Packaging in the dietary supplement industry is very important, as it symbolizes a product and communicates key information, while also providing a first line of regulatory compliance. Conformity to FDA packaging and labeling standards in the United States ensures protection of consumer interests, at the same time preserving brand integrity. Packaging must protect stability and safety, while the labels clearly provide information that concerns identity, ingredients, and usage. Failure to meet such commitments brings about misbranding, regulatory enforcement, or even consumer mistrust.
Along with its related provisions, the regulations under 21 CFR Part 101 ensure that, from a purely regulatory-protection point of view, the supplement is appropriately identified, the description is truthful, and the packaging is transparent. Good packaging and labeling can therefore form part of a strong risk-management strategy for brands entering or operating in the U.S. marketplace. Here is the detailed FDA supplement packaging guidelines.
Key FDA supplement packaging guidelines and Labeling Requirements for Supplements
and Labeling Requirements for Supplements
What constitutes a “dietary supplement” under US law?
In general, a “dietary supplement” according to US regulation is defined as a product (other than tobacco) that is intended to supplement the diet and bear or contain one or more of the following: a vitamin, mineral, herb or other botanical, amino acid, dietary substance for use by human to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of those ingredients. It was established under the Dietary Supplement Health and Education Act of 1994, commonly referred to as DSHEA.
Because dietary supplements represent a class of foods unlike conventional foods and drugs, the packaging and labeling regulations are appropriately different: a “Supplement Facts” panel replaces the “Nutrition Facts” panel used for foods.
Labeling structure: Principal Display Panel, Information Pane, and Supplement Facts panel
Labeling of dietary supplements generally follows the structure established in the Food Labeling regulations 21 CFR Part 101. The Principal Display Panel is considered to be that part of a label that is most likely to be displayed at the time of purchase, and must bear the statement of identity (the name of the dietary supplement) and the net quantity of contents.
The Information Panel, in the U.S., traditionally sits to the immediate right of the PDP, and must bear the name and place of business of the manufacturer, packager, or distributor, the ingredient list, and any necessary warnings or directions.
The packaging also has to bear a ‘Supplement Facts’ panel, which represents serving size, servings per container, and a quantitative listing of the dietary ingredients included in the product. To be more exact, it is required for dietary supplements by 21 CFR 101.36.
Examples of the statements to be included are identity, net quantity, directions, warnings, and manufacturer information.
Five statements that should be on the label of a dietary supplement are as follows :
1) statement of identity,
2) net quantity of contents,
3) “Supplement Facts” panel,
4) ingredient list, and
5) name and place of business of manufacturer, packer, or distributor.”
The net quantity declares the contents in terms such as weight (oz, g), count (tablets, capsules), or measure, and must appear on the PDP.
Appropriate directions, warnings, and cautionary statements are given where needed. In the case of dietary ingredients, for example, there could be cautionary advisories on interaction or intake limits per day. The container or packaging shall have enough physical space and material quality that would enable such statements to be placed thereon in a legible fashion under normal conditions.
Labels bearing none of the required statements, or bearing them in unreadable form or place, are considered misbranded within the meaning of the FD&C Act.
Correct Listing of Ingredients and Health Claims
Correct order and naming of ingredients
Ingredients shall be listed in descending order of predominance by weight unless exempted. Sometimes, the part of the plant or the source may also be required when a particular item is listed, such as root, leaf, or extract.
Dietary ingredients and their quantities per serving are declared on the Dietary Supplement Facts panel. The ingredient list does not have to include those components already declared in the Dietary Supplement Facts panel, but must include any excipients or other ingredients in descending order of weight. A high degree of specificity in nomenclature and in the order of listing of ingredients has contributed to consumer transparency and regulatory compliance.
Structure/function claims vs. disease claims
If a dietary supplement label makes a structure/function claim-“supports bone health” or “promotes immune function,” for example-it must meet certain requirements. The FDA describes structure/function claims as statements that “describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body.”
Disease claims are claims that a product diagnoses, mitigates, treats, cures, or prevents disease. A supplement can’t make a disease claim unless it has been pre-market reviewed and authorised by the FDA.
It’s all in the context: a claim like “reduces the risk of osteoporosis” is a disease claim, whereas “supports bone strength” is an allowable structure/function claim.
Warnings on health-related claims
Whenever a structure/function claim is made, labeling must bear a disclaimer that states:
“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.”
This is set out under 21 CFR 101.93(b). Legal Information Institute
The company must also submit a notification to the FDA no later than 30 days after marketing the product with the structure/function claim.
This gives the regulatory agency transparency for monitoring purposes.
Packaging Materials for Safety and Stability
For any supplement, however, the packaging will be the greatest determinant in supplement safety, quality, and regulatory status. Packaging design prevents contamination, maintains stability, and ensures clear communication on the label.
For supplements, certain plastics, glass, blister packs, etc. These are some of the materials approved by the FDA.
Though no list of “FDA-approved packaging materials for supplements” is published, industry practice draws from rules applied to drugs and food contacts. For example, § 21 CFR 211.94 addresses drug-product containers and closures: those containers must “not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity” of the product, and must protect against external factors in storage and use that may cause deterioration or contamination.
Dietary supplements fall under a different regulatory path, 21 CFR Part 111, but the concept is the same: the container/closure system shall protect the integrity of the product. Common packaging materials for dietary supplements will include HDPE bottles, amber glass jars, aluminum blister packs, and polypropylene tubes-all selected based on being compatible with ingredients, barrier properties, and compatibility with labeling.
Protection from contamination, moisture, light, and temperature
The packaging should provide adequate protection to the drug from foreseeable external factors. Various examples of such external factors include humidity, exposure to light, heat fluctuation, air ingress, and mechanical damage. Rule 211.94 clearly explains that the containers of drugs should not be affected by such external factors. In the context of supplements, CGMP rules, 21 CFR 111, require every manufacturer to establish specifications for packaging material and maintain controls over storage and handling to ensure product quality.
For example, a hygroscopic powder supplement that has been placed in a low-barrier container will absorb moisture and degrade, while a light-sensitive ingredient requires an opaque container. With this in view, packaging design must relate to material selection and correlate with product formulation and stability profile.
Tamper-evident and child-resistant packaging standards
Tamper-evident feature seals, shrink bands, break-away closures, and child-resistant closures are considerations with supplements, especially liquids or powders that could be considered dangerous when the supplement might be confused with food, or children can access the supplement. The dietary supplement GMP regulations do not individually state the type of closure to be used, but the CGMP system under 21 CFR 111 requires controls for packaging and labeling operations as part of production and process control.
The drug container rule 211.94 also informs how closures should prevent contamination and deterioration. Legal Information Institute. Although this is a rule for drugs, the industry looks to it as a guideline for supplement package quality. In practice, packaging engineers have to make sure that closures will maintain integrity through shelf life, shipping, handling, and display.
Custom Label Designs that Pass FDA Review
One important thing to consider in label design is that it is not just about marketing; actually, it is one very important aspect of regulatory compliance. Just as a custom label has to support brand identity, it has to meet requirements on typography, layout, and content.
Typography, layout, and legibility requirements
There is a general requirement under the FD&C Act that labels be legible, and supplement labeling guidance explains what that means. The Supplement Facts panel and other required information must be in a print or type that is both clear and readable and placed appropriately: for example, small type or decorative font that reduces legibility can make the label non-compliant. Part 111 CGMP rules require that labeling operations be controlled and consistent with master records.
The material used for packaging must present clarity of print, sufficient contrast, and sufficient durability such that the label is readable through all life stages of the product-from storage and shipment through display to consumer handling. Placement of “Supplement Facts” panel and allergen statements. Supplement Facts panel. This is a required feature on the label of a dietary supplement. It shall be placed on the information panel or other label panel in accordance with 21 CFR 101.3.6. Part 101 is technically for foods, but supplement labeling follows the same structure -in this case, with “Supplement Facts”.
Label design must make room for this feature. Allergen disclosure rules apply. If a supplement contains a major allergen ingredient, such as soy, milk, it must declare that fact. Supplement rule guidance places emphasis on proper ingredient lists and statements. The packaging design should be such that all the required statements come in the right series and form according to the regulations for the label, namely, net quantity, name of manufacturer or place, and directions/warnings. The presence of any such required information that is not correctly placed will render a product misbranded.
Avoid Misleading or Unsubstantiated Graphics. Label graphics also cannot be misleading to the consumer about product function or regulatory status. For example, disease treatment imagery may convey a drug claim, rather than a dietary supplement claim. And it should not suggest “FDA-approved” or “clinically proven cure” when that cannot be substantiated legitimately. The guide to supplement labeling, as well as the structure of DSHEA, emphasizes labeling that is truthful and non-misleading. In addition, packaging design needs to balance branding and creativity with regulatory disclosures well and not overpower those disclosures. In other words, designing the label artwork to contain both brand identity and compliance can avoid last-minute redesigns.
Supplement Brand Compliance Checklist
A robust checklist translates rules into action. Here’s a multi-faceted checklist related to labeling, packaging integrity, storage/distribution, and GMP.
Labeling accuracy checklist
Statement of identity, e.g., “Dietary Supplement”, present
The net amount declared in suitable units such as capsules, ounces, or grams
Supplement Facts panel present and correctly formatted.
Ingredients listed in descending order, in appropriate form, and highlighting allergens
Directions for use, warning, and manufacturer/packer/distributor name & place of business included.
No unauthorized disease claims. Structure/function claims accompanied by required disclaimer
Branding graphics do not obscure required information.
Packaging integrity checklist
Materials chosen are compatible with the supplement formulation and are evaluated for moisture, light, oxygen, and shipping stress.
Container-closure system validated for integrity; closures tested for child-resistance or tamper evidence if required.
Print quality supports the legibility of the label over its shelf life.
Qualified packaging supplier and converter with documentation and change control procedures.
Storage and distribution documentation checklist
The master manufacturing record shall include packaging specification, label artwork version, and inspection criteria.
Material traceability documentation includes: Lot of raw material; lot of packaging component; lot of product; label version.
The distribution plan confirms temperature/humidity storage conditions during shipment, storage, and at retail.
Records of packaging changes, supplier audits, and quality control inspections retained.
GMP compliance tie-in
The regulatory standard for dietary supplements—21 CFR Part 111—requires firms to establish and follow current good manufacturing practices covering manufacturing, packaging, labeling, or holding operations of finished dietary supplements. Part 111 Subpart E covers packaging and labeling operations specifically. Consistent recordkeeping, personnel training, facility/equipment hygiene, and master records are all required. Failure to comply with Part 111 can result in warning letters, seizures, or injunctions.
Packaging and labeling checks with regard to GMP routines confer an additional advantage to brands in terms of their ability to embed compliance within the workflow of operations rather than having compliance be an afterthought.
Common Examples of FDA Warning Letters
Case examples of supplement packaging or labeling violations
One notable case involved Formulation Technology Inc., which was cited in its July 9, 2024, warning letter from the U.S. Food and Drug Administration (FDA). Misbranded dietary supplements due to serving size declaration being inconsistent with the usage directions. The “Supplement Facts” panel also did not conform to the format requirements in 21 CFR 101.36.
In another case, the firm C R Supplements, LLC, received a warning letter regarding misbranding dietary supplements of Silver and Magnesium in April 2022. Among the failures in labeling, the nutrition panel format was wrong, failed to provide age-group servings, and “Other Ingredients” was placed above instead of immediately below the nutrition panel.
The FDA issues a cumulative, searchable list of warning letters relating to food, beverages, and dietary supplements, which are specific examples of how packaging, labeling, and claims mistakes prompt regulatory action.
Lessons to be learnt from enforcement actions and recalls
Key takeaways from these cases:
The differences between the usage and declared serving sizes are a cause for concern.
Deviations in formatting or placement in the “Supplement Facts” or “Other Ingredients” sections are actionable.
Claims implying treatment of disease or FDA “approval” can advance the product to drug status.
The packaging and labeling should be part of a logical, appropriate system and should also be attractive, as weaknesses in design may result in misbranding.
How to prevent violations before market entry
Preventative measures include: full label review against 21 CFR 101 & Part 111; verification of packaging materials and conversions to place label panels in correct placement and size; confirmation that serving size aligns with directions for use; and confirmation that marketing copy avoids the implication of disease claims or FDA endorsement. The law firm analysis points out that paying heed early to certain “red flags”-disease-treatment claims and label/packaging inconsistencies, among others-can help avoid a warning letter.
Trends in Sustainable and Smart Packaging: Bonus Section
FDA Views on Recycled Materials and Safety Testing
Although much of this regulation for food contact materials is more directly mature, its relevance extends to supplements as well. FDA’s “Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)” outlines that material containing post-consumer recycled polymers must demonstrate suitable purity, control of contaminants, and suitable migration performance. Although supplements use packaging instead of food contact materials, the same principles about the safety of materials, migration control, and integrity apply. The broader “Food Packaging & Other Substances that Come in Contact with Food” page explains that “through a voluntary program, the FDA reviews recycling processes to ensure that the recycled material is suitable for use in food contact applications.”
These documents highlight that sustainability goals such as recycled content and reduced waste must consider and balance safety, traceability, and regulatory diligence, particularly when packaging has the potential to impact either product stability or integrity.
Eco-friendly packaging opportunities for US supplement brands
Supplement brands have increasingly moved to mono-material containers, PCR jars, refill systems, and pouches. All of these options are very appealing from both the branding and sustainability standpoints, but packaging selection cannot be allowed to compromise the legibility of label information, barrier performance (moisture/oxygen/light), or traceability of material changes. Where packaging is designed from the outset to meet all regulatory requirements-material selection, label placement, durability, audit documentation-brands adopting these eco-friendly formats benefit in brand image.
QR code application for traceability and consumer transparency
Smart packaging now will start to incorporate features such as QR codes linked to batch data, sustainability credentials, sourcing information, or traceability records. For US supplements, these features complement compliance efforts rather than substituting for required label information. Put another way: while required panels are still to appear on the visible label-such as Supplement Facts, warnings, manufacturer name, QR code offers added transparency and consumer engagement, not regulatory substitution. Digital traceability is being put into practice, and physical label compliance is maintained with a view to increasing credibility.
Conclusion
The most critical components of regulatory compliance for dietary supplements in the U.S. have to do with packaging and labeling. Examples through FDA warning letters show that even minor discrepancies in serving size mismatches, label format violations, and ambiguous claims might heighten the risk of enforcement. Innovations in sustainability and smart packaging strongly differentiate the brands but need to be complemented by the safety of materials, label integrity, and regulatory documentation. Compliance integrated with brand design right from the very early packaging decisions secures quality product, consumer trust, and market access.
Encouragement to design the product to meet FDA rules for long-term growth.
Taking a step-by-step approach to packaging and labeling material safety, clear label panels, proper claim language, supplier and change-control documentation will place the supplement brand in a position for sustainable growth in the U.S. market. Investment in packaging compliance and transparency today will underpin brand reputation, mitigate regulatory risk, and reinforce long-term consumer confidence.