These products fall into a *gray* area of regulation. Unlike new drugs, which must be reviewed thoroughly, older ingredients were left on the market with a much less stringent review. In this case, FDA has never reviewed data on the safety and effectiveness of over the counter cough and cold medications in children. In the 1970s, an advisory committee warned FDA about the lack of such data, and advised that companies not be allowed to market them for use in infants or babies. But over time, these products have grown in popularity. The data that has accumulated (while never reviewed formally by FDA) fails to show the products are safe or effective. And companies market them widely for use by infants and babies. Essentially, these products slid under the radar screen. To fix this particular problem, FDA should review these data immediately (something the agency has said it will do). The doctors and medical student who signed the petition are asking FDA to: (1) Provide a public warning that these products have not been shown to be safe or effective; (2) Pursue enforcement action against companies that market for use by children under age 6; (3) Put a warning label on products for older children so that they aren't used for young children. This example does raise some broader questions of FDA policy, which are too much to address here.