Legal and regulatory developments of the 1990s in oral care products: learning from what has come before

The development of oral care products has occurred faster than congressional enactments regulating these products. Terms such as "cosmetic, drug, and new drug" are defined. A history of scientific publications and common acceptance by experts is necessary for the FDA to categorize a product as "generally recognized as safe and effective" (GRASE). The FDA classification process of the numerous over-the-counter drugs into a few categories, each of which required a three-part approval process, is not complete. Delays in the FDA's OTC review resulted in an "OTC moratorium," which allows new products to enter the market at the owner's risk. The relative risks and benefits of marketing an oral care product with or without an approved New Drug Application are discussed. Increased resources at the FDA are recommended to expedite fairness to manufacturers and to eliminate inappropriate oral care products from the market.