FDA has authority

This is in response to the article (BDN, Oct. 25), “UM specialist testifies about supplements danger,” in which you report Dr. Mary Ellen Camire’s assertion that Vitamin A and iron supplement overdoses can be a health hazard. Your reporter then implies that the proposed FDA rules are necessary for the agency to regulate such hazard.

In point of fact, the FDA already has the authority under Section 402 of the Federal Drug and Cosmetic Act to remove these substances from the marketplace.

Your reporter also quotes FDA Commissioner Kessler, “… just clean up the label. … That’s all we ask. … We’re not talking about denying access.”

In point of fact, the FDA already has the authority under Section 201 and 403 of the same act to seize any product whose labeling is “false or misleading in any particular.” Simply stated, the FDA already has the power it says it needs to protect the safety of those who consume diet supplements.

For the past 40 years the FDA has manifest a strong bias against those consumers who assume some responsibility for their own health care through the use of diet supplements. The proposed FDA regulations would make it illegal for manufacturers or resellers of these products to report ongoing research linking supplements to health care unlesS there is significant scientific agreement of the efficacy of the health claim. A standard that makes some sense if applied to potentially toxic products as synthetic drugs, but not an iota of sense to supplements whose lack of toxicity is a matter of record.

For example, the American Association of Poison Control Centers, which issues annual reports from 1982 to the present, reports only one death caused by an overdose of vitamins. A subsequent review of that person’s case history suggests that the cause of death could have equally well been a drug.

It is probably not productive to ascribe motive to the FDA’s continuing hostility to the growing use of diet supplements. Nor do I attempt to do so. Nonetheless, I believe the FDA must be responsible for its public pronouncements. In that spirit (and without editorial comment) I quote from page 2 of the FDA’s “Dietary Supplements Task Force Final Report”:

“The (FDA) Task Force considered various issues in its deliberations, including … what steps are necessary to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development.” Walter E. Corey Deer Isle