Table of Contents
FDA Consumer magazine
May-June 2000

Letters to the Editor

To the editor:

It was improper and unprecedented for the article to suggest that individual FDA reviewers were "never" satisfied with the accuracy and efficacy data for a device cleared by FDA, in this case, one of Futrex's body fat analyzers. We submitted substantial performance data to support our application to market the device. Based on these data, FDA found that Futrex's body fat analyzer met the statutory standard: substantial equivalence to legally marketed devices designed to estimate body fat. All body fat analyzers cleared by FDA met the same legal standard, which we did, and there is no excuse for singling out our device for criticism.

In fact, FDA has cleared both Futrex's F-5000 and F-6100 body fat analyzers. FDA's approval of Futrex's devices--not the opinion of individual reviewers--is all that is relevant. Notwithstanding the misimpression created by the article, none of the government charges referred to in the article had anything to do with the quality of our body fat analyzers.

Futrex distributes the only body fat analyzer using near-infrared light to estimate body fat percentage, a technology we believe superior to competitors' bioimpedance technology. Moreover, we have notified FDA that our leading competitors' products are currently being marketed without FDA clearance.

The article also repeated a former, disgruntled Futrex employee's allegations that data had been "fabricated." As the article acknowledges, these allegations were not substantiated. No data were fabricated. I strongly object to FDA's dredging up old, inaccurate allegations in the article. Moreover, since the devices have been cleared by FDA, independent researchers have shown that our body fat analyzers meet the "gold standard." For more information about our devices, see www.futrex.com.

Our company's most important new product is a non-invasive blood glucose meter, mentioned in the last paragraph of the article. It is currently undergoing clinical trials. Despite our belief that FDA has treated and is treating Futrex unfairly, for the sake of the 16 million Americans with diabetes, we pray that FDA will consider these clinical trials based on their scientific merits.

Sincerely,

Robert D. Rosenthal,
President, Futrex, Inc.

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