Introducing a new cosmetic product to the market involves more than just checking that it is safe to use. Businesses need to consider how the product is classified, who takes regulatory responsibility for it, what can be said about it, and how claims are substantiated.
Which regulatory regime applies?
The word “cosmetic” covers a wider range of products than might be expected, from creams applied to the skin to products used on the teeth. Classification can be difficult, and increasingly we are finding that there are products that sit on the borderline between cosmetics, medicines and foods. Claims can play an important role here, and any language suggesting that a product treats or prevents a medical condition could push it towards classification as a medicine, even if it was originally developed and marketed as a cosmetic. Equally, promoting a product in a way that suggests ingestion could make it more likely to be classified as a food. From a regulatory perspective a product can only sit in one category, and it is important to know which regulatory regime applies as the rules can be quite different.
Businesses must also be clear about where the product will be targeted. Although the UK cosmetics regime is largely inherited from EU law, there has been some divergence between the UK and EU rules following Brexit. For products placed on the market in Great Britain, the cosmetics rules sit alongside the wider product safety framework. This differs from the position for food and medicines, where the food and medicine regulatory regimes displace the general product safety rules. It is therefore important for businesses to consider if they are targeting the UK, EU or both as this will impact which rules apply from a regulatory perspective.
Have you got the fundamentals right?
Before a cosmetic product reaches the market, businesses should check that its ingredients are permitted and comply with any applicable restrictions. Every product must also have a responsible person, who has legal responsibility for matters including the safety assessment and product information file. Prior notification must be given to the Secretary of State before the product is placed on the market.
Are cosmetics claims compliant?
As for any advertising claim, cosmetic claims must not mislead. Medical claims present an additional risk as a cosmetic product should not be advertised as curing, treating or preventing a medical condition – these claims are restricted to authorised medical products. It is not just the words but also the overall presentation that matters. Images, branding and context can all affect how the average consumer is likely to understand a claim so medical imagery such as doctors, green crosses and similar will all contribute to the impression that a product is making a medical claim. There may be limited scope for carefully framed secondary medical claims, where a product has a main cosmetics purpose and a secondary preventative purpose. However, businesses should be cautious about using language that comes too close to suggesting that it treats or prevents a medical condition.
Can you substantiate your claims?
All advertising claims must be properly substantiated. The more novel the claim, the stronger the supporting evidence is likely to be. The ASA has provided specific guidance on the substantiation of novel, or ‘breakthrough’, cosmetics claims. There is a raised threshold for substantiation in these cases, requiring at least one controlled human trial. Businesses should therefore take care to identify any breakthrough claims early, and assess whether the available testing and data genuinely supports them.
If you require advice or assistance with any of the issues highlighted in this article, please don’t hesitate to contact the Mills & Reeve advertising team.
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