Consumer health manufacturers attempting to navigate the increasingly complex regulatory environment for food supplements in 2025 should be aware of numerous potential pitfalls, according to HBW Insight’s panel of experts.
But there are reasons to be positive too, they say, with opportunities for agile firms to bring innovative new products to market.
What will 2025 be the year of?
Luca Bucchini, PhD, Managing Director, Hylobates Consulting
2025 will be the year of…
…Clarity on Maximum Permitted Limits (MPLs) on vitamins and minerals in food supplements.
The Commission has promised repeatedly that it will bring a proposal forward to harmonize MPLs, but has failed to do so multiple times. Stakeholders have been very worried about the direction of discussions, and 2025 will show if those concerns were warranted, and also if the Commission is still determined to make MPLs happen, or if it gives up.
…Make or break for Gaullism in food supplements.
The new French authority (DGAL) is testing EU law on food supplements and on food to its limits (or to destruction, some fear), to an extent that not even the Danes have ever dared to. There is a concrete risk that this aggressive approach to regulate food supplements - restrictive, national - will undermine the European internal market. In 2025, we will see if France’s DGAL gets its way, or whether courts, stakeholders and the Commission bring in some proportionality (and reason) to its approach.
…Continued fighting over botanicals.
A court win for the botanical sector has given the Commission pause in its approach to some botanicals and other substances, but the consequences and significance of the court decision - even if it is appealed - will become clear in 2025.
…Challenges for European contract manufacturing organizations.
EU-based CMOs have long enjoyed a quasi-monopoly on the production of finished food supplements. While Chinese and Indian businesses have been the dominant suppliers of ingredients and raw materials for a relatively long time, also through subsidiaries of multinationals based in the Far East, manufacturing of finished products has remained Europe-based. US-based manufacturers have had scarce incentives to comply with complicated EU regulation. But Asian manufacturers have worked hard to build compliant operations, or to buy production sites in the EU. On the other hand, some EU CMOs have been acquired by private equity, which some report as having reduced quality and competitive edge.
…Uncertainty over tariffs.
EU food supplement businesses still eye the US market with interest, but the feasibility of manufacturing food supplements in the EU for the US market will be tested by potential tariffs.
…Re-alignment of the EU and UK, to some extent.
In 2024, the direction of the UK was unclear. Now, it seems that 2025 will be the year where the UK aligns more closely with the EU on food matters, although with a degree of autonomy. This will be good news for an industry facing international competition among other challenges, and often a lack of a level playing field with policymakers distracted from enforcement.
Jérôme Le Bloch, PhD, Head of Scientific Affairs, FoodChain ID
2025 will be the year of significant regulatory clarifications that will profoundly affect the food supplement market.
One of the key developments will involve progress on the European harmonization of authorized doses of vitamins and minerals. While this harmonization aims to create uniformity across EU member states, it is expected that certain vitamins and minerals will only be authorized at low doses, and, regrettably, some nutrients may be entirely prohibited in supplements. These changes will necessitate substantial reformulation efforts for many food supplement products in Europe.
Additionally, 2025 may see long-awaited clarity on the status of pending health claims for botanicals. After years of prolonged debate, increasing pressure is being placed on the European Commission and the European Parliament to establish definitive procedures for evaluating these claims. Although the European Food Safety Authority will not publish opinions on botanical health claims during 2025, procedural guidance is expected. Two primary options are under consideration: adherence to EFSA’s existing scientific assessment criteria, which would likely lead to the rejection of most pending claims, or the recognition of traditional use, an approach advocated by the European Federation of Associations of Health Product Manufacturers (EHPM) and supported by several member states.
Furthermore, regulatory uncertainty surrounding the application of Article 8 of Regulation 1925/2006 to botanicals is expected to be addressed. This follows the annulment of Regulation 2021/468, which had banned hydroxyanthracene derivatives (HADs). The European Commission will need to provide guidance on how Article 8, which governs the prohibition or restriction of substances in foods, should be applied moving forward. Notably, a draft regulation proposing the inclusion of alpha-lipoic acid (ALA) in Part A of Annex III (prohibited substances) is expected early in 2025. Moreover, EFSA opinions on key substances such as fennel, hydroxycitric acid, and berberine are anticipated around May 2025. The recent annulment of the regulation on HADs could also have far-reaching implications for the use of Article 8 in the future. This decision may delay new Article 8 requests linked to the heads of European food safety agencies (HoA) report and influence the broader regulatory landscape for botanicals throughout 2025.
Mari Eskola, PhD, Team Leader of Regulatory Science and Reports, Medfiles
2025 will be the year of possible political surprises in relation to food and dietary supplement safety in the US.
It is hard to see what the possible new steps by the Trump administration will be. Already during the recent past there has been some debate that the US Food and Drug Administration should improve its dietary supplement framework. It has been discussed that it does not provide enough safety guarantees and that there are supplements on the market which should not be there.
Also, GRAS has got criticism. There have been very recent voices in US Congress suggesting that the GRAS procedure should be discontinued, arguing that it allows companies to declare their ingredients as safe without FDA approval and oversight. GRAS is an important tool to get dietary supplements on the market without the NDI notification to FDA. Time will tell where this ongoing debate will lead – if anywhere.
In the EU, the European Food Safety Authority continues its tasks with a slow but steady speed. Many new scientific and data requirements for the novel food dossiers, including food supplements, were communicated to us through EFSA’s new novel food guidance document. Some improvements were also seen; the experimental animal data have less prominence than before. The importance of deep understanding of the EFSA data requirements help when making the application dossiers for food supplements. Now with the new guidance even more expertise is needed when interpreting what EFSA actually needs. The EU transparency rule lives its own life and adds to the workload when preparing dossiers.
The UK and Food Standards Agency are in progress of streamlining their regulatory authorization processes. It can be seen from the discussions that they aim at a simpler system than the EU one, while at the same time they want to keep food quality and safety at a high level. Undoubtedly, the EU food safety system is the strictest in the world and it is interesting to see which elements the UK will keep and which it will lose. At least the UK does not seem to want to adopt the EU transparency rule or something similar.
Matevž Ambrožič, Marketing Director, PharmaLinea
2025 will be the year of new opportunities in nutraceuticals.
Firstly, we are noticing a new venue of growth opening in supporting individuals during and after chronic conditions such as cancer, cardiovascular disease, and diabetes, emphasizing quality of life through clinically backed solutions.
Moreover, in 2024, GLP-1 drugs have reshaped the nutraceutical landscape, sparking a 14% decline in weight management supplements but growth in adjacent markets like protein bars and multivitamins. Brands are innovating in areas such as supporting GLP-1 users with products to mitigate side effects, creating natural boosters for GLP-1 production, and developing alternatives that mimic its effects. We expect to see more such products launched in 2025.
We also see the potential for sexual health nutraceuticals. Though consumer interest in supplements for sexual wellness is rising, the category remains underrepresented. We believe brands can achieve growth in the segment with stigma-breaking marketing and scientifically supported formulations that align with broader benefits such as vitality and menopausal support.
Another white space to address in 2025 is cellular health, centered on nicotinamide mononucleotide (NMN) and nicotinamide adenine dinucleotide (NAD), as consumers are investing more and more in longevity and vitality.
In terms of delivery formats, soft chews are emerging as an interesting option for market differentiation due to higher ingredient capacity and stability compared to gummies.
In marketing, expedited clinical trials, precision health tools like AI, and the rise of healthcare professional influencers are redefining how science-based nutraceuticals resonate with consumers.
To view all articles in the HBW 2025 series click here.
