Toys and confectionery--a legally hazardous combination?

"What kind of magic has Nestlé worked on FDA?" Many in the confectionery business were asking this very question after seeing the company introduce onto the market in July 1997 - without any immediate agency intervention - a chocolate product surrounding an inedible plastic sphere enclosing a toy, bearing the moniker Nestlé Magic(R). A spate of recent publicity 1 on the controversy engendered by the new product has focused public attention on a little-known provision of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically section 402(d)(1). Adding fuel to the proverbial regulatory fire was the Food and Drug Administration's (FDA's) signaling of a possible reversal of its long-standing policy prohibiting the marketing of combination "confectionery and toy" products that contain nonfunctional, nonnutritive objects. After the product was launched, FDA, in response to a petition filed by Nestlé USA, stated its intention to 1) issue a guidance document that would purport to sanction such products on an interim basis, and 2) promulgate a regulation setting safety standards for such products and thereby authorize their marketing. Although Nestlé subsequently announced its withdrawal of the product,2 questions remain about the applicable law and FDA's authority. This article critically examines the agency's authority to authorize marketing of such products through a regulation that addresses the criteria set forth in section 402(d)(1).