IHTA 2007 AGM

LEGISLATION & REGULATION

Top 15 Threats&

Action Underway

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

‘HEALTH CLAIMS’

All health claims need prior approval

• Community List – Article 13 ‘generic’ claims

• Pan-EU Project & dossier template

• 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’

• 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

• Extensive lobbying of EU & national authorities

• Precedent of extended derogation for PARNUTs ingredients

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

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

THMPD

Threat to continuation of ‘botanical’ (herbs as food supplements)

• 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

• HFMA lobbying MHRA & EU HMPC via Herbal Forum and EHPM

THMPD

Registration assessment process has 210-day timeline ‘whilst the clock is ticking’

• Crucial for companies to understand registration requirements to minimise MHRA queries.

‘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

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

• 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 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

FINAL THREAT

Ignorance

Organisation Affiliations

EHPM BOTANICAL FORUM

IHTAHFMA

ESSNA FPBHERBALFORUM

HFMA MEMBERSHIP & AFFILIATIONS

INTERNATIONAL

EUROPE

UK

IADSA