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Why The FDA Can't Permit Scientifically Valid Health Claims.
Hint: Nothing is Perfectly Safe

Durk Pearson & Sandy Shaw

The FDA's regulation of health claims for foods and dietary supplements works tolerably well as long as there is little or no scientific evidence for a health effect (for the prevention, treatment, or mitigation of a disease) for a particular food or dietary supplement. The FDA can just deny health claims. When, however, health effects are supported by significant scientific agreement on the evidence, then the FDA has great difficulties, under its present regulatory scheme, for allowing a health claim for an effect, no matter how strongly supported by scientific evidence.

A good example is folic acid to prevent neural tube defects for which scientific evidence is very strong and agreement is universal. The FDA does not argue that folic acid does not reduce the risk of neural tube defects; the FDA agrees that folic acid has this effect. Other public health agencies (U.S. Centers for Disease Control and the U.S. Public Health Service) recommend folic acid supplements to women of childbearing age because of the strong evidence that folic acid reduces the incidence of neural tube defects. However, the FDA has been unable to determine how, under its present regulatory policies, it can permit a truthful health claim for folic acid.

If, even under conditions of the strongest scientific evidence for a health effect of a nutrient, the FDA is unable to permit a truthful nonmisleading health claim, we have to recognize that the FDA health claim approval system is severely defective and needs to be fixed. How can the public benefit from this knowledge if the FDA cannot find a way to permit its dissemination? How can the FDA health claim approvals be said to be based upon scientific evidence, when there is no level of scientific evidence that is enough to assure that the FDA will approve a health claim?

We believe that a central problem with the FDA health claim approval system is that risks are given far greater weight than are benefits, even when benefits are potentially of great magnitude. Nothing is perfectly safe and thus everything entails risks to someone at some dose. Since nothing is entirely safe, folic acid is not perfectly safe for all people at all doses.

The FDA is so twisted into knots over the fact that folic acid supplementation is not perfectly safe, that it is unable to formulate public policy for the dissemination of the facts about folic acid and neural tube defects. In its agonizing over the folic acid health claim issue, the FDA admitted that it did not know how to allow the dissemination of truthful and healthful scientific information about the effects of this nutrient. It never occurs to the FDA that many potentially far more hazardous substances that they have approved as over the counter remedies, which are easily obtained by anyone, are marked with appropriate label warning, thereby preventing the "disaster" that the FDA seems to feat with truthful non misleading health claims for folic acid, vitamin E, vitamin C, beta carotene, and other nutrients.

Further more, the FDA is biased against dietary supplements as a means for increasing the intake of nutrients. The FDA is considering mandatory folic acid fortification of certain foods or food ingredients, such as flour. The problem with this approach, and one the FDA is struggling with, is that all segments of the population will thereby receive the extra folic acid, not just the targeted population of women of childbearing age. Moreover, the dose received will vary enormously from person to person, depending upon how much they eat of the foods or food ingredients with FDA mandated fortification.

The FDA is biased against the use of supplements containing appropriate health informa-tion and warnings, which would be a far more selective method of delivering precise amounts of folic acid to the targeted population. Please see pp 22-27 in our book Freedom Of Informed Choice for an analysis of the problems with mandatory food fortification with folic acid that would be avoided by folic acid supplements. The fact that folic acid supplements might mask the hematologic symptoms of the pernicious anemia of vitamin B-12 deficiency is not generally a problem for women of childbearing age, the targeted population for folic acid supplementation.

Vitamin B-12 deficiency and the pernicious anemia that can result from it is generally a problem of the elderly. Small and safe amounts of vitamin B-12 could be added to folic acid supplements, protecting women of childbearing age who have a vitamin B-12 deficiency and the elderly. We have to ask: Why hasn't the FDA thought of this? Why is it so hard for the FDA to permit truthful nonmisleading health claims? Why does the FDA prefer to expose an entire population to increased levels of a substance in order to deliver that substance to a fraction of the entire population?

The FDA used to claim that dietary supplements were of no value and that those promoting the use of such supplements were quacks. They did not permit health claims for supplements because they didn't think that any health claim was truthful, other than one claiming that a nutrient supplement could eliminate a deficiency of that nutrient (where "adequate" levels are defined by the RDA).

Now, the FDA is having a hard time denying the considerable scientific evidence for significant benefits over risks for supplements such as vitamins C and E and beta carotene (to reduce the incidence of disease, such as cardiovascular disease and certain cancers) and, in the case of women of childbearing age, folic acid to reduce the incidence of neural tube defects. Yet, the FDA appears to be paralyzed when it comes to permitting health claims no matter how strong the evidence.

One can only conclude that their system for health claim approval doesn't work. Small risks or risks to certain people, which can be handled by label warnings, are keeping them from approving health claims with potentially immense benefits, such as markedly reduced incidence of some types of cancer and of cardiovascular disease with antioxidant vitamins and beta carotene.

The FDA Health claim approval system is in great need of reform in order for the FDA to meet the requirements of its charter to protect the health of Americans.

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