Diet Pill Makers Fined by FTC, Not FDA

This journal has no problem with grown-ups taking any kind of drug for medicinal or recreational reasons. The former is often a miracle of human technology, while the latter is stupid, but it does society too much damage to prohibit it. However, when a pill manufacturer fails to disclose what it knows or when it tells lies about its product’s efficacy, it is engaged in fraud, and it deserves to be punished. The Federal Trade Commission has just fined four companies that make “diet” pills for making claims “not supported by competent and reliable scientific evidence.” It’s about time.

The makers of Xenadrine EFX, CortiSlim, TrimSpa and One-A-Day WeightSmart will pay a combined total of $25 million. That’s peanuts since Americans are going to pay over $1 billion to stop being so damn fat this year (Hint: spend less on food). It would be one thing if these and similar products could be shown to work. However, there isn’t any evidence that they do.

More damaging is the widespread belief among widespread Americans that the Food and Drug Administration has tested food supplements. Two-thirds of Americans think that the FDA has OKed these things when in fact, the FDA is prohibited by law (and a very bad law it is) from testing “herbal supplements” unless they are suspected of actually making people ill. This is a far cry from what a “drug” has to go through to make it to market; “drug” here meaning anything other than a device “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”

In order for a new drug to get FDA approval, a substance has to go through as many as four distinct phases. The FDA explains on its website: “Phase 1 trials include the initial introduction of an investigational new drug into humans . . . . Phase 2 trials include controlled clinical studies conducted to evaluate the drugs effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug . . . . Phase 3 trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide an adequate basis for physician labeling . . . . Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (Phase 4) studies to delineate additional information about the drug’s risks, benefits, and optimal use.”

The flawed legislation that lets diet supplements avoid this is the Dietary Supplement Health and Education Act of 1994 (DSHEA). The truth is that the FDA doesn’t have the resources to ensure that everything Americans put into their bodies is safe, let alone effective. That the FTC has levied these fines is telling. Of course, if one wants drugs that are safe, food supplements that can prove they do what their makers claim, and food that is fit for human consumption, one is going to have to pay for it. Taxes, in other words.

© Copyright 2007 by The Kensington Review, Jeff Myhre, PhD, Editor. No part of this publication may be reproduced without written consent. Produced using Fedora Linux.

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