The FDA Stamps Out 2,500 Deformed Babies Like This Every Year

The FDA Stamps Out 2,500 Deformed Babies Like This...

The FDA Stamps Out 2,500 Deformed Babies Like This Every Year

Vitamin deficiency horror story continues as FDA stymies preventive measures

By Bill Sardi |

Professor Emeritus Philip Rudnick PhD, Chemistry, West Chester University of Pennsylvania, has created a time line (below) of the preventable tragedy that strikes American families an estimated 2500 times a year. The shocking photograph above is what a newborn spina bifida baby looks like because its mother did not have adequate folic acid levels at the time of conception.

While there are efforts to encourage fertile women to take folic acid supplements, these efforts are not working. Only food fortification will adequately prevent this ongoing tragedy. For the past 31 years health authorities have known that folic acid deficiency leads to severe birth defects. In that time, an estimated 75,000 American babies have been born with horrible, yet preventable, birth defects.

The preventive measure consists of adding less than 1 milligram (700 micrograms) of folic acid to foods that fertile women commonly consume, like grains and flour that have been stripped of this essential nutrient. The nutrient stripping is allowed, its replacement is forbidden!

Dr. Rudnick points out in 1991 the FDA flatly denied that a vitamin deficiency is responsible for these birth defects, then later declared in expert fashion that they had to protect the population at large from folic acid masking symptoms of a vitamin B12 deficiency and therefore could not take action. The thousands of malformed babies continued to be born.

What the FDA is talking about is that, largely among senior adults, many whom are vitamin B12 deficient, symptoms of B12 deficiency (a condition called pernicious anemia) would be hidden if folic acid were to be fortified in foods alone. OK, let's add B12 to the foods too since about 40% of senior Americans are overtly deficient. Nothing doing says the FDA. Let senior Americans suffer with short-term memory loss, burning feet, fatigue, back aches, the typical symptoms of B12 deficiency, rather than prevent these problems altogether.

Emory University epidemiologist Godfrey Oakley, who in 2002 openly declared in the British Medical Journal that any government that did not fortify its foods with adequate amounts of folic acid was committing public health malpractice ( ), has led the charge to urge the FDA to take timely action.

A timeline of Dr. Godfrey’s efforts to influence the FDA to take action is provided at this Emory University webpage: )

A PBS interview with Dr. Godfrey can also be found online here:

Despite this publicity, the FDA has not taken timely and forceful action. The malformed babies continue to be born.

Now the FDA has drummed up yet another reason for continue its foot dragging. It says when it began to increase the amount of folic acid in foods the rate of colon cancer rose. However, the amount of folic acid fortified in foods was equal to that provided in the 5-7 servings of fruits and vegetables recommended by the National Cancer Institute. The FDA reticence to take action amounts to stone-walling.

A percentage of adults don’t even metabolize folic acid properly and need more, not less, of this vitamin. Dr. Bruce Ames of the University of California at Berkeley notes that DNA cannot be adequately repaired without sufficient folic acid and that such a deficiency may promote cancer. The FDA has deaf ears to these arguments.

No only would folic acid food fortification at the 700 microgram level avert birth defects, it would likely inhibit Human papilloma virus infections that are known to cause cervical cancer among women. A shortage of folic acid has also been linked to senile dementia (Alzheimer’s disease). Somehow in America the FDA has permitted foods to be laced with hydrogenated fats, MSG and aspartame, but not sufficient amounts of folic acid.

Without top-down reform starting from the Executive branch of government, don’t anticipate Congressional committees to reform the FDA. Problems like these are too long-standing to believe anything but pretend reforms will be evident anytime soon.

Dr. Rudnick’s timeline with commentary is presented below:

The FDA declares that folic acid does not prevent birth defects among high-risk women

Philip Rudnick, PhD Professor Emeritus, Chemistry West Chester University of Pennsylvania.

Folic Acid, Neural-Tube Defects and the Unborn Children Permanently Maimed by FDA Officials With “…nutritional policy from prehistoric times”:

A Medline search of the words: [folic neural tube defects] yields 1464 citations.

The first Medline citation on the association of neural tube defects and folic acid deficiency dates from 1976:

Vitamin deficiencies and neural tube defects.
Smithells RW, Sheppard S, Schorah CJ.
Archives Diseases Childhood 1976 Dec;51(12):944-50.
"Serum folate, red cell folate, white blood cell vitamin C, riboflavin saturation index, and serum vitamin A were determined during the first trimester of pregnancy in over 900 cases. For each of these there was a (sic) social classes I + II showed the highest levels which differed significantly from other classes, except for serum folate. In 6 mothers who gave birth to infants with neural tube defects, first trimester serum folate, red cell folate, white blood cell vitamin C, and riboflavin values were lower than in controls. In spite of small numbers the differences were significant for red cell folate and white blood cell vitamin C. These findings are compatible with the hypothesis that nutritional deficiencies are significant in the causation of congenital defects of the neural tube in man."

In 1980:
Possible prevention of neural-tube defects by periconceptional vitamin supplementation.
Smithells RW, Sheppard S, Schorah CJ, Seller MJ, Nevin NC, Harris R, Read AP, Fielding DW.
Lancet. 1980 Feb 16;1(8164):339-40.
“Women who had previously given birth to one or more infants with a neural-tube defect (NTD) were recruited into a trial of periconceptional multivitamin supplementation. 1 of 178 infants/fetuses of fully supplemented mothers (0.6%) had an NTD, compared with 13 of 260 infants/fetuses of unsupplemented mothers (5.0%).” [8-fold increase]

In the years following the Smithells 1980 Lancet paper, despite additional, corroborating evidence of a folate-neural-tube-defect link and appeals to the FDA by numerous health practitioners and organizations, the FDA remained adamant – it would allow the stripping of folic acid from grains through food processing, but would forbid its reintroduction in grain products at a level needed to prevent spina bifida in unborn children. It also forbid folic acid in vitamin supplements at such preventive levels. Over a span of the next 16 years, FDA officials first used one spurious argument, and when that collapsed succeeded it by a different spurious one, to rationalize their refusal to allow the fortification of grains or supplements with folic acid. Their first stance was simply to deny any link between folic acid deficiency and neural tube defects.

Fall 1991: The FDA declares that folic acid does not prevent birth defects among high-risk women… November 1991: The FDA asks CDC officials to sign off on a statement in the Federal Register to read "Folic acid does not prevent spina bifida. The CDC declines.

When this stance proved hopelessly untenable for them, they retreated to a different argument – the hypothetical masking of undiagnosed pernicious anemia in the elderly by folic acid. These officials could have guided their actions by the Precautionary Principle, calling for the fortification of grains with both folic acid and B-12. This would have addressed the need to treat both undiagnosed pernicious anemia in the elderly and the neural-tube-risk of pregnant women. Instead they took a surreal tack – the concomitant disallowance of fortification of grains with B-12. Then – Alice in Wonderland – they used their own tack on B-12 as a basis for their new argument for not fortifying grains with folic acid, viz., the specter of masking pernicious anemia with folic acid alone, in the absence of B-12! Obsessively adhering to their anti-nutrition mindset, these top FDA officials, employing this Catch-22 ploy of obstruction, continued to disregard the plight of at-risk unborn children and ended up crippling thousands of them.

To this day, FDA officials have continued to play their anti-nutrition cards on this subject. When, after years of denial, they were finally forced to admit both a neural-tube-defect-folate link and the need for folate fortification, they then acted as oracular authorities on the suddenly obvious benefits of folate, issuing a proclamation of omniscience that an intake of 0.4mg folate was sufficient for preventing neural tube defects, but that supplementation with more than 0.4mg folate was both of no benefit and not allowed.

“…when the fortification decision was made, it wasn't made to give women of reproductive age enough folic acid, so the fortification gives the average woman only one fourth of what is recommended by the Public Health Service and by the Institute of Medicine…To me, the guilt belongs at the doorstep of the commissioner of the Food and Drug Administration. Whoever is sitting in that job can this minute solve the problem for the whole country by changing one thing: The concentration of folic acid required in enriched cereal grains should be about 700 mcg, or five times what it currently is… due to human stupidity, roadblocks are set up…It is nutritional policy from prehistoric times that is keeping this important fortification from taking place… the policy on folic acid is a flaming failure leading to an epidemic of birth defects we don't need to have… the Institute [of Medicine] provided cover for the FDA to add B12 to bread which people over 50 need, and the FDA hasn't moved on that, either.”

The victims of the FDA folic-acid ban?
The children with preventable spina bifida born over the period 1980-1996.

“According to David Satcher, M.D., Ph.D, Director, Centers for Disease Control and Prevention [1990-93], CDC estimates that there are approximately 4,000 pregnancies each year, including 2,500 live births, affected by spina bifida and other neural tube birth defects.”

Even if just 50% of these cases could have been prevented by folic acid, this leaves a toll of 32,000 children afflicted with spina bifida over the 16-year period 1980-1996 which could have been prevented by folic acid fortification of food.

The top officials of the FDA are responsible for more than 32,000 cases of nutritionally-preventable neural tube defects in unborn children covering a period of sixteen years.

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