Caffeine Products: Guide to FDA Regulations

Caffeine is a stimulant many consumers in the U.S. incorporate into their daily lives. Coffee and tea are among the most popular caffeine sources, as are energy drinks and carbonated soft drinks. Though caffeine is considered safe for most adults in moderate amounts, excessive amounts of caffeine consumed in a short period of time can be dangerous, and even toxic.

The U.S. Food and Drug Administration (FDA) regulates many products that contain caffeine, including beverages, food, supplements and over-the-counter (OTC) drugs. FDA caffeine regulations differ based on the type of product being marketed.

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Read on for more information about FDA’s regulation of products containing caffeine.

Is Caffeine Regulated By FDA? 

The heart of the issue lies in how FDA regulates substances added to food, beverages, supplements and drugs. For conventional foods and beverages, FDA must approve ingredients as “food additives” or be “generally recognized as safe” (GRAS).

FDA affirms some substances as GRAS, but allows qualified experts to establish a GRAS status without FDA administrative action. Therefore a company may make its own determination that their use of caffeine is GRAS. FDA has only affirmed the use of caffeine at a tolerance level of 0.02 percent in cola-type beverages.

The dietary ingredients found in supplements are exempted from food additive/GRAS regulation. However, they are subject to the “new dietary ingredient (NDI)” notification requirement if they were not on the marketplace before October 1994. Caffeine has appeared on lists of “old” dietary ingredients and companies can include them in supplements without the NDI notification.

As an over-the-counter (OTC) drug, caffeine is subject to FDA’s OTC Drug Review, which establishes conditions of use for hundreds of active ingredients. These active ingredients are the subject of “monographs” that specify precise dosages and acceptable intended uses for many drug categories.

FDA has published a final monograph for caffeine as an OTC stimulant (soon to be published as a “deemed final order”) that allows companies to market these products with no further review or approval from the agency.

FDA Caffeine Regulations for Labels

So how would a consumer know exactly how much caffeine they are consuming?  If being taken as an OTC stimulant drug, the answer is right on the box. FDA’s drug labeling requirements include a “Drug Facts” panel that provides the exact amount in each dose of the drug. The Drug Facts panel also includes directions for safe use and applicable warning statements mandated by FDA.

For a conventional food/beverage or supplement, the answer might not be so clear. If directly added to a food or beverage (such as an energy drink or soda) as an ingredient, caffeine will be included in the label’s ingredients list. However, no regulation specifies that the actual amount must be declared.

Further clouding the issue, the presence of caffeine may not be disclosed present due to the incorporation of other ingredients. A product containing ingredients such as coffee, tea, or guarana will not list caffeine in the ingredients. If not referenced elsewhere on the label, a consumer would have to know these ingredients inherently contain caffeine.

The mandatory “Supplement Facts” panel often lists the caffeine amount alongside the declaration of caffeine as a dietary ingredient. However, similar to the scenario described above, caffeine could be omitted from the label if present as a constituent of another ingredient.

It’s important to note however, that these other ingredients such as tea are further regulated by the Preventive Controls rule under the Food Safety Modernization Act (FSMA).

FDA Response to Highly Concentrated Caffeine Products

On April 13, 2018, FDA released a guidance on highly concentrated caffeine in dietary supplements. The guidance was intended for firms that manufacture, market, or distribute dietary supplements containing pure or highly concentrated caffeine, or are considering doing so. The guidance provided information about the circumstances under which FDA considers a product containing highly concentrated caffeine to be adulterated.

The guidance explains that, for both powdered and liquid products containing pure or highly concentrated caffeine, consumers are required to accurately measure the amount the package indicates as a serving size.

While FDA may consider the serving size of such products to be safe, the guidance notes that a consumer could inaccurately measure the product, easily leading to consumption of a lethal amount of caffeine. FDA does not consider a warning label on these products to be sufficient to make the products safe.

Although FDA caffeine regulations don’t specify a limit for caffeine in food, FDA has penalized companies for distributing products that contain a potentially dangerous amount of caffeine. Since 2015, FDA has issued several Warning Letters to firms distributing dietary supplements that contain pure and highly concentrated caffeine.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at, or chat with a Regulatory Advisor 24-hours a day at

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