In the EU, foods for special medical purposes (FSMP) are a sub-category of foods intended for particular nutritional uses (PARNUT), also called “dietetic foods.” FSMPs are intended for the dietary management of diseases in patients with impaired digestive function such as absorption, making them the most medically-oriented food category (all other food products, including supplements, are forbidden from even mentioning the word “patient” or “disease” on their labels).

Indeed, FSMPs are attractive for manufacturers, since it is possible to make strong claims while avoiding the restrictions of the Health Claims Regulation. The wording of the respective claim is mandated by the relevant regulation and goes along the lines of “for the dietary management of [a certain illness].”

The applicable regulation is EU 609/2013, which has replaced the regulation on dietetic foods that was in place until June 12, 2013. EU 609/2013 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.

Criteria & Compliance
In order to be marketed as an FSMP, the food must meet a number of criteria. First of all, the food must be safe and must comply with the intended purpose and requirements of the regulation of dietetic foods with regard to its composition and its target group (patients suffering from some sort of nutritive deficiency). An FSMP must differ significantly from a normal food due to its manufacturing process or composition.

Also, the claimed effect must be sufficiently substantiated. The requirements for this have increased—sometimes even to gold standard clinical trials standards.

An FSMP must be suitable for its stated dietary requirement. This criterion can also arise from a medical situation when a patient can benefit from the controlled uptake of certain nutrients, and not just because of a nutrient deficiency.

This definition has not changed, and it likely won’t. It is, however, vague enough to be interpreted very differently among member states, which is why the European Food Safety Authority (EFSA) has published a guideline, and the European Commission, too, is considering including a guidance document for FSMPs.

Regulatory Definitions & Revisions
The current situation has led to a number of discussions at an EU-wide level regarding what an FSMP is and what it is not. Unfortunately, the applicable regulations are currently not clear. Therefore, whenever an FSMP is challenged, it frequently remains on the market, since no one can really make a decision that is backed up by the regulation.

In order to change this situation and to clear up the relevant Foods for Special Groups Regulation 609/2013 (FSGR), which specifies the definition of FSMP, the EU Commission plans to revise the current FSMP legislation 1999/21/EC via delegated act by July 2015. This act, specified in Article 3 of the FSMP legislation, would give the EC the possibility to decide whether a given food falls within the scope of the FSGR, and, if so, to which specific category a given food belongs.

This delegated act will be published by July 20, 2015. EFSA has been asked for a scientific opinion on scientific and technical guidance for the assessment of FSMPs. With the opinion, EFSA will also indirectly provide elements for a guidance document on the definition and classification of FSMPs.

Following the receipt of this opinion and a period of public consultation, the delegated act will apply beginning July 20, 2016. From that date on, the verification of the status of a food product as FSMP following a challenge will be made much easier.

With this change looming on the horizon, product development in the EU will most likely begin to favor the food supplement category instead of the FSMP category. It is also not clear yet what the demonstration of efficacy will entail, especially compared with requirements for health claim substantiation in foods, which are conducted on healthy people. However, that is a discussion for another time.

Supplement Solution?
For many existing FSMP products in Germany, manufacturers have decided that the ground is becoming a little too hot and are already re-launching them as food supplements.

However, the supplement option is not a satisfying solution, especially for products whose main active ingredients are botanicals. Unless money and time is invested in a proprietary health claim application, food supplements, being subject to the Health Claims Regulation, can only use generic claims from a positive list, and currently, botanicals are not on that list. Manufacturers can still use the pending botanical health claims until they are actually rejected, but that is a legal gray zone, and also a temporary solution at best.

Experts are therefore expecting that the Traditional Herbal Medicinal Products (THMP) category will also see an increase. Provided that a tradition of use for a given botanical in a given indication can be proven, a THMP authorization for an herbal drug product bearing a relatively strong claim is feasible.

Experienced consultancies such as analyze & realize can help manufacturers decide which course to take for their FSMP products.

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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, Fax: +49-30-40008500; E-mail: [email protected], Website: www.analyze-realize.com.