February 17, 2000

Futrex Files Law Suit Against the FDA Futrex, Inc. (Gaithersburg, MD), has filed a Civil Action in the United States District Court of the District of Maryland against the FDA. This action follows the recent publication by the Food and Drug Administration ("FDA") of an article entitled "Unapproved Body Fat Tester Fetches Mighty Fine." Futrex alleges that "the article contains numerous inaccurate, malicious and unlawful statements about both Futrex and Futrex's president, Robert Rosenthal. As a result of the article, Futrex and Rosenthal are suffering extensive and irreparable harm to their reputations and their business." Futrex is claiming that in addition to publishing harmful innuendos about Futrex and Rosenthal, the article also contains a strikingly large number of errors of fact. The law suit also alleges that this recent misleading and gratuitously derisive article is only one example of a pattern and practice of FDA abuse leveled at Futrex and Rosenthal that has harmed both plaintiffs. One example cited in the Complaint is that the "FDA improperly delayed action on Futrex 510(k) premarket notification of FUTREX-5000/5000A Body Fat Testers. Futrex had submitted a 510(k) which is intended to give FDA 90 days notice prior to distributing the device in interstate commerce in 1992. However, the FUTREX-5000 devices were not cleared for marketing until December 28, 1995, 1,304 days after Futrex had filed for the FUTREX-5000 and FUTREX-5000A 510(k)s." Similarly, the Complaint alleges "FDA improperly delayed action of Futrex 510(k) Premarket Notification for the FUTREX-6100/XL Body Fat Analyzer" where the company had filed a 510(k) on August 20, 1996. On August 19, 1998 - 729 days after Futrex filed the 510(k), FDA informed Futrex that the agency considered the 510(k) "to be withdrawn". On September 25, 1998 Futrex brought suit against the FDA in this matter. On December 1, 1998, the FDA cleared the 510(k) application for the FUTREX-6100/XL. The FDA never explained why it did not clear the 510(k) until after the law suit had been filed. Another example cited in the Complaint is the FDA's detention of Futrex's DermaView Facial Scanners and its inordinately slow review of Futrex's response to the Notice of Detention. Furthermore, the Complaint notes that although the FDA prosecuted Futrex for selling body fat testers without FDA clearance, other companies' body fat testers have remained on the market without clearance and without FDA enforcement action even though FDA is aware of these unlawful sales. In the suit, Futrex is seeking several remedies including preventing FDA from further dissemination of portions of the article via the FDA web site. It is requesting the court to order the FDA to withdraw portions of the article from the web site as well as to print a full and prominent corrective statement in a future issue of the FDA Consumer Magazine. Moreover, Futrex is seeking the court to order FDA to treat Futrex and Rosenthal like similarly situated regulatory parties. (This court case does not directly involve the Futrex non-invasive blood glucose meter - - - the Dream Beam Analyzer. However, the request to be treated "like similarly situated regulated parties" has a direct bearing on the planned submittal of a marketing application to FDA of the non-invasive blood glucose meter.) # # #

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