license.
In 2018 the ASA investigated website content about a product range which included claims that the products could “treat, clear and prevent adult acne” and that each product was “designed to be layered upon the skin to provide around-the-clock, maximum control of the main factors that contribute to acne”. The ASA considered that because the ads presented the products as treatments for adult acne (an adverse medical condition), the claims were medicinal in nature and could not be considered cosmetic, even if the products were otherwise presented primarily as having a cosmetic function (Dermalogica UK Ltd, 17 October 2018).
Also in 2018, the ASA considered claims for a cosmetic product which claimed to be a “rapid action treatment cream” which was “clinically proven to reduce spot size and redness in as fast as 4 hours” and that “when fighting breakouts, faster is better”. In this case the marketer disputed that the claims or the mode of action of the product were medicinal in nature and believed they were about the cosmetic appearance and general condition of the skin, due to the cleansing action of the cosmetic product on the skin and pores. The ASA disagreed and concluded that the claims would be understood by consumers to mean that the primary purpose of the product was to treat existing spots (as opposed to cleansing the skins to help prevent new ones) and as such, were medicinal in nature (RB UK Commercial Ltd, 17 October 2018).
Marketers should also be aware that the ASA is likely to apply the same principles to the way in which a group of products are categorised in an ad. For example, the ASA previously considered a website selling a large range of products under the headline title “Women’s skincare For Acne and Problem Skin” which also described the category as a whole as containing products to treat acne, which are medicinal claims. In that case the ASA ruled that because the medicinal claims were made in both the title and the description of the category in its entirety, all of the products that appeared within that category were being presented as medicines and should have been licensed as such (Feel Unique International Ltd, 17 October 2018).
Marketers that do hold a medicines licence for their acne/spot treatments are reminded that advertising claims should adhere to the terms of that license and the Summary of Product Characteristics (SPC) (CAP Rule 12.11).
What claims are likely to be acceptable?
Depending on the presentation, claims that cosmetic products clean pores and/or otherwise keep skin in good condition in order to prevent occasional outbreaks of “spots” are likely to be considered acceptable without the need to hold a medicines licence. The ASA considered an ad for a cream wash which included claims that the product would "Deep clean your skin to help prevent breakouts” and “cleans deep into your pores to help prevent spots”. Because the ad made clear that the product could help prevent spots through the cleansing action rather than treating existing spots, the ASA considered the product was primarily presented as a cosmetic and that consumer understanding of the claims would be in line with the secondary prevention claims that could be made in relation to a cosmetic (Johnson & Johnson Ltd, 17 October 2018).
Marketers are reminded that efficacy claims for cosmetic products (including those with permissible secondary medical claims) should be supported by robust clinical evidence (CAP Rule 12.1).
What about prescription acne and spot treatments?
Prescription-only medicines (POMs), including prescription treatments for acne, cannot be advertised to the public (rule 12.12).
A series of Instagram posts for an acne treatment provider included references to a consultation for Accutane and Roaccutane, both or which are POMs. The ASA ruled that the ads breached the Code because they advertised POMs to the public (Person(s) unknown, 20 April 2022).
See CAP Advice on Prescription only medicines.
What about medical devices and therapies?
Claims that a device can treat or prevent spots or acne are likely medicinal (see above). If the product is determined to be a medical device, that device must be appropriately certified through the relevant applicable conformity marking and must be registered with the MHRA prior to being sold and advertised. See CAP Advice on Medical Devices.
Marketers are reminded that even if they hold the appropriate certification and MHRA registration for their medical device, they must also hold robust clinical trial evidence to support the claims.
Claims that a therapy, such as those administered in a clinic setting, can treat or prevent spots and acne will need to be supported by robust documentary evidence.
This CAP Guidance explains the types and levels of evidence the ASA would expect to see to support efficacy claims for medical devices and therapies.