Caffeine is a substance that is consumed all over the USA regardless of age. The current regulation is so relaxed on caffeine intake that many Americans do not even know how much is safe. In the European Union (EU), the Health Claims Regulation requires approval before any caffeine-related health claims are made. Caffeine health claims were positively appraised by the EFSA, but these claims were blocked from being officially authorized by the Parliament. [1]

Regulatory Limits on Caffeine in Functional Beverage: USA vs European Regulations

Regulation, April 23, 2025

Caffeine is a substance that is consumed all over the USA regardless of age. The current regulation is so relaxed on caffeine intake that many Americans do not even know how much is safe. In the European Union (EU), the Health Claims Regulation requires approval before any caffeine-related health claims are made. Caffeine health claims were positively appraised by the EFSA, but these claims were blocked from being officially authorized by the Parliament. [1]

Regulators are concerned about the rapidly growing categories, such as energy drinks, nootropics, and sports drinks, that all tend to have increased caffeine content. Caffeine, known as a stimulant, enhances performance and wakes people up; yet the increasing consumption of caffeine among children and adolescents has drawn the attention of regulators in the U.S. and EU for potential health hazards. [2]

Caffeine Regulation in the United States (U.S) (FDA Guidelines)

Caffeine is recognized by the Food and Drug Administration (FDA) in the United States as Generally Recognized as Safe (GRAS) when consumed in moderation. However, the caffeine content of products marketed for the younger population is now coming under the regulatory microscope.

Summary of the Regulations Pertaining to Caffeine in the U.S.:

Caffeine added to food is subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). 11
Caffeine Status: The FDA recognizes caffeine as a GRAS substance, meaning it is considered safe for consumption, when it is used properly.
Recommended Safe Limit: The FDA recommends that healthy adults should reduce their caffeine intake to 400 mg/day, which is approximately the amount contained in 4 cups of coffee, per day (Two to three 12-fluid ounce cups of coffee).
According to 21 CFR 182.1180, caffeine is considered generally recognized as safe (GRAS) when used in cola-type beverages at levels up to 0.02% (or 200 parts per million), as long as it’s used in line with current good manufacturing practices (cGMPs).

Limit in Beverages: There is no generally codified limit on the amount of caffeine in individual beverages, and caffeine levels are generally self-regulated by manufacturers themselves. However, products containing high levels of caffeine must be obeying labeling requirements.
Labeling Requirements: Caffeine is not required on labeling unless it has been added as such (i.e., sodas or energy drinks).
Effects in Children and Adolescents: Although there is no federal limit from the FDA on caffeine consumption by children and adolescents, it is not recommended, and voluntary warning messages tend to be added in the packaging which is to inform consumers of potential risks.
Caffeine Content Examples: Energy drinks contain caffeine within a general range of about 80-300 mg per serving, depending on brand and product type.
The term “energy drink” was created by the food industry to describe certain types of beverages. Typically, these drinks contain anywhere from 54 to 328 milligrams of caffeine per 16 fluid ounces, though some brands have between 41 to 246 milligrams per 12 fluid ounces.
In most energy drinks sold in the U.S., the total amount of caffeine from all sources — including ingredients like guarana, which naturally contains caffeine — is usually listed on the label.
As for regulation, the FDA doesn’t have any rules made specifically for energy drinks. Instead, these products must follow the general safety regulations that apply to all food and beverage ingredients.

In the last couple of years, much discussion has centered on products with high caffeine content, notably energy drinks, which are attacked for being marketed to minors. In July 2023, U.S. Senator Chuck Schumer called for the investigation by the FDA into Prime Energy Drink due to high caffeine content and potential appeal of the product to children. [3] [4]

Table 1: Types of Caffeine-Containing Products and Their Labeling Rules

Product Category	Examples	Must Say It Has Caffeine?	Must Say How Much Caffeine?	Caffeine Limit?
Sodas with added caffeine (regular food)	Coca-Cola	✅ Yes	❌ No	✅ Yes
Drinks & foods with caffeine naturally in them (regular food)	Coffee, Tea, Coffee Ice Cream, Chocolate, Cracker Jack’d	❌ No	❌ No	❌ No
Foods with added caffeine (regular food)	Jelly Belly “Extreme Sport Beans”, Perky Jerky, Wrigley’s Alert Energy Gum	✅ Yes	❌ No	❌ No
Energy drinks labeled as dietary supplements	5-Hour Energy	✅ Yes (but may be hidden in an ingredient blend)	❌ No	❌ No
Over-the-counter drugs	NoDoz

Caffeine Regulation in the European Union (EFSA Guidelines)

Caffeine, classified as a stimulant, is treated with stringent standards in the European Union with safety limits within which it can be used in foods and beverages.

Some Essential Aspects Relating to Caffeine Control in the EU:

Caffeine Status: It is governed by the EFSA and is treated as a stimulant, which regulates its use in food and beverages.
Safe Limit: The EFSA defined 200 mg as an upper limit in a single dose, while 400 mg is an upper limit daily value in a healthy adult.
Limit for Beverages: No limit has been set on caffeine content in beverages, but there are labeling requirements for caffeine levels exceeding certain thresholds.

Labeling Requirements: Beverages with more than 150 mg/L caffeine must contain the warning: “High caffeine content. Not recommended for children, pregnant or breastfeeding women.” Energy drinks and similar beverages are included within this labeling sphere.
Children and Adolescents: According to EFSA advice, caffeine intake for children should not exceed 3 mg/kg of body weight per day, while the limit is 100 mg/day or about one energy drink for adolescents.
Health and Safety Considerations: EFSA recommends the limited consumption of caffeine-containing drinks; manufacturers should pay attention to the possible health hazards of excessive consumption, especially among susceptible groups like children, adolescents, and pregnant women. [5] [6]

Recent Developments and Actions in the EU

In November 2024, Czech government Proposed a ban on sale of high-dose caffeine energy drinks to the individuals under the age of 15. According to the Czech government, the use of those drinks for children is linked to obesity, high blood pressure and tooth decay-troubles, among others. In addition, those were expected to ensure that children do not have excessive consumption in sugary and high-caffeine drinks.

Restricting Proposed Czech Proposals: The Czech government plans to put a stop on health problems that arise from the use of energy drinks among minors. It is the bill now before the legislature for comments to protect the youth from health effects of too much caffeine consumption.

It Declared as “Harmful to Humans When Swallowed” Caffeine in the new classification Chemical Safety Guidelines Announced by the EU at the Beginning of 2025. The Main Reason for Classifying Caffeine Under this Area Was to Use that as a Pesticide. However, this classification raised eyebrows about the future restriction of the amount of caffeine in food and beverages.

Health and Safety Concerns Around Caffeine Consumption

Heart Problems: Increased heart rates, palpitations, and arrhythmias (irregular heartbeat).
Psychiatric Effects: Anxiety, nervous feelings, and sleep disturbances.
Physical Effects: Weight gain due to overdoses on sugar, very high blood pressures, and dehydration.
Addiction: Dependence and withdrawal symptoms in caffeine among regular users, especially in younger populations.

The FDA and EFSA have both expressed a growing concern regarding those risks and have urged manufacturers to exercise caution in marketing caffeinated products to younger populations. [7] [8]

Differences Between U.S. and EU Regulations

While both the U.S. and the EU focus on consumer safety, there are several key differences in their regulatory approaches to caffeine in functional beverages. [9]

Aspect	United States	European Union
Regulatory Authority	FDA (Food and Drug Administration)	EFSA (European Food Safety Authority)
Caffeine Status	GRAS (Generally Recognized as Safe)	Classified as a stimulant
Daily Limit for Adults	Up to 400 mg per day	Up to 400 mg per day
Daily Limit for Children	No federal limit, but discouraged	Max 3 mg/kg body weight per day
Mandatory Labeling	Not required unless caffeine is added separately	Required for caffeine > 150 mg/L: “High caffeine content” warning
Sale Restrictions	No restrictions for minors	Bans or restrictions in countries like Czech Republic and Poland
Health Claims	Must be substantiated with evidence	Regulated, with specific conditions for health claims
Legal Consequences	Post-market surveillance and consumer complaints	Mandatory recall and fines for non-compliance

Concerns and Manufacturer Compliance

Health Risks: Caffeine consumption in excess can pose serious health risks, especially to children and adolescents, as declared by both the FDA and EFSA. The organizations encourage the setting of limits on caffeine level in foods consumed by younger people.
Manufacturer Responsibilities: Manufacturers of beverages are expected to be vigilant and able to cope with changing regulations to ensure safe limits and labeling on their products in the local area. Caffeine in the U.S. is regarded as GRAS, though companies are encouraged to label caution for transparency. However, in comparison, the EU will have stricter regulations where there will be a mandatory warning label on energy drinks that contain high caffeine concentrations. [10]

Conclusion and Future Outlook

Caffeine regulation in functional beverages is evolving faster than ever and so must the manufacturers keep up with these changes. The first consideration focuses on:

Compliance with Regulations: Products should comply with caffeine content, labeling, and health claims whether made in the U.S. or EU.
Consumer Awareness: Labels must be clear and informative, especially for products targeted at young consumers.
Product Innovation: Consider working with products at lower levels of caffeine while maintaining effectiveness.

A growing emphasis on caffeine regulation reflects a proliferation of concerns regarding consumer health and safety. These ever-changing regulatory frameworks will continue to be modified as scientific evidence and public health trends develop. Collaboration with the Food Research Lab, which provides the development of safer and more innovative formulations and helps to understand regulatory challenges in the nutraceutical and functional beverage industry, will be beneficial for manufacturers.