Members
e-Letter Issue 1 (May 2007)
In This Issue
EU Food Supplements Directives, Codex and what they can mean to you no matter where you live.
The Approved List: What vitamins will still be available in 2009
The Latest FDA Warnings: More Pharmaceutical Side Effects
Big Pharma’s End Run*
European Union legislation backed by well funded vested interests is set to undermine many of the food supplements, vitamins, minerals and herbs that we normally take for granted.
Worse yet, the United Nations, through the Codex Alimentarius Commission (CODEX), is seeking to adopt this restrictive European legislation and apply it worldwide in their campaign for “Trade Harmonization.” The World Trade Organization (WTO) will then act as the enforcement branch for all member nations ensuring that no member nation will have a trade advantage over another. Although that might appear reasonable from a world economic perspective, what it really means is that the US and other nations will no longer be able to hold onto their “haven” status for available natural health remedies. No, the fact is that they will have to conform to stringent EU and UN guidelines as regards the short list of approved vitamins, their drastically lowered allowable dosages, what they can say or advertise concerning physiological and mental benefits and more...
If the United States and other more progressive nations spearheading natural health remedies wish to continue to enjoy their ‘safe haven’ of alternative and innovative products and therapies, then each citizen will need to keep a close eye on very determined efforts to undermine and dismantle the Dietary Supplement Health and Education Act (DSHEA) of 1994, which opened the door for unprecedented scientific and product advancement in this industry.
The first of the EU Food Supplement Directives has already been approved and drastically limits the number of currently available vitamins and substances commonly used in (natural) products today. Nearly 2/3rds of all available vitamins were banned and will disappear from the shelves in 2009 with few exceptions. A very slow, complex and highly expensive procedure was arbitrarily put into place for those who wished to have a banned substance reconsidered for inclusion in the approved list and time is running out on this process.
The European High Court, facing strong legal challenges and recommendations against it from their own Advocate General, still upheld the directive on July 12, 2005. EU legislators are working on the next phase; the “Human Medicinal Products Directive,” which attempts to reclassify food based vitamin substances as medicines and drugs. This is a real boon for Pharmaceutical companies who can proceed to patent synthetic, chemical versions of vitamins and legally eliminate natural products.
The Food and Drug Administration (FDA), and Central American Free Trade Agreement (CAFTA) call for close monitoring and fast action to dissuade their current efforts to follow in the footsteps of the EU.
Despite volumes of existing scientific evidence, countless scientific studies, peer review journal articles and credible expert opinions in worldwide support of natural healthcare, innovative products, alternative therapies, and freedom of choice, a basic human right of access to natural health remedies is at very real risk.
Make no mistake, this anti-vitamin, anti-natural health legislative effort will only increase and continue to adversely impact the Innovative and Natural Health Industries. The vitamin and herbal remedy manufacturers, their distributors, retailers, local health food stores and professional nutritionists as well as the natural health practitioners whose practices and patients – will each be adversely affected.
Perhaps most importantly, these efforts will impact and adversely affect the consumers and patients the industry serves.
- Many vitamins and mineral forms may be eliminated completely
- Maximum permitted dosages may be drastically reduced to "placebo" therapeutic levels
- Herbal ingredients may also be severely restricted
- Information concerning product benefits can be severely censored
*End Run: (informal) To bypass (an impediment) often by deceit or trickery: “The plan to end-run the Senate committee ran into instant resistance”.
The Approved List
The Vitamins & Minerals Positive List
Only the following nutrient sources will be allowed under the EU Food Supplements Directives (these compounds being listed in Annexe II).
This is the so-called “positive list.”
|
VITAMINS 1. VITAMIN A 2. VITAMIN D 3. VITAMIN E 4. VITAMIN K 5. VITAMIN B1 6. VITAMIN B2 7. NIACIN 8. PANTOTHENIC ACID 9. VITAMIN B6 10. FOLIC ACID 11. VITAMIN B12 12. BIOTIN 13. VITAMIN C |
MINERALS • calcium carbonate |
MINERALS • zinc acetate |
|---|
Some of the 300+ vitamin or mineral sources excluded from the Food Supplements Directive positive list
| Substance |
Benefit |
|---|---|
Mixed (incl. gamma) tocopherols, tocotrienols (i.e. almost the whole spectrum of naturally-occurring Vitamin E) |
Antioxidants, which protect against damage by free-radicals which are associated with cancer and other degenerative diseases |
Mixed/ natural spectrum of carotenoids |
Protective against infections, antioxidants, use in cancer prevention/treatment |
Boron (all forms) |
Required for absorption of calcium |
Vanadium (all forms) |
Controls diabetes or blood-sugar levels, better in combination with bioavailable chromium forms |
Silica (all forms) |
Works in conjunction with boron, calcium, magnesium, potassium, and ascorbic acid to support bones, arteries, connective tissue, healthy hair, skin, and nails. |
Sulphur (all forms) |
Includes glucosamine suphate for support of joint tissue and MSM (methyl-sulfonyl-methane) with wide variety of known health benefits. |
Selenium (14 different forms, including selenium yeast products) |
Antioxidants. Important for heart function. Very low or non-existent in foods owing to mineral depletion of agricultural soils |
Colloidal or ionic trace elements derived from natural sources |
Very wide range of health benefits |
Calcium ascorbate |
A type of Vitamin C for those who cannot tolerate ascorbic acid |
Calcium (23 different food forms) |
Includes many bioavailable forms of calcium needed for bones, teeth and cell function. Dairy products do not provide substantial bioavailable forms of calcium |
Chromium (in 17 different forms) including picolinate and polynicotinate |
Important for balancing blood sugar levels; manages arteriosclerosis; widely used by diabetics |
Copper (24 different forms) |
For artery strength, maintaining connective tissue |
Iron (21 food forms, including iron-based yeast) |
For blood and many enzymes involved in energy metabolism |
Magnesium (30 different forms) |
For healthy bones and teeth, nerve transmission and muscle contraction |
Molybdenum (15 different forms of amino acid chelate) |
Essential component of enzymes involved in the production of genetic material. May reduce tooth decay |
Potassium (21 different forms) |
Maintains blood pressure and heart beat rhythm |
Colloidal silicic acid |
Helps in the maintenance of healthy nails |
*By, 2007, the European Commission will most likely issue further restrictive positive lists for other nutrient groups including essential fatty acids, amino acids, phytonutrients, antioxidants, etc. **pending submission of Scientific Dossiers; see www.foodsupsinfo.net for details.
Source: The Alliance for Natural Health www.alliance-natural-health.org.
The Latest FDA Warnings
This section of the newsletter is dedicated to providing the lasted ALERTS issued by the FDA on Pharma products
FDA Issues Safety Alert on Avandia
The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.
Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.
"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."
Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.
Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.
Avandia is manufactured by GlaxoSmithKline, which is based in Research Triangle Park, N.C.
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