Classifying borderline products

We reported on our sister blog a court battle over glucosamine, and where it fits in the landscape of medicinal products and borderline products such as food supplements.

Back in 2014, the High Court decided that UK medicines regulator the MHRA had been right in its treatment of different glucosamine products. The MHRA had categorised one particular glucosamine-containing product, sold as Dolenio, as a medicine. This meant that it was subject to extensive regulatory regime applicable to medicinal products. In contrast, many other glucosamine-containing products, sold for years as food supplements in health food shops etc, were not subject to the same onerous regulation.  

In 2016 the Court of Appeal reversed this decision. Unlike the High Court, the Court of Appeal was not satisfied with the approach the MHRA had taken to the glucosamine market as a whole. Where glucosamine-containing products are to be taken orally, contain glucosamine-sulphate as the active ingredient and have a recommended dose of 1500mg, they

“share several significant characteristics with a product classified in the UK as a medicinal product; and… must be classified in the same way unless they have another significant characteristic that takes them outside the definition”.

This case highlights the difficulty of classifying borderline products correctly. Classification as a medicinal product can be under the “presentational limb” – essentially whether the product is presented as having properties for treating or preventing disease; or the “functional limb”.  

Several characteristics are relevant to the functional limb analysis, including:

• composition of the product
• the product’s pharmacological properties, to the extent to which they can be established in the present state of scientific knowledge
• how the product is used
• the extent of the product’s distribution
• familiarity to consumers
• risks which use of the product may entail.

Glucosamine-containing products can be prescribed by doctors for certain types of osteoarthiritis, but their wider presence on the market and purchase for self-medication by patients will influence how they are classified, and (said the Court of Appeal), the MHRA should have gone into that in much more detail.

The fact that different EU member states have reached different conclusions about glucosamine products shows just how difficult it is to make the assessment.

Now the Supreme Court has refused to hear a further appeal and so the story ends there. Which is a shame, as this is an area where greater clarity would be welcome.