The decision not to classify - a plain violation of the statute - is thus a reviewable decision.

FDA's choice of cheerleader for amalgam, instead of regulator of amalgam, is not acceptable. FDA otherwise bans, limits, and warns against other products, drugs, or foods containing mercury, while other federal health agencies and the health regulators of other nations condemn mercury amalgam.

FDA not only ducks classifying, but also refuses to do an environmental assessment, which would plainly indicate the need for an environmental impact statement. Nor will FDA seek a timely and valid panel recommendation - the previous one being too old (1994), procedurally invalid (no statement for departing from Class III), and sub silentio overruled in September 2006. The writing is on the wall in both cases: An environmental assessment will plainly indicate the need for an environmental impact statement, which report would show alternatives to toxic mercury can be used in fillings, thereby eliminating the major source of mercury in the nation's wastewater - amalgam. In September, the FDA panel decisively rejected the FDA staff's pseudo-science about amalgam (e.g., it is safe because it's been used for a long time), so FDA ducks asking the panel for formal action.

FDA keeps amalgam on the market via a sham substantial equivalence test, pretending that a powder half-device containing no mercury equates to a full device capsule that is 50% toxic mercury. When asked by Senator Kennedy why this practice is allowed, Commissioner Von Eschenbach in writing denied that FDA considers the two devices to be substantially equivalent. Since the staff has ten times approved amalgam under this test in the past six years (and many times before that), perhaps the Center for Devices is engaged in rogue activity unknown to the Commissioner's office.

The correct recourse is not a mere order to classify, allowing an unclassified, unregulated device - with 50% mercury and for which substitute materials are legal and available for any dentist to place - to remain in commerce, but to remove it from commerce temporarily until FDA complies with its legal duties.

CONCLUSION

This Court must direct FDA to start being amalgam's regulator instead of amalgam's cheerleader. Whether by intention or lethargy, FDA's Center for Devices has protected the marketing of mercury fillings by doing none of its regulatory duties - neither classifying nor requiring proof of safety nor doing an environmental assessment nor seeking a valid recommendation from the scientific panel. Since they have ducked and dodged classifying encapsulated amalgam after classifying all other dental filling materials in the 1980s, the mercury apologists at the Center for Devices by now realize that completing any of these tasks will lead straight to the end of mercury in dentistry.

Thus, an order to classify is not enough. The legal prerequisites (environmental impact statement and Panel referral) mean the process will take months; the record of bad faith suggests it will take years. Amalgam is illegally in commerce. It must be removed from commerce forthwith, temporarily, until FDA chooses to complete its regulatory duties.