Transcript DA `Threats` Presentation - May 2007

IHTA 2007 AGM
LEGISLATION & REGULATION
Top 15 Threats
&
Action Underway
SOME APPLICABLE LEGISLATION
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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
‘HEALTH CLAIMS’
All health claims need prior approval
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Community List – Article 13 ‘generic’ claims
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Pan-EU Project & dossier template
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But approval criteria are unclear
‘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
‘HEALTH CLAIMS’
Special approval process required for
- ‘disease risk’ claims
- ‘children’s development and health’ claims
- claims based on ‘emerging science’
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Extensive consultations with EU & national
authorities especially re definition of ‘children’s
development and health’ claims
FOOD SUPPLEMENTS DIRECTIVE
‘Missing ingredients’ are not safe – derogation
expires in 2009
Scrutiny of most dossiers has yet to start
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Extensive lobbying of EU & national authorities
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Precedent of extended derogation for PARNUTs
ingredients
FOOD SUPPLEMENTS DIRECTIVE
Maximum Permitted Levels could be way below
existing UK levels.
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Thanks to extensive lobbying, UK Government is
fighting for UK industry & consumers
Pan-EU lobbying campaigns
Legal opinions being taken
FOOD SUPPLEMENTS DIRECTIVE
Potential extension to further categories –
botanicals, amino acids, fatty acids, probiotics etc.
EU Commission to submit Report by July 2007
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European organisations heavily involved in
relevant activities.
- EHPM
- European Botanical Forum
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IADSA preparing scientific support
THMPD
Threat to continuation of ‘botanical’ (herbs as food
supplements)
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European Botanical Forum developing strong
legal & scientific rationale and liaising with key EU
organisations.
THMPD
Crucial guidance for registrations is late e.g.
Combination Products
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HFMA lobbying MHRA & EU HMPC via Herbal
Forum and EHPM
THMPD
Registration assessment process has 210-day
timeline ‘whilst the clock is ticking’
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Crucial for companies to understand registration
requirements to minimise MHRA queries.
‘SPORTS NUTRITION DIRECTIVE’
Publication possible by end 2007
Could prove highly restrictive for specialist sector
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ESSNA set up at meeting convened by HFMA in
late 2004
ESSNA is negotiating with EU Commission &
other trade bodies to protect specialist interests
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
CONTAMINANTS & IRRADIATION
‘Name & shame’ surveys threaten company
reputations
EU contaminants legislation may hit food
supplements
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HFMA discusses issues with FSA scientists c.f.
Irradiation Workshop
HFMA lobbies EU re proposed legislation
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.
IMPORTS FROM CHANNEL ISLANDS
£70m of “supplements” sold direct to UK consumers from
Guernsey & Jersey
Channel Islands are not subject to UK or EU legislation
Many mailings and websites carry medicinal claims &/or
‘illegal’ products
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HFMA committed to eradicating all ‘unfair & illegal
competition’ from whatever source.
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Major UK Parliamentary campaign underway to stimulate
UK Government into pan-departmental action
FINAL THREAT
Ignorance
Organisation Affiliations
HFMA MEMBERSHIP & AFFILIATIONS
IADSA
INTERNATIONAL
EHPM
EUROPE
UK
ESSNA
BOTANICAL
FORUM
HFMA
IHTA
HERBAL
FORUM
FPB