FDA labeling regulations for non-alcoholic beverages are confusing and hard to locate as there is tonnes of information spread across various sources.
However, mislabeling a product will result in product recalls and class action lawsuits for the manufacturers.
That's why we've created a detailed guide outlining the key differences between non-alcoholic beverages and liquid dietary supplements. We’ve also compiled a list of essential labeling statements for the former.
Let's get started with the differences between liquid dietary supplements and non-alcoholic beverages.
Marketing conventional beverages as dietary supplements may result in penalties for misbranding a product as their legal definitions are markedly different.
A beverage is a conventional food that eliminates thirst and provides fluids, nutritional value, taste or aroma.
On the other hand, dietary supplements are products that one can't consume as a sole item of a meal or a diet.
To help you avoid instances of misbranding, we’ve listed 7 factors which can be used to determine whether the product is a beverage or a dietary supplement.
The FDA considers statements and graphics on product labels, websites, and social media while evaluating a product's representation and intended use.
For instance, a product having a supplement facts label is still a conventional food if its primary purpose is to “rehydrate” or “refresh” the drinker.
Graphics like vignettes and pictorial serving suggestions also help distinguish beverages and liquid dietary supplements.
If your product has graphics that imply that it's a refreshment, it'll be considered a beverage and not a dietary supplement.
For example, a label having a picture of a person quenching their thirst with your product is representative of a beverage.
Product names representing conventional food terms under a specific category of the Code of Federal Regulations (CFR) can't be termed a "dietary supplement."
Common names representing conventional foods include beverages, drink, water, soda, iced tea, apple cider, etc.
In situations where one can't exclusively associate product names with conventional foods like teas, the FDA evaluates name usage with a broader context.
Packaging conveys whether a product can be used as a beverage or supplement through various characteristics like shape, size, color, design, and similarity of packaging used for beverages.
For instance, a liquid packaged in a pop-top aluminum can with the messaging "cola supplement" implies that the product is a soft drink (beverage) designed for a single serving.
However, a product may be labeled a dietary supplement based on other factors like labeled serving size and *Recommended Daily Intake (RDI) despite having packaging similar to beverages.
* The Recommended Daily Intake or the Reference Daily Intake is the amount of nutrients you must consume to meet 97-98% of nutrient requirements every day.
An individual must consume about 1.2 liters of fluid every day, according to the 2005-2006 National Health and Nutrition Examination Survey.
So, a liquid that must be consumed in quantities that provide a significant part of the daily fluid intake, is a conventional food, even if labeled otherwise.
If the product packaging states or implies that the product provides hydration, it's considered a beverage.
In contrast, recommendations or suggestions to use the product in a manner consistent with other dietary supplements make it a supplement (e.g., one teaspoon twice a day.)
Products having labels, packaging, and advertising materials that compare it to a beverage are considered beverages.
However, simply recommending that a product be taken along with a meal doesn't make it a beverage, as one must also consume dietary supplements with food for the best effects.
And promoting a product as a substitute for a beverage doesn't always make it a beverage.
For instance, a Vitamin-C drink presented as an alternative to orange juice would be a supplement, as the drink is a convenient source of the vitamin and doesn't substitute a beverage that quenches thirst.
Beverages and liquid dietary supplements have overlapping ingredients.
But this overlap doesn't imply that a beverage can be labeled as a dietary supplement simply because it contains certain dietary ingredients.
It must also contain food components related to its health claims and not be a copy of a common beverage with added dietary ingredients.
For example, you can't label your product a "ginkgo supplement" only because it contains a botanical ingredient in a common beverage like kool-aid or non-alcoholic eggnog.
Every label has a Principal Display Panel (PDP) and an Information Panel (IP) to accommodate important labeling information on the product.
The PDP is the most prominent part of the label i.e., it’s the part of the label the consumer will view first when they look at the product.
Most products' PDP is the front portion of the label but some packages have alternate PDPs because of their shape.
Defining the area of a PDP helps calculate the type size of the net quantity of contents. The table below helps you calculate the area according to the container shape.
Note: If your package has more than one PDP, you must print the required label statements on all PDPs.
The panel to the PDP’s right (as observed by an individual facing it) is called the Information Panel (IP).
If this panel is unusable because of packaging design (e.g., folded flaps), then the most distinguished panel to the unusable panel’s right must be used as the IP.
All the packages and containers must include the following label statements on their labels
Placement of Information
The label statements should be on the front panel, PDP, or IP of the label in type sizes no less than 1/16" with an aspect ratio (ratio of width to height) of 3:1.
Your labels must also not contain any obscuring vignette or graphic on your label, and the label’s background color must sufficiently contrast the type color.
The statement of identity of food is the common or usual name of the food and describes the fundamental nature of the food and its purpose as specified by the law.
It's placed on the PDP, parallel to its resting base.
The following FDA regulations will help you come up with an accurate statement of identity for different kinds of beverages.
Beverages containing fruits and vegetable juices in less than 100% concentration must have qualifying terms such as "beverage," "drink," "cocktail," if they contain the term "juice."
For instance, your grape drink must be called "Grape juice drink" or "Diluted grape juice drink," if it contains less than 100% grape juice.
If the beverage consists of a diluted blend of multiple juices, then your product name must include the name of all juices in descending order of predominance.
However, this order will change if the juice must highlight a specific flavor of the fruit.
Let’s say that your beverage contains raspberries, peaches, and apples.
If the drink is raspberry flavored, then your product name would be "raspberry-flavored peach and apple drink," irrespective of the concentration of raspberry.
If your product label represents one or more juices but not all of them, you must indicate that more juices are present.
For example, a beverage made from apples and two other fruits would be called "apple juice blend" or "apple juice in a blend of two other fruits."
The term "dietary supplements" adequately is a valid statement of identity as it describes the nature and purpose of the beverage.
You may also add descriptive terms to lengthen the statement of identity (e.g., Vitamin C supplement) or replace the word "dietary" with other appropriate terms (e.g., Vitamin supplement)
The FDA defines imitation food as a product that contains less nutrition than traditional food.
For instance, a fruit-flavored drink is an imitation of natural fruit juice and your label must clearly mention the fact.
Note: Brand names aren't part of the statement of identity, so you must not make them more prominent than the statement of identity.
Consumers must be able to get in touch with you if they've any queries regarding your product.
That's why it's essential to include the Name and Place of Business along with other ways to contact you. E.g., phone number, QR code, etc.
The name and place of business include details of the manufacturer, packer, or distributor, i.e., the firm name or principal place of business.
If you can't include the address of your firm because the products are manufactured elsewhere, you must add "manufactured by" or "distributed by" in front of the address.
Note: All addresses must be declared in the format" 'street address, city name, state name, and zip code."
The Net Quantity of Contents refers to the volume of beverage that the package or container has and must be expressed accurately using the US Customary system.
Although the net quantity declaration needn’t be preceded with additional terms, you may use “Net Contents” or “Net” to precede it.
The following table lists the acceptable units in which you can express the volume of your beverage:
The type size of your net quantity of contents depends on the PDP area and the following table shows the minimum type sizes according to area.
(Refer to the Principal Display Panel section above to see how to calculate the area of the PDP.)
We've listed the acceptable type sizes in the table below.
Note: Type size of fractions must be one-half the minimum height requirements set for the remaining text.
The Net quantity must appear within the bottom 30% of the PDP, parallel to the container’s resting base.
Express the volume of the liquid in the largest whole unit (quart), and the remaining volume in the next largest whole unit (pints)
For instance, if your beverage is 1 ¾ quarts, the correct declaration would be:
Net contents 56 fluid ounces (1 quart 1 1/2 pints)
You must express liquid measures in the largest whole unit (gallon), and the remaining volume must be expressed in the next largest whole unit (pints and quarts).
Here are examples for a correct net quantity declaration for 2 1/2 gallons
Net contents 2 1/2 gallons
Net contents 2.5 gallons
Net contents 2 gallons 2 quarts
Note: Only common fractions, i.e., ¾, ½, ¼, ⅛, 1/16, and 1/32, must be used in a declaration.
Multi-unit retail packages must have a net quantity declaration outside the package along with the number of units, volume of liquid that each unit holds, and the total content of the multi-unit package in parentheses.
If a beverage label states that it contains juice explicitly or implicitly (through vignettes), it must have a % juice declaration on it. The declaration is compulsory for all beverages, including carbonated and non-carbonated beverages, full-strength juices, diluted juices, etc.
The % Juice is calculated by dividing juice weight and the total weight of the fruits and multiplying it by 100.
The % juice declaration appears on the IP, near the top. You may place it above the product name, brand name, and universal product code.
The type size of % juice declaration mustn't be less than the largest type size on the IP. The type must be bold and visible.
Note: If the package doesn't have an IP, the % Juice Declaration must appear on the PDP of the panel in a type size not less than the size used for the net contents declaration.
You may express the % Juice using the following statements:
“Contains ____ % Juice”
"Contains % of ____ Juice."
If the beverage contains negligible amounts of juice for flavoring purposes, they're not required to bear a % Juice Declaration provided that:
Nutrition labels list the nutrients and the caloric value of the product. All conventional foods (including beverages) must have a nutrition label unless their product is exempt from a declaration.
Every nutrition label must have the following nutrient information:
Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, iron, etc.
Nutrient information must appear on the IP before or after the ingredient listing along with the name and place of business.
It’s usually set parallel to the container’s base but it can also be perpendicular if it doesn't hinder visibility and legibility at the time of purchase.
If the FDA has classified your beverage as a dietary supplement, you must use a Supplement Facts panel instead of a nutrition labeling panel.
A Supplement Facts panel lists dietary ingredients without the Recommended Daily Intake (RDI) or Daily Reference Values (DRVs).
It also allows the source of the dietary ingredient to be listed on the table, while the nutrition label doesn’t allow it.
Check out our FDA labeling guide for dietary supplements to learn more about the supplement facts panel.
The following table shows you how to round off calories and list them on your label.
Ingredients are compounds used to manufacture your beverage. It also includes binders, colors, filler, flavors, and excipients.
The ingredients are listed in descending order of predominance and preceded with the term “ingredients”
Note: If your beverage is a dietary supplement, you must list the source of the dietary ingredients along with the ingredients.
You must place the Ingredient labeling list immediately below the Supplementary Facts or the Nutrient Labeling panel.
The type size mustn't be less than 1/16" and it’s the equivalent of a lowercase “o.”
The following section explains how you must declare flavors, spices, coloring, etc. on your label
You can use the terms "spices," "artificial flavor," or "natural flavor," or use specific, common, or usual names to declare spices, natural flavors, or artificial flavors.
The term “spice & coloring” must be used to list the ingredient if it can also be used for coloring.
E.g., Turmeric and paprika may be listed under "spice and coloring”, as they provide flavor and color.
Use specific or abbreviated names to list certified colors. E.g., "FD&C Red No. 40" or "Red 40."
If the color is not certified, you may list the color using terms like "Artificial Color," "Artificial Color Added," or "Color Added."
List the common or usual name of a preservative followed by the purpose. E.g., Sodium benzoate to help protect flavor.
Mislabeling your beverage as a dietary supplement and not including required label statements on your product label will result in misbranding penalties.
To help you from avoiding an unpleasant scenario, we’ve created a comprehensive guide that’ll not only explain the differences but also explain how to declare required label statements. Try our label management platform to speed up your label design process while meeting all regulatory requirements.
Bonus: Our FREE labeling checklist helps reduce artwork edits and save time by taking away the pressure of numerous reworks, as the checklist acts as a compass for your design team. To download it, jump to the top of the page and enter your details after clicking the FREE checklist button.