Complimentary medicine and the FDA

I have just received this information from The Alliance for Natural Health which is fighting tooth and nail to keep hold of our supplements and vitamins. Between Codex and the FDA we seem to be losing this battle which is costing a fortune in legal fees in Europe.
Please read and absorb if you can find the time as the possibilities of all SUPPLEMENTS and VITAMINS becoming branded officially as DRUGS is now very real.

CAM THERAPIES IN THE USA IN TURMOIL FOLLOWING RELEASE OF FDA DRAFT GUIDANCE DOCUMENT.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In December 2006 the FDA finalised a draft guidance document (Docket No. 2006D-0480] entitled “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration”.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

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 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 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
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 Supplement
[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=htt p://www.fda.gov/dockets/ecomments.

The Guidance and comments already submitted can be viewed at: http://www.fda.gov/ohrms/dockets/docket
Tony