In 1994, the Food and Drug Administration (FDA) released the Tentative Final Monograph (TFM) requiring a product’s average reductions to meet the log10 reduction requirements. Later, they changed this to the lower bounds of the 95% confidence intervals. Then they added the 70% responder rates. Both test and control products must meet 70% responder rates, which creates a major obstacle. Now, the common control products cannot meet requirements. The industry has pushed back through the American Cleaning Institute.