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Poland has established a
government-backed group briefed with developing criteria
relating to the classification of a range of nutrients
under either food or medicine law.
The Panel on Dietary Supplements will spend 4-6 months
drawing up an electronic database of all on-market
supplements and passing opinion on how they should be
regulated.
The panel seeks a "precise differentiation between dietary
supplements and medicines" with the objective of improving
consumer "safety and to facilitate entry and functioning
on the market for manufacturers and distributors",
according to a post on www.polishmarket.com.
As is the case in many EU member states that are still
determining which products should be classified as foods
and which as medicines, Poland's panel is likely to
classify products under three broad categories: food
supplements, medicines and "borderline" products - those
that have both food and supplement uses.
It is "borderline" products that are the most
controversial as dosage and usage issues arise that can
make classification problematic. It's the age old
question: what is a food and what is a medicine?
This dilemma was a fundamental motivation behind the
creation of the Traditional Herbal Medicinal Products
Directive (THMPD), which seeks to create a category of
herbal medicines with its own registration criteria that
lies somewhere between food and medicines law.
While vitamins and minerals are classified under the Food
Supplements Directive (FSD) there are a range of nutrients
such as probiotics, animal-derived ingredients such as
glucosamine, some essential fatty acids as well as most
botanicals that have not been registered under the THMPD,
that are open for individual member state classification.
While probiotics, glucosamine, fish oils and other
specialist nutrients appear to have their foods and
supplements use mandated in most member states for the
moment, herbals are considered to be in more jeopardy for
most in industry would see as the draconian and
inappropriate classification of herbs as medicines.
Botanical backlash
Some member states - most recently Belgium - have
indicated it will adopt a conservative approach and
classify a ranger of "borderline" botanicals such as
Echinacea and ginkgo under medicines law.
"The problem is that the EU has left it to member states
to determine whether a product is classified as a medicine
or a food supplement," said Lorène Courrège, director of
regulatory affairs at the European Federation of
Associations of Health Product Manufacturers (EHPM).
"Indeed dietary supplements are regulated by the FSD of
2002 but this does not harmonise the use of ingredients
other than nutrients (vitamins & minerals) such as
botanicals, fatty acids etc."
She said EHPM was concerned about momentum within some
member states to classify botanicals as medicines and it
was difficult to see a harmonised criteria being put in
place in the EU soon.
A European Commission report was due in April into
possible ways to go about classifying botanicals and other
nutrients.
In Belgium, about 250 herbal products that have been
legislated under food law for more than a decade may soon
be reclassified as medicines, according to the supplements
trade association there. |
