Dietary supplement labeling requirements come from the FDA under the Dietary Supplement Health and Education Act of 1994, and every label must carry a statement of identity that includes the word “supplement,” a net quantity of contents, a Supplement Facts panel, an ingredient list, the name and address of the manufacturer, packer, or distributor, allergen disclosures, and specific warnings and disclaimers when they apply. The FDA does not approve supplement labels before products go on sale. The company whose name appears on the package is responsible for making sure the label is truthful and that the product is neither adulterated nor misbranded.1U.S. Food and Drug Administration. Dietary Supplements Getting any piece wrong can trigger warning letters, seizures, injunctions, or criminal prosecution.
Statement of Identity
The principal display panel is the part of the package a shopper is most likely to see. It must carry a statement of identity that tells consumers what the product is, and for supplements that statement has to include the term “dietary supplement.” The word “dietary” can be replaced with something more descriptive, such as “herbal supplement” or “calcium supplement,” but the word “supplement” itself must stay.2eCFR. 21 CFR 101.3 – Identity Labeling of Food in Packaged Form A product name that misleads consumers about what the product actually is can cause the entire product to be classified as misbranded.
Net Quantity of Contents
The front panel also has to declare how much product is inside, as a distinct item expressed in weight, measure, numerical count, or a combination. A bottle of capsules might read “60 capsules”; a powder might state its weight in grams. The declaration goes in the bottom 30 percent of the principal display panel, parallel to the base of the package, and minimum type size scales with the panel’s area. Packages with a display panel of five square inches or less are exempt from the bottom-30-percent placement rule but still have to meet the minimum type size.3eCFR. 21 CFR 101.7 – Declaration of Net Quantity of Contents
The Supplement Facts Panel
The Supplement Facts box is the most format-intensive part of the label, governed line by line under 21 CFR 101.36. It opens with the serving size and the number of servings per container, and every amount that follows is tied to that serving.4eCFR. 21 CFR 101.36 – Nutrition Labeling of Dietary Supplements
Ingredients inside the panel fall into two groups. The first covers nutrients with an established Reference Daily Intake or Daily Reference Value, such as vitamin D, calcium, iron, and potassium. Each appears by name with the amount per serving and the percent daily value. The second group covers dietary ingredients without an established daily value, such as botanical extracts, probiotics, or enzymes. These are listed below the first group and must carry a symbol, usually an asterisk, in the daily-value column, pointing to a footnote reading “Daily Value not established.”4eCFR. 21 CFR 101.36 – Nutrition Labeling of Dietary Supplements
Heavy black bars separate the major sections of the panel: one below the servings-per-container line, one after the last nutrient with a daily value, and one after the last ingredient without a daily value. The layout is enforced strictly, because the standardized format lets consumers compare products at a glance. Every ingredient included for its nutritional or supplemental value belongs inside this panel.
Other Ingredients on the Information Panel
The information panel sits immediately to the right of the principal display panel, with some flexibility when that space is too small or unusable.5eCFR. 21 CFR 101.2 – Information Panel of Package Form Food Anything not already disclosed inside the Supplement Facts box must appear in a separate list here, typically under the heading “Other ingredients.” That list covers inactive materials such as fillers, binders, coatings, and flavoring agents, and it must be in descending order by weight.6eCFR. 21 CFR 101.4 – Food; Designation of Ingredients
Manufacturer, Packer, or Distributor
Every label must show the name and place of business of the manufacturer, packer, or distributor, including city, state, and ZIP code. The street address is also required unless the business is already listed in a current city or telephone directory. When the company on the label did not actually make the product, the label has to say so with a qualifying phrase such as “Manufactured for” or “Distributed by.”7eCFR. 21 CFR 101.5 – Food; Name and Place of Business of Manufacturer, Packer, or Distributor When a safety issue surfaces, regulators and consumers need to know who to contact.
Major Food Allergen Disclosures
Supplements are subject to the same allergen labeling rules as conventional packaged food. Federal law recognizes nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.8U.S. Food and Drug Administration. Food Allergies Sesame became the ninth allergen under the FASTER Act, effective January 1, 2023.9U.S. Food and Drug Administration. The FASTER Act: Sesame Is the Ninth Major Food Allergen
If any ingredient contains or is derived from one of these allergens, the label must disclose the source, and there are two acceptable formats. The allergen name can appear in parentheses after the ingredient (“lecithin (soy)”), or the label can add a “Contains” statement immediately after the ingredient list (“Contains milk and soy”). For tree nuts, fish, and crustacean shellfish, the specific species has to be named rather than the general category. The FDA has not set threshold levels for any allergen, so even trace amounts from intentional use require disclosure.
Iron Warning Statement
Any supplement in tablet, capsule, or other solid oral form containing iron or iron salts must carry a specific 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.”10eCFR. 21 CFR 101.17 – Food Labeling Warning, Notice, and Safe Handling Statements The warning has to appear prominently on the information panel, set off in a box using hairlines. If the immediate container sits inside a retail package, both layers need the warning.
Structure/Function Claims and the FDA Disclaimer
A structure/function claim describes how a nutrient or ingredient affects a normal body function, such as “supports healthy digestion” or “helps maintain strong bones.” These are among the few health-related statements allowed on a supplement label without prior FDA authorization, and the tradeoff is a mandatory disclaimer.
Any supplement making a structure/function claim must display this exact text: “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.” The disclaimer must be in boldface type no smaller than one-sixteenth of an inch. When it sits next to the claim, no box is required. When it appears elsewhere on the label, it must be set off in a box and linked to the claim with a symbol such as an asterisk.11eCFR. 21 CFR 101.93 – Certain Types of Statements for Dietary Supplements On multi-page labeling such as catalogs or brochures, the disclaimer must appear on every page carrying a claim.
Where Structure/Function Ends and Disease Claims Begin
This is where companies get into the most trouble. A structure/function claim describes how an ingredient affects normal body processes. A disease claim says or implies that a product can prevent, treat, or cure a specific illness. Supplements may not carry disease claims; only FDA-approved drugs can.
The difference is often subtle. “Supports joint health” is a permissible structure/function claim. “Reduces the pain and stiffness associated with arthritis” is a disease claim that would turn the same supplement into an unapproved drug in the eyes of the law. Disease claims can be explicit or implied. Naming a product “CarpalHealth” or “CircuCure” creates an implied disease claim through the product name alone. Using symbols like a heart or an EKG tracing, citing journal articles about disease treatment, or listing an ingredient well-known for treating a condition (aspirin or digoxin, for example) can all cross the line.12U.S. Food and Drug Administration. Small Entity Compliance Guide on Structure/Function Claims Even saying a product helps people deal with the side effects of a disease therapy can be treated as a disease claim if the side effect itself qualifies as a disease.
Claiming a product belongs to a drug class triggers the same prohibition. Calling a supplement an “antibiotic,” “antidepressant,” or “antiviral” is treated as a disease claim regardless of what the ingredients actually are. If a claim crosses that line, the FDA can treat the product as an unapproved new drug and pursue seizure, injunction, or criminal charges.
30-Day Notification for Structure/Function Claims
Once a supplement bearing a structure/function claim goes on sale, the manufacturer, packer, or distributor has 30 days to notify the FDA’s Office of Dietary Supplement Programs. The notice must include the company’s name and address, the exact text of the claim, the dietary ingredient or supplement the claim is about, and the brand name of the product. A responsible individual must sign the notice and certify that the company has substantiation showing the claim is truthful and not misleading.11eCFR. 21 CFR 101.93 – Certain Types of Statements for Dietary Supplements
The FDA sends an acknowledgment letter after receiving the notification. That letter is not an approval. It confirms receipt, and the agency can still take enforcement action later if it determines the claim is false, misleading, or crosses into disease-claim territory.13U.S. Food and Drug Administration. Notifications – Structure/Function and Related Claims in Dietary Supplement Labeling
Substantiation Behind the Claim
Putting a claim on the label is easy. Defending it if challenged is where the cost lies. The company has to have substantiation in hand before the product ships, and the person signing the 30-day notification certifies that substantiation exists. The FDA applies the same principles to label claims that the Federal Trade Commission applies to supplement advertising: the evidence must be competent and reliable, developed and evaluated objectively by qualified experts using accepted methods.14Federal Trade Commission. Health Products Compliance Guidance Many supplement companies do not clear that bar.
Other Requirements That Affect Whether the Product Can Ship
A few obligations sit next to the label but decide whether a compliantly labeled product can lawfully be sold at all. They are worth flagging so a well-designed label is not undone by something outside the panel.
If a supplement contains a dietary ingredient not sold in the United States before October 15, 1994, and not present in the food supply in an unaltered form, the manufacturer or distributor must submit a new dietary ingredient (NDI) notification to the FDA at least 75 days before selling the product, and the product cannot ship during that window. Without notification, the product is adulterated by default.15eCFR. 21 CFR Part 190 Subpart B – Requirement for Premarket Notification
The company whose name appears on the label (the “responsible person”) must report any serious adverse event associated with the supplement to the Secretary of Health and Human Services within 15 business days of receiving the report, and must include a copy of the product label. Follow-up medical information received within a year gets another 15 business days.16Office of the Law Revision Counsel. 21 USC 379aa-1 – Serious Adverse Event Reporting for Dietary Supplements A serious adverse event includes death, a life-threatening experience, hospitalization, a persistent disability, a congenital anomaly, or any event that requires medical intervention to prevent one of those outcomes.
Anyone who manufactures, packages, labels, or holds dietary supplements must also follow current good manufacturing practice regulations under 21 CFR Part 111, which cover the identity, purity, strength, and composition of the finished product. A supplement can have a perfectly compliant label and still be treated as adulterated if it was produced outside those requirements.
Supplements containing bioengineered ingredients may also need a disclosure under the National Bioengineered Food Disclosure Standard, administered by the USDA rather than the FDA. Disclosure is required when an ingredient is on the USDA’s List of Bioengineered Foods (including corn, soy, canola, and sugarbeet) and the modified genetic material is still detectable. Products certified under the National Organic Program are exempt, as are very small manufacturers with annual receipts under $2.5 million. Inadvertent bioengineered content of no more than five percent of a given ingredient does not trigger disclosure.17Federal Register. National Bioengineered Food Disclosure Standard