Reviewed and Approved by Maged Sharaf, Ph.D., Senior Director, Labeling, Cannabis and Claims Consulting Services, EAS Consulting Group, a Certified Group company
1-Minute SummaryFor manufacturers of dietary supplements, a key area that always garners attention is the distinction between supplement facts vs nutrition facts. For quality assurance teams, it is essential to grasp these differences to ensure your product labels are compliant with FDA regulations.
This blog post focuses on the requirements of your supplement facts panel, but also touches on some requirements of nutrition facts panels to help draw distinctions and clear any confusion.
At first glance, both nutrition facts and supplement facts panels might seem similar, but their primary functions and what they represent are distinct.
Nutrition Facts: Found on food products, they detail the nutritional content of the item.
Supplement Facts: Exclusive to dietary supplements; highlight their ingredients, quantities, and other specifics.
Nutrition facts panels are used on food products and include information about the product’s nutritional content.
Supplement facts panels are used on dietary supplements and highlight the product’s ingredients.
When navigating the specifics of a supplements facts panel, there are certain mandatory elements that you must include to ensure you’re meeting regulatory requirements. Let’s walk through each requirement and cite the relevant regulation:
This represents the quantity of the supplement that is recommended for consumption in a single instance. For example, on a vitamin C supplement label, the serving size might be listed as "1 Capsule". 21 CFR 101.36(b)(1)
This information isn’t required when it is the same information as in the net quantity of contents statement. For example, if the net quantity of contents statement is “50 Capsules” and the Serving Size is “1 Capsule”, the Servings Per Container is 50 Capsules and does not need to be listed. 21 CFR 101.36(b)(1)(ii)
This includes:
These ingredients must be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods. 21 CFR 101.36(b)(2)(i)
The percent of the Daily Value of all dietary ingredients declared under 21 CFR 101.36(b)(2)(i) must be listed; no percent of the Daily Value shall be given for subcomponents for which DRVs or RDIs have not been established (e.g., total sugars). 21 CFR 101.36(b)(2)(iii)
You must declare dietary ingredients for which FDA has not established RDIs or DRVs and that are not subject to regulation under 21 CFR 101.36(b)(2). These are referred to as “other dietary ingredients” and shall be declared by their common or usual name when they are present in your product. 21 CFR 101.36(b)(3)(i)
You should end up with a supplement facts panel that looks close to this example provided by FDA:
21 CFR 101.36 includes thousands of words of information that can quickly confuse even seasoned labeling experts, so read the regulations closely and reach out to an expert for help if needed, such as those at EAS Consulting Group.
There are several differences between supplement facts panels and nutrition facts panels. A good starting point when parsing these differences is this list on FDA’s website of 5 major differences between supplement facts panels and nutrition facts panels:
Everything in this industry, it seems, is heavily regulated, and that includes the design elements on the labels in general and on the supplement facts panel specifically.
Nutrition labeling of food is covered under 21 CFR 101.9. For supplements labeling, 21 CFR 101.36 contains regulations for label design elements, such as font size, text justification, and more. Here are a few examples:
There are several more label design requirements throughout 21 CFR 101.36, so read closely. This Labeling Type Size Guide from our regulatory arm, EAS Consulting Group, can help you design compliant labels.
It's also worth noting that advertisements of both foods and dietary supplements are under the jurisdiction of the Federal Trade Commission and, while the FDA sets the baseline, there may be additional state-level regulations that companies must adhere to.
Always ensure you are updated with both federal and local regulatory standards.
As you can see, dietary supplements labeling, as per the guidelines set forth by the U.S. Food and Drug Administration (FDA), is governed by rigorous regulations to ensure consumers are well-informed about what they are consuming.
Understanding FDA regulations helps in:
If you need help, Certified Group Companies have you covered.
EAS Consulting Group can review your dietary supplement labels for compliance.
Certified Laboratories can perform your dietary supplement testing.
Reach out and we’ll be glad to help.