Why is Celsius not approved by the FDA?

December 21, 2025 •

4 min read

According to the FDA, most energy drinks, including Celsius, are regulated as dietary supplements, a category of products that are not required to obtain pre-market approval. This fundamental distinction is the core reason why Celsius is not approved by the FDA, as the agency's regulatory oversight for supplements differs significantly from its requirements for conventional foods and drugs.

Quick Summary

The lack of FDA approval for Celsius stems from its classification as a dietary supplement, which unlike drugs, does not require pre-market approval. Manufacturers are responsible for product safety and labeling, while the FDA provides oversight through post-market monitoring and enforcement actions.

Key Points

No Pre-Market Approval Required: The FDA regulates Celsius as a dietary supplement, a category not required to obtain agency approval before being marketed and sold.
Manufacturer Responsibility: The burden of ensuring product safety and truthful labeling for Celsius, and all dietary supplements, falls on the manufacturer, not the FDA.
Post-Market Surveillance: The FDA monitors the market for safety issues and can issue recalls or take enforcement action against Celsius or other products deemed unsafe or misbranded.
Higher Caffeine Levels Allowed: As a dietary supplement, Celsius is not subject to the same caffeine limits that apply to conventional cola-type beverages, allowing for significantly higher concentrations.
Proprietary Blend Concerns: Ingredients in Celsius may be part of a proprietary blend, which means the exact amounts of each component do not have to be disclosed on the label.
Recent Recalls Demonstrate Oversight: A 2025 factory mix-up incident involving Celsius cans mistakenly filled with alcohol led to an FDA-initiated recall, illustrating the agency's post-market enforcement authority.
Not a 'Banned' Product: The lack of FDA approval does not mean Celsius is banned or unsafe, but rather that it operates under a different set of regulatory rules compared to pharmaceuticals.

Understanding the FDA's Regulatory Framework

The FDA's approach to regulating consumer products is not a one-size-fits-all model. The key to understanding why is Celsius not approved by the FDA lies in its classification. The agency categorizes ingestible products into distinct groups, each with its own set of rules. This includes pharmaceuticals, conventional foods, and dietary supplements. Celsius is explicitly marketed and regulated as a dietary supplement, which is a crucial detail that dictates the entire scope of the FDA's involvement.

Unlike drugs, which must undergo a rigorous approval process involving extensive clinical trials to prove safety and efficacy, dietary supplements do not require this pre-market clearance from the FDA. Instead, the onus is on the manufacturer, Celsius in this case, to ensure their products are safe and that all label claims are truthful and not misleading. The FDA's role shifts to post-market surveillance, where they can take action against unsafe or misbranded products after they are already on shelves. This system creates a very different dynamic of oversight compared to a product that must be 'approved' by the agency before it can be sold.

The Dietary Supplement vs. Conventional Food Distinction

The FDA maintains a clear line between conventional foods and dietary supplements. This difference can be subtle, especially for liquid products like energy drinks, and is determined by a combination of factors including product labeling, packaging, and marketing claims. For instance, a product marketed as a beverage to be enjoyed as part of a meal is a conventional food, while one marketed to supplement the diet and provide a specific physiological effect is a supplement.

Labeling: Dietary supplements feature a 'Supplement Facts' panel, while conventional foods have a 'Nutrition Facts' panel. Celsius, and many other energy drinks, carry the 'Supplement Facts' label, signifying their regulatory classification.
Packaging: The size and design of the packaging can also be a factor. Historically, products in larger, single-serving cans were often viewed as conventional foods, but the lines have blurred over time.
Marketing Claims: Claims like 'enhances performance' or 'boosts metabolism' are typical for supplements, whereas claims for conventional food are more focused on nutritional content.

The Ingredients and FDA Scrutiny

Celsius contains a blend of ingredients, including caffeine, guarana, and a variety of vitamins. While caffeine itself is considered 'generally recognized as safe' (GRAS) by the FDA for certain uses, like in cola beverages, there are no specific limits for it in dietary supplements. This lack of a ceiling for caffeine content has led to concerns, especially regarding potential cardiovascular effects and other side effects at high doses.

Caffeine Levels: The significant caffeine content in Celsius (typically 200mg per can) is well above the limits set for some soft drinks, a fact that has drawn scrutiny. Since supplements don't have the same restrictions, companies can add high levels of stimulants.
Proprietary Blends: Ingredients are often listed in a proprietary blend on the 'Supplement Facts' panel. This allows the company to list ingredients without disclosing the exact quantity of each, which limits transparency for consumers and regulators alike.
Potential for Misbranding: Concerns over misleading claims can lead to regulatory action. In the past, Celsius faced a class-action lawsuit over misbranding related to its 'no preservatives' claim, which was later settled.

Comparison of Celsius Regulation vs. FDA-Approved Drugs


Feature	Celsius (as a Dietary Supplement)	FDA-Approved Drug
Approval Required	No pre-market approval.	Yes, mandatory pre-market approval.
Regulatory Oversight	Primarily post-market enforcement.	Strict pre-market and post-market regulation.
Safety & Efficacy	Manufacturer's responsibility to ensure safety; no requirement to prove efficacy.	Required to submit robust clinical data proving safety and effectiveness for a specific use.
Labeling	'Supplement Facts' panel; can use proprietary blends.	Detailed drug facts label with precise ingredient amounts.
Advertising	Claims must be truthful and not misleading, but less scrutinized pre-market.	Heavily regulated; all claims must be substantiated by clinical evidence.
Ingredient Limits	No specific limits for stimulants like caffeine.	Dosage, formulation, and manufacturing are strictly controlled.

Conclusion: The Nuances of FDA Oversight

Ultimately, the reason why is Celsius not approved by the FDA is rooted in regulatory nuance rather than a direct rejection of the product. The FDA does not 'approve' dietary supplements in the same way it does pharmaceuticals. Celsius and similar products are regulated under a different legal framework, one that places a higher degree of responsibility on the manufacturer. Consumers must be aware of this distinction and understand that 'not approved' does not mean 'unsafe' but instead signals a different level of pre-market regulatory control. The FDA does monitor supplements and can intervene if safety concerns arise, as evidenced by recalls or enforcement actions related to misbranding or contamination. Therefore, consumers should always research ingredients and consult with a healthcare professional, especially when using products with high levels of stimulants or other active compounds.

Recent Events and Continuous Scrutiny

It is important to note that the regulatory landscape is not static. Recent incidents, such as a factory mix-up in 2025 that led to Celsius cans being filled with an alcoholic beverage, prompted an FDA-initiated recall and consumer warning. While this was a product recall and not a condemnation of Celsius itself, it demonstrates the FDA's ongoing oversight role in protecting consumer safety when issues arise in manufacturing and distribution. These events serve as a powerful reminder that even in a post-market regulatory environment, the agency maintains the authority to act when necessary.

An authoritative outbound link for further information on FDA regulation of supplements and food: FDA Regulations and Compliance.

Frequently Asked Questions

No, Celsius is not an FDA-approved product because it is regulated as a dietary supplement. Unlike drugs, dietary supplements are not required to undergo a pre-market approval process by the FDA.

The FDA does not approve energy drinks because they are generally classified and marketed as dietary supplements, not as conventional foods or drugs. This places the responsibility of safety and labeling on the manufacturer, with the FDA overseeing the product after it hits the market.

The main difference is that drugs must prove their safety and effectiveness to the FDA before being sold, a process called pre-market approval. Dietary supplements, like Celsius, do not require this and are instead subject to post-market surveillance.

While the FDA does not approve Celsius, the agency monitors dietary supplements for safety issues. However, the high caffeine content and other stimulants could pose risks, especially for individuals with sensitivities or underlying health conditions. Consumers should research ingredients and consult a doctor if concerned.

The FDA performs post-market surveillance on dietary supplements. It can issue warnings, mandate recalls, and take enforcement action against manufacturers like Celsius if products are found to be unsafe or contain misleading claims.

The 'Supplement Facts' panel indicates that Celsius is regulated as a dietary supplement. This panel, rather than a 'Nutrition Facts' panel found on conventional foods, often lists ingredients within proprietary blends, which allows the company to avoid disclosing the specific quantity of each ingredient.

Yes, in 2025, the FDA issued a consumer warning and recall related to a factory mix-up where some Celsius cans were mistakenly filled with an alcoholic beverage. This demonstrates the FDA's authority to act on safety issues in the market.