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A Vitamin D lable that FDA would not approve

The Dietary Supplement Label the FDA Doesn’t Want You To See By Bill Sardi Nov 24, 2011


Clips from the article

Example of drugs which rarely work

"An example would be statin cholesterol-lowering drugs that only avert a non-mortal heart attack in 1 of 71 high-risk subjects over a 5-year period of time.
There is an even more remote chance statin drugs will save lives when used among healthy adults who have no risk factors for heart disease."

Drugs and Supplements which work virtually all of the time

"In the era prior to controlled studies, drugs like insulin, penicillin, aspirin, digitalis, sulfa drugs and many vaccines came into common use
because it was obvious they worked in nearly all subjects.

The same is true for vitamins.
Except for those individuals with absorption or transport problems,

  • vitamin C cured scurvy every time;
  • vitamin D cured rickets nearly every time;
  • thiamin (vitamin B1) cured beri beri every time;
  • vitamin B12 cured pernicious anemia every time. "

However, a provision in the Dietary Supplement Health & Education Act (DSHEA) of 1994 states that dietary supplements can, in fact, make disease/cure claims for frank nutrient deficiency diseases, such as scurvy (vitamin C), rickets (vitamin D), beri beri (vitamin B1), or pernicious anemia (vitamin B12).

However, the FDA effectively negates the freedom to make disease/cure claims for dietary deficiency diseases by clarifying this law on its own terms.
The FDA says any health claims that dietary supplements prevent, treat or cure disease have to be made in the context of what are called structure and function claims.
That is, what structure or function in the body does a particular nutrient address?
A dietary supplement manufacturer can’t really mention a disease, like scurvy, beri beri, pellagra or rickets, is "cured" by a dietary ingredient.

The assumption here is that nutrients are like drugs and are intended to target a disease in a specific location of the body, like gastric ulcers or skin infections.

Natural molecules have broad effects upon the entire body and defy such a narrow description.

The drug industry in the same article


A Vitamin D lable that FDA would not approve        
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