issue 1 2017

analysis & control 55
The glucosamine case: Implications for
marketing ‘borderline products’ as food
supplements in the UK
Last year, in R. (on the application of Blue Bio Pharmaceuticals Ltd) v Secretary of State for Health [2016] EWCA
Civ 554, the Court of Appeal quashed the decision by the Medicines and Healthcare Products Regulatory Agency
(MHRA) not to classify certain glucosamine-containing products (GCPs) as medicinal products, and left the MHRA
in light of the court’s decision to re-visit the question as to whether some or all GCPs that are sold in the UK as
food supplements should be classified as medicinal products. The MHRA is the UK authority which regulates
products under the EU Directive on Medicinal Products (Directive 2001/83/EC). This is the final decision on the
litigation as, in December 2016, the Supreme Court rejected the MHRA’s application for permission to appeal
against the Court of Appeal decision.
The Court of Appeal’s judgment is
significant and is likely to have
wider implications beyond GCPs.
Marketing and placement of
borderline products in the UK as
food supplements may need to be
revisited following this decision, in
particular once the MHRA
introduces changes to its practice
following the judgment.
This article discusses the
implications of this judgment for
manufacturers and suppliers which
currently sell or plan to sell socalled
‘borderline products’
(products on the borderline
between medicinal products and
food supplements) in the UK as
food rather than medicine.
Background and issues
Dolenio is a GCP authorised and
sold as a prescription-only
medicine in the UK. It was first
authorised in Denmark and then in
the UK in 2009. Each tablet
contains 1,885mg of glucosamine
sodium chloride. 1,500mg of the
tablet is glucosamine sulphate, of
which 1,178 is glucosamine which
is the active ingredient.
There are only two other GCPs
authorised as medicinal products
in the UK, both of which are by
prescription only and for treatment
and relief of symptoms in mild to
moderate osteoarthritis of the
www.foodmagazine.eu.com issue one | 2017