Since December 2023, American health accounts FSA and HSA can fund dietary supplements without a doctor's prescription. This groundbreaking change in US tax regulations has the potential to influence supplement manufacturer strategies worldwide, including in Poland and the European Union.
Changes in FSA/HSA Regulations in the United States
The change concerns Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA) - systems that allow employees to set aside pre-tax funds for medical expenses. Until December 2023, dietary supplements could only be funded from these accounts on the basis of a written doctor's recommendation. The new rules removed this requirement, allowing consumers to independently fund supplements without medical confirmation.
The change is primarily fiscal and regulatory in nature. It represents recognition by US authorities that dietary supplements are a legitimate medical expense, comparable to OTC medicines or doctor's visits. It is estimated that the US supplement market, worth over $150 billion annually, will gain new consumers thanks to the option of paying from health accounts.
- Elimination of the written medical certificate requirement
- Expansion of the catalogue of products qualifying for FSA/HSA
- Increased financial accessibility for consumers
- Increased competition in the supplement market
Dietary Supplement Regulations in the European Union and Poland
The European Union takes a considerably more restrictive approach to dietary supplements than the USA. Supplements are regulated under Directive 2002/46/EC and Regulation (EC) No 1925/2006, which define supplements as food rather than medicinal products. This means supplements cannot carry claims of therapeutic properties or be promoted as medicines.
In Poland, the Act on Food Safety and Nutrition of 2006 applies, implementing EU provisions. Dietary supplements are subject to notification with the Chief Sanitary Inspectorate (GIS) and must meet requirements concerning composition, labelling and safety. The key difference compared to the USA is the lack of automatic recognition of supplements as medical expenses reimbursable from public funds.
- Supplements classified as food, not medicines
- Strict restrictions on health claims (EFSA)
- Mandatory registration in national systems (e.g., GIS in Poland)
- No reimbursement systems similar to FSA/HSA
- Requirement to comply with Regulation (EU) No 1169/2011 (labelling)
Expert Advice: Supplement manufacturers exporting to the USA can benefit from FSA/HSA changes by adapting their marketing strategy to the new funding options. At the same time, they must maintain compliance with EU requirements for European markets - these are two entirely different regulatory landscapes.
Prospects for Introducing Similar Systems in Europe
Although the changes in the USA are significant, introducing analogous systems in Europe faces serious institutional and ideological obstacles. European health systems, based on the Bismarck or Beveridge model, fundamentally differ from the American approach based on private insurance. Most European countries do not have health accounts in a form similar to FSA/HSA.
In Poland, medical expense reimbursement occurs primarily through the National Health Fund (NFZ) and private insurance. Dietary supplements are not reimbursed from public funds because they are not classified as medicines and do not meet reimbursement criteria. Changing this would require political decisions at national and EU level, which seems unlikely in the near term.
However, there are indirect possibilities for adapting the European system to new trends. Some European countries (e.g., Germany, Austria) are experimenting with employer-funded wellness programmes that may include supplements. Furthermore, growing consumer health awareness and industry pressure may contribute to changes in health policy.
- No direct equivalent of FSA/HSA in European systems
- Reimbursement mainly through NFZ and private insurance
- Possibility of employer-funded wellness programmes
- Growing pressure from consumers and industry for a change in approach
- EU-level harmonisation requirements hinder national changes
Implications for Supplement Manufacturers and Distributors
For supplement manufacturers operating in international markets, the US change has significant business implications. Firstly, it increases market potential in the United States by expanding the group of consumers able to fund supplement purchases. Secondly, it changes competitive dynamics, as supplements can now be positioned as medical expenses rather than luxury wellness products.
For distributors and retailers, the change means the need to update payment systems to accept FSA/HSA cards. This requires cooperation with payment system operators and financial intermediaries. It also requires adapting marketing and consumer communications to explain the new funding options.
In Europe and Poland, manufacturers must currently focus on regulatory compliance and marketing strategies adapted to the existing legal framework. However, it is worth monitoring potential changes in health policy, particularly in the context of debates on reimbursement of preventive products and health spending.
- Adapting sales systems to accept FSA/HSA cards in the USA
- Changing marketing strategy - positioning as medical expenses
- Increasing investment in consumer education about FSA/HSA
- Monitoring regulatory changes in European countries
- Preparing for potential changes in reimbursement policy
- Strengthening compliance with health claims regulations
Expert Advice: Manufacturers exporting to the USA should consider certifying their supplement products as FSA/HSA-eligible. This requires cooperation with suppliers and verification that products meet the definition of a dietary supplement under the American Dietary Supplement Health and Education Act (DSHEA). In Europe, full compliance with labelling and health claims requirements must be maintained simultaneously.
Practical Advice for the Supplements Business
For supplement manufacturers and distributors operating in international markets, understanding the regulatory differences between the USA and Europe is key. A uniform marketing strategy cannot be applied to both regions - it requires separate approaches, adapted to local requirements and opportunities.
- Conduct a compliance audit for the US market (DSHEA, FDA) and the European market (EFSA, Directive 2002/46/EC)
- Identify products that may qualify for FSA/HSA in the USA
- Establish cooperation with payment system operators supporting FSA/HSA
- Develop separate marketing strategies for the American and European markets
- Monitor changes in health policy in European countries, particularly regarding reimbursement
- Invest in training the sales team on regulatory changes
- Maintain documentation confirming product compliance with regulatory requirements
- Consider liability insurance covering new risk areas
Conclusions and Future Outlook
The change in FSA/HSA regulations in the USA represents a significant turning point for the dietary supplements industry, but rapid replication of these changes in Europe should not be expected. Systemic, ideological and regulatory differences between the United States and the European Union are too deep to allow for quick adoption of analogous solutions.
However, the US change may serve as a catalyst for discussion about the role of supplements in health prevention and potential changes in reimbursement policy in Europe. In the long term, growing consumer health awareness and demographic pressure on health systems may encourage European governments to consider a more inclusive approach to funding preventive products, including supplements.
For supplement manufacturers and distributors, remaining flexible and responsive to regulatory changes in both regions is key. This requires investment in compliance, team education and monitoring of political changes. At the same time, the US changes open new business opportunities that can be immediately exploited by entities operating in the American market.