Positive Health Online

UK Food Standards Agency Official Accused Of Abusing Legal Process

by Robert Verkerk PhD

The future of one of the UK's most innovative food supplement manufacturers is held in the balance by a Welsh Magistrates Court. Last Thursday, the Court heard a criminal case brought by the Torfaen Trading Standards Office, which claims that a species of ryegrass contained in the natural sleep aid product Asphalia is an unauthorised 'novel food'.  After a day of deliberations, and expert evidence provided by both sides, the magistrate adjourned the conclusion of the case until 28th July.

At the Abertillery Magistrates Court, barrister Hugo Charlton of 1 Grays Inn Square, London, acting on behalf of Asphalia Food Products Ltd, accused the expert witness acting for the prosecution, Dr Chris Jones of the Food Standards Agency, of serious abuse of legal process. During proceedings, the defendant, Roger Coghill MA(Cantab) C Biol MI Biol MA(Environ Mgt), managing director of the small Welsh food supplement company Asphalia, demonstrated that the novel food status of the ryegrass species, Festuca arundinaceum, for which his company had been indicted, had been unclear, as demonstrated by the European Commission's online Novel Foods Catalogue which categorised the status as 'uncertain' up until days before yesterday's hearing.

But Dr Jones, called as an expert witness for the prosecution, had failed to disclose that he was also a member of the European Commission's Working Group on novel foods. In this capacity he was able to apply his influence to alter the status given to particular foods or food ingredients. During cross-examination, it emerged that just a few days before the trial occurred, Dr Jones had persuaded his colleagues to alter the classification given in the Novel Foods Catalogue. The new status categorises Festuca arundinaceum unequivocally as a 'novel food'. It became apparent during the cross-examination that the motive to push through this change was to assist the prosecution's case. The implications of this are considerably greater given the case's criminal, rather than civil, nature.

Robert Verkerk PhD, acting as an expert for the defence, commented, "This case epitomises what is wrong with so many European laws, and how they may work to interfere with people's fundamental rights and freedoms. There is no question of any harm being caused by the product, while hundreds of people have provided written testimonials to the company citing its benefits. Yet, because of an arbitrary date of enforcement of a law enacted in Brussels that was originally intended to protect people from GM foods, a small Welsh company's future is now held in the balance while the company's director could be made a criminal."

The basic premise of the case, as with others where the regulator has challenged a company for sale of an unauthorised novel food, is simply that foods or food ingredients which have not had a significant history of use prior to the date in which the European Novel Foods Regulation (No. 258/97) came into effect, namely 15 May 1997, must pass through an onerous pre-market authorisation process. The prosecution is arguing that Asphalia contained a novel food ingredient which had not been submitted for authorisation.  The authorisation process, which requires that extensive scientific evidence of the safety of the food or ingredient is submitted, can be prohibitively expensive, often exceeding £300,000 per ingredient, as well as time consuming, sometimes taking years to finalize or ultimately being rejected for lack of evidence.

There has been extensive criticism of the Regulation, not only within the EU, but as far afield as the USA and the United Nations, given its discriminatory and disproportionate effects. When the Regulation first came into effect in 1997, it aimed to primarily protect consumers from biotechnological processes, especially genetic modification (GM). Subsequently, a distinct regulatory regime has been built for GM foods, and the existing Regulation now acts as a serious barrier to innovation and use of non-European foods and botanicals.

The defence barrister, Hugo Charlton, pointed out that Dr Jones had forced the re-classification through in the last few days even though he was fully aware that the defendant had been in dialogue with Dr Jones' own colleagues in the Food Standards Agency for some months. The purpose of this dialogue was clearly to provide Asphalia with an opportunity to demonstrate that ryegrass powder, like wheatgrass and barleygrass powders, had a significant history of use prior to 1997, therefore could not be regarded as a 'novel food' ingredient. Rye grains are used traditionally in rye bread and beer products, but the leaves from a variety of ryegrasses are also used as ingredients in a number of leading 'supergreens' products which have been in production by US companies for several decades.

Since the court hearing on 19 July, the Quality Control Director for Pines International Inc, Kansas USA confirmed that Pines International had placed on the market their product Mighty Greens prior to 26 Dec 1996 for sale to the general public in the USA and across European Member States. Might Greens is a food supplement containing a variety of grasses including rye grass.

This  now establishes beyond doubt that ryegrass was being sold in Europe before May 1997. The question now is was that  particular variety in the Pines product. Here the fact that Tall fescue is listed by the USDA as the major ryegrass of Kabsas where Pines operate, and that Pines harvest some 3000 acres there makes is most probable that this was the variety being used.
 
Due to procedural reasons on 28 July the Magistrates have presently ruled that this crucial new evidence cannot be admitted into Court. Roger Coghill has written to the UK FSA asking them to apply for a changed status for Tall Fescue, is waiting to hear back from this in this regard, and thinks it may now be difficult for them to refuse. He thinks that they are unlikely to respond before the trial is resumed on 5 August.
 
The implication of a verdict in favour of the prosecution (Toprfaen County Borough Council) are that all the dozen or so firms selling ryegrass in Europe will have to withdraw their ‘supergreens’ food supplements: these include Udo’s Chopice and Pines, but there are also about 90 importers, many from China now importing ryegrass powders for inclusion in natural food supplements.
 
The ruling on the case is expected to be issued when the case is reconvened on 5th August.

Further Information

Sophie Middleton, Alliance for Natural Health
Tel:  01306 646 600
www.anhcampaign.org
 

What is Asphalia?

Leading health journalists have referred to Asphalia as one of the biggest breakthroughs in natural sleep aids. The product has no known no side effects, is sold in over 400 UK health food stores and was the winner of a Highly Commended award for best New Food Supplement of 2008 at the premier natural products trade show, Natural Products Europe. The product was developed by Roger Coghill and colleagues at Coghill Research Laboratories of Pontypool, Wales.

The defendant company removed the minor ryegrass ingredient in Asphalia in January 2009 when first advised of a Prosecution Notice; therefore present Asphalia supplement stocks do not contain the ryegrass ingredient. www.asphalia.co.uk   

Trade Associations Call for a Formal Dialogue on Article 13 Health Claims Process

Three European trade associations are calling for the European Commission to reassess the process for developing the article 13 list of health claims.

The European Federation of Associations of Health Product Manufacturers (EHPM), the European Responsible Nutrition Alliance (ERNA) and the European Botanical Forum (EBF) have expressed deep concerns about the way in which article 13 of the EU nutrition and health claims is being implemented, and that issues with the process should be urgently addressed before the European Food Safety Authority (EFSA) releases its first article 13 claims evaluation at the end of July.

The three federations represent more than 2,500 food supplements manufacturers, of which 80 percent are small and medium sized companies.

"We fear that the current process will lead to dismissal of a majority of the article 13 entries, not because of insufficient substantiation but because of a lack of clarity on an important number of issues that should first be addressed," said Gert Krabichler, Chairman of ERNA. "Therefore we believe that the EC should take the time to carefully clarify all issues in a formal dialogue with stakeholders."

Echoing his comments, Peter van Doorn, Chairman of EHPM, said: "The nutrition and health claims regulation is of crucial importance for our member companies, as food supplement products need to indicate their effect and intended use in order to allow consumers to make an informed choice. These indications are considered as health claims and the vast majority are based on generally accepted scientific evidence, covered by the article 13 claims list. Many of these have been on the market for decades. We have entered a crucial phase now with the publication of the first EFSA opinions on these claims expected by the end of July, and we are extremely concerned that the process followed is not working."

The federations highlighted that despite several rounds of consultation over the last year between the Commission and member states, EFSA has sent back about half of the 4,000 claims initially submitted by the Commission for clarification.

All three federations provided input into the clarification process, and stressed the need for dialogue with stakeholders, as a number of issues surrounding EFSA's method of evaluation still remain unclear. They regret that the EFSA technical meeting with stakeholders of June 15 is not scheduled to address article 13.1 claims issues.

Manfred Ruthsatz, Chairman of the European Botanical Forum (EBF), said: "We have identified a number of significant issues that need to be addressed to ensure that all article 13 claims are subject to an evaluation by EFSA based on the totality of available evidence, including traditional usage for botanicals, and that the Commission and member states are able to fulfil their role as risk managers. We believe that a constructive dialogue among all parties involved before the first opinions are published is the only way forward to avoid further confusion."

Further Information

European Federation of Associations of Health Product Manufacturers (EHPM):
Tel + (32) 2 209 11 45; lorenecourrege@ehpm.be  www.ehpm.org  
European Responsible Nutrition Alliance (ERNA)
Patrick Coppens, Secretary General, ERNA, 50 Rue del'Association, 1000 Brussels.
Tel: (+32) 2 209 11 50
European Botanical Forum (EBF)
50 Rue de l'Association, 1000 Brussels
Tel: (+32) 2 209 11 50  www.europeanbotanicalforum.org   

Rebuttal to: Scientist Seeks Ban on Homeopathic Products

Dr Peter Kay responds to an article by the physicist D. Singh entitled Scientist Seeks Ban on Homeopathic Products published in The Age on 10th July, 2009.

In a recent article in The Age (10th July), Dr Singh questioned the validity of homeopathic remedies claiming that there was no scientific evidence in support of their use, and that homeopathy was a dangerous practice.

There are in fact numerous peer reviewed reports in the literature that confirm the beneficial properties of homeopathic remediation.[1]  Moreover, millions of relieved sufferers worldwide would attest to their benefits. 

In the past, Dr Singh, along with his colleague Dr Ernst, have condemned homeopathy, (as well as other non-allopathic approaches to the relief of suffering), because its practice is not founded on the principles of evidence based medicine (EBM). Basically, EBM is used to determine the efficacy of pharmacologically based drugs by assessing the consequences of administering them to a group of sufferers.  Unfortunately, the reliance on EBM based directions suffers from serious shortfalls in a clinical setting. 

For example, often, evidence from EBM studies is weak and of limited use, because large numbers of participants have to be included in the trials before 'evidence' can be found. With courage and honesty, the [now deceased] medical practitioner, Dr Horrobin alludes to the limitations of EBM and brings our attention to the limited value of many pharmacological agents used in allopathic medicine.[2]

Quoting Dr Horrobin "As almost any physician who becomes sick personally, or who has a sick friend or relative knows, many of our present medical interventions, although wonderfully documented (and based on the results of EBM), are not very effective. With some obvious exceptions, like peptic ulcer pain, infections by many bacteria, pain in general, or acute asthma, it is difficult for either the doctor or patient to attribute with confidence any change in condition to a drug effect. This is because often only 5-20% of patients benefit more than those given placebo. What we desperately need in medicine are medications that work 80-100% of the time, and where effects are so dramatic that neither doctor nor patient can have any doubts about the impact of treatment."

Another reason why the principle of EBM is of limited value in a clinical setting is that for most drugs to work effectively, the recipient must have the correct genetic blueprint.[3] So, because everyone is genetically different (except for monozygotic sibs), drugs that works well for some people may not work at all for some or may even have fatal consequences for others.  General principles of EBM do not take genetic variation of the target group into account. To overcome these difficulties, new pharmacogenetic or personalised medical approaches, based on the recipient's genetic profile are being developed.[3]

Fortunately, the safety of homeopathic remedies is assured because they do not work by pharmacological intervention.     

Part of the reasoning behind Dr Singh's rejection of homeopathy is that it is not known how it works. That is true. But it is also true that it is not known how many drugs work either.  One thing that is certain though is that, unlike pharmacologically based drugs, homeopathic treatments must have the capacity to reorganise the expression profile of the genetic blueprint. Other non-pharmacological mind/body interventions, such as hypnosis and exposure to stress, for example, have been proven to have a dramatic affect on reorganisation of the genetic blueprint's expression profile.[4]

Why must homeopathic remedies have the capacity to reorganise the genetic blueprint's expression profile? Because the beneficial biological changes associated with homeopathic remediation (1) can only be brought about by changes in the activity of the genetic code.

Dr Peter Kay, the developer of Homeovitality (see www.homeovitality.com and www.ppcherbs.com.au) urges that more effort and thought be put into understanding homeopathy's modes of action and how highly diluted substances affect mind/body interactions involving the genetic code. In the same way that pharmacogenetic considerations may now be applied in allopathic medicine, homeopathic  investigators should be permitted to be less reliant on classical EBM approaches until more is known about the interaction between homeopathic remediation and the genetic code.

References

1. http://www.trusthomeopathy.org/export/sites/bha_site/research/evidence_by_condition_refs.pdf  
2. Horrobin D.F. Evidence-based medicine and the need for non-commercial clinical research directed towards therapeutic innovation. Exp. Biol.  Med. 227:435-437. 2002
3. http://www.parliament.uk/documents/upload/postpn329.pdf
4. Rossi, The psychobiology of gene expression. 2002. WW Norton & Company, New York.

Dr  Peter H Kay PhD
peterhkay@gmail.com