Understanding Medicinal, Biocidal, and Cosmetic Claims: Definitions, Overlaps, and Regulatory Challenges

Introduction

In today's fast-evolving beauty and health market, there is a wide variety of products claiming to provide benefits ranging from enhancing personal appearance to treating skin conditions or eliminating harmful microorganisms. These claims fall under three key categories: medicinal, biocidal, and cosmetic. While these claims may seem similar on the surface, they carry distinct legal and regulatory implications that brands must be mindful of. More importantly, the lines between these categories are often blurred, leading to confusion among consumers and companies alike. In this blog, we'll explore medicinal and biocidal claims, how they differ from cosmetic claims, and where they overlap.

What Are Medicinal Claims?

1. Definition of Medicinal Claims

Medicinal claims are statements that suggest a product can treat, prevent, or cure diseases or medical conditions. In most jurisdictions, such claims are strictly regulated because they indicate that the product has pharmacological, immunological, or metabolic properties. This means that any product making a medicinal claim must undergo rigorous testing and approval by health authorities prior to marketing, such as the Medicines and Healthcare products Regulatory Agency (HMRA).

2. Examples of Medicinal Claims

• "Clears acne."

• "Heals and repairs damaged skin tissue."

• "Provides relief from eczema symptoms."

These claims imply that the product alters the structure or function of the body, and as such, it would be categorized as a medicine under regulatory guidelines.

What Are Biocidal Claims?

1. Definition of Biocidal Claims

Biocidal claims refer to statements that a product can control harmful organisms through chemical or biological means. Biocidal products include disinfectants, insect repellents, and preservatives. A biocidal claim implies that the product is designed to neutralize or destroy harmful organisms, including bacteria, fungi, viruses, or pests.

2. Examples of Biocidal Claims

• "Kills 99.9% of germs."

• "Eliminates mold and mildew."

• "Prevents bacterial growth on surfaces."

• “Kills bacteria responsible for acne.”

These claims are typically associated with products like hand sanitisers and disinfectant sprays but can misleadingly be used in association with cosmetic products.

What Are Cosmetic Claims?

1. Definition of Cosmetic Claims

Cosmetic claims refer to statements that a product can improve or maintain the appearance of the skin, hair, nails, or teeth without affecting the body’s structure or function. Cosmetic claims focus on beautification, cleansing, moisturizing, or perfuming rather than healing or treating a medical condition.

2. Examples of Cosmetic Claims

• "Moisturises dry skin."

• "Reduces the appearance of fine lines."

• "Leaves hair soft and shiny."

These claims do not imply any medical treatment, prevention of disease, or interaction with pathogens, meaning that cosmetic products fall under different regulatory frameworks than medicinal or biocidal products.

The Overlap Between Medicinal, Biocidal, and Cosmetic Claims

The boundary between medicinal, biocidal, and cosmetic claims is not always clear-cut. Many products, especially in the skincare and personal care industries, fall into a gray area where these claims can overlap. For instance, a hand lotion that claims to "moisturize the skin" would be classified as a cosmetic. However, if the same lotion also claims to "heal damaged skin" or "prevent infection," it 2ould cross into the territory of medicinal or biocidal claims.

Here are some areas where overlaps commonly occur:

1. Anti-Aging Products

Many anti-aging products claim to reduce the appearance of wrinkles, hydrate skin, and improve elasticity, which are considered cosmetic claims. However, when these products start making claims like "stimulates collagen production" or "repairs DNA damage," they could be perceived as making medicinal claims. This is because the product is now suggesting an effect on the body's structure and function.

2. Acne Treatments

A facial cleanser marketed to "cleanse pores and reduce oil" would fall under cosmetic claims. However, if the same product claims to "treat acne" or "reduce inflammation caused by acne," it crosses over into medicinal claims. In this case, it might be subject to regulatory scrutiny and require approval as a medicinal product.

3. Hand Sanitizers

Hand sanitizers are a prime example of products straddling biocidal and cosmetic claims. If the product claims to "moisturize and soften hands," it would be a cosmetic. However, if it also states that it "kills 99.9% of germs," it must be approved as a biocidal product, often regulated by both the FDA and the EPA.

4. Anti-Dandruff Shampoos

An anti-dandruff shampoo that simply cleanses the scalp would be considered a cosmetic. However, when the product claims to "eliminate dandruff-causing bacteria" or "treat scalp conditions," it makes both biocidal and medicinal claims, thus requiring a more stringent regulatory pathway.

Best Practices for Manufacturers

To navigate the complexities of medicinal, biocidal, and cosmetic claims, manufacturers should consider the following best practices:

• Consult Regulatory Guidelines Early: Engage with regulatory agencies and legal experts during product development to ensure that claims are compliant.

• Substantiate Claims with Evidence: Ensure that all claims made on product labels and marketing materials are backed by robust scientific evidence, especially for medicinal and biocidal claims.

• Clear and Precise Language: Avoid vague or ambiguous language that could be interpreted as making medicinal or biocidal claims unless the product is appropriately regulated.

• Stay Updated on Regulatory Changes: Regulatory frameworks evolve frequently, so staying informed on changes in laws and regulations is critical.

Conclusion

Understanding the differences and overlaps between medicinal, biocidal, and cosmetic claims is crucial for both manufacturers and brands. The blurred lines between these categories can lead to regulatory challenges, but with careful planning and adherence to guidelines, companies can successfully navigate this complex landscape.

How COSMESURE® Can Help:

COSMESURE®’s most popular service by far is our UK and EU Responsible Person services. However, as a full-service provider we also provide expert regulatory support for marketing assets and advertising campaigns to maximise their potential ROAS whilst helping brands to understand and minimise risk.

For an expert partner that cares, choose COSMESURE®, info@cosmesure.uk.