ihta 2007 agm legislation & regulation top 15 threats & action underway
TRANSCRIPT
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IHTA 2007 AGM
LEGISLATION & REGULATION
Top 15 Threats&
Action Underway
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SOME APPLICABLE LEGISLATION
Novel Foods Regulations 1997 & 1999 PARNUTs Regulations 2002 Food Supplements Directive 2003 Nutrition and Health Claims Regulation 2007 ‘Addition of Nutrients’ Regulation 2007 The Medicines Act 1968 etc. Traditional Herbal Medicinal Products Directive
2005
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‘HEALTH CLAIMS’
All health claims need prior approval
• Community List – Article 13 ‘generic’ claims
• Pan-EU Project & dossier template
• But approval criteria are unclear
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‘HEALTH CLAIMS’
Companies making a claim must be able to justify it
Reference to the Community List is insufficient
• Access to Pan-EU Project files available to relevant Associations and Companies
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‘HEALTH CLAIMS’
Special approval process required for- ‘disease risk’ claims- ‘children’s development and health’ claims- claims based on ‘emerging science’
• Extensive consultations with EU & national authorities especially re definition of ‘children’s development and health’ claims
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FOOD SUPPLEMENTS DIRECTIVE
‘Missing ingredients’ are not safe – derogation expires in 2009
Scrutiny of most dossiers has yet to start
• Extensive lobbying of EU & national authorities
• Precedent of extended derogation for PARNUTs ingredients
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FOOD SUPPLEMENTS DIRECTIVE
Maximum Permitted Levels could be way below existing UK levels.
• Thanks to extensive lobbying, UK Government is fighting for UK industry & consumers
• Pan-EU lobbying campaigns• Legal opinions being taken
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FOOD SUPPLEMENTS DIRECTIVE
Potential extension to further categories – botanicals, amino acids, fatty acids, probiotics etc.
EU Commission to submit Report by July 2007
• European organisations heavily involved in relevant activities.- EHPM- European Botanical Forum
• IADSA preparing scientific support
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THMPD
Threat to continuation of ‘botanical’ (herbs as food supplements)
• European Botanical Forum developing strong legal & scientific rationale and liaising with key EU organisations.
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THMPD
Crucial guidance for registrations is late e.g. Combination Products
• HFMA lobbying MHRA & EU HMPC via Herbal Forum and EHPM
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THMPD
Registration assessment process has 210-day timeline ‘whilst the clock is ticking’
• Crucial for companies to understand registration requirements to minimise MHRA queries.
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‘SPORTS NUTRITION DIRECTIVE’
Publication possible by end 2007Could prove highly restrictive for specialist sector
• ESSNA set up at meeting convened by HFMA in late 2004
• ESSNA is negotiating with EU Commission & other trade bodies to protect specialist interests
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NOVEL FOODS
Evidence of pre-May 1997 ‘significant consumption’ is increasingly elusive.
Superfoods, superfruits & sports nutrition ingredients are particularly at risk
• HFMA- holds relevant database lists of foods/ingredients- makes informal approaches to FSA- can collate data from a wide spectrum of sources
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CONTAMINANTS & IRRADIATION
‘Name & shame’ surveys threaten company reputations
EU contaminants legislation may hit food supplements
• HFMA discusses issues with FSA scientists c.f. Irradiation Workshop
• HFMA lobbies EU re proposed legislation
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GLUCOSAMINE & BORDERLINE
Glucomed is a medicine new to the UK.
Daily dose – 1250 mg. glucosamine hydrochloride.For relief of mild to moderate osteoarthritis of the
knee.
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IMPORTS FROM CHANNEL ISLANDS
£70m of “supplements” sold direct to UK consumers from Guernsey & Jersey
Channel Islands are not subject to UK or EU legislationMany mailings and websites carry medicinal claims &/or
‘illegal’ products
• HFMA committed to eradicating all ‘unfair & illegal competition’ from whatever source.
• Major UK Parliamentary campaign underway to stimulate UK Government into pan-departmental action
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FINAL THREAT
Ignorance
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Organisation Affiliations
EHPM BOTANICAL FORUM
IHTAHFMA
ESSNA FPBHERBALFORUM
HFMA MEMBERSHIP & AFFILIATIONS
INTERNATIONAL
EUROPE
UK
IADSA