Short answer: A U.S. dietary supplement label needs five required statements: the product name with the words "dietary supplement," the net quantity, a Supplement Facts panel, the ingredient list, and the name and address of the manufacturer, packer or distributor. Add a domestic address or phone number for adverse event reports, any major allergens, and the FDA disclaimer if you make a structure/function claim. [1]
Definition: A private label supplement label is the finished label your brand puts on a supplement made by a contract manufacturer. Your name goes on it, and so does responsibility: FDA says manufacturers and distributors "are responsible for evaluating the safety and labeling of their products before marketing." [9]
Key stats: supplement labels at a glance
- 5 statements are required on every dietary supplement label: identity, net quantity, Supplement Facts, ingredients, and name and place of business. (FDA Dietary Supplement Labeling Guide) [1]
- 30 days: the deadline to notify FDA after you first market a supplement with a structure/function claim. (21 CFR 101.93) [6]
- 1/16 inch: the minimum letter height for required label statements and for the FDA disclaimer, which must also be bold. (FDA Labeling Guide; 21 CFR 101.93) [1][6]
- 8 point: the minimum type size for most Supplement Facts information on a standard label. (21 CFR 101.36) [5]
- 9 major food allergens must be declared, including sesame since January 1, 2023. (FDA) [10]
- Dec. 22, 2007: supplements labeled on or after this date need a domestic address or phone number for serious adverse event reports. (FDA guidance on section 403(y)) [7]
What are the five required statements on a supplement label?
FDA's Dietary Supplement Labeling Guide lists five statements every label must carry, each tied to a section of 21 CFR Part 101: [1]
- 1.Statement of identity (21 CFR 101.3): the product name, identified as a "dietary supplement." The word "dietary" may be replaced with the ingredient name or type, as in "calcium supplement" or "herbal supplement with vitamins." [2]
- 2.Net quantity of contents (21 CFR 101.105).
- 3.Nutrition labeling: the Supplement Facts panel (21 CFR 101.36). [5]
- 4.Ingredient list (21 CFR 101.4). [3]
- 5.Name and place of business of the manufacturer, packer or distributor (21 CFR 101.5). [4]
The identity and net quantity statements go on the front of the package (the principal display panel). The others can go on the front or on the information panel, which FDA defines as the panel immediately to the right of the front panel as the shopper sees it. Required statements must be at least 1/16 inch tall, measured by the lowercase "o." [1]
Where does each element go?
| Label element | Where it goes | Key rule | Source |
|---|---|---|---|
| Product name + “dietary supplement” | Front panel | “Dietary” may be swapped for the ingredient or type (e.g., “calcium supplement”) | 21 CFR 101.3(g) [2] |
| Net quantity | Front panel | Required on every package | 21 CFR 101.105 [1] |
| Supplement Facts panel | Front or information panel | Hairline box; title larger than all other type in the panel; most text 8 point or larger | 21 CFR 101.36 [5] |
| Ingredient list | Directly below Supplement Facts | “Other ingredients” when sources are named inside the panel | 21 CFR 101.4(g) [3] |
| Name and place of business | Front or information panel | “Manufactured for” or “Distributed by” if you didn’t make it; city, state and ZIP | 21 CFR 101.5 [4] |
| Adverse event contact | On the label | Domestic address or domestic phone number | FD&C Act 403(y) [7] |
| Allergen declaration | With the ingredient list | “Contains” statement or allergen source in parentheses | FD&C Act 403(w) [11] |
| Structure/function disclaimer | Each panel with a claim | Bold, at least 1/16 inch; boxed if not next to the claim | 21 CFR 101.93 [6] |
What goes in the Supplement Facts panel?
The panel starts with the title "Supplement Facts," set larger than all other type in the panel, and the "Serving Size" line right under it. The whole panel is enclosed in a box made with hairlines. Most information must be at least 8 point; column headings and footnotes may be 6 point, and smaller packages get smaller minimums. [5]
- Ingredients with a Daily Value (most vitamins and minerals) show a % Daily Value.
- Ingredients without a Daily Value (many botanicals and specialty actives) get a symbol, such as an asterisk, tied to the footnote "Daily Value not established."
- Proprietary blends list the total weight of the blend, with the ingredients inside it in descending order by weight. [5]
Ingredients that aren't listed in the panel go in an ingredient list directly below it. If the panel already names some ingredient sources, the rest are listed after the words "Other ingredients." [3] For botanicals, the common name should match the reference Herbs of Commerce, followed by the part of the plant used (for example, root or leaves) in English; the Latin binomial name is added in parentheses when the common name isn't in that reference. [1]
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Whose name and address go on a private label supplement?
The label must name the manufacturer, packer or distributor and give the place of business: street address, city, state and ZIP code (the street address can be left out if it appears in a current city or phone directory). With private label, the brand is often the named company. Because your brand did not make the product, the name must carry a phrase showing the connection, such as "Manufactured for" or "Distributed by." [4]
Separately, federal law requires a domestic address or domestic phone number on the label through which the responsible person can receive reports of serious adverse events. A phone number needs an area code; a mailing address needs a street address or P.O. box, city, state and ZIP. FDA doesn't require set wording but recommends a clear statement, for example: "To report a serious adverse event or obtain product information, contact…" [7]
Can you make claims, and what disclaimer do you need?
Most supplement marketing uses structure/function claims: statements about a nutrient's effect on the normal structure or function of the body, such as "calcium builds strong bones." These claims are not pre-approved by FDA, and you must have evidence that the claim is truthful and not misleading before you use it. [8]
If you use one, three rules apply:
- 1.Notify FDA no later than 30 days after you first market the supplement with the claim. The manufacturer, packer or distributor submits the notice. [6]
- 2.Print the disclaimer: "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." With more than one claim, it may read "These statements…" [6]
- 3.Format it correctly: bold type at least 1/16 inch tall, on every panel that carries a claim. Place it next to the claim, or link them with a symbol such as an asterisk and set the disclaimer off in a box. [6]
Your label is only half of the picture. The FTC's Health Products Compliance Guidance (December 2022), which replaced its 1998 supplement advertising guide, expects "competent and reliable scientific evidence" for health claims in your advertising and marketing too. [12]
How do you declare allergens on a supplement?
Allergen labeling law applies to dietary supplements. The nine major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame; sesame was added by the FASTER Act and took effect January 1, 2023. [10] Declare each one in one of two ways: a "Contains" statement (for example, "Contains: Soy") placed immediately after or next to the ingredient list in type at least as large, or the allergen's food source in parentheses within the ingredient list. [11] Watch capsule shells, softgel gelatin, flavors and coatings: they are ingredients too.
The Label Lock: 5 steps to approve a private label supplement label
- 1.Lock the formula. Final ingredient amounts, sources and serving size from your manufacturer.
- 2.Build the panel. Supplement Facts with % Daily Values, "Daily Value not established" symbols, and blend weights.
- 3.Write the front. Product name with "dietary supplement" (or "[ingredient] supplement") and net quantity.
- 4.Check the claims. Structure/function wording only, evidence on file, disclaimer formatted, FDA notice calendared for 30 days after launch.
- 5.Close the back. "Other ingredients," allergens, "Distributed by [your brand]" with address, and an adverse event contact.
Printable checklist: private label supplement label
Download the fillable checklist (PDF)
Label checklist
- Product name includes “dietary supplement” or “[ingredient] supplement” [2]
- Net quantity on the front panel [1]
- “Supplement Facts” title, serving size, hairline box, 8-point minimum for most text [5]
- % Daily Value where one exists; “Daily Value not established” symbol where it doesn’t [5]
- Proprietary blend: total weight, ingredients in descending order by weight [5]
- Ingredient list directly below the panel (“Other ingredients” if sources are named in the panel) [3]
- Botanicals: plant part named in English; Latin name in parentheses if the common name isn’t in Herbs of Commerce [1]
- “Manufactured for” or “Distributed by” + your brand name, city, state, ZIP [4]
- Domestic address or phone number for serious adverse event reports [7]
- Major allergens declared (“Contains” statement or parentheses), including sesame [10]
- Structure/function claims: evidence on file, bold disclaimer at least 1/16 inch, FDA notice within 30 days of launch [6]
- Required statements at least 1/16 inch tall [1]
How does PMG handle supplement labels for private label brands?
Product Management Group makes private label and custom supplements, including capsules, tablets, powders and gummies. As our Nutraceuticals & Supplements page notes, private label programs start at 1,000 units on select stock formulas and usually launch in 60–90 days, and "a claim that passes the label review can still draw an FTC enforcement action," so we look at both. [13] For budgets, see how much it costs to manufacture supplements; for gummies, see sugar-free pectin gummies with allulose. Ready to start? Start a project with your format, actives and target units.
Frequently asked questions
Does FDA approve supplement labels before they go on sale?
No. Structure/function claims are not pre-approved by FDA, and manufacturers and distributors are responsible for evaluating the safety and labeling of their products before marketing. If you make a structure/function claim, you notify FDA within 30 days of first marketing the product with it. [8][9][6]
Can my brand's name go on the label instead of the manufacturer's?
Yes. The label can name the manufacturer, packer or distributor. If your brand didn't make the product, its name must be qualified with a phrase such as “Manufactured for” or “Distributed by,” followed by your city, state and ZIP code. [4]
Do I need a phone number on my supplement label?
You need a domestic address or a domestic phone number through which serious adverse event reports can reach the responsible person. Either one meets the requirement; many brands print both. [7]
Does every ingredient need a % Daily Value?
No. Only dietary ingredients with an established Daily Value show a percentage. Others are marked with a symbol tied to the footnote “Daily Value not established.” [5]
Do I have to list sesame as an allergen?
Yes. Sesame became the ninth major food allergen on January 1, 2023, and allergen labeling rules apply to dietary supplements. [10][11]
Glossary
- Principal display panel: the front label panel of the package.
- Information panel: the panel immediately to the right of the principal display panel.
- Supplement Facts: the boxed nutrition panel required on dietary supplements (21 CFR 101.36).
- % Daily Value: the share of a nutrient's Daily Value that one serving provides.
- Proprietary blend: a named mix of ingredients listed by total weight rather than by each ingredient's amount.
- Structure/function claim: a statement about a nutrient's effect on the body's normal structure or function.
- Serious adverse event report: a consumer report of a serious health problem after using a product; supplement labels must give a domestic address or phone number for these reports.
- FASTER Act: the 2021 law that made sesame the ninth major food allergen.
Have a product in mind? Ask us directly.
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Read the article →Sources and references
- 1.FDA, Dietary Supplement Labeling Guide: Chapter I. General Dietary Supplement Labeling https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-chapter-i-general-dietary-supplement-labeling
- 2.21 CFR 101.3, Identity labeling of food in packaged form https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.3
- 3.21 CFR 101.4, Food; designation of ingredients https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.4
- 4.21 CFR 101.5, Food; name and place of business of manufacturer, packer, or distributor https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.5
- 5.21 CFR 101.36, Nutrition labeling of dietary supplements https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-C/section-101.36
- 6.21 CFR 101.93, Certain types of statements for dietary supplements https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-F/section-101.93
- 7.FDA, Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary
- 8.FDA, Structure/Function Claims https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/structurefunction-claims
- 9.FDA, Dietary Supplements https://www.fda.gov/food/dietary-supplements
- 10.FDA, Food Allergies https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/food-allergies
- 11.FDA, Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpa
- 12.FTC, Health Products Compliance Guidance (December 2022) https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
- 13.Product Management Group, Nutraceuticals & Supplements https://productmgmtgroup.com/industries/nutraceuticals-and-supplements
Fact-checked: 38 claims verified against sources; 7 adjusted.
Private Label Supplement Label Checklist
A fillable 1-page checklist with the Label Lock steps and all 12 label checks.
PDF · 1 page
About Product Management Group
PMG is a full-service private label manufacturing partner for skincare, nutraceuticals, supplements, personal care, and wellness brands. We handle everything from R&D and formulation through manufacturing, packaging, regulatory compliance, and fulfillment, working with FDA-registered, GMP-compliant partner facilities in Florida, North Carolina, Texas, Minnesota, and Arizona. We work with everyone from first-time founders to established retail brands, with minimums starting at 1,000 units.