Maybe you take weight loss supplements and maybe you don’t. But protecting them, and the claims that the FDA recognizes are appropriate for them, has become a matter of urgency since GlaxoSmithKlein (GSK)has attacked the entire supplement industry through direct threat to our supplements and the entire supplement industry. GSK is using two arrows aimed at the heart of the supplement industry.
Two Pronged Assault
1. Restrict the information that helps people understand what a product does for them (and cripple the First Amendment while you are at it) and
2. Medicalize a category of concern for people taking the supplement and then make sure that the health indications and claims, as well as the supplement are “oozed over” into the drug category, raising their prices and driving their manufacturers out of business while more expensive drugs take their places in the customer’s shopping cart.
In my lecture “Nutricide” (http://tinyurl.com/2kvnvt), I defined Nutricide as
1. The death of the body of knowledge of the relationship between health and food and
2. The death of large populations through the manipulation of the food supply.
GSK vs. The People
GlaxoSmithKlein, a large drug company, has decided to use the powerful tool called a “Citizens Petition” to attack both free speech and the supplement industry. The Citizens Petition is the same type of document that the Natural Solutions Foundation has filed twice with the US Government). Sign the first Citizens Petition here (http://www.healthfreedomusa.org/index.php?page_id=184) to demand the FDA stop illegal “HARMonization”. Our second Citizens Petition, like the current GSK one, has not been assigned a Docket Number (and, for that matter, has ours?) so you cannot comment on it yet. We will tell you how to do that shortly.
(By the way, if you are a supplement manufacturer and you are not very happy with the lobbying representation you are getting on Capital Hill, send us an email (ralph.fucetola@usa.net) with “PROTECTION” as the subject line to join the Health Freedom Alliance, a Wellness Industry 501 (c) 4 organization we have created just for you!)
By asking the FDA to define weight loss products as disease claims, they are protecting their failed over-the-counter weight loss product, alli, while striking a blow at the continued existence of the entire supplements industry. Once weight loss is a disease, not a condition, it will be treatable only through the use of tested drugs. Will insurance companies increase your rates if you need weight loss products? Possibly. After all, we understand that many insurance companies are co-owned by Big Pharma. More diseases, more drugs. More drugs, more profits.
Click here (http://tinyurl.com/4txv62) to let Congress know your right to free speech and information about the relationship between health and supplements are important to you! (If you want a copy of “Nutricide: the DVD”, click here (http://www.healthfreedomusa.org/index.php?page_id=156).
Supplements Under Attack - Again!
GlaxoSmithKlein (GSK) makes drugs like Paxil and Avandia, the highly questionable diabetes drug which the FDA knew nearly 5 years ago increases heart attacks by nearly 43%. Covering itself, the FDA recently issued a warning to GSK about supressing data about the dangers of this supposed “block-buster” drug. Not long before that, the Senate Finance Committee found that GSK intimidated and coerced a well-known critic of Avandia to silence him from speaking out against it. And not long before that, there were serious allegations that GSK had supressed data on Paxil-related adult suicides.
GSK is also the maker of alli, the first over the counter weight loss drug. Alli has been associated with the development of aberrant crypt foci, widely believed to be associated with the development of colon cancer. It is also associated with fecal leaking, “wet gas”, diarrhea, and a sudden event where you could at any moment have an uncontrolled accidental bowel movement. Natural products are not associated with these hazards. So it would seem that anything GSK could do to silence the natural competition and grab a new market share would be welcome to its management and its shareholders.
In fact, here is what www.FDAlawblog.net has to say about the GSK Citizens Petition:
“the Citizens Petition asks the Agency (i.e., FDA, ed.) to prohibit structure/function claims for dietary supplements that expressly or impliedly reference weight loss. In addition to claims that expressly reference weight loss, the petition contends that the following categories of claims should be prohibited: energy expenditure, modulation of carbohydrate metabolism, increased satiety or suppression of appetite, increased fat oxidation or reduced fat synthesis, and blockage of fat absorption. The petition acknowledges FDA’s longstanding position that weight loss claims are permissible structure/function claims. However, the petition urges FDA to change its position on the ground that:
(1) recent evidence establishes that overweight is a risk factor for disease;
(2) consumers believe that there is a relationship between weight loss and a reduction of risk of disease;
(3) claims that a product will reduce a risk factor for disease are disease claims;
(4) the use of ineffective therapies can divert consumers from safe and effective therapies such as GSK’s weight loss drug Alli; and
(5) manufacturers of weight loss supplements should be forced to substantiate their claims through health claim petitions before going to market. Although the petition targets dietary supplements, the action it requests also would affect conventional foods.
The potential marketing value of the weight loss market and the food and dietary supplement industries’ major investment in weight loss products ensures that the petition will receive strong drug industry supported and vigorous food and dietary supplement industry opposition.
Although the petition contends that the requested action will not require rulemaking, there are arguments that would support the need for rule making given FDA’s longstanding position that weight loss claims, as opposed to claims to treat obesity, do not imply disease treatment or prevention.”
Taking advantage of the tremendous power of the Citizens Petition, GSK is asking the FDA to classify weight loss claims made for dietary supplements as disease claims. While the distinction may seem small, what it means to your supplement access could be very bad, indeed.
If the FDA finds for GSK, it will make it much easier to classify nutrients as drugs and much harder to make truthful and honest statements about the health benefits of supplements.
This is just another thrust to find yet another way to destroy the supplement industry NOT because it is bad or dangerous, but because just the opposite is true: drugs are dangerous and kill people. They are also very expensive.
Supplements are relatively cheap, very safe and do not kill people. They are, however, the greatest economic competitior to drugs and therefore the drug companies want them to disappear. They are, of course, very willing to help them do just that!
The rapidly growing weight loss sector of the supplement market in the US is about $1.3 Billion, or about $1 of every $25 spent on supplements and herbs annually. Many supplement companies depend upon these products for significant sales and staying afloat in a challenging market place.
I find it hard to see it as a coincidence that the alarming “Trilateral Cooperation Charter” (http://www.fda.gov/oia/charter.html), signed February 27, 2004 fusing
- Health Products and Food Branch,Health Canada
- US Food and Drug Administration, Department of Health and Human Services
- Federal Commission for the Protection from Sanitary Risks, Secretaria de Salud, Mexico
has decided that one of its very first priorities is eliminating so called health fraud by “enforcement action on Fraudulent weight loss products” (http://www.fda.gov/oia/charter.html#appendixc).
The Trilateral Cooperation Charter defines fraud as “the false, deceptive, or misleading promotion, advertisement, distribution, sale, possession for sale, or offering for sale of products or provisions of services, intended for human use, that are being represented as being made 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.”
If you are hearing that as an invitation to destroy the supplement industry in the US, Mexico and Canada (also known as the North American Union/Security and Prosperity Partnership), you are hearing right.
Given the battle raging around the right to make true and honest statements about the healing benefits of foods or food components, it would appear GSK’s attempt to silence its competitor is simply more of same.
Codex wants to classify sharing any information about the health benefits of food and food components as “advertising”. The FDA wants to stifle the same information by calling it “health claims” or, in this case “disease claims”. The net result, if we allow them to have their way?
Regulatory duct tape over our collective mouths if we dare to share information about how to get well and stay that way with natural products. Not today, not tomorrow and not any time after that!
Opportunity
Did I mention that the Natural Solutions Foundation is gearing up to go to the Codex Commission Meeting in Geneva in late June? Not only will we be there, but we expect to serve as advisers to a coalition of health friendly nations who have been preparing for the “push back” against the US on the issue of mandatory, species specific GMOs labeling.
As you know, the US forbids - FORBIDS - labeling any GM Foods. Most of the rest of the word is fiercely determined to have such labeling. The health friendlies are on the march!
We need your help to get there, though. Take a few minutes to send us forward to Geneva for the Annual Codex Commission meeting. Click here to make your tax deductible donations (http://www.healthfreedomusa.org/index.php?page_id=189).
Thanks for your continuing support! We are the largest and most effective health freedom force in the English speaking world! We make a great team!
