For years, the Foods for Special Medical Purposes (FSMP) category has been a convenient loophole for products containing botanicals, at least in Germany. Due to the current regulatory situation, most botanicals cannot carry any health claims (apart from the so-called pending claims, which is another gray area), leaving herbal food products including food/dietary supplements in the unfavorable situation of not being able to make any claims.

As a consequence, food business operators use vitamins and minerals as claim-carriers in their products to at least use the generic (Article 13.1) health claims.

In Germany, many FSMPs currently on the market also contain botanicals and nutrients, but, contrary to food supplements, they are able to make strong medical claims relating to the dietary management of a disease. This is possible due to the liberal interpretation of the Foods for PARticular NUTritional uses (PARNUT) Directive that was in force until July of this year.

The PARNUT Directive 2009/39/EC has now been repealed. In its place, the Foods for Special Groups (FSG) Regulation (EU) No 609/2013 has come into force. FSMPs, being part of PARNUTs and now FSGs, are now being defined more strictly, effectively closing the door on liberal interpretations.

Position Paper’s Legal Opinion
In September 2016, the German Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Drugs and Medical Devices (BfArM), jointly published a position paper intended to act as a basis for the evaluation of FSMPs (Food for Special Medical Purpose) in Germany. The document outlines the legal basis of this food category with a focus on the demarcation between FSMPs and drugs.

So, what is changing? The position paper includes the following points:

• The targeted consumers must represent a group of patients. That group of patients must consist of 1) patients “with a limited, impaired or disturbed capacity to take, digest, absorb, metabolize or excrete ordinary food or certain nutrients contained therein, or metabolites,” or 2) patients “with other medically-determined nutrient requirements.” Examples are phenylketonuria patients with specific protein requirements or patients with celiac-disease-induced malabsorption.
• Also, an FSMP product can only serve for nutrition or dietary management. The prevention and/or treatment of diseases by FSMPs is not authorized (e.g., the prevention of thrombosis by omega-3 fatty acids or the treatment of iron deficiency anemia with iron salts).
• And, most importantly, the effects resulting from an FSMP cannot be reached by modification of common nutrition. For example, for people suffering from lactose intolerance or from hyperlipidemia, a modification of the diet can be sufficient. In other words, if the effect can be reached by normal nutrition, including food supplements, then the product cannot be an FSMP.

Potential Effect
This subsidiary principle in particular, so far, has been mostly ignored by German legislators, but it is looking now like this will no longer be the case.

This could mean that dozens of FSMP products currently on the market will sooner or later disappear from the shelves, following the usual transition period.

This development hasn’t been entirely unexpected. Food business operators in Germany have been dreading the end of liberal interpretation of the FSMP regulation for a while; the surprise is just that it will happen so soon.

Many expected that regulatory authorities such as BVL would wait for the Delegated Act that regulates FSMPs within FSGs coming officially in force, which will not be the case until 2019. In fact, when the FSG regulation replaced the old PARNUT regulation in July of this year, analyze & realize asked BVL what precisely would now change for food business operators wishing to notify a new FSMP. The reply was basically “nothing.”

Clearly, this stance has now changed. For many products, this could mean a re-evaluation of the food supplement route with all the disadvantages that this entails: no medical claims, and, for botanicals, no health claims at all unless one of the “pending” claims can be made use of.

Or, alternatively, food business operators may consider applying for a product-specific health claim, or even evaluate whether a Traditional Herbal Medicinal Products (THMP) authorization is possible.

Such decisions require in-depth strategic evaluations. Food business operators may consider securing the assistance of experienced consultancies such as analyze & realize GmbH, whose consulting and strategic innovations team can offer valuable advice on this and other areas.

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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.