Foods for Special Medical Purposes: New Draft Guideline Published

Foods for Special Medical Purposes (FSMP) are a subcategory of Foods for Special Groups, regulated in the EU by Regulation EU 609/2013, which has replaced the regulation on dietetic foods and PARNUTs that was in place until June 12, 2013.

Until now, FSMPs have been attractive for food operators, since it has been possible to make strong claims while avoiding the restrictions of the Health Claims Regulation. The wording of the respective claim was mandated by the relevant regulation and went along the lines of “for the dietary management of [a certain illness].”

Defined Requirements
EU 609/2013 now defines the requirements for the composition and labeling of dietetic foods in general, and FSMPs in particular, and contains a positive list of substances that can be included in the foods it regulates. Article 3 of the Regulation states that a Delegated Act drawn up by the European Commission determines whether a given food falls within the scope of the Regulation, and to which specific category a given food belongs. This Delegated Act has also only recently been published as a draft, complementing the new Regulation.

The old dietetic food regulation was vague enough to be interpreted very differently among EU member states. Some countries only admitted foods such as sip feeding or meal replacements, while other countries also admitted supplement-like products containing, for example, botanicals and added nutrients.

In order to clarify the resulting confusion, the new Foods For Special Groups Regulation was drawn up, and the European Food Safety Authority (EFSA) has now published a new draft guideline at the request of the European Commission. The draft guideline is intended to provide scientific and technical guidance for the assessment of products notified as FSMP as well as for the information to be provided in the dossiers accompanying the notification. The European Commission is also working on another guidance document intended to help authorities and stakeholders comply with the procedure. This document is yet to be published.

Some Confusion But Also Clarification
As it turns out, this new EC guidance document will be sorely needed, since even the three documents combined—the Regulation, the EFSA Guidance and the Delegated Act—do not clear up all the confusion.

If anyone was hoping, for example, that this guidance document would offer clarification on admitted nutrients, this is not the case. Despite the existence of annexes listing admitted nutrients, the guidance states it is foreseen that FSMPs can deviate from the compositional requirements, going on to say “this flexibility is needed, taking into account the variety of conditions for the dietary management of which FSMPs are intended.”

While no clarification is given where it was expected, another aspect was further strengthened, an area that has so far also been handled differently among member states—the subsidiary principle. It states that nutrients included in the FSMP should not normally be available in this precise combination and concentration by consuming normal foods, including food supplements or functional food. Thus, specific information on how the FSMP is different from ordinary foodstuffs—including food supplements—would be required.

Dossier Requirements
A change that will likely result in additional work for manufacturers is the requirement for a dossier for the FSMP. While the existence of such a dossier for FSMPs was required in accordance with the old regulation as well, the Guidance document now clearly defines the structure and contents of the dossier. The information given in the dossier must follow a common structure format given in the guidance document. It must consist of six parts, which is a structure format very similar to a health claim application.

It must contain a variety of information related to the proposed FSMP. Characteristics of the product should contain the composition, physical and chemical characteristics, manufacturing process and stability. The disease that is targeted must be described, including criteria used for its diagnosis. The patients for whom the product is intended must be characterized, including the reasons why they would have a nutritional disadvantage from consuming only ordinary foodstuffs, including food supplements and/or fortified foods. The proposed conditions of use must be outlined, including the quantity and pattern of consumption.

Most crucially, the specific role of the proposed FSMP in the dietary management of patients with the disease for which it is intended must be described. This includes information on the evidence that the product is effective in meeting the nutritional requirements of the patients.

The special Delegated Act defining the notification requirements for FSMPs has been published, stating that the notification of the FSMP has to be submitted to the national authority of the country/countries in which it is going to be marketed, as was the case before. Furthermore, it states that national authorities can exempt food operators from the obligation of complying with the Regulation if a national system is in place that guarantees an efficient official monitoring of the product concerned.

As it seems today, the dossier will probably not be required as a basis for notification. However, the dossier should still be compiled according to the Guidance document and produced in case the notification of the FSMP is questioned for any reason. One such reason might be that the national authority disagrees with the new product being marketable as an FSMP, or that not all requirements are met for it to be classified as an FSMP. In such cases, the matter would be forwarded to the EC, which would ask EFSA for its scientific opinion. EFSA in turn would use the dossier as a basis for deciding whether the FSMP can be marketed as such or not.

In summary, the new guideline strengthens the FSMP category by clarifying the requirements for products having nutritional effects in subjects with a disease or other medical condition. The structure of the required dossier is clearly defined now. Also, EFSA may become involved in the notification of the FSMP, which has not been the case before.

For manufacturers intending to launch an FSMP, it makes sense to seek advice on the compilation of the product dossier. Also, the probability that EFSA or watchdog organizations might have questions regarding the new product is higher than it has been, and food operators should be prepared to answer them. Consultancies such as analyze & realize GmbH are competent to assist.

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.