we will heal - will we ?
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We will heal - will we ?. Health claims. Krisztina Grimm Hungarian Competition Authority 13 March 2014. The frame. The claims The products The specifics The cases The related topics. The claims. Different products , divergent claims – from cancer to IBS and weight loss - PowerPoint PPT PresentationTRANSCRIPT
We will heal - will we?
Krisztina GrimmHungarian Competition Authority13 March 2014
Health claims
The frame
1 The claims
2 The products
3 The specifics
4 The cases
5 The related topics
The claims
Different products, divergent claims – from cancer to IBS and weight loss
The product determines the applicable sectorial law
The products
1 Pharmaceuticals
2 Food
3 Medical devices
4 Cosmetics
5 Others
The specifics - pharmaceuticals
Pharmaceuticals may not be advertised (to the general public) if they can be dispensed from the pharmacy solely with a prescription
OTC pharmaceuticals can be advertised accordig to the conditions enumerated in the Act XCVIII of 2006 Art. 17.
- i.e. it shall not contain any reference or expression which refers to the recomendation by scientists, health professionals or celebrities
Evaluation of the health claims:- whether the advertisement demonstrates the pharmaceuticals based on the summary of the product characteristics (SPC)- if yes, but another problems can be identified: UCP Act, misleading
The cases - pharmaceuticals
Vj/77/2012. – Panadol – begins to dissolve in 5 minutes – not based on the SPC, infringement of sectorial law, more specific
Vj/82/2012. – Normaflore – eliminates the source of diarrhoea, direct link with the vitamin supply - s. above
The specifics - food
Health claims: generally prohibited , but under certain circumstances (enumerated in Regulation (EC) No 1924/2006) they are applicable (Art. 10. 1.)Curing effect: investigated on the basis of the Act No. XLVI. on food chain and its control (Éltv.)
The GVH pays attention to the EFSA consolidated list – wordig of the claims is very strictThe GVH takes into account the scientific opinions of the other competent authorities
The cases – food 1
Claims on weight loss - Vj/26/2012. ( Vital Direkt Ltd. - Cabbage Forte capsules), 98/2012. (Direkt Market Ltd. - Biocaptol capsules)
- claims which refer to the rate or amount of weight loss – UCP Act with reference to the Regulation (EC) No 1924/2006 Art. 12.- claims on easy and fast weight loss - UCP Act, misleading advertising
The cases – food 2
General health claims, i.e. probiotics – Vj/52/2012. (TEVA – Lactiv probiotics), Vj/12/2013. (Vitaminkosár Ltd. - Protexin IBS Florea)- „Helps maintain the healthy gut flora” or „Helps restore the unbalanced gut flora”- UCP Act
The cases – food 3
Curing effect – Vj/97/2012. (Direkt Market Ltd. - Snail Elixir – from snail shlime extract) - stated that the product (a food supplement) cures arthritis - sectorial and UCP Act
The specifics – medical devices
The GVH examines the clinical evaluation
If the claims exceed the statements of the clinical evaluation: breach of the UCP Act
The specifics – medical devices Vj/1/2012. (Magneter mattress), Vj/15/2012. (Impulser)
UCP Act
The specifics - cosmetics
According to the special provisions on cosmetics therapeutic effects are prohibited
These commercials are investigated on the basis of UCP Act - the general clause of the UCP Act with reference to the cosmetics regulation
The cases - cosmetics
Vj/42/2012. (Telemarketing International Ltd. - Abexine)therapeutic effect – stated, that the gel can cure arthritis, headache, inflammation, etc.
Vj/35/2012. (PSO-ROOZ)therapeutic effect, stated that the shampoo can heal psoriasis (an incureable skin desease)
General prohibition of unfairness (UCP Act Art. 3(2)) with reference to the cosmetics regulation
The specifics - others
Any other devices, clothes, goods, etc., which are not certificated as pharmaceuticals, foods, cosmetics or medical devices
Health claims are investigated on the basis of the UCP Act
The cases - others
Vj/56/2012. (Energy Spiral)
The related topics
1 Fines
2 Commitments (Vj/18/2013., Teva)
Thank you for your attention!