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IRISH HEALTH TRADE ASSOCIATIONWorking together towards a healthier Ireland

Annual General MeetingCrowne Plaza Hotel, Santry, Dublin

23 April 2013

Alan Ruth, Chief Executive Officer

Overview of main IHTA activities

• Regular & ongoing contact with the regulatory bodies

• Regular Member Updates on Regulatory Issues

• Provision of ‘one to one ‘ information/advice/guidance to members

• Updates on new scientific studies both positive & negative

• Provision of rebuttals to negative/biased scientific studies

• Communication with journalists and editors to defend our industry

• Activity with MEPs

• Continuous & ongoing participation in the IHTA’s VAT & other working groups

• Very active participation in EHPM Board activities

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Overview of IHTA main activities

Participation in the EHPM Health Claims Task Force

Recruitment of an EHPM Director-General – I wrote job description, participated in interviewing, & persuaded the successful candidate to apply

Very active participation in and oversight of EAS’s activities

Very actively raising the IHTA profile within EHPM and within the entire European industry sector

Acting as a catalyst for very positive change within EHPM

Ongoing activity in International Information Sharing Network

Participation in regular IHTA Executive Council meetings

Trying to secure new IHTA members and retain existing members

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We’re trying to BEAT THE VAT MANbut it’s a very long process!

Revenue eBrief published November 2011 – wording was such that many of our products could be target for 23% VAT

Raised as an issue with Council in February 2012

Met with a consultant in March 2012 to take advice

Letter sent to Chairman of Revenue Commissioners on 26 September

mid October – received a letter from Revenue Chairman’s Private Secretary – instructing me to contact John Farrell, Principal, VAT Branch of Revenue

23 October – contacted JF to arrange a meeting

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We’re trying to BEAT THE VAT MANbut it’s a very long process!

15 November - IHTA VAT Working Group (JG, BC, AR) met with JF and two other Revenue Officials

JF welcomed our proposal to develop a Framework Document – a very lengthy and challenging process

Final IHTA VAT submission and Framework Document sent early February 2013

Revenue response received end February 2013

19 March – IHTA sent a response to Revenue’s response – clarified confusion on BS’s part, sought clarification on 6 issues, asked for a further meeting

During all this ongoing process the VAT Working Group has met about 4 times, there has been a very substantial exchange of e-mails, CH has met with Revenue a number of times and had many phone conversations

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Dealing with the Regulators!

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Food Safety Authority of Ireland/IHTA Interaction

November 2012 – Katherine Morrow & I had 2 hour meeting with Ray Ellard, FSAI, Director-Consumer Protection

Goals: –

- Gain more clarity re FSAI’s stance in relation to various issues concerning the NHCR, bearing in mind that claims not on the authorised list could no longer be used after 14 December 2012

- Find out the FSAI’s flexibility re a ‘transition period’

Ray explained that FSAI had no power to make any concessions but unofficially indicated that they would be flexible and would NOT be policing things

Main message s

– provided companies weren’t stockpiling & provided nobody made a complaint about a product, companies shouldn’t have a problem.- Health claims wouldn’t be a priority for the 320 EHOs involves with food products

We asked Ray to provide GUIDANCE on 10 topics concerning the NHCR

We deliberately avoided asking specific questions for fear we might get answers we didn’t want8

Food Safety Authority of Ireland/IHTA Interaction

14 March 2013 – Information Session at FSAI offices on interpretation issues re the NHCR

FSAI staff in attendance – Ray Ellard, Dr. Mary Flynn, Dr. Edel Keaveney, & Dorothy Guina Dornan

Main topics covered (mainly by Mary Flynn) were the 10 which Katherine Morrow and I raised in the November 2012 meeting

The IHTA attendance was very good and feedback from attendees immediately afterwards was positive

Underlying message from Ray Ellard was that provided companies do not make outrageous claims & provided the FSAI receive no complaints, companies should NOT have a problem.

Ray offered to have regular meetings with the IHTA as and when there was a significant issue to be discussed.

New updated version of FSAI guidance booklet on the NHCR will be published in the near future

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‘IRISH MEDICINES BOARD – IHTA’ INTERACTIONMay 2012 - an IHTA Herbals/Botanicals Task Force met Dr. Mike Morris (Director of Scientific Affairs), John Lynch (Director of Compliance) and Ann O’Connor (Director of Human Products Authorisation & Registration).

Main goal - Clarification of ambiguity of information on the IMB website.

Dr. Morris was asked if the IMB would be happy add wording such as the following to provide clarity: “Some herbal substances which are mentioned in list (1) might be considered acceptable for inclusion in products which could be regulated as food supplements (subsequent to the approval of the Food Safety Authority of Ireland) where no medicinal claim is made.”

He agreed.

JL was asked who the IMB would chase if an Irish retailer is buying from a UK based wholesaler (or ordering on the internet) a product classified as a FS in the UK but not in Ireland.

JL replied – focus would be on retailer & the UK supplying WS. IMB would provide details to MHRA & request them to advise the UK wholesaler to stop this.

Dr. Morris was asked if the IMB accepted the following statement : “In a long-awaited ruling dated March 5, 2009, the European Court of Justice (ECJ) confirmed that the quantity of active substances is the key criterion to distinguish foods from medicines, thereby confirming the dual regime applying to medicinal plants.” Dr. Morris confirmed that the IMB did accept this statement.

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‘IRISH MEDICINES BOARD – IHTA’ INTERACTION November 2013 – an IHTA delegation (2 Council members & I) met Dr. Mike Morris & 4 other IMB staff.

Main issue discussed – improving IMB communication with IHTA members (including UK based ones)

The situation in relation to use of echinacea in under 12s was given as an example.

Despite saying “This is not a serious issue ....” the IMB implemented an urgent recall!

I asked if any other competent authorities in the European MSs had also implemented a recall and I received no reply!

I made the point that based on consulting the EMA website it appeared that the recall decision was made on the basis of one study which had shortcomings & weaknesses & did not support a contradiction in children under 12.

One of the IMB staff attempted to justify the recall decision but not very convincingly !

I made the point that everything happened very quickly – the IHTA was informed only 1 hour before the press release embargo expiry time.

I made the point that some of the media who reported the story , distorted & exaggerated the facts.

Mike Morris conceded that the notice given was very short & said they would endeavour to give more notice in future

He also reiterated that he was happy to have regular meetings with the IHTA when there was a significant issue to be discussed

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Defending our industry against the media

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THE IRISH TIMESTuesday, April 10, 2013

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‘Why food supplements can exceed your daily recommendations’

- by Jill Nesbitt

Some vitamins can “even increase mortality” - - infamous & discredited meta-analysis by Bjelakovic et al

RDAs -– not designed to achieve optimal health but to prevent deficiency diseases

Prescription level of B6 in Ireland is 50 mg – Tolerable Upper Intake Level (UL) set by IOM is 100 mg

B12 considered a medicine @daily dose above 25 mcg – - Based on international comparisons, this is a very low dose of B12 to act as a prescription threshold.  

- IOM did not establish a Tolerable Upper Intake Level for vitamin B12 because of its low potential for toxicity- Health Canada - maximum daily safe dose of vitamin B12 for adults is up to 1000 mcg per day.

- FSA (UK) taking 2,000 mcg or less per day is unlikely to cause harm

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‘Why food supplements can exceed your daily recommendations’

Vitamin A can lead to birth defects - - no increase in the risk of vitamin A-associated birth defects has been observed at doses of preformed vitamin A from

supplements below 3,000 mcg/day - pregnant women should avoid multivitamin or prenatal supplements that contain more than 1,500 mcg (5,000 IU) of

vitamin A. - Vitamin A from beta-carotene is not known to increase the risk of birth defects. 

In mid 1990s a trial on beta-carotene had to be stopped early because it put smokers at greater risk of death -

- Applied to long term smokers and asbestos workers who were given beta-carotene supplements- CARET study found that beta-carotene may decrease the risk of lung cancer in former smokers

- no increased risk was observed in the Physicians’ Health Study (PHS) which included more than 2,000 smokers and lasted approximately 12 years,

“High doses of folic acid can interfere with chemotherapy” - - Out of context this short statement is a complete red herring!

• I also drew attention to an inaccurate statement (attributed to Dr. Mary Flynn) re why a UL was not set for B12 15

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Punching Above our Weight!

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Punching above our weight in EHPM Very active participation in EHPM Board activities

Participation in the EHPM Health Claims Task Force

Recruitment of an EHPM Director-General – I wrote job description, participated in interviewing, & persuaded the successful candidate to apply

Very active participation in and oversight of EAS’s activities

Very actively raising the IHTA profile within EHPM and its member associations throughout Europe

Acting as a catalyst for very positive change within EHPM

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at EHPM - which was very long overdue!

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A major turning point for EHPMIn May 2012 I wrote and circulated to the EHPM Board a ‘Discussion Paper on Improving the Performance of the EHPM Board’

The aims of this paper were: • To stimulate discussion and critical comment from fellow EHPM Board members

• To lead to actions which will result in improved effectiveness and efficiency in the functioning of the EHPM Board

• To improve the effectiveness of EAS and the EHPM member associations in their efforts to achieve their goals/objectives  

This paper was to be the foundation for a draft blueprint for a plan of action to improve the performance of the EHPM Board, and in doing so significantly improve the performance of EAS and the value for money we received from this service provider.

In July 2012 I welcomed the fact that Alban Maggier, President of Synadiet (the French trade association) circulated a document fully supporting my Discussion Paper .

Soon afterwards support emerged from the majority of the Board

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Raising the IHTA’s profile in Europe

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Raising the profile of the IHTA in Europevia Nutraingredients.com

Published articles written by me:

‘Vitamins and dietary supplements: Too much of a good thing – The science would suggest not ‘3 August 2012

The above was my response to a Nutraingredients.com article based on a blog written by a Euromonitor International Analyst which stated ““there is a growing body of evidence showing that overdoing it on certain nutrients can indeed be harmful”.

‘Marketing makeover: lobbying, education and the new EU food supplements landscape ‘20 August 2012

Marketing without health claims26 September 2012

To be published next month:

‘Serving companies’ interests in the Irish marketplace’ – to be published in Health Food Business (UK)

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Activity with Irish MEPs

Successfully arranged for 3 Irish MEPs (Liam Aylward, Pat the Cope Gallagher and Brian Crowley) to challenge Commissioner John Dalli on his dismissive comment re SMEs.

Supplied them with relevant information on the importance of SMEs to the European economy.

Encouraged them to cite the ALDE campaign to strengthen SMEs and made them aware of other SME supportive ALDE MEPs in other Member States.

Suggested they contact an SME supportive Belgian MEP, at the request of the President of the Belgian trade association NAREDI.

Sent members a copy of the 3 Irish MEPs’ challenge to Dalli, together with Dalli’s reply to that challenge.

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Members are the IHTA’s Life Blood!

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THANK YOU FOR YOURONGOING SUPPORT