FDA Supplement Facts Labeling: What You Need to Know
When creating Supplement Facts panels, manufacturers, formulators, and regulatory teams must follow a special set of FDA requirements. The FDA’s supplement labeling regulations govern which nutrients are listed and when, the sequence of nutrients and ingredients, how the information is formatted, and more.
Here’s a breakdown of what makes a Supplement Facts panel FDA-compliant.
How are Supplements Regulated in the U.S.?
Unlike Nutrition Facts (used for packaged foods and beverages), Supplement Facts (used for vitamins, minerals, botanicals, amino acids, proteins, and pre-/pro-biotics) are governed by different FDA rules, under the Dietary Supplement Health and Education Act (DSHEA) and outlined in 21 CFR § 101.36.
The regulations require that all dietary supplements display nutritional content in a specific format that is unique from food and beverage labels, and the details matter.
What are the Required Elements in a Supplement Facts Panel?
Per 21 CFR § 101.36(b), your Supplement Facts panel should include:
- Serving size information
- Nutrient information - The same nutrients that are either required or voluntarily listed on the Nutrition Facts panel are listed on the Supplement Fact panel only if the amounts “exceed the amounts that can be declared as zero”. The order these nutrients should appear in is different than on the Nutrition Facts panel.
- Other dietary ingredients, which are ingredients that do not have an established RDI/DV, including botanicals, amino acids, and proprietary blends, can be included in the panel.
- Amount per serving of each ingredient and nutrient listed in metric measurements
- % Daily Value (%DV) where established (otherwise, mark with an asterisk)
- Footnote explanation for dietary ingredients without established DVs
- Proper formatting - For example, “Supplement Facts” must span the full width of the panel and be in a type size larger than all other text in the panel
What are the Key Differences Between Supplement Facts and Nutrition Facts Panels?
- Ingredients without established RDI/DVs, such as botanical extracts, are listed in the Supplement Facts, which is not allowed in the Nutrition Facts panel.
- The source of a nutrient can be listed next to or beneath the nutrient, like “Magnesium (as magnesium glycinate)”, in the Supplement Facts panel. This is not permitted in the Nutrition Facts panel. If the source is not listed, it must be included in the ingredient statement.
- Botanical dietary ingredients must include the part of the plant from which the ingredient is derived, regardless of whether they are listed in the ingredient statement or in the Supplement Facts panel.
- “Proprietary Blends” of ingredients can be included on the Supplement Facts panel. The total amount of the blend per serving should be included, and all individual ingredients in the blend should be listed in descending order by weight.
- In the Supplement Facts panel, nutrients that are not present or are present with “amounts that can be declared as zero” can not be listed. On the Nutrition Facts panel, all mandatory nutrients are required to be listed regardless of whether or not the amounts are declared as zero or are present in the product’s formula.
How ENTR Helps Supplement Teams
ENTR supports teams in formulating and generating FDA-compliant Supplement Facts panels with advanced calculations, editing, and reporting features.
Whether you’re creating a complex panel from scratch or updating labels after a formula change, ENTR makes your workflows more efficient.
Looking for solutions to support your supplement workflows? Contact us here.
