Download Borderline products - European Commission

Borderline products
Foods or
medicines?
Martijn Martena, PhD
the Netherlands Food and
Consumer Product Safety
Authority
Utrecht, the Netherlands
Belgrade 19-20 March 2012
Food supplements:
Foodstuffs the purpose of which is to supplement the normal diet and
which are concentrated sources of nutrients or other substances with a
nutritional or physiological effect, alone or in combination, marketed in
dose form…
source: article 2 (a) of Directive 2002/46/EC
Similarities with medicines
Pharmaceutical appearance, in the form of tablets, powders, liquids
in small quantities
indicated to support or maintain a good health status
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Workshop on PARNUTS - Belgrade, 19-20 June 2012
Differences medicinal products and food
supplements (Dutch situation)
Medicinal products
Food supplements
Pharmacy, drug store
Medical indication
Contra-indications
Pharmacological activity
Synthetic ingredients (mostly)Marketing authorisation
Medicines inspection
-
Supermarket, drug store, internet etc.
Health or nutrition claim
No contra-indications
Physiological or nutritional activity
‘Natural’ ingredients
Notification (in 22 of 25 MS, not in Nl)
Food inspection
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Medical claims on foods
The labelling and methods used must not:
attribute to any foodstuff the property of preventing, treating
or curing a human disease, or refer to such properties
These prohibitions also apply to:
a) the presentation of foodstuffs (shape, appearance or packaging),
the way in which they are arranged and the setting in which they
are displayed
b) advertising
source: article 2 of Directive 2000/13/EC
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Medical claims on foods
An example of a medical claim:
“omega 3-fatty acids lower cholesterol levels. High cholesterol
levels increase the risk on cardiovascular disease”
Health claims are possible however, but:
health claims may only link foods to maintaining good health
An example of a health claim:
“Omega 3 fatty acids support healthy blood vessels”
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Commodities which can overlap with medicinal
products
Foods:
Food supplements
Herbal preparations (under Dutch Commodities act)
Novel foods
Foodstuffs for particular nutritional purposes
Dietary foods for medical purposes (FSMPs)
Fortified foods
Cosmetics (topical application for cleaning, perfuming etc.)
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Workshop on PARNUTS - Belgrade, 19-20 June 2012
Commodities act decree “Herbal preparations”
In the Netherlands food supplements containing
herbal ingredients also fall under the definition of
“herbal preparation”.
The decree contains amongst others a:
Ban on several potent herbs and fungi used in
phytotherapy (e.g. Datura stramonium,
Atropa belladonna, Mandragora officinarum,
Claviceps purpurea, kava kava)
Thornapple (Datura stramonium)
Mandrake (Mandragora officinarum)
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Workshop on PARNUTS - Belgrade, 19-20 June 2012
Novel foods or medicinal products?
Novel food Regulation 258/97/EC
Becel Pro-active:
A vegetable fat spread with plant sterol esters
Commission decision 2000/500/EC concerning Becel Pro-active:
Labelling requirements:
Article 2,
c. There shall be a statement that the product is for people
who want to lower their blood cholesterol levels.
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Food supplement?
BMI 23: product for weight loss
containing cellulose powder
– Characteristics of a food supplement
– Labelling contains a CE marking
The product is classified as a medical device as
assessed by a notified body
A medical device can bear a medical indication
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Borderline products and 2001/83/EC
In Europe the number of ‘borderline’ products between
medicinal products and other regulated products is
growing
To resolve this issue directive 2001/83/EC on medicinal
products for human use was amended by Directive
2004/27/EC
In principal 2001/83/EC does not apply to foods, food
supplements, cosmetics, biocides or cosmetics, but:
In cases of doubt 2001/83/EC applies!
Even when the product may fall within a definition
covered by other legislation
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Workshop on PARNUTS - Belgrade, 19-20 June 2012
Medicinal products
Definitions:
‘Regular’ medicinal products
‘Regular’ herbal medicinal product
Traditional herbal medicinal products
Homeopathic medicinal products
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Medicinal product:
a) Any substance or combination of substances presented as
having properties for treating or preventing disease in
human beings; or
a) Any substance or combination of substances which may be used
in or administered to human beings either with a view to
restoring, correcting or modifying physiological functions by
exerting a pharmacological, immunological or metabolic
action, or to making a medical diagnosis.
Source: article 1, Directive 2001/38/EC, amended by Directive 2004/27/EC
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Herbal medicinal product:
“Any medicinal product, exclusively containing as active
ingredients one or more herbal substances or one or more
herbal preparations, or one or more such herbal substances in
combination with one or more such herbal preparation”
Source: Directive 2001/83/EC, as amended by Directive 2004/24/EC
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Traditional herbal medicinal product:
• Herbal medicinal product with a long tradition of use in the EU ( >
30 or > 15 years)
• Simplified registration procedure
• Efficacy of the medicinal product is plausible on the basis of longstanding use and experience
• Its traditional use proves not to be harmful in specified conditions
of use
• Products should comply with quality standards in relevant
European Pharmacopoeia monographs or those in the
pharmacopoeia of a MS
Source: Directive 2001/83/EC, as amended by Directive 2004/24/EC
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How to classify Borderline products: case by
case!
Approach 1:
Is the product presented as having therapeutic qualities?
Food supplements aim to maintain physiological
homeostasis, medicinal products aim to prevent or
treat diseases.
Presence of a medical claim on the labelling (even
when it has no therapeutic value) or on accompanying
information in leaflets or internet. ( ECJ ruling C219/91; Ter Voort)
Food supplements lawfully manufactured and/ or
marketed as such in a member state can be considered as
a medicinal product by an other Member State where the
product is imported!
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How to classify Borderline products: case by
case!
Approach 2:
Does the product provide a dose of active ingredients that
is pharmacologically active?, for instance:
Synthetic pharmacological substances
‘Natural’ active ingredients, such as pharmacologically
active amount of a herbal ingredient
Vitamins above 3 times the RDA were considered
medicinal products in some Member States but European
Court of Justice does not accept such a general rule for
classification
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Food supplements classified as a
medicinal product in the Netherlands (1)
• Plants from the genus Ephedra (Ma-huang) and
Sida contain ephedra alkaloids (e.g. ephedrine
or norephedrine)
• Products with ephedra alkaloids were sold as
“Herbal ecstacy” in smart shops in the
Netherlands
• Effects similar to adrenaline
• Toxicity of ephedra alkaloids: anxiety, tremors,
hypertension and cardiovascular events (even
myocardial infarction)
Products with ephedra alkaloids were therefore
classified as medicinal products in 2005
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Smart shop product with
Ephedra
W. Beltman, A. van Riel, NVIC
Workshop on PARNUTS - Belgrade, 19-20 June 2012
Food supplements classified as a medicinal
product (2)
FOOD
VERY URGENT - TRES URGENT
ALERT NOTIFICATION: 2005.004-add09
ADDITIONAL INFORMATION
SUBJECT: UNAUTHORISED SUBSTANCE
ACETILDENAFIL IN
FOOD SUPPLEMENT FROM CHINA VIA THE
NETHERLANDS AND VIA SWITZERLAND
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