Vitamin B15 “Unsafe Food Additive”?
As you’ll soon see, the issue between the FDA and pangamic acid is purely about regulation and semantics, and it has nothing to do with any law per se.
First, Vitamin B15 (Pangamic acid), in the USA, has failed to reach the level of “Vitamin” because the FDA claims that there isn’t a proven correlation linking pangamic acid, or DMG deficiency, within a disease condition…namely cancer.
I am going to prove why the FDA is wrong and how they contradicts itself!
FDA Contradicts Itself
It should be known, however, that having the labeling of a food additive is not inclusive of also having the classification of a vitamin. Vitamins C and B5 (ascorbic acid and pantothenic acid respectively) are also labeled as food additives, as well as Vitamins A-K!
So, it is not surprising that pangamic acid would have fallen in the classification of a food additive.
The next step in the world of food additives is if it is designated to this category, then it must be proven to be safe. This in of itself is an FDA contradiction when you look at a large range of current FDA-approved food additives that have been shown as increased risk factors of major diseases such as cancer.
Let’s consider the artificial sweeteners saccharin and aspartame. Both food additives have shown an increase of bladder cancer and lymphomas/leukemias respectively in laboratory rats. In both these cases, the question of whether these may or may not contribute to cancer was dismissed.
Yet, pangamic acid (with no evidence at all of causing cancer) is deemed as “unsafe” under the pretense that it “may cause” cancer, so “they” say.
But wait it gets even better!
FDA and their Double Standards!
So, given just the two examples of saccharin and aspartame (and I didn’t even mention monosodium glutamate [MSG]; a major contender for a cause of cancer), then the claim that pangamic acid is unsafe must fall under a different area for suspicion.
The National Cancer Institute has its own explanation, including that of the FDA, regarding food additives:
“Artificial sweeteners are regulated by the U.S. Food and Drug Administration (FDA). The FDA, like the National Cancer Institute (NCI), is an agency of the Department of Health and Human Services. The FDA regulates food, drugs, medical devices, cosmetics, biologics, and radiation-emitting products.
The Food Additives Amendment to the Food, Drug, and Cosmetic Act, which was passed by Congress in 1958, requires the FDA to approve food additives, including artificial sweeteners, before they can be made available for sale in the United States.
However, this legislation does not apply to products that are “generally recognized as safe.” Such products do not require FDA approval before being marketed.”
Doesn’t this statement provoke questions? Like:
- Now what does the bolded area mean?
- Just how does a product become “generally recognized as safe”?
- Who is in charge of deeming what needs to be proved as safe and what does not?
- And who is in charge of claiming that something is safe despite obvious proof of causing illnesses such as cancer as with many “approved” food additives today?
Clearly more is involved here…much more!
Let’s go back and re-read the sentence prior to the bolded area. It reads as follows:
“The FDA regulates food, drugs, medical devices, cosmetics, biologics, and radiation-emitting products. The Food Additives Amendment to the Food, Drug, and Cosmetic Act, which was passed by Congress in 1958, requires the FDA to approve food additives, including artificial sweeteners, before they can be made available for sale in the United States.”
Could this be the correlation we are looking for?
In order to know for sure, we have to go to the FDA directly.
In 1976, when the FDA banned pangamic acid, the following excerpt is from the actual issued statement:
CPG Sec. 457.100 Pangamic Acid and Pangamic Acid Products Unsafe for Food and Drug Use (CPG 7121.01) Issued: 1976
“Pangamic acid has been promoted both as a dietary supplement and as a drug. Information available to us indicates that there has been no identity established for a substance characterized by the name pangamic acid (or “Vitamin B-15”). The chemical structure and nature of such a substance has not been definitely determined.
In addition, we are not aware of any accepted scientific evidence which establishes the nutritional properties of pangamic acid or which has identified a deficiency of this substance in man or animals.
We are also unaware of a suitable specific analytical method for its determination. A similar product, containing a mixture of calcium gluconate and dimethyl glycene, has been promoted as the building blocks of “calcium pangamate,” a salt of the so-called Vitamin B-15.”
So first, this statement addresses the FDA’s reasoning for why pangamic acid will not be accepted as a vitamin in the USA.
The key words here are “accepted scientific evidence” Sadly, the USA will not accept the hundreds of documented research data from Russia.
So why the blatant lie here?
The FDA and Their Love for Drugs!
Well, don’t worry. I’m coming to that!
Continuing with the policy as stated by the FDA:
“POLICY: The Act defines the term “drug” in part as “… articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals ….” Pangamic acid has historically been promoted as a treatment for cancer, along with other disease conditions. If pangamic acid is offered for such purposes, it would be considered a drug and require clearance under the new drug provisions of the Act. Since pangamic acid has no approved new drug application it must also be considered a new drug without an approved new drug application.”
So here comes the “ah-ha”!
Again, it all boils down to the “drug” rule!
But where is the mention of pangamic acid being a food additive? My guess is that using the term “food additive” was the only way around what comes next. You see, there are two “Acts” (amendments) that need to be considered here:
- The Food Additives Amendment to the Food, Drug, and Cosmetic Act
- Dietary Supplement Health and Education Act
If pangamic acid is defined as a food additive rather than vitamin, then it becomes much easier to be controlled for “other uses”. Conveniently, if any vitamin proves to cure a disease or condition, apparently it must immediately fall under the category of a drug. Why? Well, can’t you smell the dollar bills? Simply, read the issue surrounding Vitamin B6!
On top of all of this, the FDA’s argument that pangamic acid is only a food additive is proving to be a false one.
Pangamic acid is easily demonstrated as an intermediary metabolite that is naturally present in many foods such as: many types of seeds from pumpkin and sunflower, apricot kernels (as well as many fruits), rice (unpolished) and other whole grains, brewer’s yeast, and organ meats such as liver.
And all of these mentioned foods fall low on the new modern diet of today. Can you remember the last time you ate any of these vital foods?
Furthermore, N, N-dimethylglycine (DMG), a component of pangamic acid, is found in all cells of both animal (and humans) and plants.
With all this said, declaring pangamic acid as a food additive is now looking pretty slim for the FDA, and especially the claim of it being “unsafe”.
Although Russia, as well as other European countries, recognizes B15 as a Vitamin, the USA holds fast to its proclamation that there is no attainable scientific evidence that undeniably proves that pangamic acid is, indeed, necessary for health and/or prevents disease in the wake of deficiency.
Medical “advancements” change consistently with old treatments, such as bloodletting which is now considered as archaic. Even as recently as the 1950’s electric shock treatment and lobotomies were considered “state of the art” technologies.
How can we say, with such arrogance yet, that today’s treatments are the “end all” of all treatments? The same is true of the science of nutrition and its relationship to human physiology. With the mechanism of development of so many major diseases still unknown, again, how can we be so arrogant with what we “think” we know?
Sure, the addition of Vitamin C cures and prevents scurvy and this was still in an age where our world was hundred-fold less polluted than our world of today.
Today, we have so many chemicals in the air, soil, and water that the mere interactions of these chemicals (which create NEW chemicals) are virtually unknown. Interesting how the diseases that plague our world today are always on the increase, never on the decrease. How can we possible know the effects of living in this world of artificial chemicals, in other words…a world of poisons, will have on our health?
The more we process and irradiate our foods in the name of “purity” and add so many chemicals to preserve them for years; the more any logical-minded person should question the outcome on human health. Yet, science and medicine continue on their quest for more and more drugs, rather than taking serious interest in what our bodies are really crying out for…nutrition!
At best, the AMA and FDA support only a “tease” of nutrition in their current recommendations (RDA). And even go as far as to say that you should be leery of natural treatments, organic foods, and most recently even fruit has been put on their “hit” list of dangerous foods!
How can science really claim “to know” the complexity of the human body and the nutrition the body requires to thrive, and not just to survive? It is for this reason that “Vitamins” B15 and B17 have been so controversial. On one side of the controversy, are those who seem to understand the complexity whereas on the other side, are those who apparently miss the point all together.
So, science has determined what a vitamin is and is not. As long as we lack the technology or proper research experiments, then obvious essential components that exist in our natural environment are criticized as not necessary for health. Such as it is with pangamic acid (B15), or its component of DMG, as well as or Vitamin B17 (Laetrile).
Many holistic doctors (and even some medical doctors) have come to the conclusion that these two organically found substances are indeed part of the human diet and may be the answer to the preventing the development of cancer as well as other health conditions!