What happened, exactly?
The CJEU received a request for a preliminary ruling concerning the interpretation of Regulation (EU) No 609/2013, which regulates FSMPs, in the context of a proceeding involving two particular products marketed under that category with the claims ‘support the immune system using nutritional science’ for ‘the dietary management of nutrition-related immune deficiencies’ (for example, recurrent respiratory infections’)’ and for the ‘dietary management of advanced age-related macular degeneration’, respectively.
The key question was whether food products can be classified as FSMPs if they exclusively provide general benefits to patients, rather than providing a nutritional support required by the disease they are associated with. The view of the CJEU was that food products cannot qualify as FSMPs solely based on the fact that the substances they contain counteract the disorder or alleviate its symptoms, and that FSMPs must cover specific nutritional requirements generated by the disease.
Why did this happen?
The main problem emerges from the intrinsically borderline situation in which FSMPs are placed from the regulatory standpoint, as they lie between Foods, category to which they do indeed belong, and Medicinal Products (‘drugs’). This situation derives, in turn, from the fact that both FSMPs and Medicinal Products target diseased populations, whereas all other Foods (including Food Supplements) target healthy individuals. A more precise demarcation of FSMPs was exactly one of the main objectives of the legal acts concerning them introduced in the EU between 2013 and 2019. However, grey areas persist.
Also, the legal definitions of FSMPs and Medicinal Products, respectively, leave a crucial uncertainty around the mechanisms by which each of those products may benefit patients. According to the law, substances added to Medicinal Products may work via physiological functions by exerting a pharmacological, immunological or metabolic action, whereas the ones added to FSMPs should have a nutritional or physiological effect. Those physiological and pharmacological activities are not legally defined, and those nutritional effects from FSMPs can legally only be linked to protein, carbohydrate, fat, fibre, sodium, vitamins and minerals.
Authorities may now have the pinion that the strict regulation on health claims on Foods in the EU, together with the fact that FSMPs can make quite strong disease claims, have led some companies to develop products that may be seen as borderline FSMP-Food Supplements and even borderline FSMP-Medicinal Products. And they do not like that – too many borderlines together.
Can this really change the EU market of FSMPs?
The answer is yes, it may, as the CJEU is entitled to interpret EU law with final binding authority. In fact, CJEU case-law is increasingly translating into regulations in the EU, as we recently saw with the implementation of the Mutual Recognition Regulation. It is however difficult to know how, when or even if all this will have any impact on EU market of FSMPs. Nonetheless, we have been in analogous situations which led to regulatory changes before – namely Medical Devices some years ago.
As Medical Devices are aimed at diseased population, they are allowed to make commercially-attractive disease claims. Back then, the Authorities thought that some Medical Devices on the market, such as certain ingestible and vaginal ones, were not correctly classified in this category. Emerging from decisions from National Competent Authorities and rulings from the CJEU, the regulatory framework for Medical Devices was updated in 2017. This new framework introduced multiple and profound changes, including the impossibility to regulate specific products (or ingredients), such as live or dead microorganisms, as Medical Devices. When the new regulations came into force, those borderline Medical Devices were forced to abide by Medicinal Products regulations in order to keep their disease claims. The result was that many products were withdrawn from the market, although many ingestible ones were repositioned as Food Supplements without their former disease claims, sometimes just bearing softer health claims.
It is, nonetheless, unlikely that the actual regulatory framework of FSMPs changes in Europe in the short term, as the CJEU ruling just calls for a stricter interpretation of the existing Regulation. What can be expected is that National Competent Authorities may become stricter, maybe preventing certain borderline products from being marketed as FSMPs. This would mainly affect new products; however, a closer monitoring of existing products could also happen.
Can this be the very beginning of a regulatory change in the longer term? It may be, as it is not unthinkable that the Authorities may want to separate FSMPs and Medicinal Products further apart. Potential changes in this direction may involve stricter requirements to formulate FSMPs exclusively with ingredients with well-validated evidence about their nutritional support (maybe direct or indirect) value, leaving out other active ingredients acting through distinct mechanisms.
Which products may be impacted? What are these borderline products, anyway?
Again, the implications of these potential changes are difficult to predict, but some categories may be first or more directly impacted than others.
Most FSMPs on the EU market are indeed positioned as such based on the nutritional benefits conferred to a patient population in need of medically-defined nutritional support. These have a lower risk of experiencing consequences from the new ruling. However, there may be longer-term impacts for some FSMPs which contain additional active ingredients that do not provide a nutritional value, as discussed above.
Nevertheless, an increasing number of FSMPs which do not provide a nutritional benefit to patients exist in the EU. For example, several products in the form of butyrate capsules indicated for IBS patients, or enzyme formulations for the management of certain metabolic diseases. These are the main ones under the spotlight, as their benefit to patients may be regarded as not strictly nutritional based on generally-accepted science.
Where would these products need to go, then?
Looking at the recent past and to the broader existing EU law, borderline products would have four options, mainly depending on the claims that their marketing companies want to make on their labels (i.e., their intended use). Simply put, these options are:
- Withdrawal: Simply disappearing from the market – not good.
- Drug pathway: Companies wishing to continue to make disease claims on their products will be forced to abide by the regulations for Medicinal Products. Given the multiple and very profound implications of this pathway, it is highly unlikely that this option would be chosen by many.
- Food pathway: formulation permitting at different levels, some borderline FSMPs could become Food Supplements or Fortified Foods by removing their disease claims and/or by substituting them with authorized health claims. This is in fact the option preferred by the Authorities and would likely be the alternative chosen by the industry.
- Reformulation to stay within FSMPs: an option that seems viable in the light of the existing regulations and their recent interpretation by the CJEU is product reformulation. However, this pathway may not be suitable for all products attending to technical or clinical reasons, and should be evaluated on a case-by-case basis. Also, potential regulatory changes discussed above may limit the viability of these alternatives in the longer term.
Where may innovators in the FSMP space want to go from here and now?
In the light of all this, the largest and most risk-averse FSMP players may change the way they think about innovation in the category. This may therefore also alter the way smaller innovators want to go about novel ingredient developments. Which strategy to adopt is a complex issue that requires a case-by-case analysis from the scientific, clinical, commercial and regulatory points of view.
Nevertheless, there is still huge room for innovation in FSMP ingredients emerging from new science and opportunities generated by the broader EU food regulatory framework, even with a narrower view of FSMPs themselves. Innovators must just be mindful of this stricter opinion about FSMPs, and must know that generating evidence, especially mechanistic one, may be crucial to future-proof their pipelines.