‘Killer’ Cosmetic Claims

Introduction:

The cosmetic industry, an ever-evolving realm of beauty and self-care, has recently witnessed an upsurge in claims that toe the line between punchy innovation and potential deception. This blog aims to delve into the intricacies of borderline claims, with a particular emphasis on medicinal, biocidal, and medical device assertions, within the framework of the stringent regulations laid out by the United Kingdom (UK) and the European Union (EU).

Medicinal Claims and the Borderline:

In the UK and the broader EU, regulatory bodies play a pivotal role in ensuring the safety and accuracy of cosmetic claims. Medicinal claims, which suggest therapeutic benefits, are closely scrutinized to prevent the encroachment of cosmetics into pharmaceutical territory. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) at the EU level enforce guidelines that delineate the boundaries between cosmetics and medicinal products.

Cosmetic products, by definition, are not intended to treat or diagnose medical conditions, and claims suggesting otherwise raise ethical concerns, mislead the consumer, and put your brand at risk of regulatory action with no justifiable defense. Claims such as “reduces inflammation” would be considered medicinal as inflammation is a disease state. Regulatory bodies act as guardians, upholding the distinction between cosmetics and medicines, thereby safeguarding consumer welfare and maintaining the integrity of the industry.

Biocidal Claims, A Delicate Balancing Act:

Promising antimicrobial and antiviral properties are especially alluring in light of the wake of global health concerns. However, in the UK and EU, cosmetic products boasting such attributes are subject to rigorous scrutiny. Regulatory frameworks, such as the Cosmetic Regulation in the EU and the Cosmetic Products Enforcement Regulations in the UK, demand scientific evidence supporting biocidal claims, ensuring products meet strict safety and efficacy standards. Furthermore, specific conditions must be met for the use of biocidal claims on cosmetic products. Biocidal claims are those that convey a message that upon application of the product bacteria, fungi and viruses will be killed. Claims such as “kills 99.9% of the coronavirus” would be considered biocidal out outside of the scope of a cosmetic product.

The potential misuse of such claims not only poses risks to individual health and brand reputation but also contributes to the broader issue of antimicrobial resistance, a serious threat that regulatory bodies are actively working to mitigate.

Divisive Medical Device Claims:

As cosmetic products increasingly incorporate advanced technologies blurring the lines between cosmetics and medical devices, particularly as many medical devices are topical in nature. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the safety and performance of cosmetic devices, while at the EU level, the European Medicines Agency (EMA) provides guidelines through the Cosmetic Regulation.

Innovations like barrier-forming films and creams, the use of nanoparticles, and multi-phasic materials blur the lines between cosmetic products and medical devices. Claims surrounding the prevention or treatment of a disease through a physical or mechanical mechanism are likely to be suited to a medical device rather than a cosmetic. “Forms a barrier to prevent infection” and similar claims would be well suited for a medical device due to a medical effect being produced by a physical or mechanical method rather than a physiological method. however, these claims would be unsuitable for a cosmetic product, even if true. The regulatory bodies in the UK and EU are striving to establish clear guidelines to ensure the safety and proper usage of these products, highlighting the importance of transparent claims and adherence to rigorous testing and compliance standards.

Conclusion:

It is important to ensure that all product and marketing claims are suitable for the intended classification and function of the product. Understanding the applicable regulatory frameworks and horizontal legislation becomes paramount to ensure that all marketing materials, romance copy, and claims do not put your brand at risk of regulatory action.

Reach out to COSMESURE here for an assessment of your borderline claims to understand their suitability, risk, and substantiation requirements.

info@cosmesure.uk