Supplement vs. Nutrition Facts Panels
Does Your Beverage Need a Supplement Facts Panel or Nutrition Facts Panel?
The short answer is, it’s complicated. As beverages venture further into the functional realm, the line between beverage and supplement can become more challenging to navigate. Although no pre-approval is required to market your product as a beverage or supplement, failing to understand the FDA’s definitions and distinctions can open your beverage or supplement company to costly legal and compliance risks.
Products classified as a beverage will have a Nutrition Facts Panel (NFP) that contains the nutritional information of a product and is required on most packaged food in many countries. If a product is classified as a supplement, it will display a Supplement Facts Panel that appears similar but differs in several ways when it comes to what can be listed and how it appears on the label.
A product’s name, ingredients, packaging, serving sizes, marketing claims, and label can lead to your product being classified as a liquid supplement. The FDA appears to be holding firm on the guidelines they’ve laid out for the naming, labeling, manufacturing, and marketing of supplements vs. beverages. Here are some of the important distinctions to be aware of as you position your product.
Ingredients in a product positioned as a beverage must be approved food additives or generally accepted as safe (GRAS). The U.S. Food and Drug Administration (FDA) maintains a list of Substances Affirmed as GRAS in Food as stated in the Federal Food, Drug, and Cosmetic Act. If a beverage company wants to use an ingredient that is not GRAS or intends to use an ingredient outside the scope of GRAS regulation, they must make a “self-affirmed” GRAS determination for the ingredient specific to the amount used and for the specific purpose intended. These reports are extensive and usually expensive to assemble.
In contrast, the ingredients in a dietary supplement must be dietary ingredients as defined by the Federal Food, Drug, and Cosmetic Act. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Under existing law, the FDA can remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).
In May 2022, the FDA issued a warning letter to Complete Nutrition for including 5-alpha-hydroxy-laxogenin as a dietary ingredient in one of their products, even though it is not a dietary ingredient under Section 201(ff)(1) of the FD&C Act, nor is it GRAS under the conditions for use of the product.
Although the regulations regarding ingredients may be stricter for beverages, manufacturing regulations are more stringent for supplements. Food, beverage, and dietary supplement manufacturers in the United States follow the FDA’s Good Manufacturing Practices (GMPs) – or Current Good Manufacturing Practices (CGMPs) that govern the design, monitoring, and control of manufacturing processes and facilities.
Since June 2007, a different set of CGMPs has applied to dietary supplement manufacturers, with additional supporting guidance issued in 2010. FDA Regulation 21 CFR Part 111 for supplement markers requires certain activities to ensure a dietary supplement contains what’s labeled and doesn’t include harmful or undesirable substances such as pesticides, heavy metals, or other impurities. It also requires activities to ensure the identity, purity, quality, strength, and composition of dietary supplements.
Many regulations and guidelines surround the types of claims that are allowed on a product and how those claims can be made. One major difference between supplements and beverages comes into play when looking at structure-function claims.
Dietary supplement products are allowed to make structure-function claims like, “calcium builds strong bones,” or “fiber maintains bowel regularity.” Still the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification of the claim to the FDA no later than 30 days after marketing the dietary supplement with the claim.
Structure-function statements for beverages must be limited to statements regarding taste, aroma, or nutritive value. Beverage manufacturers do not need to notify the FDA about their structure/function claims, and disclaimers are not required.
More cases are emerging in which beverage companies are alleged to be overstating or misstating the health benefits of a product or lacking sufficient scientific substantiation for claims. Unsubstantiated claims are an area that has been addressed as a regulatory issue by the FDA and Federal Trade Commission. Recently, consumer class action lawyers and competitors are also suing companies for allegedly exaggerating health benefits or failing to substantiate claims. Before making any claim on your product, whether it’s a beverage or a supplement, it’s important to review and understand all of the rules and regulations for each of the three categories of claims: health claims, nutrient content claims, and structure/function claims.
There are several major differences between the Nutrition Facts Panel displayed on a beverage and a Supplement Facts Panel that appears on a supplement. Here are some of the ways the labels differ:
- A Nutrition Facts Panel must list certain nutrients, regardless of the amounts, whereas, on a Supplement Facts Panel, nutrients in zero amounts are not allowed to be listed on the label.
- A Nutrition Facts Panel lists only nutrients, vitamins, and minerals, whereas on a Supplement Facts Panel, all ingredients with nutritive value are listed.
- A dietary supplement disclaimer must appear on any dietary supplement label on which structure-function claims are made.
Marketing and Advertising
The area that is probably the most confusing for brands is the marketing and advertising practices that may cause a product to be deemed a beverage instead of a supplement or vice versa. Marketing includes labels, advertisements, social media, or promotional activities.
The FDA issued guidance in 2014 to help beverage and dietary supplement companies determine if they are correctly classifying their products. Some of the factors listed include serving size, recommended use, packaging, and the use of terms associated with beverages. For example, the use of product or brand names that use terms such as “beverage,” “drink,” “water,” “juice,” or similar terms could indicate a beverage and not a supplement product.
Examples of marketing practices that may signal to the FDA that a product is a beverage and not a supplement include promotional activities that favorably compare the product to a category of beverages, or that market the product based on typical beverage criteria, like taste and refreshment.
The FDA’s main area of concern seems to relate to companies confusing consumers by switching between the two categories with one product. For example, if a product uses a Supplements Facts Panel and then markets or represents it as a beverage, the FDA may intervene.
In 2012, the FDA issued a warning letter to Rockstar Inc., stating that the “Rockstar Roasted Coffee & Energy” products that were being marketed as supplements should be classified as beverages. The letter cited various factors like the product name, packaging and appearance, and statements made by the company about the products using the word “beverage.” Because the products also contained Ginko, an unapproved food and beverage additive that had not been generally recognized as safe (GRAS), the product line was deemed to be an “adulterated” beverage.
A similar letter was issued to Revolt Distribution for its Slowative Relaxation Drink, which was also determined to be marketed as a beverage while being labeled a dietary supplement. A key ingredient in the product, melatonin, is only allowed to be sold in supplement form, so the product was also determined to be “adulterated.”
Pick A Lane
The overarching guidance is to choose one category, know the rules, and follow them. Understanding your target market will help you reach the goals you have for your brand. Where do you envision your product to be in a supermarket, who is your intended consumer, what competition do you have? If you’re going to be a supplement, create, label, and market a supplement. If you are going to be a beverage, make sure your label and claims follow food and beverage guidelines. When in doubt, consult an experienced regulatory consultant or lawyer.
The FDA will ultimately determine whether a product should be classified as a supplement or a beverage on a case-by-case basis. The companies that understand the guidelines and build their products and strategies accordingly will mitigate the risks and costs associated with being out of compliance with the laws administered by the FDA.
Quick Reference Guide
|Ingredients must be dietary ingredients as defined by the Federal Food, Drug, and Cosmetic Act
Must be GRAS and are limited to “mandatory nutrients” and a limited number of “voluntary” vitamins and minerals.
Required/Mandatory nutrients include total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, total sugars, added sugars, protein, Vitamin D, calcium, iron, and potassium.
|Sources of Dietary Ingredients
May list the source of a dietary ingredient
Example: Hydrolyzed collagen (from bovine hide)
Not required to list source of dietary ingredient if it is listed in the supplement facts panel
Cannot list the source of a dietary ingredient
|Part of Plant
Must include the part of the plant the dietary ingredient is derived from by common or usual name. Listings of botanicals must specify the part of the plant from which the ingredient is derived and include Latin name.
Example: Organic Ashwagandha Extract (Withania Somnifera) (roots and leaves)
Cannot list part of the plant
|Cannot list zero amounts of any nutrients. Must only show ingredients that are present in measurable amounts.
|Must list “zero“ amounts of mandatory nutrients
|Structure Function Claims
May focus on effects derived from non-nutritive and nutritive effects
Example: Calcium builds strong bones
Must submit FDA notification
Must include disclaimer
Must only focus on effects derived from nutritive value.
FDA notification is not required
Disclaimers are not required
|May list only the total amount of the blend
|Must list each ingredient
|Drink, Beverage, Water, etc.
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Editor's Note: This post was originally published in September 2017. It was updated in August 2022 with new examples, insights, and more accurate information.
Disclaimer: The information in this article is intended to convey general information regarding beverage regulations and compliance. It does not constitute legal advice. This is for informational purposes only, and we strongly encourage you to seek independent legal counsel for advice on specific legal issues.