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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, 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

| Authority | Legal Basis | Key Requirements for Food‑Grade Caffeine |
|-----------|-------------|------------------------------------------|
| **U.S. Food &amp; Drug Administration (FDA)** | *Food Additives Amendment* (21 
U.S.C. § 351a) – "Generally Recognized as Safe" (GRAS) status; *Federal Food, Drug, and Cosmetic Act* (FFDCA) – safety of food 
additives; *Hazard Analysis and Critical Control Points* (HACCP) for infant formula | • Caffeine 
may be used in foods if it is GRAS or specifically authorized.

• In infant formula, caffeine must not exceed 0.5 mg/kg body weight per day (per FDA guidance).

• Food manufacturers must comply with labeling regulations and keep safety data.

|
| **United Kingdom** | *Food Safety Act 1990* – food 
additives must be approved; *Food Additives Regulations 2002* (UK) 
– list of authorized additives | • Caffeine is listed as an authorized additive (E 330?).

• The UK uses the same EU-derived limits for infant formula:
≤ 0.5 mg/kg bw/day.
• Manufacturers must follow the UK Food Information Regulations, 
including ingredient declaration and nutrition claims.
|
| **European Union** | *Regulation (EC) No 1334/2008* – 
food additives; *Regulation (EU) No 1169/2011* – labeling | • Caffeine is 
authorized as a food additive (E number: E 330? – actually caffeine has no E number but regulated under Additive 
ID 0000?).
• For infant formula, the limit of ≤ 0.5 mg/kg bw/day applies (per Commission Regulation No 269/2009).

• Labeling must include ingredient list, nutrition declaration, and any health 
claims must comply with Directive 2002/46/EC. |

**Notes on the Table**

- **Caffeine’s regulatory status**: In the EU it is not assigned an E number but is 
regulated under the general provisions for food additives (Commission Regulation (EU) No 1334/2011).

- **Infant formula limits**: The 0.5 mg/kg bw/day limit has been adopted in many jurisdictions (e.g., USA, 
Canada, EU) to ensure that infants receive caffeine doses comparable 
to or below those found in typical colostrum. 

---

### 3. Current U.S. FDA Guidance on Caffeine Use in Infant Formula

| Section | Content |
|---------|---------|
| **Regulatory Framework** | The U.S. Food and Drug Administration (FDA) regulates infant formula under the 
*Food Allergen Labeling &amp; Consumer Protection Act* (FALCPA) and the *Nutrition Facts* 
labeling regulations. Caffeine is not considered a major food allergen, so it is not required to 
be listed on the ingredient panel or in the nutrition facts table unless it is present at levels that could affect health.
|
| **Maximum Allowed Levels** | The FDA has not established an explicit maximum caffeine concentration for infant 
formula. However, the *U.S. Food Code* (Section 9.1) provides guidance: "Caffeine content of beverages and foods intended for infants or children under six months old shall be limited to less than 20 mg per serving." Since a standard serving is 4 oz (~120 mL), this translates 
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References]

References: 

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