Natural Solutions Foundation
My nominee for the Hall of Shame: FDA with reference to its banning of Pyridoxamine, a form of Vitamin B-6.
Read on and see if you agree with me.
Big Pharma is part of a mega-cartel that makes its money when you are sick. We might want to call it “Big Sick.” The FDA serves the needs of that super cartel without so much as a second thought; it’s built into the bureaucratic structure. It is an agency that Dr. Ron Paul says engages in “abuses of power.” It is increasingly blatant about it, though, as if there is nothing that can be done to stop it.
Well, there is, but it takes a lot of effort. Push-back works. We’ve proven it!
The FDA has, for a long time, banned truthful claims and information about the health benefits you can expect from foods and nutrients. Nutrient benefits will cut into the drug pushers’ market substantially, after all. Unless you do not know the good things you can expect from those items, leaving you all the more vulnerable to the drug pushers who are permitted to sell their deadly wares to you over the TV, in magazines and through your doctor’s prescription pads.
Remember that the 1994 law which gives us the right to nutrients in whatever dose we want them, the Dietary Supplements Health and Education Act (DSHEA) also gives us the right to truthful information about nutrients, herbs and food components. In clear violation of that law, and the First Amendment of the Constitution, however, the FDA uses a variety of powers, real and assumed, to suppress both science and facts. Take away the information and you effectively kill the alternatives to the deadly drugs the Big Pharma cartel pushes…
To make matters worse, this same gag rule on truthful speech concerning nutrient health benefits has been brought — by the FDA, of course, to Codex Alimentarius (the “world food code”) where it has been globalized through the efforts of the US delegate (previous Hall of Shame “Honoree” Dr. Barbara Schneeman, head of the FDA’s Department of Dietary Supplements, no less!) and approved by the Codex Committee on Food Labeling and then by the Codex Commission.
Codex says that any information offered to consumers about the health benefits of food or food components is illegal because it is advertising as if advertising were banned. The whole thing lacks logic, but has reason: the reason is to kill nutritional medicine in favor of drugs. This process has gone dangerously far in the EU and is advancing through FDA “HARMonization” of US rules with Codex restrictions.
Remember, our video “Nutricide” is called that for two reasons.
First, “Nutricide” means the death of the body of knowledge of the relationship between health and food components
Second, “Nutricide” means the death of a large number of people through the manipulation of the food supply. You can watch this important lecture by going to www.HealthFreedomUSA.org and scrolling down the video section. It is well worth your time.
This effort to kill nutrients is blatant as blatant can be.
How blatant? This blatant. Read the excellent article below which discusses the absurd ban on a form of activated B6, Pyradoxamine, to see just how shameless this organization is. This form of B6 has been available for decades. Then remember that when we, in our numbers, push back against the FDA, experience shows that we deflect their plans. Yes, they come back again, but we do push them away from the brink time and time again. With your magnificent help.
We thank you for your activism. After reading this article, I am sure that you will agree that eternal vigilance is the price of protecting high potency nutrients and information about them, from those who want to take away our right to access natural health options, including foods that heal!
The Natural Solutions Foundation continues to fight for your health. Please “stay tuned” for action items to oppose the evil that FDA’s bureaucrats seek to perpetuate. Remember to open our Health Freedom Action eAlerts when we send them to you! Please give generously so that we can continue that fight, with you by our side.
Dr. Rima E. Laibow, MD
PS – Our Counsel and Co-Trustee, Ralph Fucetola JD blogged about this sordid story this past January:
Big Pharma and the FDA: Suppress the Science, Ban the Natural Substances, Sell the Drugs!
Michael D. Ostrolenk
Thu, Jun 11, 2009 at 12:31 AM
In 2005, an up-and-coming pharmaceutical company made a big mistake: they invested millions of dollars into developing a drug only to discover that the only active ingredient of the drug, pyridoxamine, was really a common, naturally occurring substance that has been sold for decades at low cost to consumers in the form of a dietary supplement, and has always been available in commonly consumed foods such as chicken and brewer’s yeast.
We’re taught as children that when you make a mistake, you should own up to it and face the consequences. Apparently the pharmaceutical company in question, Biostratum, Inc., has yet to learn that lesson. Instead of owning up to their mistake, Biostratum tried to game the system to their advantage by asking the US Food and Drug Administration (FDA) to declare supplements containing pyridoxamine “adulterated” and effectively ban anyone but Biostratum from selling pyridoxamine.
Sadly, Biostratum’s desperate ploy to save their investment worked. Earlier this year the FDA agreed to ban companies from selling pyridoxamine as a dietary supplement. They denied the request to declare products containing pyridoxamine “adulterated,” but instead they declared that such products are not dietary supplements at all—claiming they are excluded from the definition of dietary supplements under the “prior market clause” [21 U.S.C. 321(ff)(3)(B)(ii)] and so may not be marketed as such.
Please note that nowhere in the FDA’s response letter is anything said about safety concerns. In fact, the FDA’s letter specifically says that “to allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.” Fair to the pharmaceutical companies? What about fairness to consumers, some of whom rely on affordable pyridozxamine supplements to provide the levels of vitamin B-6 required for their survival? Is it fair to force those consumers to pay for expensive prescription drugs and doctors’ visits to supply their B-6 needs when they could get the exact same thing for a fraction of the cost in the form of a supplement? Isn’t this why our health care system is so ineffective?
This is hardly the first time the FDA has attacked naturally occurring substances. On October 17, 2005, the FDA banned information about the health benefits of cherries from appearing on websites—scientifically proven benefits, such as tart cherries’ ability to reduce the risk of colon cancer because of the anthocyanins and cyanidin contained in the cherry. Cherries, according to the latest research, help ease the pain of arthritis and gout; reduce risk factors for heart disease and diabetes; help regulate the body’s natural sleep patterns, aid with jet lag, prevent memory loss, and delay the aging process; and helps lower body fat and cholesterol—risk factors associated with heart disease. Moreover, Scientists at Johns Hopkins have found that tart cherry anthocyanins reduced painful inflammation as well as a non-steroidal anti-inflammatory drug, indomethacin.
When the 2005 ban was instituted, the FDA sent warning letters to twenty-nine companies that market cherry products. In these letters, they ordered the companies to stop publicizing scientific data about cherries. According to the FDA, when cherry companies disseminate this peer-reviewed scientific information, the cherries become “unapproved new drugs” and are subject to seizure. The FDA warned that if those involved in “cherry trafficking” continue to inform consumers about these scientific studies, criminal prosecutions would ensue.
But fresh fruit and vegetables are not the FDA’s only target: As we reported in this newsletter recently, General Mills was recently issued a warning letter by the FDA for illegally marketing Cheerios Toasted Whole Grain Oat Cereal. The problem was the claim on the cereal box that Cheerios can lower cholesterol 4% in six weeks, and the statement on their website that “diets rich in whole grain foods can reduce the risk of heart disease.” The letter, dated May 5, 2009, called the above claims “serious violations” of the Federal Food, Drug, and Cosmetic Act and applicable regulations. FDA stated that based on the claims made, Cheerios is now an unapproved drug, and must go through FDA new drug approval process. Note that the FDA isn’t disputing the claim. It’s disputing the company’s right to make the claim.
As one newspaper columnist humorously put it, “One of these things is not like the others: morphine, penicillin, aspirin, Cheerios. Most drugs, if taken improperly, will kill the consumer or cause substantial bodily harm. An entire bottle of aspirin at one sitting will harm or kill. If Cheerios is a drug, therefore, one should be able to commit suicide by consuming the entire box.”
For years, the FDA barred health claims about the benefits of fish oil for heart, cancer, depression, body pain, and various other conditions until a drug company paid a great deal of money to go through the approval process. This type of enforcement effectively censors scientific information and greatly restricts consumer access to scientific studies that provide valuable information.
In the case of pyridoxamine, the FDA did not act out of concern for public safety. This is about money, and about a profit-seeking corporation taking advantage of what is supposed to be a public health organization in order to save their skins.