Medical foods vary from general foodstuff in that there are not dedicated to healthy population.
In EU, they are integrated in the regulation dedicated to the food products dedicated to specific groups/populations.
In the U.S., Medical Foods and Foods for Special Dietary Use (FSDU) are regulated as foods, but as distinct categories separate from conventional food.
Medical foods require robust scientific support.
Infant formulas (both exempt and non-exempt) are also regulated as foods in the U.S. but as distinct categories with unique requirements and regulations from conventional food.
Determining the most appropriate regulatory classification is an important first step in the strategy and development for your product and requires an understanding of the regulations and nuances for each product category.
In the EU/UK, assessment and marketing authorization of all the Foods for Specific Groups (FSGs):
- Food intended for infants and young children
- Food for special medical purposes
- Total diet replacement for weight control
Focus on FSMPs
- Creating a market strategy best suited to your product, taking potential regulatory classification pathways into account
- Assessing the regulatory compliance of your formula and label
- Consultation with competent authorities
- Drafting of applications for reimbursement programs in Europe and UK
- Drafting mandatory Scientific supporting files for your product
- Notification before market placement
- FSMPs must be notified in each Member State prior to marketing. This is also the case for the UK post Brexit
- Assessing compliance of your product advertisement
In the USA and worldwide
- Regulatory framework for specific product classification categories
- Product review for potential to meet requirements for a product category
- Support and strategic development for product positioning
- Analysis of the regulatory compliance of the formula
- Analysis of supporting data
- Consultation with the authorities as appropriate