Proper supplement labeling is essential for small and intermediate-sized packages to ensure compliance, consumer transparency, and trust. These compact products each require a precise Supplement Facts label that meets strict regulations while remaining clear and legible.
In this dietary supplement labeling guide, we explore key requirements across different regions and practical compliance solutions. This will help manufacturers understand these standards and avoid mislabeling risks whilst protecting consumers.
What Are Small and Intermediate-Sized Supplement Packages?
Small and intermediate-sized packages include a variety of compact containers, often designed for reduced volume, weight, or dimensions. In the context of dietary supplements, these packages may differ from standard packaging to accommodate specific product needs. These are commonly used for travel-friendly products, sample sizes, and limited-space packaging, making them convenient for consumers and cost-effective for manufacturers.
Challenges Associated with Labeling Small & Intermediate-Sized Packages
Labeling these packages presents unique challenges, such as fitting mandatory information within restricted space while maintaining legibility. Regulations still require essential details like ingredient lists, dosage instructions, and warnings, making design considerations crucial. Manufacturers must use strategies such as optimized layouts, high-contrast fonts, and alternative labeling solutions to ensure compliance.
Properly formatted labels help maintain product credibility, protect consumers, and meet dietary supplement labeling requirements across different markets.
Labeling Requirements for Small and Intermediate-Sized Packages
Understanding regulations for small and intermediate-sized supplement packages is essential, as labeling requirements differ across markets. While some regions follow similar guidelines, others have distinct rules regarding Supplement Facts labels, mandatory statements, and permitted claims.
Factors such as net quantity display, ingredient declarations, and health claims must align with country-specific laws to ensure compliance.
The following sections outline key labeling standards in different regions, helping manufacturers navigate these complex requirements and avoid mislabeling risks.
Supplement Labeling Requirements in the United States
In the United States, dietary supplement labeling is regulated by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act (DSHEA).
While all supplement labels must include essential information such as the Supplement Facts panel, ingredient list, net quantity, and manufacturer details, the FDA provides certain flexibilities for small and intermediate-sized packages to accommodate space limitations.
Small Packages Supplement Labeling Requirements
The FDA classifies small packages as those with less than 12 square inches of available surface area for labeling. Due to the limited space, the FDA allows specific modifications to ensure compliance while maintaining readability.
Required information on the immediate package:
- Product name
- Supplement Facts panel (alternative formats permitted)
- Net quantity of contents
- Name and place of business of the manufacturer, packer, or distributor
- Ingredient list
- Warning statements (if applicable)
Exemptions and modifications for small packages:
- Minimum font size: The FDA allows a 4.5-point font for small packages to maintain legibility.
- Alternative layouts: Manufacturers must display supplement facts information in a tabular or modified format to fit within the available surface area.
- Contact information in place of full Supplement Facts panel: If a product makes no nutrition or health claims, the Supplement Facts panel may be omitted from the label, provided that a phone number or website is listed where consumers can access the information.
- Placement flexibility: If space constraints prevent full disclosure on the immediate container, certain elements may be placed on an attached leaflet, tag, or peel-back label.
These exemptions help manufacturers comply with FDA regulations while maintaining clarity and transparency for consumers.
Intermediate-sized Packages Labeling Requirements
The FDA classifies intermediate-sized packages as those with between 12 and 40 square inches of available surface area for labeling.
While these packages offer more space than small packages, they may still present challenges in fitting all required labeling elements clearly. To address this, the FDA allows moderate labeling adjustments while ensuring that key product information remains visible and accessible.
Required information on the immediate package:
- Product name
- Supplement Facts panel
- Net quantity of contents
- Name and place of business of the manufacturer, packer, or distributor
- Ingredient list
- Warning statements (if applicable)
Exemptions and modifications for intermediate-sized packages:
- Minimum font size: For intermediate-sized packages with fewer than 16 dietary ingredients, you must use a 6-point font. For intermediate-sized packages that have more than 16 dietary ingredients and 20 to 40 inches of total surface area available to bear labeling, a 4.5-point type must be used.
- Condensed Supplement Facts panel: If the product contains 16 or fewer dietary ingredients, the Supplement Facts panel may use an abbreviated format to fit within the available space.
- Alternative panel formats: A linear format or a two-column layout may be used when necessary.
- Extended labeling options: If space is still insufficient, additional labeling elements (e.g., full usage instructions or extended warnings) may be placed on an outer carton, leaflet, or peel-back label.
By following these guidelines, manufacturers can ensure FDA compliance while making effective use of limited label space on small and intermediate-sized supplement packages.
Supplement Labeling Requirements in Canada
Health Canada regulates dietary supplements under the Natural Health Products (NHP) Regulations.
There are different requirements and exemptions for packages defined as small and very small, ensuring that labeling remains clear and compliant despite space limitations.
Labeling requirements for very small packages in Canada
Health Canada classifies very small packages as those with 90 cm² or less of available surface area. Due to the limited space, certain exemptions are allowed to ensure compliance while maintaining readability.
However, essential consumer information must still be accessible to ensure product transparency and safety.
Required information on the immediate package:
- Product name
- Active (medicinal) ingredients
- Lot number
- Expiry date (if applicable)
- Net quantity
- Contact information of the manufacturer/distributor
Exemptions for very small packages:
- Product Facts Table (PFT) is not required on the immediate container but must be available elsewhere (e.g., outer packaging, leaflet, or peel-back label).
- Warnings, directions for use, and full ingredient details can be relocated to the outer packaging or an insert.
- Single-use products (e.g., sachets) and immediate containers with three or fewer dosage units may be exempt from displaying all standard labeling.
- Lowest-risk products (e.g., those with a duration of use of one day or less) may qualify for additional exemptions based on Health Canada’s risk-based approach.
- Bilingual labeling (English and French) is still required for all mandatory information.
Labeling requirements for small packages in Canada
Health Canada classifies small packages as those with more than 90 cm² of available surface area but still not large enough to fit all relevant nutritional information on it. While these packages offer more space than very small packages, they can still pose challenges for including all required labeling elements.
To address this, Health Canada permits certain adjustments while ensuring that essential product details remain visible and accessible to consumers.
Required information on the immediate package:
- Product name
- Active (medicinal) ingredients
- Lot number
- Expiry date (if applicable)
- Net quantity
- Contact information of the manufacturer/distributor
- Product Facts Table (PFT) with medicinal ingredients, recommended use, warnings, and dosage instructions
- Bilingual labeling (English and French) is mandatory for all required text
Exemptions and flexibilities for small packages:
- Reduced text sizes are permitted to maintain legibility within space constraints.
- Extended warnings and usage instructions may be displayed on outer packaging, an insert, or a peel-back label instead of the immediate container.
- Abbreviated Product Facts Table (PFT): If space is insufficient, some elements may be shortened or moved, but essential safety and compliance information must remain available.
Supplement Labeling Requirements in the European Union & UK
In the European Union (EU) and the United Kingdom (UK), dietary supplement labeling is governed by Regulation (EU) No 1169/2011 on the Provision of Food Information to Consumers (FIC Regulation) and Directive 2002/46/EC, along with specific national laws in each country. These regulations ensure that consumers receive accurate, transparent, and legible information about dietary supplements and special dietary needs, regardless of package size.
While standard labeling requirements apply to all supplement packages, the EU and UK allow for certain modifications for small and very small packages, balancing regulatory compliance with practical design constraints.
Labeling Requirements for Very Small Packages in the EU & UK
The EU and UK classify very small packages as those with the largest surface area of less than 10 cm². Due to the limited space, specific exemptions apply to ensure essential information remains accessible.
Required information on the immediate package:
- Name of the food (product name)
- Allergen information
- Net quantity
- Best-before or use-by date
Exemptions and modifications for very small packages:
- The nutrition declaration (Supplement Facts panel) is not required, unless a nutrition or health claim is made.
- The minimum font size for mandatory text is reduced to 0.9 mm x-height instead of the standard 1.2 mm.
- Additional details, such as full ingredient lists and usage instructions, may be provided on an outer carton, leaflet, or peel-back label.
Labeling Requirements for Small Packages in the EU & UK
Small packages are those with the largest surface area between 10 cm² and 80 cm². While these packages must still meet core labeling requirements, certain adaptations are permitted to maintain clarity within limited space.
Required information on the immediate package:
- Product name
- Ingredient list
- Net quantity
- Expiration date or best-before date
- Storage conditions (if necessary)
- Manufacturer or distributor details
Exemptions and modifications for small packages:
- The minimum font size for mandatory text is 1.2 mm x-height, ensuring readability.
- If the largest surface area is less than 80 cm², the nutrition declaration can be reduced in size but must remain legible.
- If space is insufficient, extended details may be placed on an outer carton, leaflet, or peel-back label.
By following these guidelines, manufacturers can ensure compliance with EU and UK supplement labeling regulations while accommodating the constraints of small and very small packaging formats.
Supplement Labeling Requirements in Australia
In Australia, dietary supplements are classified as complementary medicines and are regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Order (TGO) 91. These regulations ensure that labeling remains clear, compliant, and accessible to consumers, regardless of packaging size.
While standard labeling requirements apply to all dietary supplements, the TGA allows certain modifications for small and very small packages to balance regulatory compliance with packaging constraints.
Labeling Requirements for Very Small Packages in Australia
The TGA defines very small packages as those with a container capacity of 3 mL or less. Due to extreme space limitations, certain adjustments are permitted to ensure legibility while maintaining compliance.
Required information on the immediate package:
- Product name
- Active ingredients
- Dosage form
- Batch number
- Expiry date (if applicable)
Exemptions and modifications for very small packages:
- The medicine name must be displayed in a minimum text size of 1.5 mm.
- Other required text may be reduced to a minimum of 1 mm to fit within the available surface area.
- Additional information, such as full ingredient lists, warnings, and directions for use, must be provided on an outer carton, leaflet, or peel-back label.
Labeling Requirements for Small Packages in Australia
The TGA considers small packages to be those with a container capacity of 25 mL or less. While these packages have more available space than very small packages, they may still require labeling adjustments.
Required information on the immediate package:
- Product name
- Active ingredients
- Dosage form
- Batch number
- Expiry date (if applicable)
- Storage conditions
- Manufacturer or sponsor details
Exemptions and modifications for small packages:
- The full label must appear on the primary outer packaging, while the container label may include a condensed version.
- Smaller text sizes are permitted to ensure readability within the limited space.
- If space is insufficient, extended warnings, directions for use, and additional details may be placed on an outer carton, leaflet, or peel-back label.
By following these guidelines, manufacturers can ensure compliance with TGA regulations while adapting to the constraints of small and very small packaging formats.
Supplement Labeling Requirements in Mexico
In Mexico, dietary supplements are regulated by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) under the General Health Law and NOM-051-SCFI/SSA1-2010, which governs food and supplement labeling. These regulations ensure that consumers receive clear, accurate, and transparent information about dietary supplements, regardless of package size.
While standard labeling requirements apply to all supplement products, COFEPRIS allows for certain adjustments for small and very small packages to balance regulatory compliance with space limitations.
Labeling Requirements for Very Small Packages in Mexico
In Mexico, very small packages are generally considered those with less than 10 cm² of available surface area. Due to space constraints, some flexibility is granted while ensuring that key product information remains accessible to consumers.
Required information on the immediate package:
- Product name
- Ingredient list with active ingredient concentrations
- Net quantity
- Recommended dosage
- Warning statements (if applicable)
Exemptions and modifications for very small packages:
- The Front-of-Package (FOP) warning labels required under NOM-051 may be omitted if the package does not have sufficient space.
- Peel-back labels or attached inserts may be used to provide extended information, such as detailed ingredient lists and usage instructions.
- The nutrition declaration is not required, unless the product makes nutrition or health claims.
- Bilingual labeling (Spanish and an additional language) is required when applicable, ensuring accessibility for Mexican consumers.
Labeling Requirements for Small Packages in Mexico
Small packages are defined as those with between 10 cm² and 40 cm² of available surface area. While these packages must still meet core labeling requirements, some adaptations are permitted to optimize space.
Required information on the immediate package:
- Product name
- Ingredient list with active ingredient concentrations
- Net quantity
- Recommended dosage
- Manufacturer or distributor details
- Expiry date (if applicable)
- Warnings and precautionary statements
Exemptions and modifications for small packages:
- Reduced font sizes are permitted to maintain legibility while fitting required text.
- Linear or stacked text formatting is allowed for the Supplement Facts panel to optimize space.
- Peel-back labels or attached inserts may be used for extended warnings, storage conditions, and additional regulatory information.
- The Front-of-Package (FOP) warning label requirements still apply, but adjustments in placement may be allowed depending on available space.
By adhering to these regulations, manufacturers can ensure compliance with COFEPRIS guidelines, allowing dietary supplements in Mexico to maintain clarity and transparency while adapting to small and very small packaging formats.
See How FoodLabelMaker Can Help You
Best Practices for Compliance and Accuracy
Ensuring that dietary supplement labels are compliant and accurate is essential for consumer safety and regulatory adherence. Here are key practices to achieve this:
- Use Clear, Legible Fonts and High-Contrast Designs: Select fonts that are easy to read and maintain sufficient contrast between text and background. This approach enhances readability and helps meet minimum size requirements set by regulatory bodies.
- Leverage Alternative Labeling Solutions: When space is limited, consider options like peel-back labels or incorporating QR codes. These methods allow consumers to access additional information without overcrowding the primary label.
- Conduct Regular Compliance Checks and Stay Updated on Regulations: The regulatory landscape for supplements can change. Regularly reviewing and updating labels ensures ongoing compliance with current laws across different markets.
Adhering to these practices ensures supplement label compliance, fosters consumer trust, and promotes health by providing precise and accurate product information.
How Food Label Maker Helps with Supplement Labeling
Food Label Maker streamlines the creation of dietary supplement labels with a cloud-based platform designed for accuracy and compliance. Its powerful features include:
- Regulatory-Compliant Label Creation – Generate Supplement Facts labels that meet all industry regulations in just a few clicks.
- Extensive Ingredient Database – Access a verified database of over 10,000 ingredients to ensure accuracy and transparency.
- Customizable Label Formats – Tailor labels to specific regulatory requirements while maintaining readability.
- Recipe Costing – Easily calculate formula costs to support better financial planning and decision-making.
- User-Friendly Interface – Simplify recipe formulation with an intuitive system that ensures compliance.
- Automated Compliance Checks – Reduce errors with built-in regulatory verification and allergen detection.
By integrating advanced technology, Food Label Maker helps manufacturers stay compliant with regulations, minimize errors, and optimize labeling efficiency. For brands that require Nutrition Facts labels, we also offer a Nutrition Label Maker to ensure compliance across all product categories.
Final Thoughts on Labelling for Small and Intermediate-Sized Supplement Packages
Labeling small and intermediate-sized supplement packages correctly is essential for compliance, consumer trust, and product transparency.
However, limited space creates challenges in displaying Supplement Facts labels, ingredient lists, and regulatory warnings while maintaining readability.
Manufacturers must adopt adaptable solutions, such as alternative layouts and multilingual formatting, to meet region-specific and global requirements.
By using Food Label Maker, businesses can streamline the dietary supplement labeling guide process with automated compliance checks, customizable label formats, and precise formula management. For expert guidance, contact us or consult a labeling expert to ensure full compliance with evolving regulations.
Explore the FLM resource hub which covers related topics such as updates to FDA healthy content claims, how to understand and use nutrition facts labels, and more.
