# Caffeine > Source URL: https://additivefacts.com/additives/caffeine > Markdown URL: https://additivefacts.com/additives/caffeine.md **Safety rating:** SAFE **CAS number:** 58-08-2 **Category:** flavoring **FDA GRAS:** no **Adverse events (FDA AERS):** 0 **FDA recalls:** 0 **Last updated:** 2026-04-04 ## Summary Caffeine (CAS 58-08-2) is a naturally occurring alkaloid stimulant found in coffee, tea, and cacao that is also synthetically produced for use as a flavoring agent and adjuvant in food and beverages. It enhances the sensory profile and perceived taste of products while delivering its characteristic stimulant properties. ## Regulatory status | Country | Status | | --- | --- | | United States | approved | | European Union | not_evaluated | | United Kingdom | approved | | Canada | approved | | Australia | approved | | Japan | approved | | South Korea | approved | | Brazil | approved | | China | approved | | India | approved | ## Detailed analysis ## What is Caffeine? Caffeine is a naturally occurring purine alkaloid with the chemical formula C8H10N4O2. While it occurs naturally in plants like coffee beans, tea leaves, and cacao pods, it is also synthetically manufactured for commercial use. In food applications, caffeine serves as both a flavoring agent and flavoring adjuvant, contributing to the characteristic taste profile of beverages and foods while functioning as a stimulant compound. ## Common Uses Caffeine is widely used in the food and beverage industry across numerous products. Coffee and tea beverages are the primary sources of natural caffeine consumption, but it is also added to soft drinks, energy drinks, chocolate products, and some confections. In formulated beverages and foods, caffeine may be derived from natural sources (coffee extract, tea extract) or synthesized chemically. The compound is particularly valued for both its sensory contribution and its recognized physiological effects that consumers actively seek. Caffeine levels in products vary significantly: a cup of coffee typically contains 95-200 mg, a cup of tea contains 25-50 mg, and soft drinks contain 30-40 mg per serving. Energy drinks often contain 80-300 mg per serving. ## Safety Assessment Caffeine has been extensively studied for decades with a substantial body of scientific literature on its safety profile. The FDA has not formally designated caffeine as GRAS (Generally Recognized as Safe) for all food applications, though it has been permitted in cola-type beverages since the early 20th century and appears on the FDA's list of substances permitted in foods. This distinction reflects regulatory history rather than safety concerns, as caffeine has been in widespread use for centuries in traditional beverages. According to FDA records, there have been zero adverse events and zero recalls specifically attributed to caffeine as a food additive, indicating an extensive safety history in food use. The European Food Safety Authority (EFSA) has also evaluated caffeine and established safe consumption levels, particularly for sensitive populations. Moderate caffeine consumption—typically defined as 400 mg per day for healthy adults—has not been associated with adverse health effects in the majority of the population. However, certain individuals may experience sensitivity, including those with anxiety disorders, pregnancy, certain cardiovascular conditions, or caffeine sensitivity. Children and adolescents may experience greater sensitivity to caffeine's effects due to body weight and developmental factors. ## Regulatory Status Caffeine's regulatory status is unique compared to most food additives. Rather than being explicitly approved as a food additive through standard pathways, it exists in a longstanding regulatory category of permitted substances with a history of safe use. It is permitted in cola-type beverages under 21 CFR 182.1180 and appears in FDA guidance documents. The FDA requires that caffeine-containing products bear appropriate labeling when caffeine is added, and some products must include warning statements. Many countries permit caffeine in specified food categories with labeling requirements. The European Union permits caffeine as a food additive (E150a-E150d refer to caramel coloring, with caffeine regulated separately) with mandatory labeling on high-caffeine products. ## Key Studies Decades of epidemiological and clinical research have examined caffeine safety. Large prospective cohort studies have not identified significant health risks from moderate caffeine consumption in the general adult population. Research has characterized caffeine's pharmacokinetics, metabolism, and physiological effects. Studies in sensitive populations, including pregnant women, have informed regulatory guidance on consumption limits. The National Institutes of Health and multiple international health organizations have reviewed caffeine literature and established evidence-based consumption recommendations. ## Brands using Caffeine - Red Bull (24 products) - Dr Pepper (22 products) - Mountain Dew (20 products) - Coca-Cola (19 products) - Pepsi (17 products) - Monster Energy (16 products) - Monster Energy Company (8 products) - Crystal Light (4 products) - PEPSI (4 products) - Ale-8-One Bottling Co (3 products) - Red Bull North America, Inc. (3 products) - Coke (2 products) - Cutting Edge Beverages (2 products) - Dr. Pepper (2 products) - Fanta (2 products) - MONSTER ENERGY (2 products) - Sprite (2 products) - Vital Pharmaceuticals, Inc. (2 products) - Alani Nutrition LLC (1 product) - CLIF BAR (1 product) - Cirkul (1 product) - Clif Bar and Company (1 product) - Coca-Cola USA Operations (1 product) - DR PEPPER (1 product) - Death Wish Coffee Company LLC (1 product) - Fair Oaks Farms Brands, Inc. (1 product) - Glacéau (1 product) - Harmless Harvest Inc. (1 product) - Hydrant, Inc (1 product) - JOLLY RANCHER (1 product) ## Sources - FDA Substances Added to Food (CFSAN) - OpenFDA Adverse Event Reporting System (AERS) - OpenFDA Food Recalls - EFSA OpenFoodTox - EU Food Additive Portal ## Citation Additive Facts. "Caffeine — Safety, regulation, and evidence." https://additivefacts.com/additives/caffeine. Accessed 2026-05-20.