Tryptophan

[Guest guest]

As ANH has always feared, medicinal law can be used at the

Regulator's discretion to classify products we think of as foods or

food supplements, as medicines.

 

Patrick Holford, a well known UK nutritionist and author, who is the

Founder of the Institute of Optimum Nutrition and is also a member

of the ANH Scientific Expert Committee, finds himself in the front

line of the battle to save therapeutic dosages of the amino acid

tryptophan.

 

Tryptophan was banned in the US, UK and many other countries as a

food or dietary supplement after a contaminated batch from Japan was

found to cause flu-like symptoms. In the US, the ban occurred just

four days before the anti-depressant drug Prozac was launched on the

market. See Kevin Miller's film, We Become Silent, for a rare

interview on this very subject with Michael R Taylor, the FDA's

deputy commissioner for policy.

 

The natural amino acid tryptophan is a key precursor to serotonin

and has been long used, safely, to help improve mood and sleep

patterns in many parts of the world.

 

The UK's Food Standard Agency, the principal regulator of foods in

the UK, following continued pressure from Patrick Holford and

others, has agreed to rescind the ban.

 

It has however decided to limit the maximum dosage of tryptophan to

220 mg as a food supplement. This determination comes because this

level is considered to be approximately 1/10 of the average

therapeutic dose, the dosage that works! The decision appears to

have nothing whatsoever to do with safety.

 

So, here we have the Regulator preventing us accessing beneficial

dosages, precisely the reason why medicinal law needs to be re-

assessed and potentially challenged in the European courts. It's as

outlandish as saying that all healthy and beneficial foods should be

classified as licensed medicines.

 

The development of a legal challenge to the overly broad scope of EU

medicines law is one of several of the ANH's key focuses at the

present time. Please read the circular below that Patrick has asked

us to distribute - and forward it as widely as you can.

 

Despite this being an issue that affects the UK, we have sent this

to our international database for information purposes. We ask UK

citizens in particular to respond to their Member of Parliament and

Member of the European Parliament, as requested by Patrick.

 

Please consider donating to support preparatory work that ANH is

undertaking with its lawyers and scientists relating to the

potential challenge of the EU Human Medicinal Products Directive and

the incorporated Traditional Herbal Medicinal Products Directive.

 

 

 

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STOP PRESS!!

 

Before reading Patrick's key correspondence on tryptophan, we would

like to draw your attention to an eye-opening article, written by

Dutch writer and supplement company owner Bert Schwitters.

 

Click here to download Bert's article (as PDF file: Get free Acrobat

Reader if you cannot view article).

 

The article gives an incredibly accessible, detailed and, at times

even amusing, account of the current state of play with the EU's

Food Supplements Directive. We at the ANH argue that there is now

everything to play for, but transforming the benefits of the

European court judgment into policy requires a continued and

coordinated effort across Europe. We will update you on progress in

a future e-blast.

 

Now, over to Patrick...

 

 

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READ THIS TO BRING BACK TRYPTOPHAN

 

By Patrick Holford

 

Tryptophan is an essential amino acid that's vital for your brain

and body. Many people find it helps sleep and mood. It got banned in

1990 due to a contaminated batch, and thanks to a campaign last

year, the Food Standards Agency have agreed to rescind the ban BUT

only allow it back at much too low an amount, namely 220mg. It used

to be sold at 1,000mg without any adverse effects.

 

In a consultation process dozens of top scientists advised the FSA

to up the amount on the basis of safety. (The 220mg level was

arrived at as the average GP prescription divided by 10!) Their

submissions were made, no response was given and, we've just heard,

the FSA have made no changes and intend to enact the legislation in

November, bringing it back (good news), but with this highly

restrictive low level (bad news).

 

The scientists in question have written to the FSA, a copy of their

letter is shown below.

 

If you believe in the freedom to choose safe supplements, in setting

safety levels on the basis of real dangers, and in a democratic

process whereby government agencies do consult with key individuals

and organisations, do share opinions and listen, then all you need

do is send your version of the attached letter, also shown below,

today to your MP, personalising it as much as possible. You can find

the name, address and email of your MP at

http://www.locata.co.uk/commons/>

<http://www.locata.co.uk/commons/>, then either email or mail them

your version of the Draft MP letter, shown below:

 

DRAFT LETTER TO YOUR MP

 

Your MP

House of Commons

London SW1A 1AA

 

Dear MP

 

I am a member of your constituency and I believe in the right to buy

safe nutritional supplements. I understand from the attached that

the Food Standards Agency a) intends to restrict my right to buy an

essential amino acid, tryptophan, not on the basis of safety, but on

the basis of dividing the average amount prescribed by doctors by

10; b) has ignored the advice of a large body of scientists,

doctors, psychiatrists and experts in tryptophan; c) has grossly

failed to involve such experts in a process of transparent

consultation.

 

I would like to know why the Food Standards Agency is:

 

1. Proposing to limit an essential nutrient on grounds other than

safety?

 

2. Ignoring the basis for both setting Safe Upper Levels for

vitamins and minerals, on this amino acid, and giving the public the

ability to make an informed choice by mandatory label warnings,

rather than a ban, on supplements containing more than the Safe

Upper Level?

 

3. Violating due process in the consultation process which has, so

far, involved only submissions, followed by silence, followed by

legislation, due to be enacted on November 11th?

 

I can see no reason why tryptophan should be restricted below 1,000

mg, as was previously allowed in Britain for decades without any

safety issues being raised, and is still permitted in other EU

countries (although Holland has an upper level of 600mg). [if

relevant you could add words to the effect: I personally have

supplemented this level without any ill-effects.]

 

I would be most grateful for your raising this matter with Gill Fine

of the FSA and with the Minister, Caroline Flint MP.

 

Perhaps you would be kind enough to please copy me on any reply you

receive.

 

 

Thank you.

 

Yours sincerely

 

[Your name]

 

 

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Note: We would be most grateful if you could please forward any

reply electronically to info or, by

post, to ANH, Tryptophan Campaign, Unit 5, Forge End, St Albans,

Hertfordshire, AL2 3EQ.

 

 

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LETTER SENT TO THE FOOD STANDARDS AGENCY

- FOR YOUR INFORMATION ONLY

 

Jon Bell

Food Standards Agency

Room 608, Aviation House

125 Kingsway

London WC2B 6NH

 

7th October 2005

 

Dear Jon

 

We represent the Institute for Optimum Nutrition's Scientific

Advisory Committee on Tryptophan, and fellow scientists, doctors,

psychiatrists and nutritionists. On the basis of our submission

regarding the scientific evidence that the cases of eosinophilia

myalgia syndrome reported in the late Œ80¹s associated with

tryptophan, were exclusively attributed to a contaminated batch, and

not to tryptophan, and that tryptophan was not associated with

adverse reactions in the amount formerly available as supplements

(up to 1,000mg), you sought the advice of the Committee on Toxicity,

who similarly agreed that tryptophan should be returned to over the

counter sale.

 

2. Earlier this year, with a closing date of May, you sought via a

consultation process, views from organisations such as ourselves to

rescind the ban on tryptophan, proposing a limit of 220mg of

tryptophan per supplement capsule on the basis of dividing the

average therapeutic dose by 10. We submitted clear evidence (see

attached) that, to limit the supplemental intake on this basis was

wholly inappropriate for an essential nutrient and that safety

should be the only criteria for limitation, not a tenfold division

of on average prescribed dose.

 

3. To date we have had no response to this consultation process,

although have been informed that the legislation will be enacted on

November 11th without further discussion.

 

4. Having established the scientific basis for establishing a Safe

Upper Limit (SUL) for essential nutrients in the EVM Report on

vitamins and minerals, based on established a No Observable Adverse

Effect Level (NOAEL) and a Lowest Observable Adverse Effect Level

(LOAEL), why have you chosen to ignore this process for tryptophan,

an essential amino acid?

 

5. Having agreed not to impose SULs on vitamins and minerals, but

rather to insist on warnings on supplements providing more than SUL

levels, to allow the public the freedom of informed choice, why have

you chosen not to do this for tryptophan?

 

6. Having agreed to undergo a Œconsultation¹ why has this process so

far resulted in no publication of responses, nor any further

opportunity for discussion or debate about the issues raised in the

consultation process? Is this not grossly lacking in transparency or

appropriateness, especially given the expertise of the parties

involved?

 

We appreciate a rapid response to these questions, given the

timeframe in which you intend to act.

 

Yours sincerely,

 

Patrick Holford, ­on behalf of the Institute for Optimum Nutrition's

Scientific Advisory Committee on Tryptophan:

 

Professor Andre Tylee, MBBS, MD, FRCGP, MRCPsych. Professor of

Primary Care Mental Health, and Chairman of the Primary Care

Research Group at the Institute of Psychiatry based at the Institute

of Psychiatry, Kings College London

Professor John Henry FRCP, FFAEM, clinical toxicologist at Imperial

College School of Medicine

Professor Malcolm Peet, Consultant Psychiatrist in the NHS and

former Head of the University Department of Psychiatry, Sheffield

Professor Peter Ryan, DProf, MSc, CQSW, Professor of Mental Health

at Middlesex University and Educational Consultant to the Sainsbury

Centre for Mental Health

Professor Philip Cowen, MD, FRCPsych, professor of

psychopharmacology, University of Oxford

Aliya Dallara, BSc(Hons) Nutrition and Health Sciences,

representative of the Institute for Optimum Nutrition

Deborah Colson DipION, MBant, clinical nutritionist, Secretary to

the Tryptophan Committee.

Patrick Holford Bsc, DipION, FBant founder of the Institute for

Optimum Nutrition, Chair of the Tryptophan Committee.

Robert Verkerk, BSc MSc DIC PhD. Executive & Scientific Director of

the Alliance for Natural Health

Sue Croft, Director of Consumers for Health Choice and Fellow of the

Institute of Health Food Retailing.

Sue McGinty MSc DipION MBant, Honorary Secretary of the British

Association of Nutritional Therapists.

John McKee, Director of the National Association of Health Stores.

 

DON'T FORGET - PLEASE CIRCULATE WIDELY

 

Thank you.