Supplement Facts Label – FDA-Compliant Panels for Dietary Supplements

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated November 2025 • 21 CFR 101, 21 CFR 111, FDA Labeling, Dietary Supplements, QA, Regulatory Affairs

A Supplement Facts label is the structured, FDA-regulated information panel required on most dietary supplement products in the United States. It looks similar to a Nutrition Facts panel but follows different rules for serving size, dietary ingredients, units of measure, percent Daily Value (%DV) and presentation. For manufacturers operating under 21 CFR 111 (dietary supplement cGMP), the Supplement Facts label is not just marketing—it is a regulated statement of composition that must match the Master Manufacturing Record (MMR), Batch Manufacturing Record (BMR) and release specifications.

“If the Supplement Facts panel and the batch record don’t tell the same story, one of them is wrong—and FDA will assume it’s you, not the label template.”

1) Where the Supplement Facts Label Sits in the Regulatory Stack

In the U.S., the Supplement Facts label is anchored in 21 CFR 101, which defines how foods and dietary supplements must be labeled, and in 21 CFR 111, which governs how supplements are manufactured. The label panel is where formulation, claims, analytical methods and packaging all converge. It must align with the MMR/BMR, product specifications, stability data and QC release testing. Other jurisdictions (e.g. EU, Canada, Australia) use different panel formats, but the underlying principle is the same: the label is a regulated representation of composition and conditions of use, not a design element that marketing can change at will.

2) Core Components of a Supplement Facts Panel

FDA defines the structure of the panel in detail. A compliant Supplement Facts label typically includes: the title “Supplement Facts”; serving size and servings per container; a list of dietary ingredients (with their forms, such as “Vitamin D (as cholecalciferol)”); amount per serving; percent Daily Value (%DV) where applicable; and a separate list of other ingredients (excipients, flavors, colors) below the box. Footnotes and special statements (e.g. “Daily Value not established”) also follow standard wording. Fonts, line weights and how information is grouped (e.g. proprietary blends, child vs adult use) are all constrained by the regulation and FDA guidance, not by brand preference alone.

3) Relationship to MMR, BMR and Formulation Control

Under 21 CFR 111, each product has a Master Manufacturing Record (MMR) that defines the formula, theoretical yield and target label claims. The Supplement Facts label should be a direct, controlled output of that master recipe, not a separately maintained spreadsheet. During production, the Batch Manufacturing Record (BMR) or eBMR captures actual additions, adjustments (e.g. potency adjustment) and in‑process checks. If the formula or assay changes, the Supplement Facts panel must be updated via change control and tied back to revised specifications and validations before being used in production labeling.

4) Serving Size, Units and Daily Values

Serving size for supplements is not arbitrary; it must be based on the amount “customarily consumed” or specified by regulation and clearly expressed in common household and metric units (e.g. “2 capsules (1.2 g)”). Amounts of dietary ingredients are declared per serving, using the correct units (mg, mcg, IU where still permitted) and rounding rules. Percent Daily Values are based on FDA reference values and must be calculated using formulation and assay data, including overage where justified by stability studies. Errors in serving size, unit expression or DV calculation are frequent causes of FDA observations and misbranding findings, especially when formulation changes outpace label updates.

5) Dietary Ingredients vs Other Ingredients

The Supplement Facts box only lists dietary ingredients as defined by regulation (vitamins, minerals, herbs, amino acids, dietary substances and their concentrates/extracts). Excipients, processing aids, capsule shells, flavors, colors and sweeteners appear in the “Other ingredients” list beneath the panel. Keeping this separation clear in the label and in supporting systems (e.g. BOM, recipe and label control) is important for avoiding misleading presentations. For example, moving a sweetener into the Supplement Facts box as if it were a “functional” ingredient can trigger regulatory concern if it implies a nutrient or structure/function effect that is not supported.

6) Claims, Disclaimers and Structure/Function Language

While the Supplement Facts panel itself is largely compositional, it sits next to claims that are tightly regulated: nutrient content claims (“high in…”, “good source of…”), health claims, and structure/function claims. Structure/function claims for supplements require the standard disclaimer about not being evaluated by FDA and not intended to diagnose, treat, cure or prevent disease. The declared amounts in the panel must substantiate any quantitative claims (e.g. “1000 mg Vitamin C per serving”) at end of shelf life, considering manufacturing variability and degradation. Label review therefore combines interpretation of 21 CFR 101, 21 CFR 111, marketing objectives and the underlying analytical and stability data set.

7) Allergens, Warnings and Special Populations

Allergen statements (e.g. “Contains: soy, milk”) are technically separate from the Supplement Facts box but are part of the overall labeling picture. Common U.S. allergens follow FALCPA/FALCPA2, while other jurisdictions maintain their own priority lists. Supplements may also require age restrictions, pregnancy warnings, drug–nutrient interaction warnings, upper intake limit considerations or specific contraindications. Operationally, these statements should be controlled in the same way as the panel data—through governed templates, SOPs and, ideally, electronic labeling control workflows—so they cannot be omitted or altered by local artwork edits.

8) Artworking, Change Control and Labeling Governance

In most organizations, the Supplement Facts label is managed via a structured labeling control process that touches regulatory, QA, marketing and graphics teams. Any change in formula, specification, claim, serving size or regulatory expectation should trigger a controlled update to the panel via change control, with documented impact assessment and approvals. Version history must be preserved, and “old art” must be quarantined or removed from use. Electronic DMS and approval workflows are increasingly used to ensure that only the current, approved Supplement Facts panel can flow into printing or digital packaging content.

9) Line Clearance, Label Verification and On‑Line Control

Even a perfectly designed panel fails if the wrong label ends up on the product. On the shop floor, line clearance, label verification and packaging controls are critical. Typical measures include barcode scans against an expected GTIN/SSCC, camera‑based machine vision inspection of panels, and checks for lot, expiry and variable data. In GxP‑aware environments, these checks are orchestrated by MES or packaging‑line systems that enforce barcode validation and poka‑yoke at the point of application, reducing the risk of mix‑ups and mislabeling recalls.

10) Data Integrity and Electronic Label Records

Where Supplement Facts panels are generated, stored or approved electronically, they fall under general data integrity expectations and, where applicable, 21 CFR Part 11 and Annex 11. That means controlled user access, version control, audit trails for changes, and, in many cases, electronic signatures for approval. The label panel may also be referenced in eMMR and eBMR workflows, especially where batch documentation automatically populates finished‑product label content or vice versa. Poor control of label data—e.g. local .ppt files or uncontrolled PDFs—can undermine an otherwise robust supplement quality system.

11) International Variants and Multi‑Market Labels

Global brands often produce supplements for multiple jurisdictions, each with its own panel rules (e.g. EU nutrition tables, Canada’s “Supplement Facts/Information”, or markets using country‑specific RDI/RDA systems). Operationally, this leads to families of label templates sharing a common formula base but different serving sizes, units, DVs and mandatory statements. A structured labeling and specification system—ideally integrated with MES, QMS and DMS—helps maintain consistency while allowing lawful differences for each market. From an inspection perspective, being able to show how one formulation maps to several compliant panels is increasingly important.

12) Stability, Shelf Life and Overages vs Label Claims

Labels declare amounts the product must deliver throughout shelf life, not just at release. For labile nutrients (e.g. some vitamins, probiotics, enzymes), manufacturers may include intentional overages supported by stability studies. The Supplement Facts panel, the specification and the stability protocol must align: if the label guarantees 100 mg through expiry, the process must ensure this is consistently achieved with reasonable manufacturing and degradation variation. Otherwise, firms risk under‑delivery (misbranding, potential safety/efficacy issues) or extreme over‑delivery (safety concerns, especially where ULs exist). Connecting stability data, recipe versioning and label claims in a controlled data model is therefore essential.

13) Investigations, Recalls and the Supplement Facts Label

Mislabeling remains a major trigger for recalls in the supplement sector. When an issue is discovered—wrong strength, undeclared ingredient, allergen omission—the Supplement Facts panel becomes a key object in the investigation. Teams need to know which label version was used on which lots, how the panel was derived, whether the printed panel matched the approved master, and whether any notifications of change were pending. Systems that link label versions to lot genealogy, recall readiness workflows and deviation/CAPA records make it far easier to scope, manage and defend the response during FDA or customer follow‑up.

14) Practical Implementation Steps for Label Governance

Bringing Supplement Facts under control typically follows a pragmatic sequence. First, consolidate all current labels and identify the “true source” for each panel: MMR, spec, spreadsheet, or vendor portal. Second, harmonise terminology, serving sizes and units based on current regulation, and build single‑source templates governed in a DMS or labeling system. Third, embed panel generation and approval into SOPs, change control and training. Finally, link label selection and verification to MES or line‑level controls so that a non‑current or mismatched Supplement Facts panel simply cannot be printed or applied without an explicit, documented exception.

15) FAQ

Q1. Is a Supplement Facts label required for every dietary supplement?
In general, yes—most dietary supplements sold in the U.S. require a Supplement Facts panel that complies with 21 CFR 101. Limited exemptions exist (e.g. very small packages, certain bulk or institutional products), but these are narrow and should be documented via regulatory assessment rather than assumed.

Q2. Can marketing change the Supplement Facts panel without QA approval?
No. Changes to serving size, ingredient list, amounts, %DV or related claims are quality‑ and regulatory‑relevant and should go through formal change control, with QA/RA review and, where required, updated specifications, validation and stability assessment. Treating the panel as an editable design asset rather than a controlled document is a recurring root cause of mislabeling issues.

Q3. How tightly should the Supplement Facts panel be linked to the MMR?
Ideally, one master data source drives both the MMR and the label panel so that composition and declared claims are always aligned. At minimum, the MMR should explicitly reference the exact label version and include a verification step whenever the formula or label changes. In digital environments, integrating labeling with recipe management and eMMR/eBMR workflows is increasingly seen as best practice.

Q4. Who owns the Supplement Facts content in a typical organisation?
Responsibility is usually shared. Regulatory Affairs interprets the rules and proposes compliant wording and DVs; Product Development and QC ensure formulation and testing can support the claims; Quality owns the approval process and data integrity; and Marketing operates within the boundaries set. Clear RACI definitions in SOPs prevent gaps where no one feels accountable for the final panel.

Q5. What is the fastest way to identify labeling risk across a supplement portfolio?
A common approach is to inventory all SKUs, map each to its current Supplement Facts version, and compare that against the latest formula, spec and regulatory requirements. Differences are then ranked by risk—e.g. allergen declaration gaps, strength mis‑matches, outdated DVs—and remediated via a structured project. Where possible, this exercise is paired with implementing controlled templates and electronic approval workflows so the same drift does not re‑emerge.

Related Reading
• Dietary Supplements & GMP: 21 CFR 111 | MMR | BMR | Stability Studies
• Labeling & Artwork: 21 CFR 101 | Labeling Control | Barcode Validation | Machine Vision Inspection
• Systems & Data: DMS | MES | QMS | Data Integrity
• Traceability & Risk: End‑to‑End Lot Genealogy | Recall Readiness | Risk Management (QRM) | Deviation / NCR