Supplement Label Requirements: What FDA Requires and Amazon Checks
Almost every line on a supplement bottle is set by federal rules, and Amazon now expects your listing to match that label word for word. Here is the full checklist, with the regulation behind each rule.
Short answer
FDA requires five core statements on a supplement label: a statement of identity with the words "dietary supplement," net quantity of contents, a Supplement Facts panel (21 CFR 101.36), an ingredient list, and the maker or distributor's name and place of business. It also needs a U.S. address or phone number for adverse event reports, allergen labeling, and the FDA disclaimer for any structure/function claim.
What a Supplement Label Must Say
FDA does not approve supplement labels before they go to market. Its own labeling guide says label approval is not required to import or distribute a dietary supplement. That means the brand carries the risk. A wrong label makes the product misbranded, and on Amazon that can mean a pulled listing.
FDA's Dietary Supplement Labeling Guide lists five statements every supplement container needs. Other laws and rules add four more items that apply to most products or to specific situations. The table below is the full set, with the section of the Code of Federal Regulations (CFR) that controls each one.
The principal display panel (PDP) is the front of the package. The information panel is the panel immediately to its right. Required information goes on one of those two, and under 21 CFR 101.2(e) you cannot put non-required material, such as a UPC bar code, between required items on the information panel.
Identity and Net Quantity: The Front of the Bottle
The front panel must carry two items: what the product is and how much is in it. Brand name, claims and design fit around them.
Statement of identity. Under 21 CFR 101.3, the identity statement must include the term "dietary supplement." You may replace the word "dietary" with the name of the ingredient ("magnesium supplement") or a descriptive term ("herbal supplement with vitamins"). The statement must be in bold type, in a size reasonably related to the most prominent print on the front panel, and in lines generally parallel to the base of the package (101.3(d)). FDA's guide adds that a brand name is not a statement of identity.
Net quantity of contents. Under 21 CFR 101.7, the front panel must state how much product is in the package, by weight, measure, numerical count, or count combined with weight. The statement must sit as a distinct item in the bottom 30 percent of the front panel (101.7(f)), in bold, with clear space around it, and it cannot use qualifiers that exaggerate the amount, such as "jumbo" or "full." FDA's guide says that when you state weight or volume, you list both metric and U.S. customary units, for example "Net Wt. 10.6 oz (300 g)."
FDA's labeling guide says to find the front panel area by multiplying height by width for a box, or 40 percent of the circumference times the height for a round bottle. A bottle with a 7 inch circumference and a 3 inch label height has 8.4 square inches, so its net quantity needs letters at least 1/8 inch tall.
The Supplement Facts Panel, Line by Line
The Supplement Facts panel is the most technical part of the label, and it is the part your Amazon listing has to match. The rule is 21 CFR 101.36. Here is what it requires, in order.
Title and box
The title "Supplement Facts" must be bold, larger than all other print in the panel, and the panel sits inside a hairline box (101.36(e)(1) and (e)(2)).
Serving size and servings per container
Serving size uses a unit that fits the form, such as tablets, capsules, gummies or scoops. Servings per container goes directly under it, unless the net quantity already states it (101.36(b)(1)).
Amount per serving
Each dietary ingredient is listed with its amount by weight per serving. The weight is the weight of the nutrient itself, not its source: list the calcium, not the calcium carbonate (101.36(b)(2)(ii)).
Nutrients with Daily Values, in a fixed order
Vitamins and minerals that have a Daily Value are listed in the order set by the rule, starting with vitamin A, vitamin C, vitamin D and vitamin E, with a percent Daily Value for each. Vitamin D must be declared in micrograms; IU is optional and goes in parentheses after the mcg amount.
Other dietary ingredients
Ingredients with no Daily Value, such as most botanicals, creatine or ashwagandha, go below a heavy bar, each with its weight per serving and an asterisk pointing to the footnote "Daily Value not established" (101.36(b)(3)).
Proprietary blends
A blend may show only the total weight of the blend, with its components listed in descending order by weight. Vitamins and minerals inside a blend still have to show their individual amounts (101.36(c)). On Amazon, you cannot claim a component amount the label does not state.
Source ingredients
You may name the source in parentheses, for example "Magnesium (as magnesium glycinate)." A source named inside the panel does not have to be repeated in the ingredient list (101.36(d)).
Type and layout
One easy-to-read type style, one color on a contrasting background where practical, and at least 8 point type for most text, with 6 point for column headings and footnotes (101.36(e)(3) and (e)(4)). Small packages under 12 square inches may use 4.5 point (101.36(i)(2)).
One more rule matters for testing. Under 101.36(f), FDA tests label compliance on a composite sample from the lot, using the nutrient rules in 21 CFR 101.9(g). For added vitamins and minerals (Class I nutrients), the product must contain at least the amount on the label. For naturally occurring nutrients (Class II), it must contain at least 80 percent. Reasonable overages are acceptable within good manufacturing practice. Your label number should be one the product still meets late in its shelf life. Our guide to Amazon supplement testing requirements shows how Amazon's testing uses the same label numbers.
Ingredients, Address, Allergens and Warnings
Ingredient list
Per 21 CFR 101.4(g), the list goes immediately below the Supplement Facts panel, or directly to its right if there is no room below. It starts with "Ingredients" or, when some sources are already named inside the panel, "Other ingredients." It must include non-dietary ingredients such as capsule shells, fillers, binders, colors, flavors and sweeteners, in descending order by weight.
Botanical names
Herbal ingredients use the common names standardized in the reference Herbs of Commerce, plus the part of the plant used ("ashwagandha root"), and the Latin name when the common name is not in that reference (101.4(h)).
Name and place of business
Per 21 CFR 101.5, the label names the manufacturer, packer or distributor. If you are a brand using a contract manufacturer, qualify your name with a phrase such as "Distributed by" or "Manufactured for" (101.5(c)). The place of business includes city, state and ZIP code, and the street address unless it appears in a current city or phone directory (101.5(d)).
Domestic address or phone for adverse events
Section 403(y) of the FD&C Act requires a domestic address or domestic phone number where the responsible person can receive serious adverse event reports. FDA's 403(y) guidance says that means a full U.S. mailing address with street or P.O. box, city, state and ZIP, or a phone number with an area code. FDA also recommends a short statement telling consumers they may report serious adverse events to that address or number.
Allergens
Supplements are covered by federal allergen labeling. FDA lists nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame, with sesame added as of January 1, 2023. Name the food source either in parentheses in the ingredient list, such as "lecithin (soy)," or in a "Contains" statement right after the list.
Iron warning
Solid supplements such as tablets or capsules that contain iron as an iron source must carry FDA's accidental overdose warning, word for word, boxed with hairlines, on the information panel (21 CFR 101.17(e)).
Disclaimer for structure/function claims
If the label says what an ingredient does in the body, such as "supports restful sleep," it needs the FDA disclaimer in bold, at least 1/16 inch tall, linked to the claim by an asterisk or placed right next to it (21 CFR 101.93). See our structure/function claims guide.
What Amazon Checks Against Your Label Image
Amazon rolled out an updated dietary supplement policy in the U.S. on March 31, 2026, according to NutraIngredients. The headline change is that detail pages are no longer treated as marketing copy. Anything your title, bullets, images or A+ content claims about the product must match the Supplement Facts panel, and the trade press reports that Amazon uses automated scanning to find mismatches.
The checks below come from Amazon's dietary supplements policy in Seller Central as of October 2026, which you can only read while logged in. Two vendor summaries say the same things in public: a June 2026 Intertek presentation (Intertek sells the testing Amazon requires) and Food Label Maker (which sells label software). Amazon edits this policy often, so confirm the current wording before you print.
A real photo of the whole label, all sides
Amazon wants images of the full English label as it appears on the product, covering every side of the package and the full facts panel. Images and documents submitted for review must be authentic and unmodified, not computer or AI generated, so a rendered mockup does not count.
Every required element readable
Amazon lists the identity statement, total quantity, Supplement Facts panel, ingredient list, directions, warnings, certification logos, the name and address of the brand owner or manufacturer, and identifying codes such as a lot number.
Listing numbers equal label numbers
Ingredient names, amounts per serving and serving sizes in the title and bullets must match the panel exactly. Amazon does not allow inflated raw herb weights, so a title that turns a 250 mg extract into "5,000 mg equivalent" when the panel lists 250 mg is the kind of mismatch to remove. State the amount the way the panel states it.
No FDA logo and no "FDA approved"
Amazon bars the FDA logo and any claim of FDA approval the product does not actually have. FDA does not approve supplements before sale.
No disease claims anywhere, including keywords
Amazon's policy bars disease claims, comparisons to prescription drugs, steroid-style claims and disease names in backend search terms.
Design the label first, then write the listing from it. Our Amazon dietary supplement policy guide covers the rest of the policy, and the main image guide covers how the bottle reads at thumbnail size.
How to Build or Audit a Supplement Label
Lock the formula and serving size
Get the final formula from your manufacturer with each dietary ingredient's amount and source form. Decide the serving, such as 2 capsules, before design work, because every panel number depends on it.
Draft the Supplement Facts panel
List nutrients with Daily Values in the order 21 CFR 101.36 sets, calculate each percent Daily Value from FDA's reference values, then list other dietary ingredients below the heavy bar with the "Daily Value not established" footnote.
Write the ingredient list
Add every remaining ingredient, including capsule shell, fillers and flavors, by descending weight, headed "Other ingredients" if sources are named in the panel.
Check allergens and special warnings
Ask your manufacturer in writing whether any of the nine major allergens are in the formula or capsule, and add a "Contains" statement if so. Add the iron warning for solid iron products.
Set the front panel
Write the statement of identity with "dietary supplement" or a variant in bold. Measure the front panel area, size the net quantity type from the table in 21 CFR 101.7(i), and place it in the bottom 30 percent.
Add the business name and adverse event contact
Use your legal company name with "Distributed by" and a full U.S. address or a phone number with area code, plus FDA's recommended adverse event line.
Review every claim
Ask of each sentence whether it describes normal body function or a disease. Link the disclaimer to each structure/function claim and notify FDA of each claim within 30 days after you first market it.
Print a proof and photograph it
Check type sizes on a physical proof, not a screen. Photograph the finished package on every side in sharp images for Amazon, then write the listing from the label.
When to Get Help and When to Do It Yourself
Do it yourself if you have a simple formula, a manufacturer that gives you a draft Supplement Facts panel, and a designer who will follow the checklist above. Check the draft against these rules and you may not need anyone else.
Get a regulatory attorney if your product uses a new dietary ingredient, sits close to drug territory (sleep, weight, blood sugar, hormones), targets children or pregnant women, or will be sold outside the U.S. Those are legal questions.
Get design and listing help if the label is right but the package does not sell, or your listing does not match the label. That is where Evolve fits. Packaging and label design is quoted per project or done inside brand management hours. Listing images, infographics and Premium A+ run $295, $495 or $595 through graphic design, and a rewrite of title, bullets and backend terms built from your label is $495 per listing through listing optimization.
Brands that want one person watching label, listing, images and launch together pick a retainer: Brand Support at 5 hours for $750 a month, Brand Manager at 10 hours for $1,250, Brand Manager Plus at 20 hours for $2,000, or Full Brand Management at 40 hours for $3,600, paid upfront and month to month. See the pricing page. If you want a second set of eyes first, request a free listing audit, email Ian at [email protected], or call or text 719-257-3557. We will tell you if nothing needs fixing.
Where These Facts Come From
eCFR: 21 CFR 101.36 Nutrition labeling of dietary supplements
ecfr.gov · Open source →
eCFR: 21 CFR 101.3 Identity labeling of food in packaged form
ecfr.gov · Open source →
eCFR: 21 CFR 101.7 Declaration of net quantity of contents
ecfr.gov · Open source →
eCFR: 21 CFR 101.4 Food; designation of ingredients
ecfr.gov · Open source →
eCFR: 21 CFR 101.5 Name and place of business
ecfr.gov · Open source →
eCFR: 21 CFR 101.93 Certain types of statements for dietary supplements
ecfr.gov · Open source →
FDA: Dietary Supplement Labeling Guide
fda.gov · Open source →
FDA: Q&A on labeling dietary supplements required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (403(y))
fda.gov · Open source →
FDA: Food Allergies
fda.gov · Open source →
Amazon Seller Central: Dietary supplements policy
sellercentral.amazon.com · Open source →
NutraIngredients: Amazon's new supplement policy could trigger delistings (March 13, 2026)
nutraingredients.com · Open source →
Intertek: Amazon supplement webinar, what sellers need to know (June 2026, vendor)
preview.intertek-ar.com · Open source →
Food Label Maker: Amazon's Supplement Update 2026 (vendor)
foodlabelmaker.com · Open source →
About the Author
Ian Smith
Founder, Evolve Media Agency
Ian has run Evolve Media Agency since 2017 and has sold on Amazon since 2015. He and Megan run brand management, launches, PPC and in-house photo and video for Amazon, Shopify and TikTok Shop brands, including supplement brands, from Colorado. Questions about this page go straight to him at [email protected].
Common Questions
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