FDA labeling compliance touches every aspect of packaging, from design to finishing. In the United States, packaging is more than a display medium; it has to support accurate, readable, and prominent disclosure of required information. For supplements, cosmetics, or other packaged goods, labeling rules ensure both consumer safety and brand integrity. Packaging design and regulatory standards meet at a crossroads when the shape, format, or materials of a container have an impact on how required label elements appear, how consumers read them, and how regulators evaluate them.
Key regulation is contained in Title 21 of the Code of Federal Regulations (CFR)-specifically, 21 CFR Part 101 (Food Labeling) and 21 CFR Part 701 (Cosmetic Labeling). Sections like § 101.1, which defines “Principal Display Panel,” and § 701.10, addressing cosmetics’ principal display panel, define how much of the packaging must be devoted to the required information and how label space and visibility are measured.
Everything from container shape to label layout to finishing treatments can affect whether the required elements appear where and how the law demands. Packaging that doesn’t integrate these requirements may render the product misbranded under the FD&C Act, exposing the brand to enforcement. A design-first mindset paired with regulatory awareness ensures packaging supports both brand identity and legal compliance.
FDA Labeling Compliance Basics Explained
Under the FD&C Act, the term “label” refers to the physical information on the container or wrapper, while “labeling” extends to all written, printed, or graphic matter accompanying the product. These definitions frame how packaging and its text are regulated. For instance, the label must convey identity, net quantity, manufacturer details, ingredient listing, etc., and must appear on the package or wrapper or accompany it.
Thus, package design should ensure space for labeling and that the required information is available to the consumer in the context of sale and use.
Overview of 21 CFR Part 101 Food Labeling and 21 CFR Part 701 Cosmetic Labeling
For foods and dietary supplements, the required labeling features are outlined in 21 CFR Part 101 and include the PDP, IP, ingredient lists, net quantity, and nutrition or supplement facts panels.
For cosmetics, 21 CFR Part 701 lists the requirements for labeling to include identity, net quantity, name/place of business, ingredient listing, and placement on the package.
Even though packaging rules apply across categories, a brand should know which part of the CFR applies to its product type and that packaging and labels correspondingly align with those.
Overview of Principal Display Panel and Information Panel
PDP is defined in § 101.1 as “that part of a label that is most likely to be displayed … under customary conditions of retail sale.” The PDP must hold certain required statements (e.g., name of product and net quantity). The Information Panel (IP) is the adjacent panel where additional required information (such as manufacturer name, ingredient list) typically appears. The packaging design must clearly delineate PDP and IP real estate and ensure that the required elements appear in the correct panel.
For example, curved bottles, pouches, or multi-panel designs make it complicated to assign which panel qualifies as PDP and which as IP. If artwork spills into the PDP without allowing space for mandatory disclosures, legal risk increases.
FDA vs. FTC Labeling Jurisdiction Differences
The FDA stipulates most required labeling and packaging content for foods, supplements, cosmetics, and drugs, ensuring that such mandatory disclosures, including ingredient lists, net quantity of contents, names/addresses of manufacturer/packer/distributor, warnings, and claims, among others, conform to the FD&C Act and accompanying CFR sections. In the case of advertising claims-especially where the claim is conveyed across the Federal Trade Commission (FTC) may also be involved, particularly in the case of performance, benefit, or health claims.
Therefore, packaging design must be performed not only in conformance with the FDA’s mandatory labeling laws but also with circumspection about claims that may fall under FTC scrutiny. Some in-package treatments-such as imagery, design cuing, and brand names-serve as claims; thus, designers must adhere to both regulatory frameworks: design an aesthetic that does not interfere with necessary disclosures while at the same time avoiding unintended problematic claims.
How Custom Packaging Affects Label Layout
Custom packaging design also introduces special challenges in terms of labeling compliance. Variables such as bottle shape, pouch format, box design, or multi-unit packs each affect how and where required disclosures appear.
Influence of Bottle Shape, Box Design, or Pouch Format on PDP and IP
The available space for the PDP and IP ais defined by the container’s size and shape. For instance, a cylindrical bottle may display its PDP on part of the circumference: § 101.1(b) says for cylindrical containers, 40 % of the product of height times circumference defines the PDP area. Legal Information Institute I. If the package has an unusual geometry – like a tall, narrow pouch, or a box with multiple compartments – the label designer must decide where the PDP will be, and ensure required statements fit within the defined panel area and that the IP is accessible.
Wrap-around graphics, embossing, or transparent windows may reduce usable label space or obscure required information, raising regulatory risk.
Minimum font size and typeface legibility
The legibility requirements are reflected in many subparts of the labeling regulations. For instance, § 701.3(b), which deals with cosmetics, states that the ingredient declaration shall appear in letters not less than 1/16 inch in height in packages that have enough surface area to accommodate the declaration. Likewise, label guides for food packaging stress that the statements required to appear must do so with prominence and conspicuousness, not obscured by graphics or design.
Packaging materials and package design shall not compromise the readability of label text under normal conditions of purchase (shelf lighting, angle of view, etc.). The use of embossed surfaces or metallic finishes may impair contrast or legibility, and such aesthetic choices shall be considered for their compliance.
How embossing, transparent labels, or curved surfaces can impact compliance
Embossed containers, metallic or transparent windows, or curved pouches present design challenges: required statements may wrap around the curvature, making them less legible; transparent windows may reveal content behind the label, reducing contrast; embossing may distort print. The regulation requires that required disclosures be visible and readable under customary conditions of sale.
If embossing or design elements impede legibility or cause crowding of required statements, the label may violate the misbranding provisions of the FD&C Act. Packaging designers must test label legibility in the real world and ensure that the required text remains clear. The law firm guide summarises this risk: “The PDP must be large enough to accommodate all the mandatory label information … without obscuring design, vignettes or crowding.” Holland & Hart
Balancing Aesthetics and Readability in Custom Design
The best package design integrates brand identity through colour palettes, typography, material finish, and shape, balanced with the need for compliance. Legibility and disclosures should be intrinsic to the design brief from the outset, rather than an afterthought. Materials, container geometry, label panels, and graphic treatments should be tested in mock-ups and scale models to confirm that required statements-identity, net quantity, manufacturer, etc.-are correctly presented, font size is adequate, and crowding or obscuring does not occur. By harmonizing aesthetics and regulation up-front, packaging avoids redesigns at the last minute, regulatory delays, or mis-branding risk.
Mandatory Labeling Elements
Proper labeling of a packaged product means that important information appears in its correct place, in the proper format, and in an easily readable form; lack of this may render the product misbranded according to FDA regulations.
Name – identity statement (product name) and net quantity of contents
The “statement of identity” is the product name descriptive name that identifies what the product is. Under § 21 CFR 101.3(a), the label shall bear the name of the food (or product) and any required information concerning the presence or absence of an ingredient. The net quantity of contents declaration must appear on the Principal Display Panel (PDP) of the package. § 21 CFR 101.7(a) states:
“The principal display panel of a food in package form shall bear a declaration of the net quantity of contents.”
The statement must indicate weight, measure, or numerical count (as applicable), and placement rules dictate that for most packages, it appears in the lower 30 % of the PDP, printed in distinct contrast and legible size.
Ingredient list placement and order rules – descending weight
An ingredient list shall appear in the Information Panel, or equivalent label area, next to the PDP and is described in the FDA’s “Dietary Supplement Labeling Guide.” U.S. Food and Drug Administration Ingredients are declared by common or usual name in descending order of predominance by weight at the time of manufacture. The inclusion of sub-ingredients or parts of ingredients may be required for transparency. Non-compliance in ingredient declaration is a frequent source of labeling violations.
Allergen statements and “Supplement Facts” or “Drug Facts” panels
For dietary supplements, the “Supplement Facts” panel is required, and its format and placement must meet the requirements. FDA guidance is that this should be placed where consumers can easily locate it, and the print should be prominent and conspicuous. If there is a major food allergen present (i.e., milk, soy, wheat), an allergen declaration needs to be present near the ingredient list or elsewhere as law dictates. Rules regarding allergen labeling (i.e., FALCPA rule) are in effect.
Warning statements and manufacturer/distributor contact information
Certain products must carry warnings or caution statements if, for example, there are special use conditions, age restrictions, or allergen concerns. The name and place of business of the manufacturer, packer, or distributor must be on the label. The “Dietary Supplement Labeling Guide” enumerates five required statements that must appear: statement of identity, net quantity of contents, nutrition or supplement facts, ingredient li, and name/place of business. U.S. Food and Drug Administration Placement of warnings and contact information within the label structure must be legible and not hidden from view by graphics or obscured by packaging design.
Placement and formatting rules for each required element
Formatting rules call for a print style that is “prominent, conspicuous, and easy to read,” with letters not more than three times as high as wide. The guide on net quantity of contents also provides that for packages having a PDP area of more than 25 but not more than 100 square inches, letter height shall be not less than three-sixteenths inch.
Additionally, spacing and contrast requirements are provided: for example, the net quantity declaration shall be separated from other printed label information by at least a space equal to the height of the lettering used in the declaration. Legal Information Institute. Therefore, the label format must be designed in conjunction with packaging shape, size, and layout so that it is readable and compliant.
Using QR Codes and Digital Labels under FDA Guidance
Packaging is increasingly using digital technology-such as QR codes, augmented content, or linking to online resources-but regulatory boundaries must be observed.
FDA guidance regarding electronic/digital labeling and the use of QR codes
The FDA has also issued voluntary guidance on the use of graphic elements and QR codes, such as those for food testing labs under the LAAF program, that caution against giving the appearance of FDA endorsement through a mark or QR code. Though many brands position QR codes as a means to extend label content beyond physical limitations, the FDA has made clear that required statements must appear physically and be readable on the package.
FDA’s “Smart Label” and “Drug Facts Updatable” digital label initiatives
While it is more developed for drugs and devices, there are implications of these on the packaging design in regulated industries. E-labeling may allow manufacturers to link to digital content for additional information, but the physical label still requires meeting the standard regulatory requirements. Guidelines for labeling highlight that no digital augmentation should replace a disclosure that may be mandated.
Trackability and supply chain transparency with QR codes
QR codes on packaging can enable traceability, batch verification, consumer information, or sustainability details. For food and supplement industries specifically, traceability programs driven by the Food Safety Modernization Act encourage investment in digital technologies to capture key data elements throughout the supply chain. From a packaging perspective, placing the QR code needs to be done in such a way as not to interfere with mandatory label panels. The contrast and clarity also need to be maintained.
Limits: what must still appear on the physical package
While digital links can enhance the depth of the information, the basic required statements (identity, net quantity, ingredient list, contact, warnings) must also be on the package physically in a readable format. The FDA Food Labeling Guide states that required statements must appear directly on the label and cannot be replaced completely with just a QR code or a web link. Any package design using digital augmentation would need to verify that the required label content is still on the label, visible, readable, and in the correct format.
Avoid Labeling Violations
The risk of a regulatory violation is increased when labeling does not match packaging design, required placement, or claims regulations. Understanding common mistakes and preparing internal review processes reduces the risk.
Common labeling mistakes that lead to FDA warning letters
Common mistakes include a lack of statement of identity, improper net quantity statements, fonts that are illegible, required panels missing or positioned improperly, claims that suggest treatment of a disease, labeling a product as “FDA-approved” when it is not, and use of confusing/misleading terminology. The FDA’s compliance policy document lists failure to utilize common or usual ingredient names and failure to state the net quantity of contents as reasons for misbranding.
Examples of misbranding under the FD&C Act Section 403
Under § 403 of the FD&C Act, a food (or supplement) may be considered misbranded if its labeling is false or misleading, lacks requisite statements, or does not show required formatting or placement. For instance, a package that bears the statement “Net Wt. 12 oz” but contains significantly less, or bears this statement in such small fonts as to be unreadable, may be misbranded. The guidance on the net quantity of contents has explicit size and placement requirements. Legal Information Institute
Case studies: incorrect “Supplement Facts” layout, misleading claims, or false FDA approval statements
Although specific supplement brand warning letters are not always publicly available, the “Food Labeling Guide” and industry commentary often mention how misplaced “Supplement Facts” panels-or cluttered artwork that obscures required statements grounds for regulatory refusals or delays. For example, a panel placed on a curved surface may be distorted or be illegible. Packaging featuring design treatments that reduce the contrast, clarity, or compliance could lead to enforcement action.
Checklist before product launch-internal review
A practical internal checklist would comprise:
Confirm statement of identity and net quantity in the correct panel and font size.
Review ingredient list and allergen statements for format and location.
Check “Supplement Facts” panel placement and spacing, font size, and clarity.
Verify warnings and contact information appear in a clearly readable area.
Confirm no claims imply FDA approval or disease treatment unless legitimately cleared.
Evaluate package design (shape, surface, finish, embossing) for readability and contrast of required label statements.
Ensure that QR codes or digital links used do not replace required physical statements.
Mock retail inspection: Look at the package as a consumer on the shelf, verify visibility of required statements.
Document verification for label approval, artwork version, supplier material changes, and packaging lot traceability
This structured review, tied into packaging engineering and design sign-off timelines, ensures labeling compliance before market entry and reduces the risk of enforcement action or recall.
Integrating Design with Compliance
One of the best ways packaging can meet both brand and regulatory objectives is to integrate design and compliance from the outset. A sound packaging program strikes a balance between creative expression and regulatory precision.
On the creative side, brand identity is expressed through shape, colour, typography, finish, and user experience. On the regulatory side, label panels, font size, required disclosure, and layout must conform to the law. For example, the Food and Drug Administration (FDA) “Food Labeling Guide” makes clear that required statements must appear on the label in legible type and be prominently displayed.
To align packaging mock-ups with label format early, mock designs should identify the PDP, the IP, and the format for required elements: identity statement, net quantity, ingredients, and regulatory disclaimers. For curved or non-standard containers, the layout must account for perspective, readability, and panel size. An easy added step: overlay the required disclosures on top of the proposed graphic design to verify readability under light and shelf view conditions.
The process requires critical cross-functional sign-offs from design, regulatory, packaging engineering, and quality. Artwork review should confirm that no graphic element obscures necessary text, required statements meet minimum size/contrast rules, and packaging materials allow durable print. Embossing, transparent windows, or heavy metallic finishes may degrade legibility and create compliance risks. A design-compliance alignment approach can help mitigate redesign costs, short-circuit pre-launch delays, and strengthen consumer trust with the delivery of aesthetically engaging yet regulation-smart packaging.
Conclusion
The journey from brand concept to shelf is navigated on two parallel tracks: creative packaging design and regulatory labeling compliance. The key takeaways are threefold:
Compliance is key. Every label needs to contain key elements: product identity, net quantity, ingredients, warnings/qualifiers, and contact information, all formatted correctly and legibly presented. The FDA Label Guidance expresses this for food labeling.
Packaging design needs to respect these regulatory constraints, not as an afterthought, but as integral to the design planning itself. A packaging concept that does not allow for readable required statements and/or appropriate panel layout introduces risk for misbranding or enforcement action.
The linkage between regulatory accuracy, consumer trust, and long-term brand success is strong. A packaging system that is regulatory compliant conveys a message of transparency and quality. Using sustainable, compliant materials, thoughtful design, and traceable labels reinforces market positions while lessening compliance risk.
In essence, packaging that marries form with function-aesthetic appeal with legal clarity-serves both brand and regulation. Early collaboration among design, regulatory, engineering, and quality stakeholders ensures packaging supports brand narrative while ticking the regulatory boxes for U.S. market entry and shelf life. Consistent attention to packaging design and compliance not only avoids regulatory pitfalls but also reinforces consumer confidence and brand longevity.