CAM THERAPIES IN THE USA IN TURMOIL FOLLOWING RELEASE OF FDA DRAFT GUIDANCE DOCU

[Guest guest]

By the Alliance for Natural Health (ANH).

Please forward widely to your contacts.

 

What's all the fuss about?

 

In December 2006 the FDA finalised a draft guidance document (Docket

No. 2006D-0480] entitled " Draft Guidance for Industry on

Complementary and Alternative Medicine Products and Their Regulation

by the Food and Drug Administration " . The document seeks to

provide " industry " – practitioners and suppliers of products – the

FDA's current thinking on the relationship between existing laws and

the practice of `complementary and alternative medicine' (CAM).

 

The document has generated everything from internet hysteria, much of

it triggered by a misinformed take circulated in early April by the

Natural Solutions Foundation through to a non-plussed `this guidance

document changes nothing' approach, which is keeping the heads of

others firmly planted in the sand.

 

Among all the hype, the ANH's US-based affiliates, the American

Association for Health Freedom and the Health Freedom Foundation,

issued a statement on the draft guidance document on April 19. Click

here to read the full statement. You'll notice that the AAHF uses

none of the `it's all over tomorrow' language, yet hints at some real

concerns over the FDA's guidance. Once the AAHF's lawyers have

completed their full assessment of the document, we'll be hearing

more from them. The AAHF should also be commended for being

successful in their appeal for an extension to the submission date

for comments. Another take came from the National Health Federation

in the US, for which Dr Rob Verkerk from the ANH acts as a scientific

advisor, particularly on Codex matters. Lee Bechtel, the NHF's

lobbyist, provided a detailed account of the Guidance, stressing the

fact that it has no legal sway at all. You can read Lee's views on

the NHF website in his release entitled Much Ado About Nothing (27

April 2007).

 

When you spend as much time as we do in the ANH looking at

legislatures around the world, and looking at trends within those

legislatures, patterns become apparent. It is the pattern that is

apparent within the FDA's CAM Guidance that we find to be of greatest

concern. Clearly, the Guidance has no direct legal impact in itself

and does not allude to any specific changes, but it certainly points

towards the often-feared, full implementation of the Dietary

Supplement Health & Education Act [DSHEA] – as well as more liberal

use of the Public Health Service (PHS) Act.

 

Since 1994, a large number of American natural health suppliers, and

many thousands of `practitioners' that have relied on use of natural

products for healthcare purposes, have lived in the belief that the

framework DSHEA would allow them to continue using therapeutic

natural products for ever and a day. This actually has never been

true, as DSHEA, since its passage in 1994, has always contained

language that could make this legislation a lot more onerous than it

is perceived to be. The FDA's post-market oversight authority alone,

together with its intentions relating to quality and purity (Good

Manufacturing Practice) of products, could have been anticipated at

the outset to pose significant challenges to many sectors of the

natural products industry.

 

Dietary supplement or drug?

 

One of the most worrying aspects of the FDA's Guidance is the fact

that it regularly refers to the possibility of licensed drugs being

prescribed by practitioners. In essence , it indicates that products

used in CAM practice might be categorised as foods or drugs. It does

this in the context where the vast majority of natural products used

in alternative medicine are in fact dietary supplements, not drugs!

 

A key criterion that turns a product that might readily be taken to

be a food (which includes dietary supplements as classified by DSHEA)

into a drug, is its intended use. Let's remind ourselves of the

definition of drug, under the Federal Food, Drug, and Cosmetic (FFDC)

Act: " articles intended for use in the diagnosis, cure, mitigation,

treatment, or prevention of disease in man or other animals "

 

The FDA Guidance speaks in plain language. We all know just how

healthy raw vegetable juices are, but we also aware that when a

practitioner deals with a cancer patient, the practitioner is very

likely to want them to recommend raw vegetable and fruit juices as

part of the recommendations offered. This could get them into a lot

of trouble, as suggested by the following quote directly from the

Guidance (page 2):

 

" If the juice therapy is intended for use as part of a disease

treatment regimen instead of for the general wellness, the vegetable

juice would also be subject to regulation as a drug under the Act. "

 

It's hard to think only of `general wellness' when someone is dying

of cancer. A good practitioner tends to be thinking much more about:

how do I modulate the immune system? How do I increase serum

antioxidant levels? How do I help the patient re-establish effective

self-healing mechanisms in the body….

 

In short, although it might be easy for products in the retail sector

to stick within the structure/function claim constraints of DSHEA,

the most difficult thing for any CAM practitioner is the context in

which he or she practices. The FDA has the legal power to say that

any practitioner who is seeing patients or clients with serious

diseases, and are then providing recommendations, is effectively

providing products which are " intended for " the " mitigation,

treatment or prevention of disease " . If this were to be the

interpretation, any use of dietary supplements by practitioners could

be considered illegal. This is at least as worrying as some of the

developments and legal and regulatory interpretations going on in

Europe, with which we are very familiar.

 

There is however a more hopeful interpretation given on page 12 of

the Guidance, where the example of cranberry for urinary tract

infections is explored. Fortunately the Guidance implies that the

context of the practitioner-patient is probably not sufficient to

constitute " intention for disease treatment " , which would otherwise

make cranberry products drugs. The Guidance proffers that it is the

label claim that is the deciding factor. If you stick within the area

of structure/function claims and state on the label " maintains the

health of the urinary tract " your product will still remain a dietary

supplement. However, should your product carry a claim like " prevent

urinary tract infections " you will then have ventured into drug

territory.

 

However, this interpretation in the Guidance could perhaps be seen as

nothing more than a temporary fix. Wait until Codex has followed the

European Union on its path towards limited health claims based

on " generally accepted evidence " – and the range of claims that might

be allowed could reduce dramatically. How can this system ever allow

for claims for emerging science? How can you ever have an innovative

product that is then not forced into a drugs regime? Some might refer

to this as a key part of the game plan for a regulatory `stitch up'

for natural products.

 

FDA Guidance pushes CAM towards 'drug' classification

 

Although there's nothing new in the Guidance in terms of legislation,

it is worth remembering that DSHEA has never been fully implemented.

It's also worth reminding ourselves that DSHEA always set out to give

the FDA powers to jump on any product that they deem to pose

an " unreasonable or significant risk of illness or injury. " None of

us have any problem with this in principle – we only have a problem

if they use flawed science or evidence to construct a case which

incorrectly classifies a product or treatment as unsafe.

 

Now this is where you really need to take stock – and see what's

going on outside the US, with full support from the FDA officials

that populate the US delegation in the Codex Committee on Nutrition

and Special Dietary Uses. This Committee is presently engaged

in `copy-catting' a flawed system of risk assessment being developed

by the EU that says that the safe maximum (supplement) level of

vitamin C might be just 1000 mg, or 10 mg of vitamin B6. It's no

better for other vitamins – the overall approach is flawed – and this

is something the ANH has been working at exposing for several years.

 

But these `upper levels' – once rubber stamped by Codex, and the FDA

delegation that is party to it, will act as the internationally

agreed borderline as to what is considered safe as a food – or a

dietary supplement. These `upper safe levels', we are told, have been

agreed by international, qualified experts, most of which have strong

ties, it seems, with the drugs companies. It's therefore not at all

difficult for a regulator to make the case that dietary supplements

marketed at doses above this internationally agreed borderline are

unsafe!

 

With this knowledge, read the following paragraph in the FDA's latest

Guidance (page 7; taken from Section 201 of the FFDC Act, of which

DSHEA is part) which defines the category of " new drug " and see what

you think:

 

" Any drug…the composition of which is such that the drug is not

generally recognized, among experts qualified by scientific training

and experience to evaluate the safety and effectiveness of drugs, as

safe and effective for use under the conditions prescribed,

recommended, or suggested in the labeling thereof… "

 

It's always a particular worry when you are reliant on those that

are " experts qualified by scientific training and experience to

evaluate the safety and effectiveness of drugs. " These so-called

experts have traditionally been some of the biggest enemies of

natural healthcare! They tend not to be keen on seeing people getting

better through the use of unpatented natural products. It goes

without saying that the biggest problem with a drug or new drug

classification is the costs involved to meet the very substantial

clinical investigations required to prove safety and efficacy. This

is simply prohibitive to any but the very largest companies. It's

obviously core business for the drug companies.

 

DSHEA vs the Public Health Service Act

 

While all eyes have been focused on DSHEA and the FFDC Act, the

Guidance reminds us of the importance of the Public Health Service

(PHS) Act. It emphasises that Section 351(a)(1) of the PHS Act firmly

includes " biological products " under its remit, and this

classification might easily sweep up a diverse range of products

including probiotics, hormonal/glandular products and animal-based

Ayurvedic and other traditional medicinal products. Again, we must

recognise that the FDA has the legal firepower to make such

classifications, and the Guidance even states that probiotics

could " conceivably " be classified as " biological products " under the

PHS Act. Should this happen – all such products would require

licensing – more money, more studies, more red tape, more prohibition

for the majority of suppliers. The FDA reminds us of its powers when

it tells us: " the PHS Act gives us the authority to establish

requirements for the approval, suspension, and revocation of

biological product licenses. " [see pages 1 and 13 from the Guidance,

in particular].

 

Totality of US legislative powers

 

There is no doubt that the Guidance provides further evidence that

the FDA is intent on tightening the regulatory burden for companies,

by bringing in fuller implementation of existing laws, through the

FFDC and PHS Acts. There is support for this in Congress, with

Kennedy's Food & Drug Administration Revitalization Act (S1082) being

the latest example.

 

In the meantime, lets add to this the additional powers already

conferred to the FDA through the Trilateral Cooperation Charter (TCC)

whereby the USA, Canada and Mexico have agreed to cooperate in

order " to increase communication, collaboration, and the exchange of

information among the three countries in the areas of drugs,

biologics, medical devices, food safety and nutrition to protect and

promote human health " .

 

The most worrying aspect of the TCC is the way in which the three

counties have agreed to define `health fraud'. In essence, they have

provided such a wide definition of health fraud that it potentially

allows the regulators in each of the three countries to go after any

company making therapeutic natural health products – even if they

present no harm to consumers and contain no false or misleading

information on their labels or associated marketing material. In fact

the FDA claims over 730 prosecutions since the TCC's inception in

2003 through to just October 2005.

 

The TCC defines health fraud as follows, but note in particular the

second part of the definition we have bolded for emphasis:

 

" The false, deceptive, or misleading promotion, advertisement,

distribution, sale, possession for sale, or offering for sale of

products or provision of services, intended for human use, that are

represented as being safe and/or effective to diagnose, prevent,

cure, treat, or mitigate disease (or other conditions), to

rehabilitate patients or to provide a beneficial effect on health. "

 

Suddenly – any product that is both safe and gives rise to beneficial

effects on health i.e. the vast majority of dietary supplements,

become potential subjects of health fraud. Is the development of a

new regional trading block in North America, for which the TCC

provides a taster, going to be the beginning of the slippery slope

towards global harmonization, led by Europe, enacted through the

Codex Alimentarius Commission, and policed by the World Trade

Organization? It looks like it.

 

Parallels with Europe

 

European citizens have seen over the last decade a remarkably rapid

transfer of power from sovereign states to unelected officials within

the European Commission. A democratically elected European Parliament

exists, but has very limited powers and it is regularly overruled by

the European Commission. We have seen the introduction of the EU Food

Supplements Directive in 2002, the first part of a framework which

aims to harmonise food supplement laws across all 27 EU Member

States. The ANH has challenged the first part of this law and, nearly

two years after the case was ruled on in the European Court of

Justice, we are beginning to see results. This progress has occurred

following the submission of test dossiers for a wide range of vitamin

and mineral ingredients in February/March 2007.

 

But the real snake pit for dietary supplements in Europe is the Human

Medicinal Products Directive. This is where all products that don't

make it into the Food Supplements Directive fall. Just like the

definitions of a `drug', `new drug' and `health fraud' in the USA,

the definition of a drug in this EU Directive is unbelievably wide.

In fact it makes water a drug. On top of this, the most recent

amendment of this Directive (2004) has broadened its scope to the

extent where this Directive has supremacy over any other Directive,

should any product meet the definitions within this Directive as well

as any other. All food supplements so happen to fit the definition of

both the Human Medicinal Products Directive and the Food Supplements

Directive.

 

This type of supremacy for drug laws seems to be a central part of

the international 'game plan'. The plan appears to be about limiting

the scope of laws maintaining natural health products as foods,

increasing the scope of drug laws – and simultaneously – giving more

and more power to medicine regulators, who we know, worldwide, tend

to work very closely with their friends in the pharma companies.

Codex provides the framework to control a limited range of substances

as foods, which will automatically exclude any foods that happen to

be therapeutic in nature, while everything else falls within the

scope of drug laws. Here, only the the pharmas have sufficiently deep

pockets to play ball. You see, the natural health stitch-up is

complete. Unless of course we all complain like we've never

complained before....

 

Telling the FDA what you think

 

The FDA want to have comments on their Guidance. These will be best

delivered through associations, clinics and other representative

bodies, rather than by individual consumers. This is because this is

Guidance for industry – so it is industry that will be listened to

most.

 

Owing to appeals by our affiliates, the American Association for

Health Freedom and Health Freedom Foundation, as well as by National

Health Freedom Action and others, we had been led to believe that the

the deadline for public comment had been extended from Monday, April

30 to Tuesday, May 29 2007.

 

[urgent Update: There is now conflicting information regarding this

extension, with the FDA claiming 'employee error' and stating that

Monday, April 30 stands. The American Association for Health Freedom

and Health Freedom Foundation continue to lobby Congress on this

issue - watch this space!]

 

Submit written comments on the draft guidance to the Division of

Dockets Management (HFA-305), Food and Drug Administration, 5630

Fishers Lane, rm. 1061, Rockville, MD 20852.

 

Electronic comments should be submitted to:

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?

from=leavingFR.html & log=linklog & to=http://www.fda.gov/dockets/ecomment

s.

 

The Guidance and comments already submitted can be viewed at:

http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm

 

To , please go to www.alliance-natural-

health.org/index.cfm?action=unsub