Supplement facts label requirements

That's the whole set of supplement facts label requirements. The rest is each piece, with the citation, and where small brands get it wrong.

Supplement Facts label requirements at a glance

Why supplements run on their own rule

Under the Dietary Supplement Health and Education Act, dietary supplements sit inside the food category, not the drug category. FDA says it plainly: "Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed," and "By law, FDA does not approve dietary supplements or their labeling" (FDA).

No premarket gate is the good news. The bad news is nobody checks your work before it's printed on 10,000 bottles. Anyone selling an "FDA-approved supplement label" is selling a thing that does not exist.

101.36(a) sets the obligation: the label "shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h)." Those exemptions are narrow — 101.36(h) cross-references 101.9(j)(1) for small retailers, 101.9(j)(18) for low-volume products, and 101.9(j)(9) for bulk shipments — and each dies the moment your label carries a nutrient content or health claim. There is no cottage-food route around a Supplement Facts panel.

The heading reads "Supplement Facts"

Not "Nutrition Facts." Under 101.36(e)(1) the title is set in a type size larger than all other print in the nutrition label, and bolded. A panel headed "Nutrition Facts" on a supplement is wrong on line one, and generic label software will happily build you one, because it doesn't know what you're making.

Serving size: get the citation chain right

This is the most-garbled point in supplement labeling advice. You'll read that supplements "don't use the RACC table." That's wrong on the mechanism, even though it lands on the right answer.

101.36(b)(1)(i) says: "The serving size shall be determined in accordance with §§ 101.9(b) and 101.12(b), Table 2. Serving size for dietary supplements shall be expressed using a term that is appropriate for the form of the supplement, such as 'tablets,' 'capsules,' 'packets,' or 'teaspoonfuls.'"

So it does route you into 21 CFR 101.12 Table 2 — the same Reference Amount Customarily Consumed table that governs cookies and hot sauce. The trick is what Table 2 says when you arrive. Its dietary supplements entry reads:

"The maximum amount recommended, as appropriate, on the label for consumption per eating occasion or, in the absence of recommendations, 1 unit, e.g., tablet, capsule, packet, teaspoonful, etc."

The reference amount for a dietary supplement is your own label recommendation. Table 2 doesn't hand you a fixed 30 g the way it does for cookies; it points back at your directions for use. So the serving size is genuinely RACC-derived and genuinely yours to set — which is why this gets mangled.

Practical version: "take two capsules daily" makes your serving size 2 capsules. A range means you use the maximum recommended per eating occasion. No directions defaults to 1 unit. Under 101.36(b)(1)(ii), "Servings Per Container" goes directly beneath, and may be omitted when it already appears in the net quantity declaration.

Which nutrients are mandatory, and when zero disappears

101.36(b)(2) covers dietary ingredients that have a Reference Daily Intake or a Daily Reference Value. Paragraph (b)(2)(i) names them: "total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium."

Two rules govern that list, and the second is where supplements diverge sharply from food labels:

1. They shall be declared when present in amounts by weight exceeding what can be declared as zero under 101.9(c).
2. Any that are not present, or present at an amount that can be declared as zero, shall not be declared at all.

On a Nutrition Facts panel you print "Total Fat 0g." On a Supplement Facts panel you delete the line. A capsule product with no measurable fat, sodium or carbohydrate typically shows no (b)(2) block at all. Rows of zeros are the clearest tell of a generic tool.

Vitamins and minerals beyond the mandatory four still carry RDIs, so they're declared with a %DV whenever they're in your formula — which for a multivitamin is the entire point of the product. 101.36(b)(2)(i)(B) fixes the sequence, vitamin A through fluoride.

Some items are voluntary unless you talk about them. Per 101.36(b)(2)(i), "Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol may be declared, but they shall be declared when a claim is made about them." Put "5 g soluble fiber" on the front and you made soluble fiber mandatory on the back.

"Daily Value not established": the bar, the symbol, the footnote

Your ashwagandha, L-theanine, CoQ10 and turmeric extract have no RDI and no DRV. They're other dietary ingredients under 101.36(b)(3)(i), declared by common or usual name with a quantitative amount by weight per serving under (b)(3)(ii). They can't carry a % Daily Value, because there isn't one. So 101.36(b)(3)(iv) requires this:

"Other dietary ingredients shall bear a symbol (e.g., an asterisk) in the column under the heading of '% Daily Value' that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement 'Daily Value not established.'"

Read the parenthetical carefully, because this is where we part company with most of what's published. The regulation says "e.g., an asterisk." That's FDA's example, not FDA's mandate. The dagger (†) on nearly every supplement bottle in America is industry convention, not a legal requirement. Either symbol is fine. What matters is that the symbol in the %DV column and the symbol on the footnote are the same character. A dagger pointing at an asterisked footnote is a defect. Same construction one level down: under 101.36(b)(2)(iii)(F), a declared subcomponent with no DRV or RDI also takes a symbol referring to a footnote at the bottom of the label.

Where the footnote sits is settled by the format rules. 101.36(e)(6) puts a heavy bar in three places: beneath "Servings Per Container" (or "Serving Size" if the former was omitted), beneath the last (b)(2) ingredient, and beneath the last other dietary ingredient. Because a bar closes the (b)(3) block, the "Daily Value not established" footnote lands below that last heavy bar and inside the box. Not floating under the panel. Inside it. Between ingredient rows, 101.36(e)(5) calls for a hairline rule.

Proprietary blend labeling rules

101.36(c) lets you keep a formula ratio private, and it's narrower than most brands assume. A blend sits in the (b)(3) list, "identified by the term 'Proprietary Blend' or other appropriately descriptive term or fanciful name." Then:

• One number. "The quantitative amount by weight specified for the proprietary blend shall be the total weight of all other dietary ingredients contained in the proprietary blend."
• Components named underneath, in descending order of predominance by weight.
• No individual amounts. That's the concession you get.

Two things it does not let you do. You cannot hide a nutrient with an established Daily Value inside a blend — anything covered by 101.36(b)(2) gets its own line, amount and %DV. And you cannot fudge the order. Descending order by weight is a factual claim about your formula; listing a marquee botanical first when it's 2% of the mass is a misbranding problem, not a marketing decision.

Botanicals must name the part of the plant

"Turmeric" isn't enough. "Turmeric (Curcuma longa) root" is.

101.36(d)(1) lets you name a source ingredient inside the panel, in parentheses following or indented beneath the dietary ingredient, preceded by "as" or "from" — the familiar "Calcium (as calcium carbonate)" pattern. It then sends you to 21 CFR 101.4: "the listing of botanicals shall specify the part of the plant from which the ingredient is derived."

101.4(h) adds the detail. The plant part is stated in English — root, leaf, aerial parts, bark, seed, rhizome — with an exception for algae, and the Latin binomial goes in parentheses unless the common name is already standardized in Herbs of Commerce. So: valerian root, echinacea aerial parts, ginkgo leaf, milk thistle seed. A bonus in 101.36(d)(1): a source ingredient named inside the panel "shall not be required to be listed again in the ingredient statement."

"Other ingredients" belongs below the panel

Capsule shell, magnesium stearate, silicon dioxide, microcrystalline cellulose, rice flour, natural flavor. Not dietary ingredients, so not in the panel.

21 CFR 101.4(g) places them: the list "shall be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label." It's preceded by "Ingredients" — unless some ingredients are named inside the panel under 101.36(d), in which case the ones outside are preceded by "Other ingredients." Nearly every real supplement names a source ingredient in the panel, so nearly all of them use "Other ingredients."

The three things outside the panel that people forget

Statement of identity. 101.3(g): supplements "shall be identified by the term 'dietary supplement' as a part of the statement of identity, except that the word 'dietary' may be deleted and replaced by the name of the dietary ingredients in the product (e.g., calcium supplement)." Per 101.3(d), bold, on the principal display panel.

Net quantity of contents. 101.7(a): principal display panel, by weight, measure or numerical count. For capsules that's a count: "60 Capsules."

Name and place of business. 101.5(a) requires "the name and place of business of the manufacturer, packer, or distributor." Use a contract manufacturer and you didn't manufacture it, so 101.5(c) requires a qualifier: "Manufactured for" or "Distributed by."

A worked example, in text

A two-capsule joint formula, top to bottom.

Line 1 is Supplement Facts, in the largest type in the box. Under it, left-aligned: Serving Size 2 Capsules, then Servings Per Container 30. A heavy bar closes that block. Then the column headings, Amount Per Serving and % Daily Value, with a light bar beneath.

The (b)(2) block is one line long, because this product has no calories, fat or sodium worth declaring and those rows therefore don't exist: Vitamin C (as ascorbic acid) 90 mg, 100%. A heavy bar closes it. Below sits the (b)(3) block, hairline-ruled:

• Glucosamine Sulfate 1,500 mg — dagger in the %DV column
• Turmeric (Curcuma longa) root extract 500 mg — dagger
• Joint Comfort Blend 250 mg — dagger — three components indented beneath in descending order by weight, no individual numbers: Boswellia (Boswellia serrata) gum resin extract, Bromelain, Black Pepper (Piper nigrum) fruit extract

A heavy bar closes the (b)(3) block. Under it, still inside the box: † Daily Value not established. Directly beneath the box: Other ingredients: hypromellose (capsule), microcrystalline cellulose, magnesium stearate, silicon dioxide.

Note what's doing the work. Vitamin C has an RDI, so it sits above the bar with a real percentage. Everything else is below the bar with a dagger. The blend shows one total, plant parts are named, and the capsule shell is outside the panel.

Common mistakes that get supplement labels rejected

• "Nutrition Facts" as the heading. Wrong regulation, wrong panel.
• Rows of zeros. Nutrients that would read zero aren't declared at all.
• Excipients inside the panel. They belong under "Other ingredients," per 101.4(g).
• Mismatched symbols, or a footnote sitting outside the box instead of below the last heavy bar.
• Botanicals with no plant part. "Ashwagandha 600 mg" fails; "Ashwagandha (Withania somnifera) root extract 600 mg" passes.
• A DV-bearing nutrient buried in a proprietary blend, or blend components in marketing order rather than weight order.
• A serving size that contradicts the directions, or vitamins out of the 101.36(b)(2)(i)(B) sequence.
• A structure/function claim with no disclaimer. Say "supports joint comfort" and 21 CFR 101.93 attaches: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease," adjacent to the claim, boldface, no smaller than one-sixteenth inch, plus notice to FDA within 30 days after first marketing.

If you'd rather not assemble this by hand, Nutrillius builds the panel from your formulation sheet in about a minute — bars, symbols, ordering, %DV math, Other ingredients placement. $39 one time, or $69/month if your manufacturer keeps changing things. Details on the supplement label page.