Our Life Sciences Legal Forum offers a series of quarterly sessions focusing on hot topics within the life sciences sector. In our recent webinar, we explored the complexities of borderline products, focusing on categories that often raise challenging questions. This blog series delves into these issues, with a particular emphasis on medicinal devices and MedTech, medicines and ATMPs, food supplements, consumer products, and advertising.
Understanding Borderline Products
Borderline products are those that may fall into more than one product category. Determining their classification requires careful consideration of factors such as intended purpose, mode of action, and product claims. Understanding these nuances is crucial for regulatory compliance and cost-effective product development.
Focus on Nutritional Supplements, Cosmetics, and Non-Medical Apps
In this third instalment, we focus on the borderlines of medicines and medical devices with nutritional and food supplements, cosmetics, and non-medical apps, along with the advertising of products to a consumer audience.
As explored in our earlier blogs (Understanding Borderline Products - Medical Devices, MedTech, and Health Apps and Understanding Borderline Products – Medicines, Drug/Device Combination Products, Engineered Tissues, and Cells), any claims to a medical purpose or health functionality may bring a product close to the borderline with medicinal products or medical devices, or indeed cross it. These product categories are subject to extensive and stringent regulation, so it is important to ensure that a product in an adjacent category (such as food supplements, wellness apps, and cosmetics) does not inadvertently stray over the line.
Claims and Regulatory Scrutiny
Manufacturers may have good commercial reasons to make claims around wellness and health benefits. However, they must take care not to overstep the line into medical claims, as this is likely to invite regulatory scrutiny and possible enforcement action. We are currently seeing increasing regulatory activity in this area, which serves as a warning but also helps clarify and define these borderline areas.
Categorising Innovative Products
We often find that innovative products can be difficult to categorise at the outset. An early-stage development project may, for example, be exploring types of laboratory-grown cells or innovative fermentation methods without a concrete idea of the final product or how it might ultimately be commercialised. Developers may wish to pivot from an earlier concept to a different kind of product. For example, an innovative new type of alternative fat could be brought to market as food such as an alternative for cocoa butter or be used to make cosmetics or even have medical applications. As a result, predicting how the product might ultimately be brought to market can be challenging.
Strict Rules Around Medical Claims
Manufacturers may be surprised by how strict the rules can be around medical claims. Referring to "acne" rather than "spots," for example, tends to indicate medical usage, as do images including medical equipment such as a stethoscope. Similarly, promoting a product to address menopause symptoms tends to be seen as making medical claims.
Dual-Purpose Promotion
It is possible for a product to be promoted separately for two purposes, such as a medicinal product and a cosmetic. While this is permitted if the products comply with the relevant regulations, it is particularly important to maintain separation between the branding and marketing of the different products and to avoid any mingling in promotional materials.
Advertising Regulations
Alongside issues around product categorisation, it is also important to be aware of the wider suite of rules governing the advertising of products to consumers. The Advertising Standards Authority is active in monitoring and enforcing compliance with these rules. Additionally, new legislation in the form of the Digital Markets, Competition and Consumers Act 2024 introduces new requirements for consumer products, including subscription services and the collection and display of online product reviews.
Conclusion
Overall, we advise manufacturers of both innovative and established products on the importance of staying within the regulatory limits of their appropriate product category, particularly if there is a risk of reclassification as medicinal products or medical devices. Clear training and policies for marketing teams, along with active oversight of compliance, are essential to navigate these regulatory challenges effectively.
Our content explained
Every piece of content we create is correct on the date it’s published but please don’t rely on it as legal advice. If you’d like to speak to us about your own legal requirements, please contact one of our expert lawyers.