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Overview

Caffeine (2‑Ribose) is a central nervous system stimulant belonging to the xanthine alkaloid family. It is naturally present in several plants—including coffee beans (Coffea arabica and Coffea robusta), tea leaves (Camellia sinensis), cacao pods (Theobroma cacao), kola nuts (Cola acuminata), and guarana seeds (Paullinia cupana)—and is also manufactured synthetically for use in food, skitterphoto.com beverage, pharmaceutical, and cosmetic products.

In the United States, caffeine is regulated by the Food and Drug Administration (FDA) as a food additive. The FDA has approved its inclusion in over‑the‑counter medications such as analgesics and cold preparations, provided it is labeled as an active ingredient. In addition, caffeine is permitted as a sweetener substitute in some beverage categories, subject to specific labeling requirements.

The following sections provide an overview of the regulatory framework governing caffeine’s use, key legal references, guidance documents, and enforcement actions relevant to food‑grade caffeine in the U.S.

1. Federal Regulatory Landscape