The Supplement Facts panel: what it must disclose, and the one figure it may combine

Two bottles on the same shelf, at the same price. The first panel says ashwagandha root extract, 500 mg. The second says Proprietary Blend, 500 mg, and then, indented beneath it, six herb names. Both panels can be entirely lawful, and the difference between them is not a loophole somebody discovered. The words “Proprietary Blend” are in the regulation, spelled out as an option, with a rule that says what the number beside them has to mean.

So the question at the shelf is not “is this legal” — it is. The question is narrower and more useful: which of these two panels gives you something to reason with? A United States supplement label is a disclosure document. It tells you what is in the product and how much of it a serving contains. Where it stops is narrower than people expect: inside a proprietary blend it gives you one combined weight instead of the weight of each ingredient, and below a stated threshold it leaves an ingredient out altogether. Both behaviours are written into the regulation. Neither is a mistake on the panel.

This article is about what that disclosure guarantees, where the guarantee stops, and how to read the difference between the two bottles in about thirty seconds. It is general information, not medical advice; whether a particular ingredient is appropriate for you, at a particular dose, alongside a particular prescription, is a question for a pharmacist or a clinician.

The bold sentence at the bottom is a legal condition

A panel that makes a structure or function statement has to carry this, prominently displayed and in boldface type:

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.

That sentence reads like boilerplate. It is not. It is one of three statutory conditions that keep the product outside the definition of a drug, and the chain that connects them is worth following once, because it explains several things that otherwise look arbitrary.

A “drug” includes, under 21 U.S.C. §321(g)(1)(C), an “article (other than food) intended to affect the structure or any function of the body.” A dietary supplement is deemed to be a food — but §321(ff) says so “except for purposes of paragraph (g) and section 350f.” The food carve-out in the drug definition therefore does not apply automatically to a supplement. What applies instead is the last sentence of §321(g)(1): a food, dietary ingredient or supplement “for which a truthful and not misleading statement is made in accordance with section 343(r)(6)” is not a drug under clause (C) “solely because the label or the labeling contains such a statement.”

That sentence is a trade. In exchange for being allowed to print, on the bottle, that an ingredient affects a structure or function of the body, the seller accepts three obligations in §343(r)(6):

• the statement has to be one of the permitted kinds, at (A);
• the manufacturer has to have substantiation that it is truthful and not misleading, at (B);
• the label has to carry the disclaimer, at (C).

21 CFR 101.93(b) names the mechanism directly: compliance with §343(r)(6) is the route to “the exemption to section 201(g)(1)(C)” — the same clause of the drug definition. So the bold sentence is load-bearing. Drop it, or make a statement §343(r)(6) does not permit, and the exemption is not available on the terms the label relies on.

What the panel is required to show

The panel itself is governed by 21 CFR 101.36, which is a different regulation from the Nutrition Facts rules for conventional food. It requires a heading, a serving size governed by the food serving-size rules, a column of amounts per serving, and a column of percentages — with its own rule for what happens when no percentage exists.

Element	Authority	What it must contain
Supplement Facts heading, then Serving Size	101.36(b)(1)(i)	The heading, with the serving size subheading beneath it and aligned left. The serving size is determined under §§101.9(b) and 101.12(b), Table 2, and is expressed in a term suited to the form, such as tablets, capsules, packets or teaspoonfuls.
Servings Per Container	101.36(b)(1)(ii)	Beneath the serving size, unless the figure already appears in the net-quantity statement.
Amount Per Serving, with the fifteen listed items	101.36(b)(2)	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, each declared when present above the amount that may be declared as zero — with weight in metric units and a percentage of the Daily Value.
Other dietary ingredients	101.36(b)(3)	Everything with no Reference Daily Intake or Daily Reference Value, by common or usual name, with its own weight per serving in metric units.
The symbol and “Daily Value not established”	101.36(b)(3)(iv); (b)(2)(iii)(F)	A symbol in the percentage column keyed to a footnote at the foot of the panel.
Source form in parentheses	101.36(d)	“Calcium (as calcium carbonate)”, or “from” — the form the nutrient arrives in. Permissive: a source ingredient identified here need not be listed again in the ingredient statement, but one that is not identified here has to be.
Non-dietary ingredients	21 CFR 101.4(a)(1)	The binders, fillers and coatings go in the ingredient list, because §101.4(a)(1) exempts only the ingredients that are declared in the §101.36 panel.
Type size	101.36(e)	Information other than the title, headings and footnotes in uniform type no smaller than 8 point, with reduced sizes permitted for small and intermediate-sized packages under (h)(3).

Two details in that table are more informative than they look.

The first is the serving size, because the cross-reference cuts the other way from what it suggests. Table 2’s entry for dietary supplements is a single line: “The maximum amount recommended, as appropriate, on the label for consumption per eating occasion or, in the absence of recommendations, 1 unit.” The reference amount is therefore the manufacturer’s own recommended intake, with one tablet or capsule as the fallback when the label recommends nothing. So the panel is not telling you what to take; it is telling you what the manufacturer assumes you take at a time. “Servings Per Container” is the line that turns a per-serving figure into a per-bottle one: a panel advertising 1,000 mg per serving, in a bottle of thirty capsules with a two-capsule serving, is describing fifteen servings, not thirty.

The second is what that row implies for everything else. A threshold is built into the rule. A (b)(2) nutrient is declared when it is present above the amount that may be declared as zero under §101.9(c) — and ingredients “that are not present, or that are present in amounts that can be declared as zero in §101.9(c), shall not be declared,” with the regulation’s own example being amounts corresponding to less than 2 percent of the RDI for vitamins and minerals. A small quantity can therefore be absent from the panel without being absent from the capsule. That is a threshold, not a blend, and it is worth keeping separate in your head: the blend combines required weights into one number, while the threshold means no number was ever required.

What a proprietary blend may combine, and what it may not

Section 101.36(c) is where the two bottles in the opening diverge.

A blend is identified by the term “Proprietary Blend” or another descriptive term or fanciful name, and it may be set in bold. Three rules follow:

1. The names stay. Ingredients in the blend that have no Daily Value are declared by name, in descending order of predominance by weight, indented under the blend’s name — in a column or linearly (c)(2). So the panel tells you the ranking.
2. The total is stated, not the parts. The weight printed beside the blend “shall be the total weight of all other dietary ingredients contained in the proprietary blend” (c)(3). One number for the group.
3. The permission has a boundary. Ingredients in the blend that do have a Reference Daily Intake or Daily Reference Value are declared under (b)(2) instead — which is to say, with their own quantity and their own percentage of the Daily Value (c)(1).

The third rule is the one readers miss. A blend can combine the weights of the herbs inside it. It cannot combine the weights of the vitamin D, calcium, iron or potassium inside it, because those are (b)(2) ingredients and (b)(2) requires the individual figure and the percentage. A blend that lists “Vitamin D3” among its components and shows no separate microgram figure and no percentage is not using the permission the regulation gives it.

The statute contemplates the same trade. Under 21 U.S.C. §343(s), a supplement is misbranded if its labeling fails to list the name of each dietary ingredient and either “the quantity of each such ingredient” or, “with respect to a proprietary blend of such ingredients, the total quantity of all ingredients in the blend.” The aggregate is written into the misbranding provision itself, which is why calling it a loophole overstates the case: it is a disclosure choice the law offers, at the cost of one number instead of six.

The dagger is not decoration

Every ingredient in the “other dietary ingredients” list carries a symbol in the percentage column, and the symbol points to a footnote reading “Daily Value not established” (101.36(b)(3)(iv)). Where the panel has no percentage column at all, the same symbol is required to follow the weight instead. The symbol also attaches to any declared subcomponent for which no Daily Reference Value or Reference Daily Intake has been established (101.36(b)(2)(iii)(F)).

Read that footnote literally. A Daily Value is a reference amount — a Reference Daily Intake or Daily Reference Value established under §101.9(c), which is what the percentage column divides by. For a botanical extract, no such reference exists, so there is nothing to divide by, and the panel prints a weight and no percentage. Across a shelf, that means the numbers you are comparing are absolute weights with no common yardstick: 500 mg of one extract and 500 mg of another are not comparable quantities of anything, and 300 mg of a standardized extract is not simply “less” than 500 mg of an unstandardized one.

The label’s job for those ingredients is to tell you what is in the capsule. It is not telling you that the amount is a recommended amount, and there is no requirement that it be.

Three kinds of claim, three different gates

The claim on the front of the bottle determines which obligations apply, and the three categories are not variations on a theme — they are different legal routes with different gatekeepers.

Claim type	What it may say	What the law requires	Authority
Structure or function	That a nutrient or ingredient affects a structure or function of the body, characterizes the documented mechanism by which it does so, describes general well-being, or claims a benefit related to a classical nutrient deficiency disease while disclosing that disease’s prevalence in the United States	One of the four permitted statement types; substantiation held by the manufacturer that the statement is truthful and not misleading; the boldface disclaimer; and a notification to the agency no later than 30 days after first marketing	§343(r)(6); 21 CFR 101.93
Health claim	That a nutrient bears a relationship to a disease or health-related condition — the “may reduce the risk of” form	One of two routes. Either compliance with regulations issued under (r)(3)(B), which may authorize a claim only on a determination of significant scientific agreement based on the totality of publicly available scientific evidence; or, for a supplement of vitamins, minerals, herbs or other similar nutritional substances, the separate procedure and standard set by regulation under (r)(5)(D)	§343(r)(1)(B), (r)(3), (r)(5)(D)
Disease claim	That the product diagnoses, mitigates, treats, cures or prevents a disease	Not available to a supplement: the product is regulated as a drug, and a new drug may not be introduced unless an approved application is in effect	21 CFR 101.93(f), (g); §355(a)

The middle row is the one with real gates, and it has two of them. Under (r)(3), a health claim has to fit a regulation the agency has issued, and a regulation under (r)(3)(B) may be issued only on a determination of significant scientific agreement among qualified experts. Subparagraph (5)(D) takes claims for supplements of vitamins, minerals, herbs and similar nutritional substances out of (r)(3) and subjects them instead to a separate procedure and standard established by regulation. Under either route, the claim is not something a manufacturer may word carefully and print: it has to correspond to an authorized claim.

The third row is where the disclaimer earns its keep. Section 101.93(g)(1) defines a disease as “damage to an organ, part, structure, or system of the body such that it does not function properly,” or a state of health leading to such dysfunction, with an exception for diseases caused by essential nutrient deficiencies. Paragraph (g)(2) then lists ten criteria the agency uses to decide whether a statement crosses the line — among them an effect on a specific disease or class of diseases, an effect on characteristic signs or symptoms, the name of the product, a citation that implies disease treatment in context, and pictures or vignettes. The tenth criterion is a catch-all — anything that “otherwise suggests an effect on a disease or diseases” — and the paragraph instructs the agency to consider the context in which a statement is presented.

Two caveats on that list, both from the text. It is not intended to classify as disease claims statements that refer to maintaining healthy structure or function “unless the statement implies disease prevention or treatment.” And an authorized health claim remains available to a supplement even where a disease is named.

What the label does not tell you

Four things, in descending order of how much they matter at the shelf.

Nothing on the panel certifies that the agency reviewed the product. The premarket duties the statute imposes run in a different direction. If an ingredient was not marketed in the United States before October 15, 1994, it is a “new dietary ingredient” under §350b(d), and the supplement containing it is deemed adulterated under §342(f) unless one of two conditions is met: the supplement contains only ingredients that have been present in the food supply as an article used for food in a form not chemically altered, or there is a history of use or other evidence of safety and the manufacturer or distributor gives the agency the information behind that conclusion “at least 75 days before being introduced or delivered for introduction into interstate commerce” (§350b(a)). Separately, a supplement prepared, packed or held under conditions that do not meet current good manufacturing practice is adulterated under §342(g), and those practices are the regulations in 21 CFR 111 — which apply to anyone who manufactures, packages, labels or holds a supplement (111.1(a)), with an exception for holding at a retail establishment for the sole purpose of direct retail sale to individual consumers, and an explicit statement that a warehouse is not a retail establishment for that purpose (111.1(b)).

Neither duty is an application for permission, and neither results in an approval of the product. The approval route is the one §355(a) describes for a new drug — no introduction into interstate commerce unless an approved application is in effect. That is the route a supplement exits if it makes a disease claim.

The panel is a representation, and §343(s) is what enforces it. Section 343(s)(2)(D) makes a supplement misbranded if it is covered by an official compendium, is represented as conforming to that compendium, and fails to conform. Clause (E) covers the other case: not covered by a compendium, and failing to have the identity and strength represented, or failing to meet the quality, purity or compositional specifications represented — including tablet or capsule disintegration. So the weight on the panel binds the seller rather than estimating: a product that does not have the identity and strength printed there is misbranded on the terms of that paragraph.

Interactions are outside the panel entirely. No part of the §101.36 disclosure is a statement about what the product does alongside a prescription, and nothing in the premarket duties above compares the ingredient list against your medications. That is the gap a pharmacist fills, and it is the reason a supplement question is worth asking at the counter rather than reading off the label.

Advertising is a different regulator with a different statute. The line is drawn in the definition itself: 15 U.S.C. §55(a)(1) defines a “false advertisement” as “an advertisement, other than labeling, which is misleading in a material respect,” and it counts the failure to reveal material facts as part of the misleading assessment. Section 52(a) makes it unlawful to disseminate a false advertisement by mail or in commerce for the purpose of inducing, or in a way likely to induce directly or indirectly, the purchase of food, drugs, devices, services or cosmetics. Labeling runs through the food and drug provisions above; advertising runs through the FTC Act. A claim that appears only in an advertisement is judged under the advertising statute rather than under §343(r)(6), and the boldface disclaimer belongs to the label, not to the ad.

At the shelf, in order

1. Find the serving size and the servings per container. Both are required, and the second one converts the panel into a per-bottle number.
2. Check whether the ingredient you came for has its own weight or is inside a blend. One number for a group means one number for a group.
3. If it is in a blend, read the order. The names are required, and they are in descending order by weight. The first name is the largest share of the blend.
4. Look for a dagger beside the ingredient. A dagger with “Daily Value not established” means the panel is giving you an absolute weight with no reference amount — which is information, but not a dose recommendation.
5. Check whether any vitamin or mineral inside a blend has its own line. If the blend lists vitamin D or calcium by name with no separate microgram figure and no percentage, the panel is not doing what (c)(1) requires.
6. Identify the claim type. A structure or function claim requires the boldface disclaimer; a disease claim is outside what a supplement may say at all.
7. Keep the number on the label. Section 343(y) requires a domestic address or domestic phone number for serious adverse event reports, and §379aa-1(c)(1) gives the firm 15 business days from receipt to report to the agency. The number is the statutory channel, and it is the one to use if something goes wrong.