In " `Vitamin War' has gotten out of hand" (Oct. 5), you justified FDA's role in attempting to expand its regulation of dietary supplements in order to protect consumers and reassured the public that FDA isn't going to take away its Flintstones.
What FDA says it is going to do and what FDA is proposing in its regulations and task force report are not always the same.Although FDA says it does not intend to limit vitamin potencies or remove products from the market, it proposes in its regulations that when "vitamins are intended to be consumed at those levels (which it defines as "far above those normally characteristic of food") . . . they are drugs and not foods."
In addition to limiting potency on vitamins, FDA will "regulate single amino acids and mixtures of amino acids as drugs." The task force report says that FDA also intends to regulate herbs as food additives now and "continue to bring actions against those substances that are represented for use as drugs" (i.e., almost all herbs, according to their health claims statement which identifies them as drugs).
FDA says that all it wants is for health claims to be proved. But it neglects to say that because of preconditions for filing applications, it would be almost impossible for herbs, amino acids and many other supplements to even submit an application for obtaining approval for a health claim.
Even when applications for health claims are accepted, evidence of FDA's reluctance to approve them is reflected in the fact that out of thousands of dietary supplements, only one supplement/disease link has ever been approved by the FDA, and that is calcium and osteoporosis. Recently, under pressure, FDA proposes to allow the folic acid/neural tube defects link.
FDA already has all the power it needs to act against companies that make false and misleading claims about products. It also has sufficient authority already to remove any product from the market that is unsafe.
Many of us who consume dietary supplements are concerned about the unnecessary power that the current proposed regulations would give the FDA unless legislation sponsored by Sen. Orrin Hatch is passed.
Rae Howard
Orem