What's REALLY going on in CAM regulations in US and Europe - a must read
Posted: Wed May 02, 2007 9:04 pm
Hi Everyone,
I wanted to pass this on and have taken the
liberty of giving the full text - I know the
people at ANH and they have been doing incredible
work for years in Europe taking the Codex issue
to the European court and so far winning. The
same issues are coming here - the tri-lateral
agreement with Canada and Mexico is already
functioning - it's all about "harmonization" -
the decision making is being shifted from elected
officials to appointed officials with all that
that means for the electorate. Ultimately only
the players with the deepest pockets (Big Pharma)
will be able to afford to play, the requirements
for manufacture and testing will be so costly to
implement. It talks about the recent FDA
Guidance doc and S1082, about their implications
and how it fits into the future plan. It's part
of what I've been talking about recently in other
arenas - it's a long and depressing read but it
lays out in very clear terms just what we are
facing and underlines my assertion that as a
community we HAVE to get organized and link up
with the CAM community - none of us can go it
alone.
And for those amongst us who only wants info that
relates to homeopathy - the Human Medicinal
Products Directive which in Europe will take
precedence over all other directives - has the
power to define anything which has a
physiological effect on the human system as a
drug......so homeopathy is potentially caught
between a rock and hard place - as 'just a
placebo' we are deemed to be duping the public
and in the UK right now that's being used to
remove homeopathy from the NHS - and when we
prove that what we do works then homeopathy is
having a physiological effect and can be deemed
to be a drug and so for most of us, by definition
we could be practicing medicine without a
license. It's a very, very critical time for us
and the work we do and imho we cannot sit with
our heads in materia medica. We need to get
organized, mobilize grass root support and be
pro-active in the fullest sense of the word.
Hold that vision of our healthy homeopathic world AND please pass this on..
Carol
Carol Boyce MCH, CCH, RSHom(NA)
Director of Education
The Homeopathic Symposium
www.homeopathicsymposium.com
Date: Wed, 02 May 2007 15:20:09 +0100
From: Alliance for Natural Health
Subject: CAM THERAPIES IN THE USA IN TURMOIL
FOLLOWING RELEASE OF FDA DRAFT GUIDANCE DOCUMENT
CAM THERAPIES IN THE USA IN TURMOIL FOLLOWING
RELEASE OF FDA DRAFT GUIDANCE DOCUMENT.
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, t
reatment, 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 prosecutionssince 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 scopeto the extent
wherethis Directive has supremacy over any other
Directive, should any productmeet the definitions
withinthis Directive as well as anyother. 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 fordrug 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,
whichwill automatically exclude any foodsthat
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 bebest delivered through associations,
clinics and other representative bodies, rather
than by individual consumers. This is because
this is Guidance for industry – soit 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 ... /ecomments.
The Guidance and comments already submitted can
be viewed at:
http://www.fda.gov/ohrms/dockets/docket ... 6d0480.htm
To unsubscribe, please go to
http://www.alliance-natural-health.org/ ... tion=unsub
I wanted to pass this on and have taken the
liberty of giving the full text - I know the
people at ANH and they have been doing incredible
work for years in Europe taking the Codex issue
to the European court and so far winning. The
same issues are coming here - the tri-lateral
agreement with Canada and Mexico is already
functioning - it's all about "harmonization" -
the decision making is being shifted from elected
officials to appointed officials with all that
that means for the electorate. Ultimately only
the players with the deepest pockets (Big Pharma)
will be able to afford to play, the requirements
for manufacture and testing will be so costly to
implement. It talks about the recent FDA
Guidance doc and S1082, about their implications
and how it fits into the future plan. It's part
of what I've been talking about recently in other
arenas - it's a long and depressing read but it
lays out in very clear terms just what we are
facing and underlines my assertion that as a
community we HAVE to get organized and link up
with the CAM community - none of us can go it
alone.
And for those amongst us who only wants info that
relates to homeopathy - the Human Medicinal
Products Directive which in Europe will take
precedence over all other directives - has the
power to define anything which has a
physiological effect on the human system as a
drug......so homeopathy is potentially caught
between a rock and hard place - as 'just a
placebo' we are deemed to be duping the public
and in the UK right now that's being used to
remove homeopathy from the NHS - and when we
prove that what we do works then homeopathy is
having a physiological effect and can be deemed
to be a drug and so for most of us, by definition
we could be practicing medicine without a
license. It's a very, very critical time for us
and the work we do and imho we cannot sit with
our heads in materia medica. We need to get
organized, mobilize grass root support and be
pro-active in the fullest sense of the word.
Hold that vision of our healthy homeopathic world AND please pass this on..
Carol
Carol Boyce MCH, CCH, RSHom(NA)
Director of Education
The Homeopathic Symposium
www.homeopathicsymposium.com
Date: Wed, 02 May 2007 15:20:09 +0100
From: Alliance for Natural Health
Subject: CAM THERAPIES IN THE USA IN TURMOIL
FOLLOWING RELEASE OF FDA DRAFT GUIDANCE DOCUMENT
CAM THERAPIES IN THE USA IN TURMOIL FOLLOWING
RELEASE OF FDA DRAFT GUIDANCE DOCUMENT.
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, t
reatment, 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 prosecutionssince 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 scopeto the extent
wherethis Directive has supremacy over any other
Directive, should any productmeet the definitions
withinthis Directive as well as anyother. 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 fordrug 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,
whichwill automatically exclude any foodsthat
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 bebest delivered through associations,
clinics and other representative bodies, rather
than by individual consumers. This is because
this is Guidance for industry – soit 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 ... /ecomments.
The Guidance and comments already submitted can
be viewed at:
http://www.fda.gov/ohrms/dockets/docket ... 6d0480.htm
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