Labelling & Claims
A label has to work for the product, the market and the evidence.
We review product labels, artwork and claims against the requirements relevant to the product and destination market. From mandatory particulars and ingredient declarations to warnings, language requirements and claim substantiation, we help identify changes before artwork is finalised.
Nutraceuticals · Dietary Supplements · Ayurvedic & Herbal · Wellness · Functional Food · Pharma
Beyond the artwork
A compliant label starts with the product behind it.
Labelling cannot be reviewed independently from the formula.
The ingredients, quantities, dosage form, serving size, intended use, claims, target consumer and destination market can all affect what appears on the final label. A product may therefore require different label versions for different markets.
One Hope connects label review with product composition, regulatory requirements and available evidence so that the artwork reflects the product and the market it is intended for. Labelling starts with product development, and claims should be considered alongside the regulatory assessment.
Label review
From mandatory particulars to the final artwork.
01
Product identity
Product name, product category, dosage form, intended use and positioning.
02
Ingredient declaration
Ingredient names, order of declaration, quantities and other market-specific declaration requirements.
03
Nutrition information
Nutrition and nutrient declarations appropriate to the product category and destination market.
04
Serving & dosage information
Serving size, recommended use, dosage instructions and related product information.
05
Mandatory particulars
Required information such as net contents, responsible business details, warnings, storage and other applicable particulars.
06
Warnings & precautions
Review of relevant warnings, precautions, restrictions and consumer-use statements.
07
Language requirements
Assessment of applicable language and translation requirements for the destination market.
08
Artwork review
Review of the complete artwork for consistency between the product, approved information and applicable market requirements.
Claims
The strongest claim is the one the product can support.
Claims can influence how a product is classified, how it is marketed and what evidence may be expected to support the statement.
We review proposed product and marketing claims against the intended product category, formulation, available evidence and destination-market requirements.
Structure / function claims
Review wording and intended meaning against the applicable product category and market requirements.
Health-related claims
Identify claims that may require additional substantiation, restrictions or a different regulatory approach.
Nutrition claims
Review statements relating to nutrients, composition or nutritional characteristics where applicable.
Marketing language
Review prominent statements, front-of-pack messaging and other wording that may create regulatory or compliance considerations.
Claim substantiation
Every important claim should have a reason for being there.
We help map proposed claims to the information and evidence available for the product.
Step 1
Claim
Step 2
Product composition
Step 3
Intended use
Step 4
Available evidence
Step 5
Market requirement
Step 6
Claim decision
Depending on the project, the review may identify:
- Claims that can be retained subject to applicable requirements
- Claims requiring clarification or qualification
- Claims requiring additional supporting evidence
- Claims that may not be appropriate for the intended product category or market
- Alternative wording for consideration
One product, different markets
The same formula may need different label decisions in different countries.
International expansion often requires more than translating an existing label.
Mandatory particulars, ingredient declarations, nutrition information, warnings, languages, claims and responsible-party information can differ between markets.
One Hope supports label and claims review for projects involving:
What you receive
A structured review your design or regulatory team can act on.
- Label compliance review
- Artwork review
- Ingredient declaration review
- Mandatory particulars checklist
- Nutrition information review
- Serving and dosage information review
- Warning statement review
- Language requirement assessment
- Claims assessment
- Evidence-to-claim mapping
- Market-specific label requirements
- Consolidated comments and recommended changes
Exact deliverables depend on the product, destination market, artwork stage and agreed project scope.
When to review
The earlier the label is reviewed, the easier it is to change.
01
Before formulation is final
Screen intended claims, product positioning and target-market considerations.
02
During product development
Align composition, dosage, claims and required label information.
03
Before artwork development
Establish the mandatory information and market-specific requirements.
04
During artwork review
Check the actual label against the agreed product information and requirements.
05
Before production
Complete final review of the applicable artwork version and outstanding comments.
Who we support
For teams that need the label to be ready for the real world.
Brand owners
For companies launching new products, refreshing packaging or entering new markets.
Manufacturers & CDMOs
For companies preparing customer and private-label artwork and documentation.
Exporters & international businesses
For companies adapting existing products and labels for destination markets.
Common gaps
Small label decisions can create larger launch problems.
- 01The product category is unclear.
- 02The ingredient declaration does not match the formula or supporting documentation.
- 03The serving size or dosage information is inconsistent.
- 04A claim is stronger than the available evidence.
- 05Mandatory information is missing.
- 06Warnings or precautions have not been considered.
- 07The artwork uses information from another market without checking local requirements.
- 08Different product documents contain inconsistent information.
- 09Translation changes the intended regulatory meaning.
- 10The final artwork differs from the information reviewed during regulatory assessment.
For export products, review the destination market before finalising artwork, and check your product's overall regulatory readiness.
Connected support
The label is one part of a larger product file.
Product Development
Formulation direction, ingredient screening, dosage-form development and product specifications.
Regulatory Support
Product classification, ingredient assessment, regulatory pathway and documentation.
Quality & Documentation
Specifications, testing information, quality records and technical file organisation.
International Market Launch
Market-entry assessment, country-specific requirements, registration support and export documentation.
Labelling & Claims questions
Frequently asked questions
Scope note
Labelling and claims requirements vary by product category, formulation, intended use, claims and destination market.
Our review is based on the information provided and the requirements applicable at the time of assessment. Final regulatory decisions remain with the relevant authority and responsible market participant.
Where scientific, clinical, translation, legal or specialist evidence review is required, the appropriate qualified specialist may need to be involved.
Before the artwork goes to print, know what needs to change.
Send us the product category, destination market and current label or artwork. We can help identify the key labelling and claims questions that should be addressed before finalisation.