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Regulation

Supplement Facts (Pregnant): US nutrition label

Supplement Facts (Pregnant), the FDA nutrition label under 21 CFR 101.36 (Nutrition labeling of dietary supplements), amount per serving, with no per-100 g column, English on pack. Generate a compliant label free.

Reviewed against 21 CFR 101.36 (Nutrition labeling of dietary supplements) · Page updated September 16, 2026

Jurisdiction
United States (FDA-regulated dietary supplements under DSHEA 1994)
Regulation
21 CFR 101.36 (Nutrition labeling of dietary supplements)
Effective
Current; updated by the 2016 rule (81 FR 33742)
Official source
www.ecfr.gov
Generate the US labelUS FDA requirements guide

Nutrition labelling requirements in the US

Packaged food sold in the US must carry a nutrition declaration under 21 CFR 101.36 (Nutrition labeling of dietary supplements). This page covers the US - Supplement Facts (Pregnant) format: Pregnant-woman DV table per 21 CFR § 101.9(c)(8)(vi). Values are declared amount per serving, with no per-100 g column. The panel is headed "Supplement Facts". English is required on pack. There is no mandatory front-of-pack warning scheme. NFL builds a print-ready FDA nutrition label from your recipe, applying the rounding rules and reference intakes for the US automatically, and exports it as PDF, PNG, SVG, JPG or EPS.

Official regulation

Citation
21 CFR 101.36 (Nutrition labeling of dietary supplements)
Effective
Current; updated by the 2016 rule (81 FR 33742)
Scope
United States (FDA-regulated dietary supplements under DSHEA 1994)
Source

Key facts

Declaration basis
Amount Per Serving, with no per-100 g column
Panel heading
Supplement Facts
Label language
English required on pack
Front of pack
No mandatory front-of-pack warning scheme
Column caption
Amount Per Serving
Percentage column
Required footnote
Nutrients with no established Daily Value are marked with a dagger.
Mandatory statements (1)
Other Ingredients: required as a separate line under 21 CFR 101.36(d)

When to use a Supplement Facts label for pregnant women

Nutrition labeling is mandatory for dietary supplements under 21 CFR 101.36, in force, unless an exemption applies. When a supplement is represented or purported specifically for pregnant women, such as a prenatal vitamin, its % Daily Values must use the reference values for that group, not the default values for adults and children 4 years and older.

The % Daily Value column heading must state clearly that it applies to pregnant women, which is mandatory. If the product is represented for pregnant women and another group with different values, separate % Daily Value columns for each group are mandatory.

"Prenatal" is not a separate legal format. It is the standard Supplement Facts panel, with pregnancy reference values and a heading that names the group.

Source: 21 CFR 101.36(b), eCFR.

Pregnancy Daily Values on a prenatal vitamin label

The reference values in force under 21 CFR 101.9(c)(8) have one column headed "Pregnant women and lactating women", and a pregnancy supplement uses that column.

A few nutrients show why the panel looks different from an adult one:

  • iron: 27 mg, against 18 mg for adults and children 4 years and older;
  • folate: 600 mcg DFE, against 400 mcg DFE; and
  • iodine: 290 mcg, against 150 mcg.

When folate is declared, the name "Folate" and units of mcg DFE are mandatory. If folic acid is added or a claim is made about it, the amount of folic acid must also be declared, in parentheses, in mcg.

Source: 21 CFR 101.9(c)(8), eCFR.

Supplement Facts panel format under 21 CFR 101.36

The pregnancy panel uses the standard supplement layout, which is mandatory: the title "Supplement Facts" in bold and larger than all other print, then "Serving Size", then "Servings Per Container" unless the net quantity already gives it, then amounts per serving and % Daily Values.

Dietary ingredients with a reference value are declared when present above the amount that can be declared as zero. Ingredients without one, such as DHA in many prenatal products, are listed by amount with a symbol linking to "Daily Value not established".

The panel is boxed, uses the prescribed heavy and light rules, and on ordinary packages uses text of at least 8 point, with column headings and footnotes at least 6 point.

Source: 21 CFR 101.36(b) and (e), eCFR.

Iron warning and other prenatal supplement label requirements

Most prenatal vitamins contain iron, which brings a mandatory warning. Under 21 CFR 101.17(e), in force, a supplement in solid oral dosage form containing iron or iron salts as an iron source must carry this exact statement:

"WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."

The warning must be prominent and conspicuous on the information panel of the immediate container, set off in a box by hairlines, and repeated on the retail package if that is different.

Other mandatory label elements include the words "dietary supplement" or an equivalent, net quantity, the business name and place, ingredients not declared in the panel, and a domestic address or phone number for adverse event reports. English is mandatory under 21 CFR 101.15(c), with the Puerto Rico and territory exception, and any foreign-language representation means all required information must also appear in that language.

Source: 21 CFR 101.17(e) and 21 CFR 101.15, eCFR.

How NFL handles it

  • Applies the correct rounding rules for every nutrient
  • Uses the right Daily Value / Reference Intake table for this jurisdiction
  • Renders the required front-of-pack warnings automatically when thresholds are hit
  • Handles multilingual labels where required (bilingual EN/FR, EN/ES, Arabic + EN, etc.)
  • Exports print-ready vector PDF, PNG, SVG, JPG, and EPS

Common questions

When is a Supplement Facts panel for pregnant women used?
When a dietary supplement is represented or purported specifically for pregnant women. The % Daily Values must use the pregnancy reference values and the column heading must name the group.
Which Daily Values apply to a prenatal vitamin label?
The "Pregnant women and lactating women" values in 21 CFR 101.9(c)(8). Examples are 27 mg for iron and 600 mcg DFE for folate.
How is folate declared on a prenatal label?
As "Folate" in mcg DFE, which is mandatory. If folic acid is added, its amount is also given in parentheses in mcg.
How does a pregnancy Supplement Facts panel differ from the standard adult panel?
Only the reference values and the column heading change. Because values such as iron and folate are higher for pregnancy, the same dose shows a lower percentage than on an adult panel.
Is an iron warning mandatory on prenatal supplements?
Yes, for solid oral dosage forms containing iron or iron salts as an iron source, under 21 CFR 101.17(e). The exact wording, a box and placement on the information panel are all mandatory.
Does a prenatal supplement label have to be in English?
Yes, required information must be in English under 21 CFR 101.15(c), except for products distributed solely in Puerto Rico or another territory where another language predominates. If another language is used on the label, the required information must appear in that language too.

How to generate one

  • Open the generator: free account, no credit card
  • Pick "US - Supplement Facts (Pregnant)" from the format rail
  • Enter your ingredients (search USDA FoodData Central or add a custom ingredient)
  • The label renders live; export in one click

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