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Unfair Trading – DC's Improbable Science

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Unfair Trading

More boring politics, but it matters.  The two main recommendations of this Pittilo report are that

  • Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine should be subject to statutory regulation by the Health Professions Council
  • Entry to the register should normally be through a Bachelor degree with Honours

For the background on this appalling report, see earlier posts.

A very bad report: gamma minus for the vice-chancellor

The Times (blame subeditor for the horrid title), and some follow up on the Times piece

The Health Professions Council breaks its own rules: the result is nonsense

Chinese medicine -acupuncture gobbledygook revealed

Consultation opens on the Pittilo report: help stop the Department of Health making a fool of itself 

Why degrees in Chinese medicine are a danger to patients

The Department of Health consultation shuts on November 2nd.  If you haven’t responded yet, please do.  It would be an enormous setback for reason and common sense if the government were to give a stamp of official approval to people who are often no more than snake-oil salesman.

Today I emailed my submission to the Pittilo consultation to the Department of Health, at HRDListening@dh.gsi.gov.uk

The submission

I sent the following documents, updated versions of those already posted earlier.

  • Submission to the Department of Health, for the consultation on the Pittilo report [download pdf].
  • What is taught in degrees in herbal and traditional Chinese medicine? [download pdf]
  • $2.5B Spent, No Alternative Med Cures [download pdf]
  • An example of dangerous (and probably illegal) claims that are routinely made by TCM practitioners [download pdf]f

I also completed their questionnaire, despite its deficiencies. In case it is any help to anyone, this is what I said:

The questionnaire

Q1: What evidence is there of harm to the public currently as a result of the activities of acupuncturists, herbalists and traditional Chinese medicine practitioners? What is its likelihood and severity?

Harm

No Harm

Unsure

Comment

The major source of harm is the cruel deception involved in making false claims of benefit to desperate patients. This applies to all three.

In the case of herbal and TCM there is danger from toxicity because herbal preparations are unstandardised so those that do contain an active ingredient are given in an unknown dose. This is irresponsible and dangerous (but would not be changed by the proposals for regulation).

In addition TCM suffers from recurrent problems of contamination with heavy metals, prescription drugs and so on. Again this would not be the business of the proposed form of regulation.

Q2: Would this harm be lessened by statutory regulation? If so, how?

Yes

No

Unsure

The proposed form of regulation would be no help at all. The HPC has already said that it is not concerned with whether or not the drug works, and, by implication, does not see itself as preventing false health claims (just as the GCC doesn’t do this). False claims are the responsibility of Trading Standards who are meant to enforce the Consumer Protection Unfair Trading Regulations (May 2008), though they do not at present enforce them very effectively. Also Advertisng Standards. The proposed regulation would not help, and could easily hinder public safety as shown by the fact that the GCC has itself been referred to the Advertisng Standards Authority.

The questions of toxicity and contamination are already the responsibility of Trading Standards and the MHRA. Regulation by the HPC would not help at all. The HPC is not competent to deal with such questions.

Q3: What do you envisage would be the benefit to the public, to practitioners and to businesses, associated with introducing statutory regulation?

Significant benefit

Some benefit

No benefit

Unsure

This question is badly formulated because the answer is different according to whether you are referring to the public, to practitioners or to businesses.

The public would be endangered by the form of regulation that is proposed, as is shown very clearly by the documents that I have submitted separately.

In the case of practitioners and businesses, there might be a small benefit, if the statutory regulation gave the impression that HM and TCM had government endorsement and must therefore be safe and effective.

There is also one way that the regulation could harm practitioners and businesses. If the HPC received a very large number of complaints about false health claims, just as the GCC has done recently, not only would it cost a large amount of money to process the claims, but the attendant bad publicity could harm practitioners. It is quite likely that this would occur since false claims to benefit sick people are rife in the areas of acupuncture, HM and TCM.

Q4: What do you envisage would be the regulatory burden and financial costs to the public, to practitioners, and to businesses, associated with introducing statutory regulation? Are these costs justified by the benefits and are they proportionate to the risks? If so, in what way?

Justified

Not Justified

Unsure

Certainly not justified. Given that I believe that the proposed form of regulation would endanger patients, no cost at all would be justified. But even if there were a marginal benefit, the cost would be quite unjustified. The number of practitioners involved is very large. It would involve a huge expansion of an existing quango, at a time when the government is trying to reduce the number of quangos. Furthermore, if the HPC were flooded with complaints about false health claims, as the GCC has been, the costs in legal fees could be enormous.

Q5: If herbal and TCM practitioners are subject to statutory regulation, should the right to prepare and commission unlicensed herbal medicines be restricted to statutorily regulated practitioners?

Yes

No

Unsure

I don’t think it would make much difference. The same (often false) ideas are shared by all HM people and that would continue to be the same with or without SR.

Q6: If herbal and TCM practitioners are not statutorily regulated, how (if at all) should unlicensed herbal medicines prepared or commissioned by these practitioners be regulated?

They could carry on as now, but the money that would have been spent on SR should instead be used to give the Office of Trading Standards and the MHRA the ability to exert closer scrutiny and to enforce more effectively laws that already exist. Present laws, if enforced, are quite enough to protect the public.

Q7: What would be the effect on public, practitioners and businesses if, in order to comply with the requirements of European medicines legislation, practitioners were unable to supply manufactured unlicensed herbal medicines commissioned from a third party?

Significant effect

Some effect

No effect

Unsure

European laws,especialliy in food area, are getting quite strict about the matters of efficacy. The proposed regulation, which ignores efficacy, could well be incompatible with European law, if not now, then soon. This would do no harm to legitimate business though it might affect adversely businesses which make false claims (and there are rather a lot of the latter).

Q8: How might the risk of harm to the public be reduced other than by orthodox statutory regulation? For example by voluntary self-regulation underpinned by consumer protection legislation and by greater public awareness, by accreditation of voluntary registration bodies, or by a statutory or voluntary licensing regime?

Voluntary self-regulation

Accreditation of voluntary bodies

Statutory or voluntary licensing

Unsure

I disagree with the premise, for reasons given in detail in separate documents. I believe that ‘orthodox statutory regulation’, if that means the Pittilo proposals, would increase, not decrease, the risk to the public. Strengthening the powers of Trading Standards, the MHRA and such consumer protection legislation would be far more effective in reducing risk to the public than the HPC could ever be.  Greater public awareness of the weakness of the evidence for the efficacy of these treatments would obviously help too, but can’t do the job on its own.

Q10: What would you envisage would be the benefits to the public, to practitioners, and to businesses, for the alternatives to statutory regulation outlined at Question 8?

It depends on which alternative you are referring to. The major benefit of enforcement of existing laws by Trading Standards and/or the MHRA would be (a) to protect the public from risk, (b) to protect the public from health fraud and (c) almost certainly lower cost to the tax payer.

Q11: If you feel that not all three practitioner groups justify statutory regulation, which group(s) does/do not and please give your reasons why/why not?

Acupuncture

Herbal Medicine

TCM

Unsure

None of them. The differences are marginal. In the case of acupuncture there has been far more good research than for HM or TCM. But the result of that research is to show that in most cases the effects are likely to be no more than those expected of a rather theatrical placebo. Furthermore the extent to which acupuncture has a bigger effect than no-acupuncture in a NON-BLIND comparison, is usually too small and transient to offer any clinical advantage (so it doesn’t really matter whether the effect is placebo or not, it is too small to be useful).

In the case of HM, and even more of TCM, there is simply not enough research to give much idea of their usefulness,  with a small handful of exceptions.

This leads to a conclusion that DH seems to have ignored in the past. It makes absolutely no sense to talk about “properly trained practitioners” without first deciding whether the treatments work or not. There can be no such thing as “proper training” in a discipline that offers no benefit over placebo. It is a major fault of the Pittilo recommendations that they (a) ignore this basic principle and (b) are very over-optimistic about the state of the evidence.

Q12: Would it be helpful to the public for these practitioners to be regulated in a way which differentiates them from the regulatory regime for mainstream professions publicly perceived as having an evidence base of clinical effectiveness? If so, why? If not, why not?

Yes

No

Unsure

It might indeed be useful if regulation pointed out the very thin evidence base for HM and TCM but it would look rather silly. The public would say how can it be that the DH is granting statutory regulation to things that don’t work?

Q13: Given the Government’s commitment to reducing the overall burden of unnecessary statutory regulation, can you suggest which areas of healthcare practice present sufficiently low risk so that they could be regulated in a different, less burdensome way or de-regulated, if a decision is made to statutorily regulate acupuncturists, herbalists and traditional Chinese medicine practitioners?

Yes

No

Unsure

As stated above, the.only form of regulation that is needed, and the only form that would protect the public, is through consumer protection regulations, most of which already exist (though they are enforced in a very inconsistent way). Most statutory regulation is objectionable, not on libertarian grounds, but because it doesn’t achieve the desired ends (and is expensive). In this case of folk medicine, like HM and TCM, the effect would be exactly the opposite of that desired as shown in separate documents that I have submitted to the consultation.

Q14: If there were to be statutory regulation, should the Health Professions Council (HPC) regulate all three professions? If not, which one(s) should the HPC not regulate?

Yes

No

Unsure

The HPC should regulate none of them. It has never before regulated any form of alternative medicine and it is ill-equipped to do so. Its statement that it doesn’t matter that there is very little evidence that the treatments work poses a danger to patients (as well as being contrary to its own rules).

Q15: If there were to be statutory regulation, should the Health Professions Council or the General Pharmaceutical Council/Pharmaceutical Society of Northern Ireland regulate herbal medicine and traditional Chinese medicine practitioners?

HPC

GPC/PSNI

Unsure

Neither. The GPC is unlikely to care about whether the treatments work any more than the RPSGB did, or the GCC does now. The problems would be exactly the same whichever body did it.

Q16: If neither, who should and why?

As I have said repeatedly, it should be left to Trading Standards, the MHRA and other consumer protection regulation.

Q17:

a) Should acupuncture be subject to a different form of regulation from that for herbalism and traditional Chinese medicine? If so, what?

Yes

No

Unsure

b) Can acupuncture be adequately regulated through local means, for example through Health and Safety legislation, Trading Standards legislation and Local Authority licensing?

Yes

No

Unsure

(a) No -all should be treated the same. Acupuncture is part of TCM

(b) Yes

Q18.

a) Should the titles acupuncturist, herbalist and [traditional] Chinese medicine practitioner be protected?

b) If your answer is no which ones do you consider should not be legally protected?

Yes

No

Unsure

No. It makes no sense to protect titles until such time as it has been shown that the practitioners can make a useful contribution to medicine (above placebo effect). That does not deny that placebos may be useful at times. but if that is all they are doing, the title should be ‘placebo practitioners’.

Q19: Should a new model of regulation be tested where it is the functions of acupuncture, herbal medicine and TCM that are protected, rather than the titles of acupuncturist, herbalist or Chinese medicine practitioner?

Yes

No

Unsure

No. This makes absolutely no sense when there is so little knowledge about what is meant by the ” functions of acupuncture, herbal medicine and TCM”.Insofar as they don’t work (better than placebo), there IS no function. Any attempt to define function when there is so little solid evidence (at least for HM and TCM) is doomed to failure.

Q20: If statutory professional self-regulation is progressed, with a model of protection of title, do you agree with the proposals for “grandparenting” set out in the Pittilo report?

Yes

No

Unsure

No. I believe the Pittilo report should be ignored entirely. The whole process needs to be thought out again in a more rational way.

Q22: Could practitioners demonstrate compliance with regulatory requirements and communicate effectively with regulators, the public and other healthcare professionals if they do not achieve the standard of English language competence normally required for UK registration? What additional costs would occur for both practitioners and regulatory authorities in this case?

Yes

No

Unsure

No. It is a serious problem, in TCM especially, that many High Street practitioners speak hardly any English at all. That adds severely to the already considerable risks. There would be no reliable way to convey what was expected of them. it would be absurd for the taxpayer to pay for them to learn English for the purposes of practising TCM (of course there might be the same case as for any other immigrant for teaching English on social grounds).

Q23: What would the impact be on the public, practitioners and businesses (financial and regulatory burden) if practitioners unable to achieve an English language IELTS score of 6.5 or above are unable to register in the UK?

Significant impact

Some impact

No impact

Unsure

The question is not relevant. The aim of regulation is to protect the public from risk (and it should be, but isn’t, an aim to protect them from health fraud). It is not the job of regulation to promote businesses

Q24: Are there any other matters you wish to draw to our attention?

I have submitted three documents via HRDListening@dh.gsi.gov.uk. The first of these puts the case against the form of regulation proposed by Pittilo, far more fluently than is possible in a questionnaire.
Another shows examples of what is actually taught in degrees in acupuncture, HM and TCM. They show very graphically the extent to which the Pittilo proposals would endanger the public, if they were to be implemented..

Jump to follow-up

I’m perfectly happy to think of alternative medicine as being a voluntary, self-imposed tax on the gullible (to paraphrase Goldacre again). But only as long as its practitioners do no harm and only as long as they obey the law of the land.  Only too often, though, they do neither.

When I talk about law, I don’t mean lawsuits for defamation.  Defamation suits are what homeopaths and chiropractors like to use to silence critics. heaven knows, I’ve becomes accustomed to being defamed by people who are, in my view. fraudsters, but lawsuits are not the way to deal with it.

I’m talking about the Trading Standards laws   Everyone has to obey them, and in May 2008 the law changed in a way that puts the whole health fraud industry in jeopardy.

The gist of the matter is that it is now illegal to claim that a product will benefit your health if you can’t produce evidence to justify the claim.

I’m not a lawyer, but with the help of two lawyers and a trading standards officer I’ve attempted a summary.  The machinery for enforcing the law does not yet work well, but when it does, there should be some very interesting cases.

The obvious targets are homeopaths who claim to cure malaria and AIDS, and traditional Chinese Medicine people who claim to cure cancer.

But there are some less obvious targets for prosecution too.   Here is a selection of possibilities to savour..

  • Universities such as Westminster, Central Lancashire and the rest, which promote the spreading of false health claims
  • Hospitals, like the Royal London Homeopathic Hospital, that treat patients with mistletoe and marigold paste. Can they produce any real evidence that they work?
  • Edexcel, which sets examinations in alternative medicine (and charges for them)
  • Ofsted and the QCA which validate these exams
  • Skills for Health and a whole maze of other unelected and unaccountable quangos which offer “national occupational standards” in everything from distant healing to hot stone therapy, thereby giving official sanction to all manner of treatments for which no plausible evidence can be offered.
  • The Prince of Wales Foundation for Integrated Health, which notoriously offers health advice for which it cannot produce good evidence
  • Perhaps even the Department of Health itself, which notoriously referred to “psychic surgery” as a profession, and which has consistently refused to refer dubious therapies to NICE for assessment.

The law, insofar as I’ve understood it, is probably such that only the first three or four of these have sufficient commercial elements for there to be any chance of a successful prosecution.  That is something that will eventually have to be argued in court.

But lecanardnoir points out in his comment below that The Prince of Wales is intending to sell herbal concoctions, so perhaps he could end up in court too.

The laws

We are talking about The Consumer Protection from Unfair Trading Regulations 2008.  The regulations came into force on 26 May 2008.   The full regulations can be seen here,  or download pdf file. They can be seen also on the UK Statute Law Database.

The Office of Fair Trading, and Department for Business, Enterprise & Regulatory Reform (BERR) published Guidance on the Consumer Protection from Unfair Trading Regulations 2008 (pdf file),
Statement of consumer protection enforcement principles (pdf file), and
The Consumer Protection from Unfair Trading Regulations: a basic guide for business (pdf file).

Has The UK Quietly Outlawed “Alternative” Medicine?

On 26 September 2008, Mondaq Business Briefing published this article by a Glasgow lawyer, Douglas McLachlan.   (Oddly enough, this article was reproduced on the National Center for Homeopathy web site.)

“Proponents of the myriad of forms of alternative medicine argue that it is in some way “outside science” or that “science doesn’t understand why it works”. Critical thinking scientists disagree. The best available scientific data shows that alternative medicine simply doesn’t work, they say: studies repeatedly show that the effect of some of these alternative medical therapies is indistinguishable from the well documented, but very strange “placebo effect” ”

“Enter The Consumer Protection from Unfair Trading Regulations 2008(the “Regulations”). The Regulations came into force on 26 May 2008 to surprisingly little fanfare, despite the fact they represent the most extensive modernisation and simplification of the consumer protection framework for 20 years.”

The Regulations prohibit unfair commercial practices between traders and consumers through five prohibitions:-

  • General Prohibition on Unfair Commercial
    Practices (Regulation 3)
  • Prohibition on Misleading Actions (Regulations 5)
  • Prohibition on Misleading Omissions (Regulation 6)
  • Prohibition on Aggressive Commercial Practices (Regulation 7)
  • Prohibition on 31 Specific Commercial Practices that are in all Circumstances Unfair (Schedule 1).  One of the 31 commercial practices which are in all circumstances considered unfair is “falsely claiming that a product is able to cure illnesses, dysfunction or malformations”. The definition of “product” in the Regulations includes services, so it does appear that all forms medical products and treatments will be covered.

Just look at that!

One of the 31 commercial practices which are in all circumstances considered unfair is “falsely claiming that a product is able to cure illnesses, dysfunction or malformations”


Section 5 is equally powerful, and also does not contain the contentious word “cure” (see note below)

Misleading actions

5.—(1) A commercial practice is a misleading action if it satisfies the conditions in either paragraph (2) or paragraph (3).

(2) A commercial practice satisfies the conditions of this paragraph—

(a) if it contains false information and is therefore untruthful in relation to any of the matters in paragraph (4) or if it or its overall presentation in any way deceives or is likely to deceive the average consumer in relation to any of the matters in that paragraph, even if the information is factually correct; and

(b) it causes or is likely to cause the average consumer to take a transactional decision he would not have taken otherwise.

These laws are very powerful in principle, But there are two complications in practice.

One complication concerns the extent to which the onus has been moved on to the seller to prove the claims are true, rather than the accuser having to prove they are false. That is a lot more favourable to the accuser than before, but it’s complicated.

The other complication concerns enforcement of the new laws, and at the moment that is bad.

Who has to prove what?

That is still not entirely clear.  McLachlan says

“If we accept that mainstream evidence based medicine is in some way accepted by mainstream science, and alternative medicine bears the “alternative” qualifier simply because it is not supported by mainstream science, then where does that leave a trader who seeks to refute any allegation that his claim is false?

Of course it is always open to the trader to show that his the alternative therapy actually works, but the weight of scientific evidence is likely to be against him.”

On the other hand, I’m advised by a Trading Standards Officer that “He doesn’t have to refute anything! The prosecution have to prove the claims are false”.  This has been confirmed by another Trading Standards Officer who said

“It is not clear (though it seems to be) what difference is implied between “cure” and “treat”, or what evidence is required to demonstrate that such a cure is false “beyond reasonable doubt” in court. The regulations do not provide that the maker of claims must show that the claims are true, or set a standard indicating how such a proof may be shown.”

The main defence against prosecution seems to be the “Due diligence defence”, in paragraph 17.

Due diligence defence

17. —(1) In any proceedings against a person for an offence under regulation 9, 10, 11 or 12 it is a defence for that person to prove—

(a) that the commission of the offence was due to—

(i) a mistake;

(ii) reliance on information supplied to him by another person;

(iii) the act or default of another person;

(iv) an accident; or

(v) another cause beyond his control; and

(b) that he took all reasonable precautions and exercised all due diligence to avoid the commission of such an offence by himself or any person under his control.

If “taking all reasonable precautions” includes being aware of the lack of any good evidence that what you are selling is effective, then this defence should not be much use for most quacks.

Douglas McLachlan has clarified, below, this difficult question

False claims for health benefits of foods

A separate bit of legislation, European regulation on nutrition and health claims made on food, ref 1924/2006, in Article 6, seems clearer in specifying that the seller has to prove any claims they make.

Article 6

Scientific substantiation for claims

1. Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence.

2. A food business operator making a nutrition or health claim shall justify the use of the claim.

3. The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with this Regulation.

That clearly places the onus on the seller to provide evidence for claims that are made, rather than the complainant having to ‘prove’ that the claims are false.

On the problem of “health foods” the two bits of legislation seem to overlap.  Both have been discussed in “Trading regulations and health foods“, an editorial in the BMJ by M. E. J. Lean (Professor of Human Nutrition in Glasgow).

“It is already illegal under food labelling regulations (1996) to claim that food products can treat or prevent disease. However, huge numbers of such claims are still made, particularly for obesity ”

“The new regulations provide good legislation to protect vulnerable consumers from misleading “health food” claims. They now need to be enforced proactively to help direct doctors and consumers towards safe, cost effective, and evidence based management of diseases.”

In fact the European Food Standards Agency (EFSA) seems to be doing a rather good job at imposing the rules. This, predictably, provoked howls of anguish from the food industry There is a synopsis here.

“Of eight assessed claims, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected seven for failing to demonstrate causality between consumption of specific nutrients or foods and intended health benefits. EFSA has subsequently issued opinions on about 30 claims with seven drawing positive opinions.”

“. . .  EFSA in disgust threw out 120 dossiers supposedly in support of nutrients seeking addition to the FSD’s positive list.

If EFSA was bewildered by the lack of data in the dossiers, it needn’t hav been as industry freely admitted it had in many cases submitted such hollow documents to temporarily keep nutrients on-market.”

Or, on another industry site, “EFSA’s harsh health claim regime

“By setting an unworkably high standard for claims substantiation, EFSA is threatening R&D not to mention health claims that have long been officially approved in many jurisdictions.”

Here, of course,”unworkably high standard” just means real genuine evidence. How dare they ask for that!

Enforcement of the law

Article 19 of the Unfair Trading regulations says

19. —(1) It shall be the duty of every enforcement authority to enforce these Regulations.
(2) Where the enforcement authority is a local weights and measures authority the duty referred to in paragraph (1) shall apply to the enforcement of these Regulations within the authority’s area.

Nevertheless, enforcement is undoubtedly a weak point at the moment. The UK is obliged to enforce these laws, but at the moment it is not doing so effectively.

A letter in the BMJ from Rose & Garrow describes two complaints under the legislation in which it appears that a Trading Standards office failed to enforce the law. They comment

” . . . member states are obliged not only to enact it as national legislation but to enforce it. The evidence that the government has provided adequate resources for enforcement, in the form of staff and their proper training, is not convincing. The media, and especially the internet, are replete with false claims about health care, and sick people need protection. All EU citizens have the right to complain to the EU Commission if their government fails to provide that protection.”

This is not a good start.   A lawyer has pointed out to me

“that it can sometimes be very difficult to get Trading Standards or the OFT to take an interest in something that they don’t fully understand. I think that if it doesn’t immediately leap out at them as being false (e.g “these pills cure all forms of cancer”)  then it’s going to be extremely difficult. To be fair, neither Trading Standards nor the OFT were ever intended to be medical regulators and they have limited resources available to them. The new Regulations are a useful new weapon in the fight against quackery, but they are no substitute for proper regulation.”

Trading Standards originated in Weights and Measures.   It was their job to check that your pint of beer was really a pint. Now they are being expected to judge medical controversies. Either they will need more people and more training,  or responsibility for enforcement of the law should be transferred to some more appropriate agency (though one hesitates to suggest the MHRA after their recent pathetic performance in this area).

Who can be prosecuted?

Any “trader”, a person or a company. There is no need to have actually bought anything, and no need to have suffered actual harm. In fact there is no need for there to be a complainant at all. Trading standards officers can act on their own. But there must be a commercial element. It’s unlikely that simply preaching nonsense would be sufficient to get you prosecuted, so the Prince of Wales is, sadly, probably safe.

Universities who teach that “Amethysts emit high Yin energy” make an interesting case. They charge fees and in return they are “falsely claiming that a product is able to cure illnesses”.
In my view they are behaving illegally, but we shan’t know until a university is taken to court.  Watch this space.

The fact remains that the UK is obliged to enforce the law and presumably it will do so eventually. When it does, alternative medicine will have to change very radically. If it were prevented from making false claims, there would be very little of it left apart from tea and sympathy

Follow-up

New Zealand must have similar laws.
Just as I was about to post this I found that in New Zealand a

“couple who sold homeopathic remedies claiming to cure bird flu, herpes and Sars (severe acute respiratory syndrome) have been convicted of breaching the Fair Trading Act.”

They were ordered to pay fines and court costs totalling $23,400.

A clarification form Douglas McLachlan

On the difficult question of who must prove what, Douglas McLachlan, who wrote Has The UK Quietly Outlawed “Alternative” Medicine?, has kindly sent the following clarification.

“I would agree that it is still for the prosecution to prove that the trader committed the offence beyond a reasonable doubt, and that burden of proof is always on the prosecution at the outset, but I think if a trader makes a claim regarding his product and best scientific evidence available indicates that that claim is false, then it will be on the trader to substantiate the claim in order to defend himself. How will the trader do so? Perhaps the trader might call witness after witness in court to provide anecdotal evidence of their experiences, or “experts” that support their claim – in which case it will be for the prosecution to explain the scientific method to the Judge and to convince the Judge that its Study evidence is to be preferred.

Unfortunately, once human personalities get involved things could get clouded – I could imagine a small time seller of snake oil having serious difficulty, but a well funded homeopathy company engaging smart lawyers to quote flawed studies and lead anecdotal evidence to muddy the waters just enough for a Judge to give the trader the benefit of the doubt. That seems to be what happens in the wider public debate, so it’s easy to envisage it happening a courtroom.”

The “average consumer”.

The regulations state

(3) A commercial practice is unfair if—

(a) it contravenes the requirements of professional diligence; and

(b) it materially distorts or is likely to materially distort the economic behaviour of the average consumer with regard to the product.

It seems,therefore, that what matters is whether the “average consumer” would infer from what is said that a claim was being made to cure a disease. The legal view cited by Mojo (comment #2, below) is that expressions such as “can be used to treat” or “can help with” would be considered by the average consumer as implying successful treatment or cure.

The drugstore detox delusion. A nice analysis “detox” at .Science-based Pharmacy