Dietary Supplement
Labeling Requirements
& Checklist

Confirm that the product belongs in this guide

Start with product classification. Calling a product a supplement does not settle its regulatory status, and claims can affect how FDA evaluates it. FDA explains that only a drug can legally claim to diagnose, treat, cure, or prevent a disease. FDA guidance.

This guide is for dietary supplement labeling, not a substitute for drug, conventional-food, cosmetic, or device requirements. Review the formulation, intended use, claims, and target market before selecting a label template.

The dietary supplement label checklist

Use this list to organize a review of the actual artwork and product information. It is not a pass/fail certificate. FDA's general labeling guide identifies the core package statements and panel-placement rules; its current supplement questions and answers also addresses adverse-event contact information and relevant exceptions. FDA general labeling guide; FDA supplement questions and answers.

Some small-volume products or eligible small businesses may qualify for nutrition-labeling exemptions, but the conditions must be examined rather than assumed. FDA guidance.

Review Supplement Facts against the formulation

FDA describes serving size, servings per container, dietary ingredients, and their declared amounts as core Supplement Facts information, with special treatment for ingredients in proprietary blends and certain nutrition-labeling exemptions. FDA guidance.

• Start with product data: reconcile the proposed serving with the formula, dosage form, and ingredient specifications.
• Compare panel and artwork: check that a late designer edit has not changed amounts, units, ingredient names, or required presentation.
• Check exceptions deliberately: do not assume a proprietary blend or small package eliminates every disclosure requirement.
• Review readability at final size: package space and panel rules can affect how information must be displayed.

The FDA guide refers to 21 CFR 101.36 for supplement nutrition labeling and applicable special provisions. FDA guidance.

Distinguish normal-function language from disease claims

Structure/function claims can describe the role of a nutrient or ingredient in normal body structure or function. They are not pre-approved by FDA, but require substantiation that they are truthful and not misleading, a qualifying disclaimer, and notification no later than 30 days after marketing the supplement with the claim. FDA structure/function claims guidance.

A disclaimer does not convert a disease-treatment claim into an acceptable supplement claim. FDA states that only a drug can legally claim to diagnose, treat, cure, or prevent disease. FDA guidance.

Not all label claims use the same rules. FDA distinguishes health claims, nutrient content claims, and structure/function claims; certain health claims require premarket review and authorization. FDA guidance.

Review the full message, not just one sentence

As a practical review step, assess the label alongside the product page, marketplace listing, images, and promotional language. Is a qualified statement on the package contradicted by a disease promise elsewhere? Document the exact wording and the evidence behind it before approval for printing.

Use the correct disclaimer and current placement guidance

For applicable claims under section 403(r)(6), use the required singular or plural wording as appropriate. The singular version is shown below; FDA's claims guide also provides the plural version. FDA claims labeling guide.

FDA's claims guide describes boldface type no smaller than 1/16 inch, adjacent placement without intervening material, or an alternative linked placement with a symbol and a box. Do not assume that adding the text anywhere on the package satisfies the applicable presentation requirements. FDA guidance.

The December 11, 2025 FDA letter is narrow

FDA's letter describes enforcement discretion for the requirement to repeat the disclaimer on each panel bearing an applicable claim. It expressly does not extend that discretion to including the disclaimer, linking it to each applicable claim, or the other requirements of 21 CFR 101.93. FDA's DSHEA disclaimer letter.

Treat that letter as a defined enforcement approach, not removal of every disclaimer rule. Check for subsequent FDA action and the applicable current requirements before finalizing artwork.

Separate business identification from adverse-event contact

The label must include the name and place of business of the manufacturer, packer, or distributor. FDA separately requires a domestic address or domestic phone number through which the responsible person can receive a serious adverse-event report. FDA guidance.

In an artwork review, identify which statement satisfies each requirement and confirm that the contact route actually reaches the appropriate responsible firm. A foreign business address, a general email, or a customer-service website should not be treated as an automatic substitute for the required domestic contact.

Do not stop the review at the artwork

A well-formatted label does not resolve ingredient safety or eligibility. FDA explains that an applicable new dietary ingredient notification must reach the agency at least 75 days before interstate marketing, with an exception described for qualifying ingredients already present in the food supply in an unaltered form. FDA guidance.

• Ingredient records: collect the formula, specifications, and the rationale for ingredient eligibility.
• Ingredient statements: reconcile dietary ingredients and other ingredients with the label.
• Allergen review: evaluate the product and label for applicable allergen disclosures rather than relying on a generic template.
• Changes: revisit the review when the formulation, supplier information, serving, package, or claims change.

This page is a labeling starting point, not a complete safety assessment, ingredient-eligibility determination, or new dietary ingredient filing guide.

A practical pre-print review workflow

Use this workflow to keep the regulatory review connected to the actual version that will be printed. These are recommended operational steps, not an assertion that FDA requires a third-party consultant.

• Collect: final formula, ingredient specifications, serving information, draft artwork, and all planned claims.
• Classify: confirm product category and separate the applicable claim types.
• Check: work through the required label statements, panel presentation, domestic contact, and claim obligations.
• Record: create an issue list showing the original wording, why it needs attention, the source requirement, and the proposed correction.
• Revise: update both package artwork and related product-listing material.
• Recheck: review the revised artwork at final print size and compare it with the product data.
• Retain: keep the approved version and supporting records; review again after material changes.

Why review before printing?

As an operational matter, a change to a design file is different from a change to printed packaging or shipped inventory. Consider potential redesign, reprint, relabeling, and launch-delay costs when planning the review, without assuming a review guarantees clearance or a fixed savings amount.

Choose the next step that matches your need

Turn this checklist into an actionable review of your label

Knowing the requirements is the starting point. Applying them to your formula, Supplement Facts panel, claims, and final artwork is the next step. Our dietary supplement label-review service is designed to identify issues and provide specific corrections, rather than simply giving you a pass/fail answer.

• Product-specific assessment: review your artwork alongside ingredient information, claims, and intended market and sales channel.
• Documented findings: understand each identified issue and why it matters.
• Prioritized corrections: receive actionable changes you can use when revising the label.

Planning a launch, revising claims, importing a product, or changing a formula? Request a label-review quote below. Tell us the number of products and your target date so we can discuss the appropriate scope and pricing before you commission the work.

• Checking for obvious concerns? Use the supplement-label red-flag self-check. Treat it as triage, not a compliance determination.
• Need an artwork and claims review? Read the dietary supplement label-review service page for the scope and next steps.
• Concerned about FDA enforcement? Read the supplement-label warning-letter guide, and assess any actual FDA notice on its own facts and deadline.
• Need broader registration or import guidance? Browse the FDA Compliance Educational Center.

FDA does not require label approval to import or distribute a dietary supplement under the regulations described in its labeling guide. Professional review is a private service, not FDA approval. FDA dietary supplement labeling guide.