Nutrition and health claim services: health claim applications and use of approved claims
Nutrition and health claims are a powerful tool for differentiating your product on the market and communicating its added value to consumers. As interest in health and wellbeing continues to grow, well-formulated claims can credibly highlight the benefits of your product. However, regulatory requirements for such claims vary significantly between regions, and compliance requires precise expertise.
Medfiles offers comprehensive and tailored services related to nutrition and health claims across the EU, UK, and the US (including structure/function and health claims). Via our audited partners we may assist also in other countries, including e.g. Japan and other Asian countries, South American and African countries. Claims are commonly used in both conventional and fortified foods as well as food supplements.
We support the full process – from claim strategy and utilization of approved claims to scientific substantiation, new claim applications, and coordination of clinical studies. Our aim is to help you communicate your product’s benefits within the legal framework – effectively and responsibly.
Free webinar: How to get health claims approved in the EU
Do you want to stand out from the competition of food products with your own, brand new health claims? In this webinar we’ll provide an overview of the health claim approval process and the related requirements in the EU. Practical examples will also be showcased.
Our nutrition and health claim services include:
- Identification and use of approved nutrition and health claims
- Regulatory review of claims on product labels, printed materials, websites, and consumer communications (including social media)
- Product development support to enable claim use
- Scientific substantiation of claims (when no application is required, e.g. structure/function claims in the US)
- Literature reviews and evaluations
- Development of claim strategy and planning of substantiation approach
- Scientific assessment and identification of any missing data
- Preparation and submission of health claim applications
- Liaison with authorities and full support throughout the application process
- Planning and coordination of clinical trials
Utilising approved claims
Not all claims need to be newly submitted – many products may benefit from the use of already approved claims, provided the conditions of use are met. We help you identify which authorised nutrition and health claims are applicable to your food or supplement and ensure you can use them in packaging and marketing in line with applicable legislation.
Compliance review of claim use in marketing
We review the use of nutrition and health claims in product labels, advertising materials, websites, and both consumer – and B2B-facing content. If needed, we also create marketing texts that are both compelling and compliant – reducing regulatory risks and enhancing the credibility of your messaging.
Product development support for claim use
Are you aiming to use a nutrition or health claim or a structure/funtion claim for your new product? We help guide formulation and recipe design at an early stage, ensuring that the product can meet the conditions for desired claims.
We consider ingredients, concentrations, labelling, and market-specific requirements – helping you avoid costly reformulations later and ensuring the product is competitive from both regulatory and marketing perspectives.
Health claim applications for EU, UK and US
Most jurisdictions allow the use of nutrition and health claims if they are properly substantiated. Medfiles has extensive experience in interpreting and applying claim regulations across regions.
We prepare claim applications for the EU, UK and US in line with legal requirements and regulatory guidance. We help you choose the most appropriate claim wording and ensure it aligns with both regulatory requirements and your marketing goals.
In the US, structure/function claims do not require prior approval but must be supported by documented substantiation. We prepare the scientific rationale and can handle the necessary notifications to the FDA. Through our network of audited partners, we also offer claim services in other markets such as Singapore, Japan, and wider Asia. Ask us about tailored solutions for your target region.
Health claim application process – step by step:
Literature reviews and scientific assessment – the foundation for a strong application
Successful health claim applications require careful preparation and robust scientific support. We ensure that your application is based on thorough analysis and meets all regulatory expectations. Our services include:
- Comprehensive literature review: We search for relevant studies and assess whether existing data is sufficient or if further evidence is required.
- Scientific evaluation: We assess the quality, consistency, and relevance of the evidence from a regulatory perspective.
- Claim wording support: We help formulate the claim in a way that is both effective and compliant.
- Expert assessment: You receive our opinion on the feasibility of the claim and recommendations for further action.
- Summary and planning: We provide a clear summary and plan for any necessary additions before submission.
Clinical trials to support claims
When existing scientific evidence is insufficient, our Clinical Research Services team can support the generation of additional data. We offer a full-service approach – from study design and regulatory notifications to implementation, reporting, and scientific publication.
We also support data protection considerations if proprietary data is to be used as part of the claim application.
Our clinical studies are tailored to your needs and designed to produce reliable, regulator-ready evidence to support your health claims.
Health claim application preparation and submission
A successful health claim application requires precise wording and thorough documentation. We ensure your application is both clear and fully compliant with regulatory requirements – in structure and in content.
An effective submission is based on comprehensive scientific evidence, including substantiation for the claim, detailed product composition, and compliant claim wording. We pay particular attention to the clarity and structure of the application to support a smooth evaluation process. When needed, we also assist in defining recommended use levels and target populations to ensure the application meets the exact expectations of the authorities.
In the US, structure/function claims do not require pre-approval, but appropriate scientific documentation must be in place. If you are targeting the US market, we can prepare the required substantiation package and handle the necessary notifications to the FDA on your behalf.
By partnering with us, you can be confident that your application is built on a solid foundation – not held back by technicalities.
Regulatory liaison and support throughout the process
We act as an active expert partner between the client and the authorities throughout the entire application process. We monitor the progress of the application and ensure that any additional questions from the authorities are answered promptly and accurately. We support regulatory dialogue and make sure that all required clarifications and supplementary information are submitted within the given deadlines.
Whether you need support with approved claims or a full health claim application, Medfiles provides expert, flexible support – for the full process or just the part where you need it most.
Experts with 20+ years of experience in nutrition and health claims:
20-30
LITERATURE REVIEWS AND GAP ANALYSES (EU, US)
10
HEALTH CLAIM APPLICATIONS (EU)
15-20
STRUCTURE / FUNCTION CLAIM EVALUATIONS (US)
500+
MARKETING MATERIAL REVIEWS AND DRAFTING
500+
DRAFTED OR REVIEWED PRODUCT PACKAGING TEXTS CONTAINING NUTRITION OR HEALTH CLAIMS
Client story: Medfiles is the perfect partner for Harmonia
Harmonia consults Medfiles in various products and projects. For example, Medfiles helps Harmonia with new food supplements and legality checks of ingredients as well as with the labelling of food supplements and health claims and writing and reviewing of marketing materials.
“For us, Medfiles has been worth its weight in gold. It feels safe to have the best experts in Finland at your disposal.” – Harmonia Life
News and insights on health claims
Our expert team regularly writes blogs about nutrition and health claims. Topics include insights on product classification, health claim applications and food marketing.
