Since December 2023, American Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA) have been able to fund food supplements without a doctor's prescription. This landmark change in US tax regulations has the potential to influence the strategies of supplement manufacturers worldwide, including those in Poland and the European Union.
Changes to 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. Prior to December 2023, food supplements could only be funded from these accounts on the basis of a written recommendation from a physician. The new rules removed this requirement, allowing consumers to independently fund supplement purchases without medical confirmation.
The change is primarily fiscal and regulatory in nature. It represents recognition by the US authorities that food supplements are a legitimate medical expense, comparable to over-the-counter (OTC) medicines or doctor's visits. The US supplement market, valued at over USD 150 billion annually, is expected to gain new consumers thanks to the ability to pay using health savings accounts.
- Elimination of the written physician's statement requirement
- Expansion of the range of products eligible for FSA/HSA funding
- Improved financial accessibility for consumers
- Increased competition in the supplement market
Food Supplement Regulations in the European Union and Poland
The European Union takes a considerably more restrictive approach to food supplements than the USA. Supplements are regulated under Directive 2002/46/EC and Regulation (EC) No 1925/2006, which classify supplements as food rather than medicinal products. This means that supplements may not carry disease claims or be promoted as medicines.
In Poland, the Act on Food and Nutrition Safety implements EU provisions. Food supplements are subject to notification with the Polish Chief Sanitary Inspectorate (GIS) and must meet requirements relating to composition, labelling, and safety. A key difference from the USA is the absence of any automatic recognition of supplements as medically reimbursable expenses from public funds.
- Supplements classified as food, not medicinal products
- Strict restrictions on health claims (EFSA approval required)
- Mandatory registration with national authorities (e.g. GIS in Poland)
- No reimbursement systems comparable to FSA/HSA
- Requirement to comply with Regulation (EU) No 1169/2011 (labelling)
Expert Tip: Supplement manufacturers exporting to the USA can benefit from the FSA/HSA changes by adapting their marketing strategy to the new funding opportunities. At the same time, they must maintain compliance with EU requirements for European markets — these are two entirely distinct 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 healthcare systems, based on the Bismarckian or Beveridgean model, differ fundamentally from the American approach built on private insurance. The majority of European countries do not have health savings accounts in any form comparable to FSA/HSA.
In Poland, reimbursement of medical expenses is handled primarily through the National Health Fund (NFZ) and private health insurance. Food supplements are not reimbursed from public funds, as they are not classified as medicinal products and do not meet reimbursement criteria. Changing this situation would require political decisions at both national and EU level, which appears unlikely in the near term.
However, there are indirect ways in which the European system could adapt to new trends. Some European countries (e.g. Germany, Austria) are experimenting with employer-funded wellness programmes that may cover supplements. Furthermore, growing consumer health awareness and industry pressure could contribute to shifts in health policy.
- No direct equivalent of FSA/HSA in European systems
- Reimbursement primarily through the NFZ and private insurance
- Potential for employer-funded wellness programmes
- Growing consumer and industry pressure for a change in approach
- EU-level harmonisation requirements complicate national changes
Implications for Supplement Manufacturers and Distributors
For supplement manufacturers operating in international markets, the change in the USA carries significant business implications. First, it increases market potential in the United States by expanding the pool of consumers able to fund supplement purchases. Second, it shifts the competitive dynamic, as supplements can now be positioned as medical expenditure rather than luxury wellness products.
For distributors and retailers, the change means updating payment systems to accept FSA/HSA cards. This requires collaboration with payment system operators and financial intermediaries. It also necessitates adapting marketing and consumer communications to explain the new funding options.
In Europe and Poland, manufacturers must for now focus on regulatory compliance and marketing strategies tailored to the existing legal framework. Nevertheless, it is worth monitoring potential changes in health policy, particularly in the context of debates around reimbursement for preventive products and health expenditure.
- Adapting sales systems to accept FSA/HSA cards in the USA
- Shifting marketing strategy — positioning supplements as medical expenditure
- Increasing investment in consumer education about FSA/HSA
- Monitoring regulatory developments in European countries
- Preparing for potential changes in reimbursement policy
- Strengthening compliance with health claims requirements
Expert Tip: Manufacturers exporting to the USA should consider certifying their supplement products as FSA/HSA-eligible. This requires working with suppliers and verifying that products meet the definition of a dietary supplement under the US Dietary Supplement Health and Education Act (DSHEA). In Europe, full compliance with labelling and health claims requirements must be maintained in parallel.
Practical Advice for Supplement Businesses
For supplement manufacturers and distributors operating in international markets, it is essential to understand the regulatory differences between the USA and Europe. A single, uniform marketing strategy cannot be applied across both regions — separate approaches are required, each tailored to local requirements and opportunities.
- Conduct a compliance audit for both the US market (DSHEA, FDA) and the European market (EFSA, Directive 2002/46/EC)
- Identify products that may qualify for FSA/HSA eligibility in the USA
- Establish partnerships with payment system operators that support FSA/HSA cards
- Develop separate marketing strategies for the US and European markets
- Monitor health policy developments in European countries, particularly regarding reimbursement
- Invest in sales team training on regulatory changes
- Maintain documentation confirming product compliance with regulatory requirements
- Consider liability insurance covering new risk areas
Conclusions and Future Outlook
The change to FSA/HSA regulations in the USA represents a significant turning point for the food supplement industry, but a rapid mirroring of these changes in Europe should not be expected. The systemic, ideological, and regulatory differences between the United States and the European Union are too deep to allow for a swift adoption of analogous solutions.
Nevertheless, the change in the USA may serve as a catalyst for discussions about the role of supplements in preventive healthcare and potential shifts in reimbursement policy in Europe. In the longer term, growing consumer health awareness and demographic pressure on healthcare systems may prompt European governments to consider a more inclusive approach to funding preventive products, including food supplements.
For supplement manufacturers and distributors, the key is to remain flexible and responsive to regulatory changes in both regions. This requires investment in compliance, team training, and monitoring of policy developments. At the same time, the changes in the USA open up new business opportunities that can be acted upon immediately by those operating in the American market.